YOUR MOST TRUSTED SOURCE OF HEALTHCARE INFORMATION IN ASIA INDONESIA NOVEMBER 2017

Managing diabetes
in primary care Statins
Highlights from slash long-term
AFOS & APCH
APDW & EASD
death risk
in men without

CVD
CONTENTS
MIMS DOCTOR - YOUR MOST TRUSTED SOURCE OF HEALTHCARE INFORMATION IN ASIA Managing Editor
Elvira Manzano

Contributing Editors
Roshini Claire Anthony, Pearl Toh,
Stephen Padilla, Jairia dela Cruz,
Elaine Soliven, Audrey Abella,
Christina Lau, Jackey Suen,
NOVEMBER ISSUE Dr Joseph Delano Fule Robles

Designer
Peggy Tio
Cover Story
6 Statins slash long-term death risk in men without CVD Production
Tetsuya Hamaki, Ho Wai Hung,
Agnes Chieng
Conference Coverage
Asian Federation of Osteoporosis Societies (AFOS 2017) 5th Annual Scientific Circulation Executive
Christine Chok
Meeting, Kuala Lumpur, Malaysia
8 Genetic advances in osteoporosis: What’s next? Accounting Manager
Minty Kwan
9 Drug holiday for osteoporosis: Who, when, how long? Advertising Coordinator
Raymond Choo
10 Best practices in assessing BMD
CEO
Yasunobu Sakai
12 Treatment failure in osteoporosis: What can be done?
CMO
Sherlynn Tan
13 1 in 4 men has osteoporosis, yet most underdiagnosed
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 COVER STORY

Statins slash long-term

death risk in men without

CVD

6
DOCTOR | NOVEMBER ISSUE

PEARL TOH
P
rimary-prevention statins were
associated with a 28 percent
reduction in long-term risk of
death from coronary heart disease
(CHD) in men with very high LDL-C
levels (≥190 mg/dL) and without es-
tablished heart disease at baseline,
according to a post hoc analysis of the
WOSCOPS* trial.
“The present analysis provides
novel supporting evidence from a
randomized trial to reinforce current
recommendations of initiation of lip-
id-lowering therapy in the primary pre-
vention of individuals with primary ele-
vations of LDL-C ≥190 mg/dL without
the need for risk estimation,” wrote
the investigators.
The post hoc analysis on
WOSCOPS includes data collected
during the randomized-trial phase and
observational post-trial follow-up of
5,529 men (aged 45–64 years) without
pre-existing vascular disease at base-
line. During the randomized-trial phase,
participants received either pravastatin
40 mg/day or placebo for 4.9 years.
[Circulation 2017;doi:10.1161/CIRCU-
LATIONAHA.117.027966]
At the end of the randomized-trial
phase, participants with LDL-C levels
≥190 mg/dL who received pravastatin
had a 27 percent reduced risk of CHD
(p=0.033) and a 25 percent reduced
risk in major adverse cardiovascular
events (MACE; p=0.037) compared
with those receiving placebo.
Over 20 years of follow-up (15 years
post-trial), the risk of CHD death was
significantly reduced by 28 percent
(p=0.020), risk of cardiovascular (CV)
death by 25 percent (p=0.009), and
risk of all-cause mortality by 18 per-
cent (p=0.004) among participants with
LDL-C ≥190 mg/dL in the pravastatin
vs the placebo arms.
COVER STORY
Compared with pravastatin-treated
participants with LDL-C <190 mg/dL,
those with LDL-C ≥190 mg/dL derived
more than twice the benefit of pravas-
tatin in terms of an absolute risk re-
duction (ARR) in deaths from CHD, CV
causes, or any cause (ARR, 2.34, 3.25,
and 5.39 percent, respectively).
Diving deeper into
long-term data
Among participants with LDL-C
≥190 mg/dL, achieving a >30 percent
(39 mg/dL) reduction in LDL-C with
pravastatin was associated with lower
risks of developing CHD and MACE
than those in the placebo group. Par-
ticipants whose LDL-C reduction with
pravastatin was <30 percent did not
differ from placebo controls in their risks
of CHD and MACE.
Based on a CV disease risk calcu-
lator, a majority (67 percent) of the trial
participants with LDL-C ≥190 mg/dL
who were free from diabetes had a 10-
year predicted MACE risk of <7.5 per-
cent at baseline, who would usually be
ineligible for statins.
“Among placebo-treated patients
with LDL-C ≥190 mg/dL the observed
risk of MACE at 5 years was already 7.5
percent, ie, double what would have
been predicted using a risk calculator,”
observed the researchers. However,
this risk was reduced to 4.8 percent
in those receiving pravastatin, corre-
sponding to a 38 percent risk reduction
(p=0.018).
“These data reinforce the notion
that among patients with a LDL-C
≥190 mg/dL, the observed risk is
much greater than would be predict-
ed through a risk calculator, and thus
global risk estimation is not neces-
sary,” they added.
Nonetheless, the researchers ac-
knowledged that the 15-year post-trial
follow-up was observational and sub-
7
15
DOCTOR | NOVEMBER ISSUE
ject – to residual confounding, includ-
ing the lack of continuing information
on medication use. Also, the study
population comprised a large propor-
tion of smokers (at least 40 percent in
each group), which according to the in-
vestigators “might mean that a similar
study today might not show as strong
an effect with a statin regimen of similar
potency.”
Added value for clinical
practice
While the ACC/AHA** cholesterol
guidelines recommend that individuals
with LDL-C ≥190 mg/dL be treated
with high-intensity statin therapy, ran-
domized trial evidence for statins were
lacking for those with very high LDL-C
but without pre-existing vascular dis-
ease.
“[W]e show that statins reduce
the risk of death in this specific group
of people who appear largely healthy
except for very high LDL levels. This
legitimizes current guidelines which
recommend treating this population
with statins,” said study principal in-
vestigator Professor Kaushik Ray of the
School of Public Health at Imperial Col-
lege London in London, UK.
“Nowadays it would be unethical to
perform a placebo-controlled trial in the
population with LDL-C ≥190 mg/dL …
Our findings provide the first trial-based
evidence to support the guidelines for
treating patients with LDL above 190
mg/dL and no signs of heart disease,”
said Ray and co-authors. “Our analysis
firmly establishes that controlling LDL
over time translates to fewer deaths in
this population.”
*WOSCOPS: West Of Scotland Coronary Prevention
Study
**ACC/AHA: American College of Cardiology/
American Heart Association

Asian Federation of Osteoporosis Societies (AFOS 2017) 5th Annual Scientific Meeting
October 6-8 • Kuala Lumpur, Malaysia
Genetic advances in osteoporosis:
What’s next?
ELVIRA MANZANO
O
steoporosis is an age-related
complex disease with a strong
genetic component. However,
the genes responsible for the disease
remain poorly defined, says an expert
at AFOS 2017.
“The 95 genes/loci identified in the
largest genome-wide association study
(GWAS) to date can only explain 5.8 per-
cent of the genetic contribution to bone
mineral density [BMD] variability,” said
Professor Peter Ebling from the Depart-
ment of Medicine at the School of Clin-
ical Sciences, Monash University, Aus-
tralia. As for the majority of the candidate
genes identified from GWAS, additional
biological evidence of their involvement
in bone fragility still lacks, opening up an
opportunity for more research.
Prof Peter Ebeling
In one study, EN1, a low frequency
non-coding genetic variant near a novel
locus, was identified and found to have
an effect size that is fourfold larger than
the mean of previously reported com-
mon variants for lumbar spine BMD.
EN1 was also associated with a de-
creased fracture risk (odds ratio [OR],
0.85). In an EN1 mouse model, condi-
tional loss of EN1 resulted in low bone
CONFERENCE COVERAGE
mass, likely due to high bone turnover.
[Nature 2015;526:112-117]
Other genes have been identified
through studies of rare monogenic dis-
orders affecting the bone, namely CO-
L1A1/COL1A2 and 13 other genes in
osteogenesis imperfecta; SEC24D and
P4HB in Cole-Carpenter syndrome;
FKBP10, PLOD2 in Bruck syndrome;
CLCN7, TNFSF11, and 5 other genes
in osteopetrosis; CTSK in pycnodys-
ostosis; SOST in sclerosteosis and
van Buchem disease, LRP5 in high
bones mass syndrome and osteopo-
rosis-pseudoglioma syndrome, and
NOTCH2 in Hadju-Cheney syndrome,
said Ebeling.
Search for candidate
genes continues
The search for the genetic basis of
extreme cases of non-syndromic idio-
pathic osteoporosis has also led to the
identification of several genes – LRP5,
DKK 1, and WNT3A linked to juvenile
osteoporosis; LRP5, MTHFR to preg-
nancy and lactation-associated osteo-
porosis; PLS3 to X-linked osteoporosis;
and WNT1 to early-onset autosomal
dominant osteoporosis. [Arch Endocri-
nol Metab 2016;60:391-401]
“As for atypical femoral fractures
[AFF], genetic factors may also play an
important role in the pathogenesis of
the disease,” said Ebeling. “The associ-
ation of AFF with seven rare monogen-
ic bone diseases, including that linked
with the COL1A1/COL1A2, CTSK,
PLS3 and LRP5 genes, supports this
concept.”
A pilot study using an exome array
in 13 patients with AFF and 268 controls
identified a greater number of rare gene
8
16
DOCTOR | NOVEMBER ISSUE
variants in AFF cases vs controls. “How-
ever, analyses were restricted to the
variants with minor allele frequencies
less than 3 percent, which limited the
ability to make meaningful inferences
about individual variants,” he added.
A recent whole exome sequencing
(WES) study in three sisters who devel-
oped AFF while taking bisphosphonates
and three unrelated AFF cases showed
a p.Asp188Tyr mutation in the GGPS1
gene, which is critical to osteoclast
function in the mevalonate pathway.
“In two targeted ALPL gene se-
quencing studies, an ALPL heterozy-
gous mutation was found in one case,
but not in the other,” Ebeling reported.
“Targeted sequencing of ALPL, CO-
L1A1, COL1A2, and SOX9 genes in
five AFF cases has identified a variant in
COL1A2 in one out of five cases.”
Future directions
Ongoing studies that can leverage
well-phenotyped cases and controls in
sufficient numbers are needed to de-
tect rare variants associated with AFFs,
while not overlooking the possibility that
common variants in multiple genes may
also come into play, said Ebeling.
“We certainly need new drug devel-
opment to circumvent AFF. To add to
that, the Biomarkers Consortium Bone
Quality Project is also attempting to
qualify a surrogate marker for fracture
prediction for use in clinical trials, obvi-
ating the need for multiple large RCTs
with fracture as an endpoint.”
If a surrogate marker is approved
for osteoporosis drug development,
that will push new therapies into the
market, Ebeling concluded.
 CONFERENCE COVERAGE
Asian Federation of Osteoporosis Societies (AFOS 2017) 5th Annual Scientific Meeting
October 6-8 • Kuala Lumpur, Malaysia

Drug holiday for osteoporosis:

Who, when, how long?
ELVIRA MANZANO

B
isphosphonates have proven
antifracture efficacy and remain
to be the cornerstone of oste-
oporosis treatment. However, a drug
holiday is of particular importance with
bisphosphonates due to some signals
with long-term use of the drug, includ-
ing rare incidence of atypical femoral
fracture (AFF) and osteonecrosis of the
jaw (ONJ), says a leading endocrinolo-
gist at AFOS 2017.

This raises questions on the need

for intermittent discontinuation of bis-
phosphonate treatment after long-term
use. The European Medical Association
(EMA), in its position statement pub-
lished this year, specifies that discon-
tinuation of bisphosphonates should be
considered in all patients with osteopo-
rosis after >5 years of treatment with
alendronate, risedronate or zoledronic
acid, said Professor Leilani Merca-
do-Asis from the University of Santo To-
mas, Manila, Philippines. “If the patient
has not had fractures before or during
therapy and the fracture risk is low, a
drug holiday can be recommended.”
However, if a new fracture is experi-
enced or a fracture risk has increased,
and BMD remains low (femoral neck
T-score ≤-2.5), anti-osteoporotic treat-
ment should be resumed, she added.
The human IgG2 monoclonal anti-
body denosumab also has a good an-
tifracture efficacy. “In cases of denos-
umab discontinuation, close monitoring
is suggested due to the possibility of
rebound fractures,” said Mercado-Asis.
Meanwhile, the International Os-
teoporosis Foundation Epidemiology/
Quality of Life Working Group advises
clinicians managing patients with oste-
oporosis to individualize treatment de-
cisions based on risk factors such as
bone density, clinical risk factors, and
history of incident fractures. The group,
however, could not agree on the du-
ration of holiday and how to monitor
treatment once on a drug holiday. [Os-
teoporos Int 2016;27:849]
As responses to antiresorptive ef-
fects differ among Asians vs Cauca-
sians, South Korea issued a position
statement which states that drug holi-
day may be considered after 5 years of
alendronate and risedronate treatment,
and after 3 years of zoledronic acid in
individuals who are not at high risk of
fracture. However, treatment should
be continued in patients at high frac-
ture risk. Annual bone mineral density
(BMD) monitoring is recommended
during drug holiday. If there are signif-
icant reductions in BMD, or if T score
reaches <2.5, or new osteoporotic
fractures occur, bisphosphonate treat-
ment may be restarted. Alternative
therapy may be used for individuals at
high risk of fractures. [J Bone Metab
2015; 22:167-174]
Drug of choice for
osteoporosis fractures
“To put this into proper perspec-
tive, bisphosphonates, in my opinion,
remain to be the drug of choice for pre-
vention and treatment of osteoporotic
fractures,” said Mercado-Asis. “The
primary action of bisphosphonates
is hitting an important physiological
mechanism – bone remodeling – which
is crucial in maintaining bone strength
and durability.”
AFF and ONJ, though rare, are
apparent side effects that are causing
realistic concerns, she added. “Drug
holiday remains controversial and are
subject to debates. Individualizing treat-
ment regimen according to the degree
of risks is of immense value. Instead of
stopping bisphosphonates, should we
consider alternative treatment?”

