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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