Clinical Research For Diet Drug Related Cardiac Diseases

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 drugassociated 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 dietdrug 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.

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