9
17
DOCTOR | NOVEMBER ISSUE

Asian Federation of Osteoporosis Societies (AFOS 2017) 5th Annual Scientific Meeting
October 6-8 • Kuala Lumpur, Malaysia
Best practices in assessing BMD
PEARL TOH
A
ccurate and reliable measure-
ments of bone mineral density
(BMD) are important to en-
sure validity of results, and clinicians
should adhere to available standards
to achieve this, said Dr John Carey,
president of the International Society
for Clinical Densitometry (ISCD) during
AFOS 2017.
“Quality BMD testing entails testing
the right people, performing accurate
and reliable test, preparing high-quali-
ty report … This will improve diagnosis
and treatment of those most likely to
benefit, and reduce or avoid unneces-
sary testing or treatment among those
least likely to benefit,” he said.
When scanning the hip, optimal
positioning and necessary attributes
are important, emphasized Carey. “Put
simply, that means having a straight
femoral shaft with correct femoral rota-
tion, there should be no obvious arte-
facts and motion, and the greater tro-
chanter should be centred and situated
vertically. You should be able to see a
little lobe at the left of the trochanter if it
is rotated appropriately.”
Dr John Carey
CONFERENCE COVERAGE
“For the spine, it should be straight,
centred, includes anatomical landmarks
[in the spine like] T12 [to the entire L1-
L4 region], and like the upper margins
of the sacroiliac joints. There should be
no movement or artefacts present, sim-
ilarly to other regions.”
According to the ISCD position
paper, the preferred skeletal sites for
taking BMD measurements in children
are the lumbar spine and total body,
less the head. In adults, femoral neck,
lumbar spine (L1-L4), and total hip are
the preferred sites, while the distal 1/3
radius is also recommended in some
instances, highlighted Carey.
The ISCD position paper also states
that post-menopausal women and men
of >50 years can be diagnosed using
the T-score while for younger men and
premenopausal women, the Z-score is
recommended instead.
“If you have had a fragility fracture
[previously], clearly you already have
osteoporosis. … [In this case,] DXA*
is not used for diagnosis, it is used for
monitoring and assessing prognosis.
For people who haven’t had a fracture,
you can also use DXA to assess risk of
fracture,” said Carey.
Repeated measures require knowl-
edge and further refinements of the
least significant change (LSC), he ex-
plained, adding that the acceptable
standards for LSC are <6.9 percent
for femoral neck, <5.0 percent for total
proximal femur, and <5.3 percent for
the lumbar spine.
How to avoid pitfalls
“The only thing that is worse than
not having access to BMD test is hav-
ing access to a really bad one,” cau-
18
10
DOCTOR | NOVEMBER ISSUE
tioned Carey. “Providing appropriate
training, certification, and support to
DXA technologists and interpreters can
help assure quality bone densitometry.”
On the other hand, the flipside of
having a low-quality BMD testing is
having an overdiagnosis, he said. “We
get credit for curing diseases that nev-
er would have harmed the patient. And
we do see collateral damage of our
well-intentioned efforts.”
To avoid pitfalls in densitometry
testing, healthcare professionals should
strive to become an expert through
training, reading and case discussion,
apply ISCD quality measures for scan-
ning patients and interpreting their re-
sults, keep up-to-date with ISCD cours-
es, certification, publication, and take a
good patient history, advised Carey.
Concluding his talk with humour,
Carey said, “In life, you only need three
bones – a back bone, a funny bone,
and a wishbone.”
*DXA: Dual-enery X-ray absorptiometry
Podcast with
AFOS president
Dr Fen
Lee Hew
Podcast with
orthopaedic
surgeon Dr Joon
Kiong Lee
 11
DOCTOR | NOVEMBER ISSUE

Asian Federation of Osteoporosis Societies (AFOS 2017) 5th Annual Scientific Meeting
October 6-8 • Kuala Lumpur, Malaysia
Treatment failure in osteoporosis:
What can be done?
ROSHINI CLAIRE ANTHONY
T
reatment failure in osteoporosis
remains a problem, even among
patients who are treatment-ad-
herent, according to a presentation at
AFOS 2017.
“The fundamental purpose of os-
teoporosis treatment is to reduce the
risk of fracture. Available effective treat-
ments only reduce fracture incidence
by 20–60 percent, thus fractures do
occur during treatment,” said Profes-
sor Yang Rong-Sen from the National
Taiwan University and Hospital, Taipei,
Taiwan. [AFOS 2017, abstract SA5.1]
While multiple factors contribute to
fractures, some patients may still expe-
rience failure with available treatment
despite high compliance. Medication
cannot treat everything, he said.
“Bisphosphonates [for example]
improve some bone biomechanical pa-
rameters, but not non-skeletal risk fac-
tors for fracture such as falls, genotype,
comorbidity, … and advanced age,” he
said.
According to Yang, the International
Osteoporosis Foundation (IOF) Inade-
quate Responders Working Group de-
fined treatment failure as, after exclud-
ing secondary osteoporosis or maximal
treatment adherence, ≥2 incident fragil-
ity fractures; or one incident fracture ac-
companied by elevations in the serum
levels of the biomarkers C-telopeptide
of type I collagen (CTX) or procollagen
type I N propeptide (PINP) at baseline
with no significant reduction during
treatment or a significant decrease in
bone mineral density (BMD) or both; or
no significant decrease in serum CTX or
CONFERENCE COVERAGE
PINP but a significant decrease in BMD.
In these situations, the Working Group
recommended a change of treatment.
[Osteoporosis Int 2012;23:2769-2774]
If the patient is not meeting good
response criteria within a year of treat-
ment initiation, treating physicians
should ensure that the patient is com-
pliant and rule out occult secondary
osteoporosis, said Yang. Following
this, the IOF Working Group suggests
treatment modifications such as re-
placing a weaker antiresorptive agent
with a stronger one from the same
class, replacing an oral drug with an
injectable one, or replacing a strong
antiresorptive agent with an anabolic
agent. Nonetheless, choice of substi-
tuted medication following treatment
failure would differ from one drug to
another, said Yang. [Osteoporosis Int
2012;23:2769-2774]
Risk factors for treatment
failure
Risk factors for treatment failure
vary according to patient, as well as
by medication type. In a retrospective
study of patients with rheumatoid ar-
thritis and osteoporosis, nonadherence
to bisphosphonates was the main risk
factor for treatment failure. [Mod Rheu-
matol 2016;26:194-199]
In a retrospective study of individ-
uals with osteopenia or osteoporosis,
prior bisphosphonate or vitamin D use
(odds ratio [OR], 1.50 each; p<0.05)
were risk factors for teriparatide treat-
ment failure, as determined by BMD
change. [Bone Rep 2015;4:17-22]
In a study of postmenopausal wom-
en with previously untreated primary
osteoporosis and at high risk for frac-
12
20
DOCTOR | NOVEMBER ISSUE
tures, current smokers and those with
baseline alkaline phosphatase total ac-
tivity levels ≥66.5 U/L were at elevated
risk of bisphosphonate treatment fail-
ure (OR, 3.22; p=0.034 and OR, 4.22;
p=0.007, respectively). [Osteoporosis
Int 2014;25:1401-1410]
Future research goals
In order to address treatment fail-
ure, the causes of treatment failure
need to be determined, and new frac-
tures, BMD, and bone turnover mark-
ers should be treated, said Yang, who
advocated for more research into de-
termining the factors behind treatment
failure.
Among the causes of treatment
failure are poor bone responders, inap-
propriate treatment, poor compliance,
medication inefficacy, and fall-related
injuries, he said.
“We still need a consensus on treat-
ment failure,” said Yang. “[With the con-
sensus], we may be able to detect true
inadequate responders to osteoporosis
treatment, identify possible associated
factors in individual patients, act on
individual additional factors to improve
outcomes, determine the intervention
threshold, and choose the most suit-
able medication for a given patient. The
goal is treat to target,” he said.
Integrated approaches are neces-
sary, said Yang.
We could also develop treat-to-
target and fall prevention strategies for
individual patients and assess and act
on clinical risk factors. Importantly, we
need to identify the real response and
the effectiveness of initiating a new
therapy, he said.

Asian Federation of Osteoporosis Societies (AFOS 2017) 5th Annual Scientific Meeting
October 6-8 • Kuala Lumpur, Malaysia
1 in 4 men has osteoporosis, yet most
underdiagnosed
PEARL TOH
A
bout one in four men in the Phil-
ippines had osteoporosis but
many were underdiagnosed,
with old age (>70 years), history of frac-
ture, and family history of osteoporosis
being the main risk factors for develop-
ing the condition, according to a study
presented at AFOS 2017.
“Osteoporosis in men similarly con-
tribute to significant morbidity and mor-
tality-associated fractures. However,
these are commonly underdiagnosed
and undertreated with still considerable
limited studies,” noted co-authors Drs
Ma. Imee Esquibel and Julie Li-Yu from
the University of Santo Tomas Hospital
and De Los Santos-STI Medical Center
in Manila, Philippines, respectively.
The retrospective study involved 219
CONFERENCE COVERAGE
men (mean age 64.58 years, 33.3 per-
cent overweight and 11 percent obese)
who underwent dual-energy X-ray ab-
sorptiometry (DXA) scan at the Universi-
ty of Santo Tomas Hospital in the Philip-
pines. [AFOS 2017, abstract PC25]
Based on DXA scanning, 39.7 per-
cent had low bone mass or osteopenia,
26 percent had osteoporosis, and 19.2
percent had severe osteoporosis. Ac-
cording to the researchers, the overall
prevalence of osteoporosis of 26 per-
cent was consistent with data from Eu-
rope, Saudi Arabia, and Brazil.
“Similarly to women, osteoporosis
in men is underdiagnosed due to lack
of evident symptoms especially among
the elderly,” observed Esquibel and Li.
Among the risk factors studied, age
of >70 years (incidence, 64.8 percent;
21
13
DOCTOR | NOVEMBER ISSUE
p=0.012), family history of osteoporo-
sis (4.6 percent; p=0.044), and histo-
ry of fracture (21.5 percent; p<0.001)
were significantly associated with an
increased risk of osteoporosis in the
male cohort.
Other risk factors such as inade-
quate calcium intake (33.9 percent),
smoking (32 percent), and weight
loss of >10 percent (incidence, 30
percent) were not significantly associ-
ated with increased osteoporosis risk
in the cohort.
“This study showed that men less
than 60 years old had comparable prev-
alence to those more than 70 years old
especially those with risk factors. This
suggests that clinicians might need to
screen males younger than 70 years
old especially those with risk factors,”
said Esquibel and Li.

Asian Federation of Osteoporosis Societies (AFOS 2017) 5th Annual Scientific Meeting
October 6-8 • Kuala Lumpur, Malaysia
Trabecular bone score not lower in T2D
ROSHINI CLAIRE ANTHONY
P
atients with type 2 diabetes (T2D)
may not necessarily have low-
er trabecular bone scores (TBS)
than nondiabetics, a finding that con-
trasts with that of previous research,
according to a study published in a
poster at AFOS 2017.
“TBS is an attempt to measure
quantitatively bone microarchitecture,
which can be a measure of bone quality
in the lumbar spine,” said study inves-
tigator Dr Yeap Swan Sim, a consul-
tant rheumatologist from the Puchong
Medical Specialist Centre in Selangor,
Malaysia.
“Previous studies have found
TBS scores to be significantly lower
in subjects with diabetes which is in
contrast to this study,” said Yeap and
co-authors. [J Clin Endocrinol Metab
2015;100:475-482]
In this study, TBS was comparable
between patients with T2D and those
without (1.289 vs 1.327; p=0.087). The
researchers noticed a correlation be-
tween age and TBS (p=0.009), as well
as a lower TBS among patients with a
prior history of fracture (median, 1.210
vs 1.327; p=0.001). [AFOS 2017, ab-
stract PC23]
While there was no significant dif-
ference in lumbar spine bone mineral
density (BMD) between patients with
or without prior fracture, patients with
a previous fracture had significantly
lower femoral neck and total hip BMD
(p<0.0001 for each comparison).
“TBS values were lower in pa-
tients who had a fracture compared
with those who had not. In our popu-
lation, this was the case despite BMD
CONFERENCE COVERAGE
being similar in both the fracture and
non-fracture group. So, the use of TBS
is an additional measurement that may
be able to detect patients with altered
bone microarchitecture who may be at
risk of fracture, despite similar BMD,”
said Yeap.
Fracture Risk Assessment Tool
(FRAX) scores also significantly differed
between patients with and without T2D
(median, FRAXmajor with TBS, 7.40 vs
3.40; p=0.007, FRAXhip with TBS, 2.45
vs 1.00; p=0.032, and FRAXmajor without
TBS, 7.10 vs 4.20; p=0.016).
However, there was no significant
difference between T2D and non-T2D
patients in terms of FRAXhip without
TBS (median, 2.00 vs 1.20; p=0.061).
“There were differences in the
FRAX scores calculated with and with-
out TBS but the differences were small
and may not be clinically significant,”
said the authors.
The study compared 56 patients
with T2D (mean age 67.4 years, me-
14
22
DOCTOR | NOVEMBER ISSUE
dian T2D duration 10 years) with 56
nondiabetic patients (mean age 60.55
years) who had undergone BMD mea-
surement between December 2008 and
June 2017. Patients with conditions that
could potentially affect bone and calci-
um metabolism or those on bone-af-
fecting medications were excluded from
the study. BMD did not differ between
diabetic and nondiabetic patients.
“In other studies with T2D patients,
they had lower TBS levels compared
to non-T2D patients, which could be a
marker of altered bone quality in T2D.
This may explain the higher fracture risk
in T2D patients without much difference
in the BMD measurements. However,
we did not show this difference in this
study, which we think may be due to …
non-T2D patients [being] younger than
the T2D patients,” said Yeap.
As these results were from a sin-
gle-centre study, Yeap said there are
plans to research this on a wider scale,
though the current lack of TBS soft-
ware at many institutions may impede
this plan.
 CONFERENCE COVERAGE
Asian Federation of Osteoporosis Societies (AFOS 2017) 5th Annual Scientific Meeting
October 6-8 • Kuala Lumpur, Malaysia

Canal-to-diaphysis ratio useful for assessing

hip fracture risk in the elderly
JAIRIA DELA CRUZ

T
he canal-to-diaphysis ratio (CDR)
appears to be a reliable indicator
of hip fracture risk in the elderly,
with a CDR of 0.60 associated with an
increased risk, according to a study.

Besides being reliable, evaluating

the CDR is an inexpensive and acces-
sible means of stratifying the risk of hip
fracture in the elderly. This is particular-
ly relevant in Asia, where most of the
countries are still underdeveloped and
have limited resources, said the team
of investigators from the Hospital Raja
Permaisuri Bainun in Perak, Malaysia.

In the study, the team measured

CDR from hip X-rays of 50 patients
(mean age 76.22 years; 72 percent
female) with trochanteric fractures and
50 controls (mean age 74.32 years; 56
percent female) without fracture. The
contralateral, intact side of the hip was
ceptable correlation between CDR derly individuals to prevent hip fracture
and age, indicating an increase in CDR and improve the quality of life in this pop-
with advancing age. ulation, as CDR is a simple method of
calculation that can be taught and under-

used in the patients to avoid errors.
Obtained at a point that was 5
cm distal to the midlesser trochan-
ter on an anteroposterior view, CDR
measurements revealed a significant
difference between the fracture and
control groups (0.13 vs 0.14 SD, re-
spectively; p=0.001). [AFOS 2017,
abstract BPA 01]
”
“ Larger scale studies
are needed to further
establish the relationship
between CDR
and hip fracture in
osteoporotic patients”
stood by all levels of medical personnel.
Nevertheless, larger scale studies
are needed to further establish the rela-
tionship between CDR and hip fracture
in osteoporotic patients as confirmed
by dual-energy X-ray absorptiometry
evaluation, they added.

At a CDR index of 0.60, the risk of
a hip fracture was fourfold greater in
the fracture group than in the control
group. This suggests that individuals
with CDR >0.60 are at a greater risk of
trochanteric fracture, the investigators
said.
The present study demonstrates a Scan this QR
code for full
significant direct relationship between
coverage of
CDR and hip fracture risk, the investi- AFOS 2017.
gators said. “Patients with CDR >0.60
should be given extra attention in treat-
ing osteoporosis as they are at a higher
risk of fracture.”

In addition, a Pearson correlation The investigators are optimistic that

coefficient of 0.843 showed an ac- CDR can facilitate wider screening of el-

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 CONFERENCE COVERAGE
Asian Federation of Osteoporosis Societies (AFOS 2017) 5th Annual Scientific Meeting
October 6-8 • Kuala Lumpur, Malaysia

Balloon kyphoplasty safe, effective for OVF

STEPHEN PADILLA

E
lderly patients with osteoporotic
vertebral fractures (OVF) should
refrain from undergoing highly in-
vasive surgery, but those with no poste-
rior wall mobility or paralysis may ben-
efit from balloon kyphoplasty (BKP) for
OVF with posterior vertebral wall dam-
age, according to a study presented at
AFOS 2017.

