Clinical Research For Diet Drug Related Cardiac Diseases

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Clinical Research For Diet Drug Related Cardiac
Diseases
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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.
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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.
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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.
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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.
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Conclusion
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