Clinical Research For Diet Drug Related Cardiac

Diseases

It is an open alert that the occurrence of obesity has reached and

has taken an epidemic form, with trends in cardiovascular risk
factors such as hypertension and diabetes that rise in parallel
leading to an excess of cardiovascular issues.

There is a need for treatment that can reduce the body mass index.
But, using anorexigens is a pricey matter. The most common drug-
associated method of weight loss makes use of the serotonin
pathways to suppress appetite and hence lower weight. To mention,
these agents have shown to lead to heart disease related to valves
very much similar to carcinoid heart disease.

It was never graphically demonstrated than the reports of the

observational Connolly et al; which worked with 24 overweight
subjects with mitral and aortic regurgitation associated with the
phentermine- fenfluramine combination. The FDA next received
additional reports of requests from more than 700,000 doctors and
institutions finally leading to the request for voluntary withdrawal of
dexfenfluramine and fenfluramine.

Irony, these agents are still available and can be used in research
for other indications, and newer, more sophisticated iterations of
these diet drugs are under evaluation. Hence there is still potential
for valve related risks. This writing reflects on case definitions of
significant valvular disease, and appropriate surveillance measures
for cardiac valve disease, and medical management.

Case Definitions

The valvular lesions are noted on both sides of the heart, a left side
valve is affected in most cases, and hence case definitions are
focused on left heart valvular lesions. Minimal degrees of
regurgitation are seen often in the overall population, which is not
considered abnormal. Minimal regurgitation is considered trace
aortic regurgitation and trace to mild mitral regurgitation. Moderate
or greater mitral regurgitation and mild or greater aortic
regurgitation meets the FDA Criteria for the case definition of diet-
drug associated valvulopathy after exposure to these agents.

Surveillance Steps for Diet-Drug Induced Valvular Issues

Echo provides a simple and easy way to perform and accurate

method of documenting and quantifying cardiac valvular disease
and thus is the method of choice for valvulopathy surveillance. Both
the 2D and Doppler echo must be performed to examine for cardiac
valvular disease. 2D echo can be used to assess for vavlular
fibrosis. Moreover 2D allows for optimization of the angle of
inference for your Doppler probe examination, which can have a
essential effect on how accurately the valvular regurgitation is
quantified. Quantification of the lesions must be in accordance with
the legalised guidance.

This full echo examination must be done at baseline for all patients
that will be given these agents. The echo examinations must be
repeatedly performed within 6 months and next within 12 months
for patients who are on the drugs for more than 3 months duration.

Data clearly states that diet drug uses for less than 6 months is
associated with a much lower prevalence of valvular lesions than
diet drug use of 6 months or more. If this surveillance will be part
of an observational or randomized controlled study, which will be
reviewed by health authorities, then echo readings should be
performed by an echo core reading lab facility rather than a central
reader. Echo care labs will have quality control measures in place
that will prevent temporal reader drift. Moreover the readings could
be well organised.

Management

Usually the valvular lesions stabilize or regress when on

discontinuation of the diet drugs and hence, it is enough to
continue to monitor the lesion similar to monitoring non-diet drug
valvular lesions, so long the lesion is not severe. Severe
regurgitation must be treated similar to non-diet drug related
valvulopathy with medication or surgery as the need. To mention,
there are no guidelines for management of diet-drug valvulopathy,
hence until specific guidelines are available, the clinician must
consider managing these patients using the general valvular
regurgitation section of the accepted guidelines for managing
valvular heart disease.

This data will definitely impact current and future clinical researches
with weight loss drugs.

We conclude the discussion here. Stay connected with us this space

for more discussions.

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