There was no mobility of middle col-

umn in either preoperative standing or
dorsal lateral view in any of the patients
included in the study. An improvement
was observed in the lumbar pain visual
analogue scale (VAS), from a preopera-
tive mean score of 8.5 (range, 7–10) to
a postoperative mean of 2 (0–7). [AFOS
2017, abstract BPA 03]

In five patients, neurological symp-

toms were improved. Furthermore, all
patients who had had difficulty in main-
taining the sitting posture became am-
bulatory following surgery. Activities of
daily living (ADL) scores did not vary,
with a mean preoperative score of 8.7
(0–9) and a mean postoperative score
of 8.6 (7–12), which suggested no cor-
relation with the spinal cord occupation
rate of the middle column.
Complications were reported in
four patients. Two participants had
bone cement leakage in the lateral
vertebral wall, with no symptom ag-
gravation, and the other two had ad-
jacent vertebral fracture that required
a brace.
In an earlier study, Gan and col-
leagues concluded that BKP is a safe
and effective method for OVF with
middle column compromise but with-
out neurological deficit. In addition,
spontaneous remodelling of the spi-
nal canal also occurs after BKP. [Injury
2014;45:1539-1544]
In the current study, “as for the ver-
tebral canal occupation rate, results
did not have a difference either,” the
researchers said.
A total of nine patients (mean age
at the time of surgery 81 years; 8
women) were included. The mean du-
ration of postoperative follow-up was
8.6 (1–24) months, and the mean du-
ration between onset and surgery was
3.6 (1–7) months.
Preoperative neurological symp-
toms presented in five patients (epico-
nus in two patients, cauda equine in
one, and nerve root in two). There were
six patients who had difficulty in main-
taining the sitting posture. The fractured
vertebral body was T6 in one patient,
T12 in two, L1 in five, and L4 in one.
In all participants, the posterior ver-
tebral wall protruded into the vertebral
canal. The posterior vertebral wall had
a mean spinal cord occupation rate of
38.2 percent (21–54 percent). The oc-
cupation rate was ≥20 percent but <40
percent in four patients, and ≥40 per-
cent but <60 percent in five patients.
Researchers evaluated pre- and
postoperative imaging findings,
scores on the lumbar pain VAS, and
ADL score (ADL part of the Japan Or-
thopedic Association scoring system)
in these patients.
“The limitation of our study was that
the number of our cases was small,” re-
searchers said.
BKP is indicated for the treatment
of OVF, in which the middle column is
often damaged during conservative
therapy, they explained.

24
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DOCTOR | NOVEMBER ISSUE
 CONFERENCE COVERAGE
Asian Federation of Osteoporosis Societies (AFOS 2017) 5th Annual Scientific Meeting
October 6-8 • Kuala Lumpur, Malaysia

FLS may improve outcomes in patients

with osteoporotic fracture history
ROSHINI CLAIRE ANTHONY

F
racture liaison services (FLS) im-
proved outcomes in older individ-
uals with a history of osteoporo-
sis-related fractures, according to a
systematic review and meta-analysis.

“[FLS] are coordinator-based mod-

els of secondary fracture prevention
services,” said study author Dr Pau-
lo Wu Chih-Hsing from the National
Cheng Kung University College of Med-
icine and Hospital in Tainan, Taiwan,
and colleagues.

“[FLS] are designed to identify pa-

tients who are considered to be at
increased risk of subsequent or sec-
ondary fractures, and, following a com-
prehensive assessment, ensure that
patients initiate appropriate treatment
via improved care coordination and weighted average rate, 23.5 percent said the researchers. Moreover, a ma-
communication,” he said. [non-FLS] vs 48.1 percent [FLS]), treat- jority of the studies were conducted in
ment initiation (unweighted average Western populations, limiting the gen-

”
“FLS play a significant
role in minimizing
the burden of
osteoporosis”
Compared with non-FLS controls,
individuals who used FLS demonstrat-
ed reductions in the absolute risk of re-
fracture (unweighted average refracture
rate, 13.4 percent [non-FLS] vs 6.4 per-
cent [FLS]) and absolute risk of mortal-
ity (unweighted average mortality rate,
15.8 percent vs 10.4 percent). [AFOS
2017, abstract PC 26]
Individuals using FLS also demon-
strated increases in the rates of bone
mineral density (BMD) testing (un-
rate, 17.2 percent vs 38.0 percent), and
treatment adherence (unweighted aver-
age rate, 34.1 percent vs 57.0 percent).
The findings were presented as a
poster at AFOS 2017.
Studies included in the analyses
were limited to 74 randomized and
nonrandomized trials, and retrospective
and prospective observational studies,
with studies on primary fracture preven-
tion and other bone diseases excluded.
Study participants were age ≥50 years
with previous osteoporosis-related
fractures.
The observational nature of many
included studies as well as variations
in baseline characteristics among the
patients may have affected the results,
eralizability of the data, they said, call-
ing for further research in non-Western
populations as well as studies evaluat-
ing long-term outcomes of FLS.
“The results of our systematic litera-
ture review and meta-analysis suggest
that FLS programmes have improved
the management of osteoporosis,
resulting in significant reductions in
refracture and mortality rates and sig-
nificant increases in BMD testing, treat-
ment initiation rates, and adherence,”
said Wu and co-authors.
“FLS are clinically effective across a
range of clinically important outcomes
in patients with osteoporosis, therefore
indicating that FLS play a significant
role in minimizing the burden of osteo-
porosis,” they said.

17
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 CONFERENCE COVERAGE
13th Asian-Pacific Congress of Hypertension (APCH) • October 6-8 • Singapore

BP target for stroke prevention in Asians

PEARL TOH get for preventing stroke in Asians, ac-

F
or stroke prevention in an Asian
population, a blood pressure (BP)
of <140/90 mm Hg is a reason-
able target and particularly, 120-130/80
mm Hg may be optimal, according to a
presentation at the APCH 2017 Meet-
ing in Singapore.
“BP targets for stroke prevention
are based largely on trials performed
in non-Asian populations,” although
the highest global stroke mortality rate
occurs in Asia (particularly in Mongo-
lia, Russia, China, and Southeast Asia)
and that the risk of stroke was higher in
hypertensive Asians than Caucasians,
noted Dr Narayanaswamy Ramani from
Raffles Hospital, Singapore. [Hyperten-
sion 2007;50:991-997]
cording to Ramani.
Based on the COPE* study in Ja-
pan, individuals with a BP of <140/90
mm Hg had a reduced risk of stroke
than those with a BP of >140/90 mm
Hg. [J Hypertens 2011;29:1649-1659;
Hypertens Res 2013;36:1088-1095]
This finding is supported by the FE-
VER** study involving 9,800 Chinese,
which shows reductions in the risk of
both fatal and nonfatal stroke by 27
percent (p=0.001), all cardiovascular
events by 35 percent (p=0.012), and
cardiovascular death by 33 percent
(p=0.019) in subjects who achieved
an average BP of 137.3/82.5 mm Hg
vs 142.5/85 mm Hg. [J Hypertens CSPPT*** study on 17,280 Chinese
2005;23:2157-2172] suggests a J-curve relationship be-
tween SBP and stroke risk: Compared
with participants who achieved an

“Hypertension is a strong risk fac-
tor for stroke, more so among Asians
… In addition, advance age com-
pounds the risk – older persons with
higher BP have [an even] higher risk
of stroke,” said Ramani. As hyperten-
sion is the most modifiable risk factor
for stroke, BP lowering is important for
stroke prevention.
However, there is no clear answer
as to what should be the ideal BP tar-
Dr Narayanaswamy Ramani
”
“Hypertension is a
strong risk factor
for stroke, more so
among Asians”
These data suggest that a BP tar-
get of <140/90 mm Hg is reasonable,
and probably even a BP of <140/80
mm Hg, for stroke prevention in Asians,
said Ramani.
Nonetheless, some studies have
demonstrated conflicting results, with
the JATOS trial in Japan showing that
achieving a systolic BP of <140 mm Hg
is no better than 140–160 mm Hg, while
the VALISH study in Japan suggests no
difference in stroke risk between those
with <130, 130–145, and >145 mm Hg
SBP. [Hypertens Res 2008;31:2115-
2127; Hypertension 2017;69:220-227]
Notwithstanding the contradictory
findings from JATOS and VALISH, the
on-treatment SBP of 120–130 mm Hg,
the risk of first stroke was increased
with SBP of 130–135 mm Hg (HR,
1.63), 135–140 mm Hg (HR, 1.85) and
particularly, <120 mm Hg (HR, 4.37).
[Hypertension 2017;69:697-704]
In general, there are limited random-
ized clinical trials on Asians, with most
of the trials done in China or Japan,
observed Ramani. However, Asians
consist of many different populations
besides Chinese and Japanese, and
hence, more trials are needed in other
Asian populations, he continued.
“The CSPPT trial suggests that a
BP target of 120–130/80 mm Hg may
be optimal in Asians … but more stud-
ies are needed,” he said, suggesting an
BP target of <130/80 mm Hg for pre-
venting stroke in Asians who have had
a stroke or transient ischaemia.
*COPE: COmbination therapy of hypertension to
Prevent cardiovascular Events
**FEVER: Felodipine EVEnt Reduction
***CSPPT: China Stroke Primary Prevention Trial

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 CONFERENCE COVERAGE
13th Asian-Pacific Congress of Hypertension (APCH) • October 6-8 • Singapore

Reducing salt intake in Asia-Pacific essential

for blood pressure control
AUDREY ABELLA Salt intake cannot be avoided as we

R
educing salt intake, particu-
larly among individuals in the
Asia-Pacific (APAC) region, is of
paramount importance as it is essential
for alleviating hypertension, according
to a presentation at APCH 2017.
“There is an urgent programme to
reduce salt intake … [in APAC which]
has the highest salt intake in the world,
particularly in northern China, northern
Japan, and Korea where salt intake is
extremely high,” said Professor Gra-
ham MacGregor from the Wolfson Insti-
tute of Preventive Medicine in the UK.
“In the UK, [we believe that] salt added
to food is a chronic poison that slowly
[increases] our blood pressure (BP) and
is a major cause of death and disability
particularly through strokes.”
According to the Global Burden
of Disease, hypertension is the sin-
gle biggest cause of death in the
world, accounting for about 10 million
deaths per year worldwide. [Lancet
2012;380:2224; JAMA 2017;317:165].
There is also evidence showing that the
risk of stroke or cardiovascular deaths
may start even with a systolic BP of 115
mm Hg. [Lancet 1990;335:765-774]
Prof Graham MacGregor
are passive salt consumers, noted Mac-
Gregor. Given this, as well as the strong
correlation between salt intake and hy-
pertension, government/public health
education and media campaigns are
strongly advocated to reduce popula-
tion BP and control high BP through salt
intake reduction. “If we did [these] strat-
egies, [even small BP reductions can
lead to] a massive reduction in strokes,
heart failure, and heart attacks.”
In a school-based randomized study
in China, salt intake decreased by an
average of 2 g/day (from 7 to 5 g/day) in
children who were educated about the
dangers of salt, and by 3 g/day (from
12 to 9 g/day) in adult family members
whom the children shared their lessons
with. [BMJ 2015;350:h770] “If this pol-
icy was long-term and spread across
the whole of China, it would prevent
[approximately] 200,000 cardiovascular
deaths per year,” said MacGregor.
Additionally, evidence shows that a
5–6 g reduction in salt intake may pre-
vent approximately 1.5 million stroke
and heart deaths per year in the APAC
region. [BMJ 2013;346:f1325; Hyper-
tension 2003;42:1093-1099]
In the UK, an ‘incremental reformu-
lation’ programme launched in early
2000 involved a progressive salt re-
duction target to 6 g across the whole
food spectrum, shared MacGregor.
This project was a success, effectively
managing hypertension and its conse-
quences, and worked counterintuitively
as it did not require diet modification,
he added.
The study results and the UK pro-
gramme demonstrate how intervention-
al and educational measures may im-
pact the public and guide them towards
a healthier lifestyle, noted MacGregor.
Furthermore, the food industry
is encouraged to participate in pub-
lic health policies that require them to
gradually remove or decrease the ex-
cessive amount of salt incorporated in
their products, noted MacGregor.
Salt intake regulation in APAC is es-
sential, said MacGregor, as ‘very little is
going on’ as opposed to regions such
as the US, Canada, Australia, and Eu-
rope, which have followed the UK mod-
el, with South America not far behind.
He expressed interest in collaborating
with health organizations in APAC to
share public health programmes being
implemented in the UK.
“We would [like to] give them ad-
vice and work with them … to try and
encourage more active salt reduction
in this area … Every country in the
world must set up a salt reduction pro-
gramme [and] implementing that plan is
the important thing. It’s the single most
cost-effective public health measure,”
concluded MacGregor.

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 CONFERENCE COVERAGE
13th Asian-Pacific Congress of Hypertension (APCH) • October 6-8 • Singapore

Timing of medication impacts BP control

TRISTAN MANALAC

A
dministration of a long-acting
medication at the time that is
most suitable for maximum pa-
tient compliance is the best approach
for controlling blood pressure (BP), said
Dr Trefor Morgan at APCH 2017.

If BP control for 24 hours is not cer-

tain, then night-time medication may
have an advantage over daytime med-
ication, he added. What is important is
that it should be “ensure[d], either by
measuring it or by knowing what the
drugs do, that sleep and awake BP is
controlled.”

