Cefpodoxime vs Ciprofloxacin

for short-course treatment

of
Acute Uncomplicated Cystitis
Faculty of Medicine
USU

Scenario
Seorang perempuan, 40 tahun datang ke dokter keluarganya dengan
keluhan sakit ketika buang air kecil dan sering buang air kecil, serta nyeri
pada daeh suprapubic. Setelah melakukan anamnesis dan pemeriksaan
fisik, dokter menduga ibu tersebut mengalami cystitis akut.
Saat akan memberikan obat, dokter tersebut mendapatkan brosur dari
petugas pemasaran obat tentang Cefpodoxime ( cephalosporin oral
generasi ketiga ), yang dianggap lebih efektif dari obat yang sudah
digunakan sebelumnya.
Bagaimana penilaian terhadap obat tersebut? Apakah bermanfaat atau
tidak untuk pengobatan Acute Uncomplicated Cystitis ( AUC) ?

A. Are the results of this single preventive or therapeutic trial valid? ?

Was the assignment of patients to

treatments randomized?
Was the randomization list concealed?
Was follow-up of patients sufficiently long
and complete?

yes, pg 3 methods @study procedure1

Were all patients analyzed in the groups to

which they were randomized?

yes, pg4 methods @Statystical analysis4

Were patients, clinicians, and study

personnel kept blind to treatment?

yes, pg 3 methods @study procedure5

Were the groups treated equally, apart from

the experimental treatment?

no, different baseline pg5 Results6

Were the groups similar at the start of the

trial apart from the experimental therapy?

yes, pg 3 inclusion exclusion criteria

@study population7

yes, pg 3 methods @study procedure2

yes, no loss of follow up > 20%
pg 3 methods @study procedure3

A1
A2
A3

A4

A5

A6

A7

B. Are the valid results of this randomized trial important?

What is the magnitude of the
treatment effect?

CER, EER, RRR, ARR,NNT

How precise is the estimate of the

treatment effect?

CI

Clinical Cure

Yes

No

Total

Experiment
Cefpodoxime

106

44

150

Control
Ciprofloxacin

124

26

150

= 0,1733

= 0,2933

= - 0,70588

= - 0,12

YOUR CALCULATIONS

Relative risk reduction

(RRR)

CER

EER

CER EER
CER

0,17

0,29

-0,70
95% CI

Absolut
Number
e risk needed to treat
reducti
(NNT)
on
(ARR)
CER EER
1/ARR
-0,12

-8

C. Can you apply this valid, important evidence about

therapy in caring for your patient?
Do these results apply to our patient?
Is our patient so different from those in the study
No
that its results cannot apply?
Is the treatment feasible in our setting?
Yes, those drugs are available
What are our patients potential benefits and harms from the therapy?
Method I : f
Risk of the outcome in our patient, relative to patients in
the trial.
Expressed as a decimal:______
NNT/f=___-8__/__1____=__-8____
Method II : 1/(PEER RRR)

(NNT for patients like ours)

Our patients expected event rate if they received the
control treatment (PEER) =______
1/(PEER RRR)=1/________=______

(NNT for patients like ours)

Are our patients values and preferences satisfied by the regimen and its consequences?
Do we and our patient have a clear assessment of their
No, because our patient dont have secondary
values and preferences?
outcome
Are they met by this regimen and its consequences?
No

Kesimpulan
Cefpodoxime dengan regimen 3 hari tidak memenuhi
kriteria noninferioritas terhadap ciprofloxacin dalam
pengobatan Acute Uncomplicated Cystitis
Dalam menelaah uji klinis, diperlukan pemahaman
komprehensif antara berbagai aspek meliputi
1.
2.
3.
4.

Klinis
Etik
Muatan local ( social, budaya,)
Ekonomi

THANK YOU