Citing various reports from the lit-
erature, Morgan established a strong
correlative link between the declining
BP during sleep and various cardio-
vascular outcomes such as ischaemic
stroke, with lower sleep BP predicting
Indeed, many studies group partic-
ipants into two: the dippers who show
the normal decline in BP during sleep
and the nondippers who do not show
this night-time fall in BP.
in the body is highly dependent on its
dose, and it is highly unusual that drugs
work for 24 hours.
It is routine practice to administer
medication in the morning and measure

better outcomes.
BP while waking up, on the other
hand, is a weak predictor of cardiovas-
cular events.
These daily fluctuations in BP may
be principally explained through the
changes in the activity of different con-
trol systems, Morgan explained. At
night, during sleep, the sympathetic
nervous system relaxes, resulting in the
decline in BP which, in turn, causes the
renin-angiotensin system to kick in.
It is important to note that these
trends do not mean that the renin-an-
giotensin system is normally turned off,
he said. Renin levels also fluctuate with
activity and posture during the day.
Moreover, because these changes
in the activity of the control systems are
not universal, they also account for the
interindividual differences in the daily
BP fluctuations.
”
its effects a couple of hours after. In this
setup, the peak and adequate BP re-
“To improve BP control,
sponse is achieved during the day and
medications are titrated is typically already gone by the critical
using the morning BP periods: during sleep and as the pa-
predose measurements tients wake up.
and administered at night”
So to improve BP control, medi-
cations are titrated using the morning
BP predose measurements and admin-
Notably, nondippers have been istered at night. That way, “you avoid
shown across many studies to have measurement at the highest peak ef-
poorer prognosis than dippers, and fect,” Morgan concluded.
thus benefit the most from pharmaceu-
tical interventions.
However, “if we have these two im- Scan this QR
code for full
portant systems controlling blood pres-
coverage of
sure with different activities, if we’re us- APCH 2017.
ing drugs that interfere with the activity
of this system, we need to make certain
the drug is present at the time when the
system is active,” said Morgan.
This makes the timing of medication
critical because the duration of the drug

28
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13th Asian-Pacific Congress of Hypertension (APCH) • October 6-8 • Singapore
Accurate diagnosis, treatment important
in resistant hypertension
ROSHINI CLAIRE ANTHONY
T
he prevalence of resistant hy-
pertension may be lower than
expected, particularly once
pseudo-resistant hypertension due to
treatment nonadherence is taken into
account, according to a presentation at
APCH 2017.
“A key aspect of resistant hyper-
tension is an accurate diagnosis,” said
Professor Bryan Williams from Univer-
sity College London and chairperson
of the European Society of Cardiology
(ESC) Council on Hypertension. This
would involve excluding secondary and
pseudo-resistant hypertension, he said.
[APCH 2017, symposium G]
Patients with pseudo-resistant hy-
pertension include those who may not
have accurate blood pressure (BP)
measurement (eg, wrong cuff size),
those with white coat hypertension,
those receiving suboptimal treatment
for hypertension, or those who are non-
adherent to treatment.
Common causes of secondary hy-
pertension are kidney or renal artery
disease, and aldosterone-producing ad-
enomas, while less common causes in-
clude Cushing’s syndrome, phaeochro-
mocytoma, and monogenic disorders.
To identify patients with resistant
hypertension, it must first be deter-
mined if the patient is hypertensive and
if yes, if the patient is receiving optimal
treatment and adhering to it. Based on
the association between a higher num-
ber of medications and nonadherence,
simplifying the treatment (eg, from mul-
tiple pills to one) may help. If none of
these are effective, secondary hyper-
tension would need to be ruled out,
said Williams.
CONFERENCE COVERAGE
“True resistant hypertension is un-
common after exclusion of pseudo-re-
sistance and secondary causes,” said
Williams, suggesting that the preva-
lence may be less than 10 percent of all
treated hypertensive patients.
”
“In terms of lifestyle
management,
high dietary sodium
consumption can
contribute to resistance
to hypertension drugs”
Treating resistant
hypertension
Lifestyle modification, BP-lowering
medication, and devices may help in
the management of resistant hyperten-
sion, said Williams.
In terms of lifestyle management,
high dietary sodium consumption can
contribute to resistance to hyperten-
sion drugs, he said.
Medication-wise, guidelines pub-
lished by the ESC in 2013 stressed
the use of diuretics in the management
of resistant hypertension, particularly
low-dose spironolactone. However, the
guidelines also highlighted the poten-
tial for hyperkalaemia with spironolac-
tone, especially among patients with a
low estimated glomerular filtration rate
(eGFR), and suggested eplerenone,
amiloride, and loop or higher-dose thi-
azide-type diuretics as alternatives, as
well as α- or β-blockers, or centrally
acting agents, said Williams. [Eur Heart
J 2013;34:2159-2219]
21
29
DOCTOR | NOVEMBER ISSUE
“[The ESC guidelines] emphasized
very strongly that all of this is based on
observational data or personal opinion,
but the evidence base is very low,” he
said.
“Resistant hypertension is predom-
inantly a sodium-retaining state that
responds best to additional diuretic
therapy. In patients with an eGFR >60
mL/min, spironolactone 25–50 mg daily
is very effective and generally safe and
well tolerated, although gynaecomastia
can become a problem in men [with
longer term use]. Higher dose amiloride
10–20 mg daily may be an alternative
to spironolactone but the same cave-
ats apply regarding renal function and
potassium,” said Williams, who under-
scored the need for further research
into determining the potential role of
other diuretics in managing resistant
hypertension.
He also pointed out the importance
of baseline eGFR and potassium lev-
els due to the increased risk of hy-
perkalaemia in individuals with eGFR
<60 mL/min or potassium levels >4.5
mmol/L, and especially in those with
eGFR <45 mL/min or with potassium
levels >5.0 mmol/L. Aldosterone-pro-
ducing adenomas are also a possibility
in patients who respond very well to
spironolactone.
With regards to devices, continuous
positive airway pressure or CPAP can
be an effective BP-reducing measure if
the primary cause of the resistant hy-
pertension is obstructive sleep apnoea,
said Williams. Evidence also points to
the potential effectiveness of barore-
ceptor stimulation, though this measure
is expensive, requires surgical implan-
tation, and is not well tolerated in some
patients, he said.

13th Asian-Pacific Congress of Hypertension (APCH) • October 6-8 • Singapore
Changing BP targets: Evidence vs opinion
PEARL TOH
C
linical practice is an art guid-
ed by good science, and clin-
ical practice guideline (CPG) is
meant to guide in integrating the art
and science of clinical practice for the
long-term benefits of patients, said Pro-
fessor Abdul Rashid Abdul Rahman, a
consultant cardiovascular physician at
An-Nur Specialist Hospital in Bangi,
Malaysia.
“CPG is a document authored col-
lectively by individuals who individually
disagreed with what was written,” Rah-
man amused the crowd with a humour
quote.
”
“We need consensus
on how to choose
evidence which
matters”
Although a general blood pressure
(BP) target of <140/90 mm Hg is rec-
ommended for all patients with hyper-
tension by major international bodies
including AHA*, ESC/ESH**, JNC8***,
ASH/ISH#, and NICE##, there have been
some discords on the ideal BP targets
for specific groups of hypertensive pa-
tients such as those with coronary ar-
tery disease, diabetes, who are elderly,
or who have previous cerebrovascular
accident, he noted.
One of the reasons for the discor-
dance in existing recommendations
lies in the choice of evidence, ie, ran-
domized controlled trials (RCTs) on
which the recommendations are based
on. Among the different committees,
the number and types of major RCTs
chosen for setting recommendations
CONFERENCE COVERAGE
differ greatly, observed Rahman. For in-
stance, the ACCOMPLISH trial was not
mentioned in the NICE guideline, while
major trials like ASCOT and HOPE were
not quoted in the ASH/ISH and JNC8
guidelines.
Not only does the choice of evi-
dence differ, the interpretation of the
evidence may also differ among the
panellists, which may contribute to the
lack of agreements between guide-
lines, according to Rahman. HYVET, a
major trial considered to bear important
evidence for elderly patients with hy-
pertension was referenced in both the
ESC/ESH and ASH/ISH guidelines (al-
though it was left out in the NICE guide-
line). However, a BP target of <150/90
mm Hg was recommended for patients
aged >60 years in the ESC/ESH guide-
line but the target age group was >80
years in the ASH/ISH guideline.
“How stringent are we with using
the evidence?” asked Rahman. “Do we
include only hypertension-dedicated tri-
als or RCTs with adequately powered
clinical outcomes? Do we include only
primary outcome trials or meta analy-
ses of RCTs?”
“When it comes to treatment rec-
ommendation, we should only stick to
hypothesis-testing studies (not sub-
analysis or post hoc analysis).”
Besides, RCTs-based guidelines
do pose some limitations in terms of
the generalizability to the real-world
scenario, he added, alluding to the
frequent exclusion of complicated pa-
tients in RCTs, compliance rates which
were often too good, and events rates
which were too low compared with
those observed in daily practice. Also,
generalizability to older or higher-risk
patients was questionable while Asian
patients were rarely studied in RCTs.
22
30
DOCTOR | NOVEMBER ISSUE
Prof Abdul Rashid Abdul Rahman
Bridging the gaps
“Gaps existing within the cur-
rent CPG should be addressed by
well-thought out research,” said Rah-
man. “We need consensus on how to
choose evidence which matters, how
to interpret evidence, be guided by re-
sults from clinically important surrogate
endpoints in the absence of RCTs, and
conduct definitive RCTs to address
specific gaps.”
According to the NICE 2011 re-
port, research questions that remain to
be answered include out-of-office BP
monitoring, method of assessing life-
time cardiovascular risk in those aged
<40 years, and the optimal systolic BP
target.
“Psychosocial and behavioural as-
pects of care must not be neglected,”
reminded Rahman, noting that recom-
mendations on lifestyle interventions
can be anticipated in the upcoming
NICE guideline due in 2018.
*AHA: American Heart Association
**ESC/ESH: European Society of Cardiology/
European Society of Hypertension
***JNC8: The Eighth Joint National Committee
ASH/ISH: American Society of Hypertension/
#
International Society of Hypertension
##
NICE: The National Institute for Health and Care
Excellence

13th Asian-Pacific Congress of Hypertension (APCH) • October 6-8 • Singapore
Home BP monitoring effective for managing
hypertension
AUDREY ABELLA
H
ome blood pressure (BP) mon-
itoring is important in the man-
agement of hypertension,
especially morning and nocturnal hy-
pertension, according to a presentation
at APCH 2017.
It is extremely important to control
morning BP as it is the strongest in-
dependent predictor of stroke, said Dr
Kazuomi Kario from the Jichi Medical
University Department of Medicine in
Tochigi, Japan. “For stroke and coro-
nary artery disease (CAD), morning is
the [riskiest] time [as] BP spontaneously
increases in the morning.”
Previous evidence has shown a
higher prevalence of silent cerebral in-
farcts and a higher incidence of stroke
events among hypertensive elderly pa-
tients with morning BP surges. [Circu-
lation 2003;107:1401-1406] Moreover,
Asians were found to have a higher risk
of stroke and CAD compared with Cau-
casians, [Hypertension 2007;50:991-
997] and Japanese individuals par-
ticularly exhibited higher morning BP
levels and BP surges vs Caucasians.
[Hypertension 2015;66:750-756; Circ J
2017;81:1337-1345]
Dr Kazuomi Kario
CONFERENCE COVERAGE
Kario and his colleagues indicated
that controlling morning hypertension
(≥135/85 mm Hg) could be clinically
relevant in the therapeutic management
of hypertension and in the prevention of
cardiovascular complications. [J Hyper-
tens 2017;35:1554-1563; Am J Hyper-
tens 2005;18:149-151]
“Uncontrolled morning BP during
trough effect hours could be a hallmark
of inadequate antihypertensive regimen
such as the use of short-acting or inter-
mediate-acting drugs, under-dosing of
drugs, or no or low use of combination
therapy,” said Kario.
On the other hand, uncontrolled
nocturnal hypertension (sleep sys-
tolic BP of ≥120 mm Hg), which was
found to be associated with a higher
UACR# and NTproBNP##, [Hyperten-
sion 2012;60:912-928; Hypertension
2015;17:340-348] could be the unre-
vealed target of antihypertensive treat-
ment, said Kario.
Given the cardiovascular outcomes
associated with morning and nocturnal
hypertension, having access to a home
BP monitoring system would help pa-
tients achieve the ideal morning and
nocturnal BP levels, said Kario.
23
31
DOCTOR | NOVEMBER ISSUE
An ICT###-based home BP monitor-
ing system is a potential alternative to
an ambulatory BP monitoring system as
this will enable patients to self-monitor
their BP levels as shown in the NOC-
TURNE* trial. [Circ J 2017;81:948-957;
Prog Cardiovasc Dis 2016;59:262-281]
Kario recommended an ICT-based
stratified strategy to achieve a ‘zero’
cardiovascular event rate in the future
or a ‘perfect 24-hour BP control’ by
monitoring the nocturnal BP dipping,
BP variability, and the morning surge.
[Hypertens 2017;31:231-243; Hyper-
tension 2015;65:1163-1169]
“The [individualized] home BP-guid-
ed approach [could] be the best ap-
proach to increase the quality of man-
agement of hypertension … [I]ts use in
clinical care would add considerably to
improving hypertension outcomes in
Asia,” concluded Kario.
#
UACR: Urine albumin-to-creatinine ratio
##
NTproBNP: N-terminal pro b-type natriuretic
peptide
###
ICT: Information and communication technology
*NOCTURNE: Comparative effects of an angiotensin
II receptor blocker(ARB)/diuretic vs ARB/calcium-
channel blocker combination on uncontrolled
nocturnal hypertension evaluated by ICT-based
nocturnal home BP monitoring

Asia Pacific Digestive Week (APDW 2017) • September 23-26 • Hong Kong
Faecal microbiota transplantation effective
for treating inflammatory bowel disease
DR JOSEPH DELANO FULE ROBLES
A
recent study from China showed
that faecal microbiota transplan-
tation (FMT) is effective as a
therapeutic option for patients with in-
flammatory bowel disease (IBD).
“In a self-control study, we demon-
strated positive results 4–6 months
after FMT treatment of patients with
ulcerative colitis [UC]. The clinical re-
sponse rate was 88.2 percent, clini-
cal remission rate was 64.7 percent,
and endoscopic remission rate was
76.5 percent,” reported primary in-
vestigator Professor Yunshen Yang of
the People’s Liberation Army General
Hospital in Beijing, China, who spoke
at APDW 2017. [Yang Y, et al, unpub-
lished data]
Significant decreases in Mayo
scores and endoscopic Mayo scores
were also found as early as 2–3 months
after FMT (p<0.0001).
“A substantial proportion of pa-
tients [76.5 percent] who received
FMT also experienced an average
weight increase of 4 kg. Erythrocyte
sedimentation rate [ESR], C-reactive
protein [CRP], white blood cell [WBC]
count, and inflammatory bowel dis-
ease questionnaire [IBDQ] also im-
proved among FMT-treated patients,”
said Yang.
A recent meta-analysis of 14 co-
hort studies and four randomized con-
trolled trials also showed higher clinical
response rate (49 percent vs 28 per-
cent; p= 0.02) and clinical remission
rate (28 percent vs 9 percent; p<
0.01) in IBD patients treated with FMT
vs placebo. [Aliment Pharmacol Ther
2017;46:213-224]
CONFERENCE COVERAGE
Possible mechanisms of FMT in-
clude re-establishment of microbiota
diversity, with increase in Roseburia
spp, Oscillibacter spp, Lachtnospira-
ceae spp and Ruminococcaceae spp.
[Transplant Proc 2016;48:402e407]
Viruses also play a role in the mech-
anism by being detectable as viral
contigs transferred from the donors,
with none of these viruses replicating
on human cells but scoring as bacte-
riophages with Siphoviridae temperate
phages transferring more efficiently as
compared with other groups. [mBio
2016;7:e00322]
Studies have previously shown that
chronic intestinal inflammation develops
in germ-free mouse models after colo-
nization with commensal gut bacteria.
IBD patients were found to have fewer
anti-inflammatory bacteria and more
proinflammatory bacteria in the gut as
compared with controls. Metabolites of
intestinal microbiota are also disturbed
in IBD. Metagenomic studies have sug-
gested compositional changes of the
gut microbiota in patients with IBD.
[World J Gastroenterol 2014;20:14805-
14820; Microorganisms 2016;4:20; Ital
J Pediatr 2014;40:32]
24
32
DOCTOR | NOVEMBER ISSUE
Significant changes in fungal com-
position are also observed in IBD.
For instance, a study revealed that
Basidiomycota spp was significant-
ly increased whereas Ascomycota
spp was significantly reduced. [Gut
2017;66:1039-1048]
Significant expansion of bacte-
riophages of the viruses of the Cau-
dovirales order were noted in IBD
patients vs healthy controls. [Cell
2015;160:447-460]
Recently, probiotics containing
Escherichia coli Nissle 1917 (EcN) was
recommended by guidelines of the Eu-
ropean Crohn’s and Colitis Organisation
(ECCO) as an effective treatment alter-
native to mesalazine in maintenance
remission among UC patients. [World J
Gastroenterol 2016;22:5505-5511]
“Currently, international and local
recommendations on FMT are weak
and use of the treatment is limited to
clinical research … A lot still need to be
addressed, such as the mechanism of
FMT, its safety, indications, preparation
of donors, follow-up of patients and
ethical implications associated with the
procedure,” Yang commented.
 CONFERENCE COVERAGE
Asia Pacific Digestive Week (APDW 2017) • September 23-26 • Hong Kong

New endoscopic technologies improve

outcomes of UGIB
NAOMI RODRIG

N
ew endoscopic technologies
have improved outcomes for
patients with upper gastroin-
testinal bleeding (UGIB), according to
Professor James Lau from the Chinese
University of Hong Kong, who reviewed
current treatment practices and latest
advances at APDW 2017.

“Injection therapy with diluted epi-

nephrine, introduced in the 1980s, has
been shown to reduce the need for sur-
gery and transfusion and shorten hos-
pital stay,” said Lau. “Some years later,
we realized that it could be improved by
adding a second modality, such as clips
or thermocoagulation. A meta-anal-
ysis published in 2004 showed that a
second modality not only reduced re-
current bleeding and surgery, but also
decreased mortality by 50 percent.
Hence, the current standard is to add
a second modality targeting the vessel
itself.” [Br Med J 1988;296:1631-1633;
Gastroenterology 2004;126:441-450]
When selecting between clips or
thermocoagulation, a meta-analy-
sis showed no significant difference
in terms of bleeding control. [Gut
2007;56:1364-1373]
“An improved clip that opens to
about 2 cm provides very nice results.
You target at the base of the bleeding
point and push in firmly to apply the
clip. Two or three clips are usually re-
quired,” said Lau. “Coaptive thermo-
coagulation, which involves irrigation,
pressure on the artery, and thermal
energy, is a technique that withstood
the test of time as it is still being used.”
[Gastroenterology 1987;92:1101-1108]
The use of haemostatic powder
spray is effective in acute nonvarice-
al gastrointestinal bleeding (ANVGIB).
“There are no published randomized
trials, but a summary of the literature
indicates that the initial bleeding con-
trol rate approaches 90 percent. Un-
fortunately, the rebleeding rate is 20
percent. The current recommendation
therefore suggests haemostatic pow-
der to stop the bleeding, allowing time
for second-look endoscopy and treat-
ment of residual stigmata,” noted Lau.
Over-the-scope clips (OTSCs) have
been shown to improve initial bleeding
control vs standard endoscopic thera-
py (96 percent vs 62 percent) and re-
duce 7-day rebleeding (24 percent vs
33 percent.) “There is an indication that
OTSCs are useful in rebleeders, but we
are waiting for the full study report,” he
remarked.
The Apollo Overstich – a device for
internal gastric plication used in obesity
surgery – has been applied for bleeding
gastric ulcers with limited success, due
to the technical expertise required and
high rebleeding rates.
Advances in identifying the stigmata
of recent haemorrhage (SRH) have also
improved treatment outcomes. “While
in the past we relied on visual interpreta-
tion with Forrest classification, new de-
vices such as a disposable ultrasound
probe or Doppler probe can better iden-
tify arterial flow and additional signals.
For example, Doppler probe can identify
nearly 70 percent of clots and 40 per-
cent of flat spots,” explained Lau. “A re-
cent study suggests that Doppler-guid-
ed endoscopic treatment is superior to
standard therapy, but this needs to be
validated in a larger series.” [Gastroen-
terology 2017;152:1310-1318]
“Reporting of endoscopic ultra-
sound-guided angiotherapy remains
anecdotal, but it is an interesting con-
cept that may be useful in selected pa-
tients,” he suggested.

25
33
DOCTOR | NOVEMBER ISSUE

Asia Pacific Digestive Week (APDW 2017) • September 23-26 • Hong Kong
Sodium phosphate tablets preferred over
PEG solution for bowel cleansing
ELAINE TAN
S
odium phosphate (NaP) tab-
lets for bowel preparation prior
to colonoscopy are safe, bet-
ter tolerated by patients, and provide
equivalent and possibly superior co-
lon cleansing compared with standard
polyethylene glycol (PEG) solution, a
Korean study has found.
In the investigator-blinded, con-
trolled study, 62 healthy Korean adults
undergoing elective colonoscopy were
randomized to receive NaP regimen (32
NaP tablets in divided doses) or stan-
dard PEG solution (4 L) for bowel prepa-
ration. Results showed no significant
difference in total Ottawa Bowel Prepa-
ration Quality Scale (OBPQS) score be-
tween the NaP and PEG groups (4.3
vs 5.4; p=0.071). Fluid scores (fluid
quantity in the entire colon), however,
were significantly better with NaP vs
PEG upon detailed analysis of individual
OBPQS scores (0.1 vs 0.6; p<0.001). A
significantly higher proportion of patients
in the NaP group achieved adequate
bowel preparation, defined as a total
OBPQS score of ≤4 (62.5 percent vs
33.3 percent; p=0.022). [Yonsei Med J
2014;55:1542-1555]
“Higher satisfaction with the given
bowel cleansing regimen was reported
by patients in the NaP vs PEG group
[8.5 vs 5.5 out of 10 on a visual ana-
logue scale; p<0.001], and significantly
more patients who used NaP indicated
willingness to repeat the same regimen
in the future [93.8 percent vs 30.0 per-
cent; p<0.001]. A less burdensome
bowel preparation regimen could lead to
increased population participation in col-
orectal screening programmes,” report-
ed lead author Dr Seung-Hwa Lee of
the Ajou University School of Medicine,
Suwon, Korea, at AFOS 2017.
CONFERENCE COVERAGE
The PEG regimen has been re-
garded as the gold standard for bow-
el cleansing, but the need to ingest a
large volume as well as the unpleasant
smell and taste of PEG frequently lead
to poor patient compliance, resulting in
inadequate bowel preparation.
“Adequate bowel preparation is es-
sential for swift and complete examina-
tion of the entire colorectal mucosa with
minimal complication to avoid missing
pathologic lesions during colonosco-
py,” said Lee.
“Low-volume fluid and efficacious
NaP regimens are popular alternative
methods for bowel preparation. How-
ever, potential associated risks include
electrolyte imbalances, irreversible renal
dysfunction, and acute phosphate ne-
phropathy,” Lee explained.
The most common adverse events
experienced by patients in the study
were nausea, vomiting, abdominal
pain, and bloating/distension. No sig-
nificant differences were observed
between the two groups for abdomi-
nal pain and bloating, but nausea and
vomiting were more frequent in patients
26
34
DOCTOR | NOVEMBER ISSUE
who used PEG (50 percent vs 25 per-
cent [p=0.042] and 43.3 vs 12.5 per-
cent [p=0.007], respectively).
Significant fluctuations in serum
chemistry and electrolytes were noted
in both groups after bowel cleansing.
Patients’ potassium and total calci-
um levels were significantly decreased
from baseline in the NaP vs PEG group
(-0.66 mEq/L and -0.45 mg/dL, respec-
tively [both p<0.001] vs -0.21 mEq/L
[p=0.004] and -0.01 mg/dL [p=0.963]),
while inorganic phosphorus levels were
significantly elevated in the NaP group
(+1.58 mg/dL [p<0.001] vs +0.13 mg/
dL [p=0.18]).
“However, the mean changes from
baseline were generally mild and tran-
sient, and none of the changes result-
ed in serious complications or adverse
events. On follow-up laboratory tests,
these changes were found to have nor-
malized,” noted Lee.
“As our sample size was small and
included only outpatients without seri-
ous comorbidities, further multicentre,
large-scale studies are needed to con-
firm these findings,” said Lee.

Asia Pacific Digestive Week (APDW 2017) • September 23-26 • Hong Kong
Immunotherapy: The future in pancreatic
cancer treatment?
JENNY NG
R
esearchers are setting their
sights high on immunotherapy
as a promising strategy in ad-
vanced pancreatic cancer, with several
agents currently in development.
“There is excitement in the use of
immunotherapy for cancer treatment
because of their mechanism in targeting
the tumour microenvironment,” said Dr
Thomas Yau of The University of Hong
Kong, who spoke at APDW 2017.
For patients with advanced pan-
creatic cancer, few treatment options
are available and chemotherapy-based
regimens remain the standard of care.
Newer strategies such as nab-pacli-
taxel, a combination of paclitaxel and
albumin used in combination with
gemcitabine to enhance drug delivery
to the tumour microenvironment, have
demonstrated some survival benefit vs
gemcitabine alone in both the first- and
second-line settings. However, the me-
dian overall survival for these patients
remains less than 1 year. [J Natl Cancer
Inst 2015, doi: 10.1093/jnci/dju413]
Research into targeted therapeutic
approaches over the last 10 years have
yielded only marginal benefits. “Erlotinib
is the first and only targeted therapy ap-
proved for treatment of advanced pan-
creatic cancer,” said Yau. “However, its
use is associated with increased toxicity
and most oncologists don’t regard erlo-
tinib as a clinically meaningful treatment
option in advanced pancreatic cancer.”
Targeting the immunosuppressive
microenvironment of the pancreatic
tumour may be the key to overcom-
ing the high resistance to treatment in
pancreatic tumours, suggested Yau.
CONFERENCE COVERAGE
Within the typical microenvironment, an
immune response would elicit activated
T cells to remove the cancerous cells.
However, pancreatic tumours are able
to activate various immune-suppres-
sive pathways to evade this immune re-
sponse. Immunotherapies act on these
various mechanisms to restore T cell
activity against the tumour.
“Pancreatic tumours can evade the
immune system by causing ineffective
presentation of the tumour antigens
to the immune system. They can also
recruit immunosuppressive cells, re-
lease immunosuppressive factors or
cause T cell checkpoint dysregulation,”
explained Yau. “The most important
components of this tumour microenvi-
ronment are the myeloid-derived sup-
pressor cells and T regulatory cells.”
“Immunotherapies currently in de-
velopment for pancreatic cancer in-
clude checkpoint inhibitors, immune
modulators, monoclonal antibodies,
27
35
DOCTOR | NOVEMBER ISSUE
therapeutic vaccines, and adoptive T
cell therapies such as chimeric antigen
receptor T cell therapy,” he continued.
More recently, the PD-1 inhibi-
tor nivolumab, used in combination
with nab-paclitaxel and gemcitabine,
demonstrated encouraging clinical ac-
tivity with low toxicity in patients with
metastatic pancreatic cancer in a phase
I study. [J Clin Oncol 2017;35(suppl
4S): abstract 412]
However, Yau warns that immuno-
therapies are not without side effects.
“PD-1 inhibitors, for example, are as-
sociated with rash that sometimes re-
quires systemic steroid treatment,” he
noted. “Other adverse effects of immu-
notherapies include diarrhoea, colitis,
and pneumonitis.”
Until further data on immunother-
apies become available, Yau recom-
mends treating advanced pancreatic
cancer with a gemcitabine-based reg-
imen (gemcitabine alone or in combina-
tion with nab-paclitaxel or erlotinib) or
FOLFIRINOX (5-FU, leucovorin, irino-
tecan, and oxaliplatin) in the first-line
setting, followed by FOLFIRINOX or a
gemcitabine-based regimen, respec-
tively, upon disease progression.
Scan this QR
code for full
coverage of
APDW 2017.

Asia Pacific Digestive Week (APDW 2017) • September 23-26 • Hong Kong
Small bowel bleeding remains
a diagnostic challenge
NAOMI RODRIG
W
hile bleeding from the small
intestine is relatively un-
common, it often presents
a diagnostic challenge. Speaking at
APDW 2017 in Hong Kong, Dr Si-
mon Lo from the Cedars Sinai Medical
Center in Los Angeles, California, US,
reviewed current guidelines and prac-
tices with a special focus on common
pitfalls.
“Small bowel bleeding should be
considered in patients with gastroin-
testinal [GI] bleeding with normal up-
per and lower endoscopic examina-
tions. With evolving technologies in
small bowel imaging with video cap-
sule endoscopy [VCE], deep enteros-
copy, double-balloon enteroscopy
[DBE], and radiography, we now have
many diagnostic tools available, and
the guidelines have evolved accord-
ingly,” said Lo. “Unfortunately, some
of these technologies are available in
tertiary-care centres only due to the
associated cost, personnel training,
and long procedure time.”
The American College of Gastro-
enterology (ACG) recommends sec-
ond-look examinations using upper
endoscopy, push enteroscopy, and/
or colonoscopy before small bowel
evaluation. VCE should be considered
a first-line procedure for small bowel
examination after other GI sources
have been excluded by second-look
endoscopy. Any method of deep en-
teroscopy can be used when there
is a strong suspicion of small bowel
lesion. Intraoperative enteroscopy is
a highly sensitive but invasive diag-
nostic and effective therapeutic pro-
cedure; its use should be limited to
scenarios where enteroscopy cannot
CONFERENCE COVERAGE
be performed. [Am J Gastroenterol
2015;110:1265-1287]
“Intraoperative enteroscopy is the
most reliable method to examine the
entire small bowel, with a diagnostic
sensitivity of around 80 percent. How-
ever, the therapeutic efficacy in pre-
venting recurrent bleeding is only 41
percent,” said Lo. “It is also associated
with significant complications, and pro-
longed recovery and hospitalization in
about 30 percent of patients.”
“Negative imaging doesn’t mean a
normal small bowel. You never know
what you would find, as the source
of the bleeding may not be what it
appears to be. Even trivial-appearing
polyps can still bleed,” he stressed.
“In some cases, the diagnosis is not in
question, but we still have a problem
managing the bleeding as it may be
deep within the lesion.”
Patients with Peutz-Jeghers syn-
drome who had undergone multiple
operations pose a technical challenge.
Surgical bypasses such as Roux-en-Y
28
36
DOCTOR | NOVEMBER ISSUE
must also be assessed with deep en-
teroscopy.
“In patients with Crohn’s disease,
strictures might preclude capsule stud-
ies and caution is recommended with
enteroscopic evaluation and treat-
ment,” suggested Lo.
Another dilemma is dealing with pa-
tients on anticoagulants who present
with obscure GI bleeding. “When you
see bleeding on heparin challenge, you
better place a tattoo mark to identify
the spot,” he advised. “Radionuclide
bleeding scans can pick up very low-
grade bleeding, but wrong localization
has been reported in up to 25 percent
of cases. Furthermore, they are time
consuming, and we can’t really use
them to direct treatment.”
“Many challenges remain with eval-
uations of obscure bleeding, such as
cases of prior surgery or altered anat-
omy, false positive or negative results
with VCE, patients on anticoagulation
and the risks of intraoperative enteros-
copy,” he concluded.
 CONFERENCE COVERAGE
53rd European Association for the Study of Diabetes (EASD) Annual Meeting 2017
September 9-15 • Lisbon, Portugal

New test facilitates diagnosis of idiosyncratic

drug-induced liver injury
CHRISTINA LAU

A
new technology involving the
use of monocyte-derived he-
patocyte-like (MH) cells has
demonstrated high sensitivity and
specificity in the diagnosis of idiosyn-
cratic drug-induced liver injury (DILI),
data presented at APDW 2017 have
shown.

“The new MetaHeps test intro-

duced at our department is currently
being evaluated in an ongoing study
with the Chinese University of Hong
Kong,” said Professor Alexander Ger-
bes of the Liver Centre Munich, Mu-
nich, Germany.

MetaHeps involves the use of pe-

ripheral monocytes derived from blood
samples of patients with acute liver in-
jury. “Using a proprietary standardized
generation protocol, these peripheral
monocytes are modified to cells with
hepatocyte-like properties with do-
nor-specific characteristics, thus allow-
ing patient-centric individualized toxicity
testing,” explained Gerbes.
In a prospective pilot study of 54
patients with acute liver injury and in-
take of at least one drug, in vitro testing
using these MH cells identified patients
with idiosyncratic DILI with an excellent
sensitivity and a higher specificity than
the Roussel Uclaf Causality Assess-
ment Method (RUCAM) score, the most
widely used score in the diagnosis of
DILI. [Gut 2016;65:1555-1563]
In the study, 31 patients were di-
agnosed with idiosyncratic DILI based
on causality likelihood. MH cell testing
with the causative drug was positive in
29 of the patients and was comparable
to assessment by the RUCAM score.
In the 23 non-DILI patients, MH cell
testing yielded no false-positive results,
while RUCAM indicated possible idio-
syncratic DILI in six cases.
“The test can be a future option in
the diagnosis of complicated idiosyn-
cratic DILI,” Gerbes suggested.
“Idiosyncratic DILI can cause acute
liver failure in more than 10 percent of
patients, with a transplant-free sur-
vival rate of approximately 20 percent
only,” he continued. [Gut 2009;58:155
5-1564; Hepatology 2005;42:481-489]
“It is also a challenge in drug develop-
ment, leading to nonapproval of inno-
vative drugs, failure in late-stage drug
development or postmarketing with-
drawal.”
“Idiosyncratic DILI is very different
from dose-dependent DILI. Its diagno-
sis is difficult because it affects suscep-
tible patients only and is a diagnosis of
exclusion. It is unpredictable and can
be caused by many drugs,” he noted.
“Hyperbilirubinaemia or gamma-GT in-
crease per se do not define DILI. While
assessment scores and expert opinion
may be helpful, these are typically un-
able to identify the culprit drug in poly-
medicated patients. Novel in vitro tests
are therefore urgently needed to assist
in the diagnosis of idiosyncratic DILI
and in causality assessment in poly-
medicated patients.”
Idiosyncratic DILI is not as rare as it is
believed to be. Its incidence is 14–19 per
100,000 population, while that of parac-
etamol-induced liver injury is 16 per
100,000 population. Amoxicillin-clavu-
lanate is most commonly implicated in
idiosyncratic DILI, accounting for 22 per-
cent of the cases, followed by diclofenac
(6 percent), azathioprine (4 percent),
infliximab (4 percent), and nitrofurantoin
(4 percent). [Hepatology 2002;36:451-
455; Pharmacoepidemiol Drug Saf
2011;20:819-826; Gastroenterology
2013;144:1419-1425, 1425.e1-3]

29
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DOCTOR | NOVEMBER ISSUE

53rd European Association for the Study of Diabetes (EASD) Annual Meeting 2017
September 9-15 • Lisbon, Portugal
TOSCA.IT: Similar CV safety for pioglitazone
and sulphonylureas in T2D
PEARL TOH
T
he incidence of cardiovascular
(CV) events at 5 years was sim-
ilar when adding sulphonylureas
or pioglitazone to metformin in patients
with type 2 diabetes (T2D) inadequately
controlled with metformin alone, ac-
cording to a head-to-head comparison
in the TOSCA.IT* trial.
“[I]f used appropriately, in terms of
patient selection and dose ... both of
these widely available and affordable
treatments are suitable options with re-
spect to efficacy and adverse events …
particularly in relation to patients with a
low CV risk,” wrote the researchers led
by Dr Olga Vaccaro of the Frederico II
University of Naples in Naples, Italy.
After a median follow-up of 57.3
months, similar rates of the composite
primary outcome comprising all-cause
death, nonfatal stroke, nonfatal myo-
cardial infarction, or urgent coronary re-
vascularization (7 percent vs 7 percent,
hazard ratio [HR], 0.96; p=0.79) or its
components occurred in both the piogl-
itazone and sulphonylurea arms, report-
ed co-investigator Dr Antonio Nicolucci
of the Center for Outcomes Research
and Clinical Epidemiology in Pescara,
Italy. [EASD 2017, session S13; Lancet
Diabetes Endocrinol 2017;doi:10.1016/
S2213-8587(17)30317-0]
Glycaemic control was slightly,
though significantly, better maintained
with add-on pioglitazone than sulpho-
nylureas (mean HbA1c over time, 7.24
percent vs 7.30 percent; p=0.01),
with fewer patients in the pioglitazone
arm experiencing treatment failure
and needing insulin rescue therapy
(p<0.0001 for both).
CONFERENCE COVERAGE
Additionally, moderate and severe
hypoglycaemic events were more com-
mon with add-on sulphonylureas than
pioglitazone (both p<0.0001).
Although pioglitazone was associ-
ated with a better long-term glycaemic
control, co-investigator Professor Enzo
Bonora of the University and Hospital
Trust of Verona, Italy, cautioned that the
study was done in patients with low CV
disease risk, and that “any extrapola-
tion to patients with high CV disease
risk for prior events (eg, myocardial in-
farction or stroke) should be avoided.”
Other findings and clinical
implications
The multicentre, prospective, open-
label, blinded endpoint study with a
pragmatic design involved 3,028 patients
aged 50–75 years with T2D who were
inadequately controlled on metformin
monotherapy. They were randomized
1:1 to add-on pioglitazone 15–45 mg or
sulphonylureas (gliclazide 30–120 mg [50
percent], glimepiride 2–6 mg [48 percent],
or glibenclamide 5–15 mg [2 percent]).
Although a moderate weight gain of
less than 2 kg occurred in both treat-
ment groups during the first 2 years,
this subsequently levelled off until
study end and there were no signifi-
cant between-group differences. Other
risk factors such as blood pressure,
eGFR**, albumin-to-creatinine ratio,
and C-reactive protein were also simi-
lar in both treatment groups during the
course of study.
No significant differences were ob-
served between the two groups with re-
gards to any type of cancer (specifically
bladder cancer [p=1.00]), macular oe-
dema (p=0.34), pathological bone frac-
30
38
DOCTOR | NOVEMBER ISSUE
tures (p=0.75), or heart failure (p=0.22).
Body weight increase and heart fail-
ure rate were lower than those reported
in previous trials, which the investiga-
tors attributed to the exclusion of par-
ticipants with heart failure (NYHA***
class I or higher) or with reduced renal
function in the current study. [Lancet
2005;366:1279-1289; N Engl J Med
2016;374:1321-1331]
“These low rates [of known side
effects] might be related to the doses
of drugs used in both groups of the
trial, which were not maximal, another
important lesson for clinical practice,”
wrote Drs Vivian Fonseca and Dra-
gana Lovre of the Tulane University
Health Sciences Center in New Orle-
ans, Los Angeles, US, in an accompa-
nying commentary. [Lancet Diabetes
Endocrinol 2017;doi:10.1016/S2213-
8587(17)30320-0]
“These findings also remind us that pi-
oglitazone lowers glucose effectively and
durably, and that it is essentially the only
available insulin sensitizer that still has a
place in clinical practice,” they added.
“[F]or patients with early diabe-
tes (baseline HbA1c in the TOSCA.IT
trial was 7.7 percent), the choice of a
second-line drug might not matter as
compared with patients who are poor-
ly controlled (HbA1c of 9 percent or 10
percent),” concluded Fonseca and
Lovre, calling for head-to-head com-
parisons of these drugs with newer
antihyperglycaemic drugs in the future.
*TOSCA.IT: Thiazolidinediones Or Sulphonylureas
Cardiovascular Accidents Intervention Trial
**eGFR: Estimated glomerular filtration rate
***NYHA: New York Heart Association functional
classification

53rd European Association for the Study of Diabetes (EASD) Annual Meeting 2017
September 9-15 • Lisbon, Portugal
FAT score predicts poor weight loss
post-RYGB
ELVIRA MANZANO
A
new score that measures fibro-
sis in subcutaneous adipose
tissue (scAT) may identify poor
responders to Roux-en-Y gastric by-
pass (RYGB), a common weight-loss
procedure for morbid obesity, a study
has shown.
Researchers created a fibrosis
score of adipose tissue (FAT score)
integrating perilobular and pericellular
fibrosis and tested its predictive value
on weight-loss response after RYGB in
183 perioperative scAT biopsy speci-
mens from severely obese patients (85
from a training cohort and 98 from a
confirmation cohort). Mean patient age
was 43 years, and average BMI was 47
kg/m2. Seven out of 10 were women,
and 39 percent had diabetes.
At 1 year post-RYGB, the FAT
score was directly associated with in-
creasing scAT fibrosis (p<0.001). Of
note, a FAT score of ≥2 was signifi-
cantly associated with poor response
to RYGB despite adjusting for pa-
tient age, diabetes status, high blood
pressure, and percentage of body
fat (adjusted odds ratio [adjOR], 3.6;
p=0.003). Poor response was defined
CONFERENCE COVERAGE
as <28 percent of total weight loss at
1-year post-surgery. Poor responders
lost an average 22.7 percent of body
weight whereas good responders lost
35.6 percent. This translates to an
average difference of 17 kg in weight
loss between groups. [EASD 2017, ab-
stract OP-32; J Clin Endocrinol Metab
2017;102:2443–2453]
“The most severe fibrosis scores
[greater than 2] presurgery were as-
sociated with a poorer weight-loss re-
sponse of 3–4 times the risk,” said lead
investigator Dr Pierre Bel Lassen from
INSERM and Pitié-Salpêtrière Hospital,
Assistance Publique– Hôpitaux de Par-
is in Paris, France.
Factors predicting poor response
to RYGB include older age, diabetes,
hypertension, and eating disorders, he
said. “[However,] if we pool these pre-
surgery factors, it can only detect 14
percent of post-bariatric weight loss.”
Colour detection of collagen in the
adipose tissue can also predict weight
loss after surgery, but the procedure
is time-consuming, depends on slide
quality, and is affected by heterogeneity
of fibrosis, he added. “We need a novel,
easy-to-use score that would be repro-
31
39
DOCTOR | NOVEMBER ISSUE
ducible in the clinic to predict outcomes
in these patients.”
The FAT score was a significant im-
provement of previous attempts to de-
termine surgical outcomes. However, it
can only predict responses in 72 per-
cent of patients, Bel Lassen acknowl-
edged. “Further refinement is therefore
needed, possibly by including other
biological or psychological factors that
are absent from the current model.”
Bel Lassen’s team would also like to
expand their study to determine if the
FAT score can be applied to other types
of bariatric surgery such as sleeve gas-
trectomy, and determine its predictive
value over longer follow-up periods.
Commenting on the study, Dr Jan
Eriksson, an endocrinologist from the
Uppsala University in Uppsala, Swe-
den, who is unaffiliated with the study,
said the work had value in finding a
measure that could predict who would
benefit from RYGB, but it is also inter-
esting from a pathobiology perspec-
tive. “It is surprising that there was an
increase in the fibrosis score following
the procedure … I would have expect-
ed the opposite, and this needs further
research.”

53rd European Association for the Study of Diabetes (EASD) Annual Meeting 2017
September 9-15 • Lisbon, Portugal
Comparable glycaemic control
with dulaglutide vs insulin glargine
for T2D patients with CKD
PEARL TOH
T
he GLP-1* receptor agonist du-
laglutide confers comparable
glycaemic control with greater
albuminuria reduction and less eGFR**
decline compared with insulin glargine in
patients with type 2 diabetes (T2D) and
moderate-to-severe chronic kidney dis-
ease (CKD), when both are used in com-
bination with the human insulin analogue
lispro, according to the AWARD-7***
study presented at EASD 2017.
“The results hold up in CKD stage
4, just as it did in CKD [stage] 3, very
similar to what was published in the
LEADER trial last week,” said Dr Kath-
erine Tuttle of the University of Wash-
ington in Spokane, Washington, US.
Equivalent reductions in HbA1c lev-
els from baseline at week 26, the pri-
mary endpoint, were seen in both the
high- and low-dose dulaglutide arms
compared with the insulin glargine
arm (-1.2 percent and -1.1 percent
for dulaglutide 1.5 mg and 0.75 mg,
respectively, vs -1.1 percent for insulin
glargine; one-sided p<0.001 for nonin-
feriority for both comparisons). [EASD
2017, abstract OP 02]
Likewise, similar proportion of pa-
tients in the dulaglutide arms achieved
an HbA1c goal of <8.0 percent (<64
mmol/mol) as those in the insulin
glargine arm (78.3 percent and 72.6
percent vs 75.3 percent).
“The effects were maintained up
to 52 weeks of treatment,” said Tuttle,
noting that the mean HbA1c reduction
from baseline and the proportion of
CONFERENCE COVERAGE
patients achieving target HbA1c were
similar among the treatment arms at 52
weeks.
By week 26, albuminuria reductions
occurred in all treatment arms, but the
extent of reduction was greater in both
the dulaglutide arms compared with the
insulin glargine arm (percentage UACR#
change from baseline, -27.7 percent
and -26.7 percent vs -16.4 percent).
Commenting on the changes in kid-
ney function in terms of eGFR, Tuttle
said, “The eGFR declined at 26 weeks
at about 2 mL/min/1.73m2 in the insu-
lin-treated group, note that in patients
at this stage of CKD we expect about
4-5 mL/min loss, so they were right on
target as expected for the insulin group.
But this was essentially extinguished in
the dulaglutide groups where there was
no significant loss in eGFR during the
26-week time period.”
The open-label phase III trial ran-
domized 576 patients (mean age 64.6
years) with T2D and stage 3–4 CKD in
a 1:1:1 ratio to dulaglutide 1.5 mg or
0.75 mg once weekly or titrated insu-
lin glargine, in addition to insulin lispro
(adjusted to target preprandial plasma
glucose value of 6.7–10.0 mmol/L).
Previously, dulaglutide 1.5 mg has
demonstrated superiority to daily insu-
lin glargine in terms of HbA1c change
from baseline in the AWARD-2 study.
The current AWARD-7 enrolled a spe-
cific group of T2D patients with moder-
ate-to-severe CKD.
As expected, fewer participants in
the dulaglutide arms experienced hy-
32
40
DOCTOR | NOVEMBER ISSUE
poglycaemia compared with the insulin
glargine arm (0 percent and 2.6 per-
cent vs 6.7 percent) at week 26, with
significantly lower hypoglycaemia event
rate (5.5 and 7.8 vs 17.1 events/par-
ticipant/year; p<0.001 for both). Also,
body weight decreased from baseline
with both dulaglutide doses at 26 and
52 weeks but increased with insulin
glargine (p<0.001 at both time points).
“Overall there was no significant dif-
ference between the insulin and either
dose of dulaglutide,” said Tuttle. “The
only difference we found was a higher
rate of gastrointestinal side effect in the
dulaglutide-treated patients, which was
expected. There was an increase in a
dose-related fashion so that the highest
rates of diarrhoea, nausea, and vomit-
ing were observed in the higher-dose
dulaglutide group.”
*GLP-1: Glucagon-like peptide-1
**eGFR: Estimated glomerular filtration rate
***AWARD-7: A study comparing dulaglutide with
insulin glargine on glycaemic control in participants
with T2D and moderate or severe CKD
UACR: Urine Albumin-to-Creatinine Ratio
#
Scan this QR
code for full
coverage of
EASD 2017.

53rd European Association for the Study of Diabetes (EASD) Annual Meeting 2017
September 9-15 • Lisbon, Portugal
Exenatide improves glycaemic control,
weight loss in uncontrolled T2D
ROSHINI CLAIRE ANTHONY
O
nce-weekly doses of the glu-
cagon-like peptide-1 receptor
agonist exenatide plus insulin
glargine improved glucose control and
weight loss in patients whose type 2
diabetes (T2D) was uncontrolled on
basal insulin and metformin, according
to findings from the DURATION-7* trial.
“Patients receiving exenatide QW
were twice as likely to have improved
HbA1c and body weight than those
treated with titrated insulin glargine
alone,” said Dr Juan Pablo Frias from
the National Research Institute, Los
Angeles, California, US, who presented
the findings at EASD 2017.
Patients recruited at screening
(n=808) were individuals with uncon-
trolled T2D (HbA1c ≥7.5 to ≤12.0 per-
cent; mean HbA1c 9.2 percent) on insu-
lin glargine (≥20 U/day) with or without
metformin and a sulphonylurea. Fol-
lowing an 8-week run-in period during
which insulin glargine was titrated,
464 patients with HbA1c ≥7.0 to ≤10.5
percent (mean HbA1c, 8.5 percent) de-
spite basal insulin and stable metformin
(sulphonylurea use was discontinued)
were randomized to receive exenatide
once weekly (n=233, mean age 57.8
years, 49.4 percent male, mean base-
line weight 93.3 kg) or placebo (n=231,
mean age 57.6 years, 46.5 percent
male, mean baseline weight 97.4 kg)
in addition to titrated insulin glargine
(mean, 50 and 52 U/day in the exen-
atide and placebo groups, respectively)
for 28 weeks.
At week 28, about 25 percent more
patients on exenatide reached the
target glycaemic goal of HbA1c <7.0
percent compared with patients on
CONFERENCE COVERAGE
placebo (p<0.001), with a more evi-
dent reduction in HbA1c in patients on
exenatide vs placebo (-1.0 percent vs
-0.3 percent; least square [LS] mean
change from baseline, -0.7 percent;
p<0.001). Patients on exenatide also
experienced a mean 1.1 kg weight loss
at 28 weeks compared with patients
on placebo who gained a mean 0.4 kg
(LS mean change, -1.5 kg; p<0.001).
[EASD 2017, abstract OP 01(3)]
Almost 20 percent (19.5 percent)
more patients on exenatide than place-
bo achieved the composite of reaching
glycaemic targets with no weight gain
or incidence of major hypoglycaemia
(p<0.001).
A greater proportion of patients
on exenatide compared with placebo
experienced HbA1c reductions of any
amount (80.9 percent vs 59.7 percent)
as well as any weight loss (62.3 percent
vs 39.8 percent).
Adverse event (AE) and serious AE
incidence were comparable between
patients on exenatide and placebo
33
41
DOCTOR | NOVEMBER ISSUE
(53.9 percent vs 57.6 percent and 4.7
percent vs 4.8 percent, respectively),
while more patients on exenatide re-
ported gastrointestinal events (15.1
percent vs 10.8 percent) and injection
site-related AEs (7.8 percent vs 3.0
percent).
Hypoglycaemia incidence was
comparable between patients on exen-
atide and placebo (29.7 percent vs 29.0
percent) and there was no incidence of
severe hypoglycaemia in either group.
“Clinical benefits of combining ex-
enatide QW with basal insulin includ-
ed a reduction in HbA1c, with a greater
percentage of patients achieving gly-
caemic targets, reduced body weight,
and no increase in hypoglycaemia inci-
dence or rate despite improved glycae-
mic control,” concluded Frias.
*DURATION-7: Phase 3 28-week study with 24-
week and 52-week extension phases to evaluate
efficacy and safety of exenatide once weekly and
dapagliflozin versus exenatide and dapagliflozin
matching placebo

53rd European Association for the Study of Diabetes (EASD) Annual Meeting 2017
September 9-15 • Lisbon, Portugal
DS-8500a improves glycaemic, lipid variables
in T2D
AUDREY ABELLA
T
he novel G-protein coupled
receptor 119 (GPR119) ago-
nist DS-8500a demonstrated
dose-dependent glucose-lowering ef-
fects and favourable improvements in
lipid parameters that extended up to 12
weeks in Japanese patients with type 2
diabetes (T2D), according to data pre-
sented at EASD 2017.
This multicentre, double-blind trial
comprised 368 patients with T2D and
HbA1c levels between ≥7 and <10 per-
cent. Participants were randomized
1:1:1 to receive once-daily administra-
tion of DS-8500a (either 25 mg, 50 mg,
or 75 mg), sitagliptin 50 mg, or placebo
for 12 weeks. [EASD 2017, abstract 847]
At week 12, a dose-dependent re-
duction in HbA1c levels was observed
among patients on DS-8500a com-
pared with placebo (-0.21 percent;
CONFERENCE COVERAGE
p=0.0233 for 25 mg, -0.34 percent;
p=0.0004 for 50 mg, and -0.45 per-
cent; p<0.0001 for 75 mg).
Compared with placebo, DS-8500a
50 mg and 75 mg also reduced fast-
ing plasma glucose (FPG, -12.7 mg/dL;
p=0.0004 and -14.4 mg/dL; p<0.0001,
respectively), area under the curve0-
3h
for glucose during a meal tolerance
test (-50.6 mg/dL x h; p=0.0020 and
-59.7 mg/dL x h; p=0.0003), and
2-hour postprandial glucose (-18.5
mg/dL; p=0.0102 and -22.0 mg/dL;
p=0.0022).
FPG reduction was sustained for
up to 12 weeks, said the researchers,
which is an improvement from other
GPR119 agonists that typically have
shorter glucose-lowering effects lasting
for up to 2–4 weeks only.
With regards to lipid profile, admin-
istration of DS-8500a 50 mg and 75
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42
DOCTOR | NOVEMBER ISSUE
mg resulted in a significant increase
in HDL cholesterol vs placebo (5.9
percent; p=0.0032 and 6.6 percent;
p=0.0009, respectively), as well as a
significant reduction in total cholesterol
(-7.0 percent; p<0.0001 and -6.2 per-
cent; p=0.0002), LDL cholesterol (-7.3
percent; p=0.0044 and -8.1 percent;
p=0.0014), and triglycerides (-32.7
percent; p<0.0001 and -30.9 percent;
p<0.0001).
Apart from two cases of clinically
relevant drug-related hypoglycaemia in
the DS-8500a 50 mg arm, DS-8500a
was generally well tolerated with no re-
ports of serious drug-related treatment-
emergent adverse events at any dose.
These results were consistent with
the findings of a previous study in an-
other Japanese cohort, [Diabetes
2016;65:abstract 119-LB] showing the
potential benefit of DS-8500a for T2D,
noted the researchers.

53rd European Association for the Study of Diabetes (EASD) Annual Meeting 2017
September 9-15 • Lisbon, Portugal
Ertugliflozin noninferior to glimepiride
in reducing HbA1c
PEARL TOH
E
rtugliflozin 15 mg once daily is
noninferior to the sulphonylurea
glimepiride in HbA1c reduction
over 52 weeks in patients with type 2
diabetes (T2D) who are inadequately
controlled on metformin, according to
the VERTIS* SU trial presented at EASD
2017.
Along with a lower HbA1c, ertug-
liflozin also resulted in greater body
weight reductions and less hypogly-
caemia, but more genital mycotic infec-
tions than glimepiride, revealed senior
investigator Dr Brett Lauring from Ke-
nilworth, New Jersey, US.
“[Although] sulphonylureas are
commonly used in patients with T2D
as second-line therapy … [they] are
associated with an increased risk of
hypoglycaemia and weight gain,” he
continued. “Ertugliflozin improves gly-
caemic control via an insulin-indepen-
dent mechanism that poses a low risk
for hypoglycaemia.”
After 52 weeks, ertugliflozin 15 mg
was noninferior to glimepiride in lower-
ing HbA1c from baseline (least square
[LS] mean difference, -0.6 vs -0.7).
Although the lower-dose 5 mg ertug-
liflozin arm also showed similar HbA1c
reduction, this did not reach noninferi-
ority compared with glimepiride. [EASD
2017, abstract OP 38]
Fewer patients in both the ertug-
liflozin arms than the glimepiride arm
experienced symptomatic hypogly-
caemia (5.2 percent and 3.1 percent,
vs 19.2 percent for ertugliflozin 15 mg
and 5 mg vs glimepiride, respectively;
p<0.001 for both comparisons), with
CONFERENCE COVERAGE
the ertugliflozin 15 mg arm showing a
significantly greater reduction in fast-
ing plasma glucose (FPG) through 52
weeks from baseline compared with
the glimepiride arm (LS mean, -1.3 vs
-0.9; p<0.001).
Also, significantly greater reduc-
tions in body weight were seen with er-
tugliflozin vs glimepiride (LS mean, -3.4
and -3.0, vs 0.9; p<0.001).
Additional key secondary mea-
sure such as systolic blood pressure
reductions from baseline were greater
with ertugliflozin than with glimepiride
through 52 weeks (mean LS, -3.8 and
-2.2, vs 1.0 mm Hg; p<0.001).
“Ertugliflozin is an orally adminis-
tered, potent, highly-selective SGLT2**
inhibitor … currently under US and
EU regulatory reviews for treatment of
T2D,” said Lauring.
However, mycotic genital infections
occurred more frequently in both the
ertugliflozin arms than the glimepiride
arm, regardless of gender (female: 10.0
percent and 7.7 percent vs 1.4 per-
cent; p<0.001 and p=0.002 for each
comparison, and male: 2.1 percent and
4.4 percent vs 0 percent; p=0.03 and
p=0.002 for each comparison).
Other prespecified adverse events
(AEs) such as urinary tract infection
(UTI) and hypovolaemia occurred at
comparable rates among the treatment
groups.
“Ertugliflozin 5 mg and 15 mg were
generally well tolerated, without a
meaningful difference in the incidence
of UTI or hypovolaemia AEs,” observed
Lauring.
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DOCTOR | NOVEMBER ISSUE
The double-blind phase III trial ran-
domized 1,326 patients with HbA1c
7.0–9.0 percent who were on met-
formin ≥1,500 mg/day in a 1:1:1 ratio
to ertugliflozin 15 mg or 5 mg, or glime-
piride for 52 weeks.
In general, similar incidence of
drug-related AEs was reported across
treatment groups (21.6 percent and
18.3 percent, vs 17.8 percent), with
comparable rates of AEs leading to
discontinuation (5.7 percent and 4.0
percent, vs 3.9 percent). Rates of se-
rious AEs were low (0.7 percent and 0
percent, vs 0.2 percent). One and five
deaths were reported in the ertugliflozin
15 mg and 5 mg arms, respectively vs
one death in the glimepiride arm, but
none was considered to be related to
the study drugs, according to the in-
vestigators.
*VERTIS: eValuation of ERTugliplozin efficacy and
Safety
**SGLT2: Sodium glucose cotransporter 2
Podcast with
Dr Bob Ryder
Podcast with
Prof Melanie
Davies

Higher vitamin E intake may lower risk
of lung cancer
STEPHEN PADILLA
H
igher consumption of dietary
vitamin E provides protection
against lung cancer, according
to a meta-analysis.
“This study is the first meta-analysis
of the dose-response relationship be-
tween dietary vitamin E intake and the
risk of lung cancer,” researchers said.
“Our results indicated that dietary vita-
min E intake was significantly associat-
ed with a reduced risk of lung cancer.”
PubMed and Web of Science were
systematically searched for relevant
studies published from 1955 to April
2015. A random effect model was ap-
plied to estimate overall relative risks
(RRs) and 95 percent CIs if p<0.05 or
I2 >50 percent; otherwise, a fixed effect
model was used.
The funnel plot and Egger’s test
were used to estimate publication
bias. The dose-response relationship
was calculated using the method of
restricted cubic splines with four knots
at percentiles 5, 35, 65 and 95 of the
distribution.
The highest dietary vitamin E in-
take, compared with the lowest intake,
correlated with a reduced risk of lung
cancer (pooled RR, 0.84; 0.76–0.93;
I2, 41.1 percent). Based on subgroup
analysis by geographic location, dietary
vitamin E intake was inversely associ-
ated with lung cancer for the European
and American populations (pooled RR,
0.85; 0.75–0.95), but not for the Asian
population.
No significant association was ob-
served between dietary vitamin E in-
take and lung cancer risk in males or
females, but there was an inverse rela-
tionship between dietary vitamin E in-
NEWSBITES
take and lung cancer risk in mixed pop-
ulation (males and females). Moreover,
an inverse association existed between
dietary vitamin E intake and lung cancer
risk among current smokers, but not
among former or never smokers. [Asia
Pac J Clin Nutr 2017;26:271-277]
Analysis by dose response showed
that for every 2 mg/d increase in dietary
vitamin E intake, the risk of lung cancer
statistically dropped by 5 percent (RR,
0.95; 0.92–0.99; p=0.009 for linearity).
Sensitivity analysis revealed that no
individual study significantly influenced
the pooled effect. In addition, there was
no evidence of publication bias based
on the Egger’s test (t=1.24; p=0.246).
These findings need to be con-
firmed further by larger prospective
studies, according to researchers,
adding that the inverse relationship be-
tween dietary vitamin E intake and the
risk of lung cancer may be explained by
several mechanisms.
First, vitamin E is a power antiox-
idant with anti-inflammatory proper-
ties that protect cells and DNA from
36
44
DOCTOR | NOVEMBER ISSUE
reactive radicals. Second, it is capa-
ble of reducing nitrite and preventing
the production of carcinogenic nitro-
soamides and nitrosoamines. [Free
Radic Biol Med 2014;66:3-12; J Im-
munol 2015;195:126-133; J Exp Ther
Oncol 2012;10:107-112; Toxicology
2002;180:195-207]
“Additionally, vitamin E may pre-
vent carcinogenesis by down regulat-
ing the nuclear factor (NF)-κB signal-
ling pathway to inhibit cell proliferation
and angiogenesis, inducing apopto-
sis,” according to researchers. [J Biol
Chem 2007;282:809-820; Eur J Can-
cer B Oral Oncol 1996;32B:114-119;
Ann Med 1991;3:3-12; Science 1983;
221:1256-1264]
The current analysis has several
limitations. First, conclusions should
be applied with caution for other re-
gions since the included studies were
limited to America, Europe, and Asia.
Second, the studies did not report the
association between vitamin E intakes
and different histological types of lung
cancer. Thus, researchers could not
conduct the stratified analysis by his-
tological type.

Tracking change in personality as early indicator
of dementia may be futile
JAIRIA DELA CRUZ
C
hanges in personality traits do
not occur prior to the onset of
mild cognitive impairment (MCI)
or Alzheimer’s disease (AD), a study
has shown.
“The trajectory of personality traits
and facets for individuals who were
later diagnosed with MCI or dementia
did not differ significantly from that of
nonimpaired older adults,” according to
a team of investigators from the Flori-
da State University, Florida, US. “These
findings provide evidence against
the reverse causality hypothesis and
strengthen evidence for personality
traits as a risk factor for dementia.”
Using data from the Baltimore Lon-
gitudinal Study of Aging, the investiga-
tors analysed personality and clinical
assessments obtained over 36 years
from 2,046 community-dwelling older
adults (mean age at first assessment
62.56 years, 45.5 percent female) with
no cognitive impairment at baseline.
All participants completed the
Revised NEO Personality Inventory, a
240-item questionnaire evaluating six
facets for each of the five major di-
mensions: neuroticism, extraversion,
openness, agreeableness, and con-
scientiousness.
During 24,569 person-years, 104
(5.1 percent) participants developed
MCI and 255 (12.5 percent) were diag-
nosed with all-cause dementia, includ-
ing 194 (9.5 percent) with AD. Partici-
pants with dementia scored significantly
higher on neuroticism (p<0.001) and
lower on conscientiousness (p<0.001)
and extraversion (p=0.02) relative to
those without cognitive impairment.
[JAMA Psychiatry 2017;doi:10.1001/
jamapsychiatry.2017.2816]
NEWSBITES
However, the rate of change in per-
sonality traits was similar between the
AD and nonimpaired groups (eg, neu-
roticism, p=0.91; conscientiousness,
p=0.24). There was also no evidence of
accelerated change in personality in the
MCI group (eg, neuroticism, p=0.98;
conscientiousness, p=0.18) and all-
cause dementia group (eg, neuroticism,
p=0.49; conscientiousness, p=0.07) vs
the nonimpaired group.
“We further found that personality
remained stable even within the last few
years before the onset of the disease,
and the high rank-order correlations
supported the reliability of the data,” the
investigators said.
The differences of approximately
0.3-SD between the AD and nonim-
paired groups on the intercept of neu-
roticism and conscientiousness were
said to be not an emerging prodromal
sign of the disease and were in line with
results from other prospective studies.
[Alzheimers Dement 2014;10:179-186;
J Psychiatr Res 2017;89:22-27]
“From a clinical perspective, these
findings suggest that tracking change
38
46
DOCTOR | NOVEMBER ISSUE
in self-rated personality as an early indi-
cator of dementia is unlikely to be fruit-
ful, while a single assessment provides
reliable information on the personality
traits that increase resilience [eg, con-
scientiousness] or vulnerability [eg,
neuroticism] to clinical dementia,” they
continued.
The investigators pointed out that
the lack of evidence suggesting that
neuroticism and conscientiousness
changed significantly as the onset of
the disease approached indicates that
such traits may confer risk for the de-
velopment of AD rather than an effect
of disease neuropathology.
The study is not without limitations.
Among those that were cited included
the use of a selective sample with a
higher educational level and the rela-
tively younger age of nonimpaired par-
ticipants.
“More research is needed on person-
ality and AD biomarkers, and how per-
sonality may increase resilience against
neuropathology and forestall the emer-
gence of clinical dementia,” the investiga-
tors said.
 RESEARCH REVIEW

GERD linked to
Music therapy of no
hypertension:
help in autism
Can PPI control both?

G
astro-oesophageal reflux disease (GERD) is correlated
with hypertension, and treatment with a proton pump
inhibitor (PPI) may help to restore oesophageal PH
and control blood pressure (BP), according to a study.

Researchers sought to investigate the impact of 14-day

therapy with omeprazole 20 mg twice daily in patients with
essential hypertension. Patients were monitored of their BP
continuously for 24 hours as well as their pH.

Of 86 essential hypertension patients, 38 had GERD.

There were 494 episodes of pathologic reflux (PR), and 684
episodes of high BP recorded. PR was significantly more

M
common at night time when in supine position (p=0.003).
Of the 684 episodes of hypertension, 102 were synchro-
nous with PR. GERD patients had significantly higher noctur-
nal BP than non-GERD patients. There was a correlation in
the frequencies of high BP and PR episodes in 24-hour period
(p=0.011).
PPI therapy led to significant reduction in oesophageal
monitoring parameters (DeMeester score, total duration for
which pH remained <4, percentage duration for which pH
was <4 in the upright and recumbent positions, number
of times pH decreased to <4, number of PR episodes and
PR-dependent BP episodes; p<0.05 for all) and improvement
in BP parameters (p<0.05 for all).
Based on these results, GERD reduction could be used
as an adjunctive therapy for essential hypertension, said the
authors. What is not clear is whether hypertension occurred
before or after onset of reflux.
usic therapy has been shown in previous trials to have
positive effects in patients with autism spectrum dis-
order (ASD), but a new study showed it was not the
case, contrary to expected results.
In the current study, researchers sought to determine
whether music therapy had long-term benefits in children aged
4-7 years with ASD who were naïve to music therapy a year
prior to study entry. Follow-up was up to 1 year after enrolment.
The children were randomly assigned to a control group or
to a low-intensity, once-weekly music therapy or a high-inten-
sity (thrice weekly) music therapy. Each music therapy session
lasted for 30 minutes. The children also received enhanced
standard of care for ASD and were reassessed at 2, 5, and 12
months after randomization.
The primary outcome was a measure of social affect, com-
paring baseline scores with results after 5 months of intervention.

Li ZT et al. The role of gastroesophageal reflux in provoking high blood pressure

episodes in patients with hypertension. J Clin Gastroenterol 2017;doi: 10.1097/
MCG.0000000000000933.
At the end of the study, both the treatment and control
groups had a slight reduction in social affect scores. However,
there was no significant difference in outcome between the mu-
sic therapy and control groups. Improvisational music therapy
added to enhanced standard of care did not provide a benefit
in social affect functioning for children with ASD.

The researchers said the results are very disappointing for

parents and healthcare professionals caring for children with
ASD.

Bieleninik L, et al. Effects of improvisational music therapy versus enhanced

standard care on symptom severity among children with autism spectrum disorder:
the TIME-A randomized clinical trial. JAMA 2017;318:525-535.

39
47
DOCTOR | NOVEMBER ISSUE
 CLINICAL INSIGHTS | IN PRACTICE
Managing diabetes
in primary care
D
iabetes is the 3rd most common
condition attended by GPs in
Singapore polyclinics. The Na-
tional Health Survey 2010 showed that
11.3 percent of residents in Singapore
aged 18–69 years have diabetes.
Dr Teh Ming Ming
More recent figure in 2014 showed
that about 440,000 residents in Singa-
pore aged ≥18 years have diabetes.
Vast majority of these cases are type
2 diabetes (T2D). However, many pa-
tients are unaware that they actually
have diabetes, necessitating efforts to
raise awareness on the symptoms and
implications of undiagnosed diabetes.
Diagnosing diabetes
Some of the key symptoms of dia-
betes include frequent urination, exces-
sive thirst, extreme fatigue, blurred vi-
sion, and slow healing wounds. Missed
opportunity of detecting diabetes early
may lead to complications involving tar-
get organ damage such as retinopathy,
nephropathy, and neuropathy.
Pearl Toh spoke with Diabetes can be diagnosed when
any one of the following conditions is
Dr Teh Ming Ming,
present: random plasma glucose of
senior consultant at the ≥11.1 mmol/L, fasting plasma glucose
Department of of ≥7 mmol/L, or plasma glucose of
Endocrinology, ≥11.1 mmol/L in the 2-hour oral glu-
Singapore General cose tolerance test. In the event of
Hospital (SGH), on the disagreement between the different di-
agnostic tests, testing can be repeated.
major challenges of
diagnosing and A major challenge in diagnosing di-
managing diabetes abetes is the lack of knowledge on di-
in primary care, abetes symptoms at the patient level,
in conjunction with the which could lead to them not seeking
World Diabetes Day medical help earlier and hence, un-
derdiagnosis of the disease.
on 14 November.
Awareness of the GPs should be vigilant of the risk
symptoms of diabetes is factors of diabetes – such as obesity,
important, and patients hypertension, and hyperlipidaemia –
should be empowered to and encourage patients with these risk
manage their conditions. factors to go for diabetes screening.
This can facilitate early detection of di-
40
48
DOCTOR | NOVEMBER ISSUE
abetes in patients who are unaware of
their condition. For some, lifestyle mod-
ifications may even alter the course of
diabetes, especially during the early
phase of the disease.
Managing diabetes
The key aims of diabetes man-
agement are to control blood glucose
levels to within the normal range and
to minimize the risk of developing dia-
betes complications. GPs can achieve
this goal through appropriate use of
diabetes pharmacotherapy and em-
powering the patients with knowledge
of diabetes management.
Metformin is the starting point for
most T2D patients if there is no obvious
contraindication. Dual therapy with the
addition of sulphonylureas, dipeptidyl
peptidase-4 inhibitors, thiazolidinedi-
ones, sodium-glucose cotransporter-2
inhibitors, glucagon-like peptide 1 re-
ceptor agonists, or basal insulin can be
considered if glycaemic control remains
suboptimum. Triple therapy can be con-
sidered if dual therapy fails to achieve
the optimum glycaemic control.
GPs should consider referring T2D
patients to a specialist if triple therapy
or combination injectable therapy is
being considered. Nonetheless, this
depends largely on how comfortable
are the GPs in managing complex di-
abetes regimens. On the other hand,
GPs should consider referring all type 1
diabetes (T1D) patients to a specialist.
For reference, GPs can consult
the Ministry of Health Clinical Prac-
tice Guidelines. [Singapore Med J
2014;55:334-347]
Major challenge – hypoglycaemia
One major challenge in diabetes
treatment lies in striking the right balance
between achieving the optimum blood
glucose control and minimizing the risk

of hypoglycaemia. Hypoglycaemia oc-
curs when blood glucose level falls to <4
mmol/L. Typical signs and symptoms of
hypoglycaemia include tremor, exces-
sive sweating, dizziness, palpitation, and
double vision, among others.
It is important to educate diabetes
patients about the symptoms and im-
plications of hypoglycaemia and to ask
for the occurrence of hypoglycaemia at
every clinic consultation. When blood
glucose drops to a very low level, the
higher executive functions of the brain
will be severely compromised, which
will pose hazards when performing
complex task such as driving or oper-
ating a machine.
Another important implication re-
lates to self-treatment of hypoglycae-
mia – the brain is no longer able to
make sensible decision on managing
hypoglycaemia if the blood glucose
drops to a critically low level. In the
case of severe hypoglycaemia – which
occurs when the patients need help
from others in treating their low blood
glucose levels – this can result in loss of
consciousness, seizure or even death if
not intervened in time.
CLINICAL INSIGHTS | IN PRACTICE
Particularly, older patients are at a mia due to diminished symptomatic
higher risk of severe hypoglycaemia. responses to hypoglycaemia, termed
This can be potentially devastating as impaired awareness of hypoglycaemia
many older patients may be living alone (IAH). IAH is a significant risk factor for
or spending most part of the day alone. severe hypoglycaemia.
The resulting loss of consciousness
can lead to fall with fractures or signifi- Patients who are at high risk of IAH
cant head injury. include:
(i) T1D patients with tight glycaemic
Therefore, empowering patients control and long duration of dia-
with the basic knowledge of diabetes betes, and
and hypoglycaemia management will (ii) T2D patients with tight glycaemic
complement the efforts of GPs in opti- control.
mizing diabetes control.
Conclusion
What patients can do in managing Pharmacotherapy is only one part
hypoglycaemia of diabetes treatment. Empowering
To avoid hypoglycaemia, patients diabetes patients with the necessary
should follow a regular meal pattern and knowledge and skill in managing diabe-
regularly monitor their blood glucose tes constitutes another important part
levels for those on insulin treatment. of diabetes care. Therefore, GPs should
Most patients can self-treat hypogly- engage their patients in diabetes care.
caemia by ingestion of carbohydrate
or glucose before their blood glucose
drops to a critical level.
Online Resources
They should also avoid unaccus-
tomed exercise. If the frequency and European Association for the Study
intensity of exercise is increased, care of Diabetes
must be taken by checking blood glu- www.easd.org
cose levels before, during, and after American Diabetes Association
the exercise such that adjustments of www.diabetes.org
diabetes medications or carbohydrate
intake can be made when necessary.
What GPs can do in managing
hypoglycaemia
Actively looking out for patients with
problematic hypoglycaemia is a good
move to improve diabetes care. There
Scan the
are some clinical tools which have been
QR code to
developed to pick up patients with
view more of
problematic hypoglycaemia. One of the
MIMS clinical
user-friendly clinical tools is the Gold
news
questionnaire, which takes less than 10
seconds for the patient to complete. A
score of ≥4 may indicate problematic
hypoglycaemia.
The questionnaire is aimed at pick-
ing up diabetes patients who have a
reduced ability to detect hypoglycae-
41
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DOCTOR | NOVEMBER ISSUE
 CALENDAR

NOVEMBER NOVEMBER DECEMBER

17-19
FRIDAY - SUNDAY
23-26
THURSDAY - SUNDAY
02-04
SATURDAY - MONDAY

European Society for Medical
Oncology (ESMO) Asia 2017
Congress
Location: Singapore
Tel: +41 0 91 973 19 26
Email: congress@esmo.org
Website: www.esmo.org/Conferences/ES-
MO-Asia-2017-Congress
22nd Congress of the ESO-ESMO-RCE Clinical Update
Asian Pacific Society of on Rare Adult Solid Cancers
Respirology (APSR) 2017
Location: Sydney, Australia Location: Milan, Italy
Tel: +64 9 360 1240 Fax: +39 0223902531
Fax: +64 9 360 1242 Email: raretumours@eso.net
Email: apsr@tcc.co.nz Website: www.esmo.org/Conferences/ESO-
Website: www.apsr2017.com ESMO-RCE-Clinical-Update-on-Rare-Adult-
Solid-Cancers-2017

DECEMBER DECEMBER DECEMBER

05-09
TUESDAY - SATURDAY
09-12
SATURDAY - TUESDAY
18-19
MONDAY - TUESDAY

San Antonio Breast Cancer
Symposium (SABCS) 2017
Location: San Antonio, Texas, US
Tel: 210 450 1550
Fax: 210 450 1560
Email: sabcs@uthscsa.edu
Website: www.sabcs.org/2017-SABCS
59th ASH Annual Meeting & 19th International Conference
Exposition on Human Genetics (ICHG 2017)
Location: Atlanta, Georgia, US Location: Bangkok, Thailand
Tel: 866 828 1231 Website: www.waset.org/confer-
Website: www.hematology.org/Annual-Meet- ence/2017/12/bangkok/ICHG
ing

JANUARY 2018 FEBRUARY 2018 FEBRUARY 2018

18-20
THURSDAY - SATURDAY
05-07
MONDAY - WEDNESDAY
08-10
THURSDAY - SATURDAY

American Society of Clinical
Oncology (ASCO) 2018 Gastroin-
testinal Cancers Symposium
Location: San Francisco, CA, US
Tel: 888 282 2552, 703 299 0158
Fax: 703 299 0255
Email: customerservice@asco.org
Website: ww.asco.org
ESMO Sarcoma and GIST
Symposium 2018
Location: Milan, Italy
Tel: +41 0 91 973 19 47
Fax: +41 0 91 973 19 18
E-mail: symposia@esmo.org
Website: www.esmo.org/Conferences/Sar-
coma-GIST-2018
2018 Genitourinary Cancers
Symposium
Location: San Francisco, CA, US
Tel: 888 282 2552; 703 299 0158
Email: customerservice@asco.org
Website: www.gucasym.org

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DOCTOR | NOVEMBER ISSUE