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What Happens to Heart Valve Damage Caused by Diet Drugs after Treatment with the Drug Has Been Stopped? FREE

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The summary below is from the full report titled “The Progression of Fenfluramine-Associated Valvular Heart Disease Assessed by Echocardiography.” It is in the 20 February 2001 issue of Annals of Internal Medicine(volume 134, pp 261-266). The authors are ST Mast, JG Jollis, T Ryan, KJ Anstrom, and JL Crary.


Ann Intern Med. 2001;134(4):S78. doi:10.7326/0003-4819-134-4-200102200-00003
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What is the problem and what is known about it so far?

In 1997, two drugs used to decrease appetite, fenfluramine and dexfenfluramine, were found to cause abnormalities of the heart valves in up to one third of people who had taken them. As a result, these drugs were withdrawn from the U.S. market. No one knows with certainty, however, what happens to heart valve function once treatment with these drugs have been stopped.

Why did the researchers do this particular study?

To find out whether valve abnormalities got better, got worse, or stayed the same after treatment with fenfluramine drugs has been stopped.

Who was studied?

Fifty patients with at least mild abnormalities of the heart valves who had taken fenfluramine drugs (sometimes in combination with other diet drugs) and were followed for at least 100 days after treatment with the drug had been stopped.

How was the study done?

All patients had a first echocardiogram after stopping treatment with the drug and had a second echocardiogram at least 100 days later. (An echocardiogram is a picture of the heart created by using sound waves; it can be used to look at heart valve function.) All echocardiograms were reviewed by two cardiologists who did not know which study was performed first. The specific valve involved, type of abnormality, and severity of damage were recorded.

What did the researchers find?

The two valves on the left side of the heart (mitral and aortic) were most commonly affected, allowing blood to leak backward after the valve should have closed completely (regurgitation). On the first echocardiogram, 38 patients had abnormal mitral valve function; on the follow-up echocardiogram, valve function was unchanged in 19 patients, had improved in 17 patients, and had worsened in 2 patients. Among the 43 patients with aortic valve abnormality on the first echocardiogram, this abnormality remained unchanged in 22 patients, had improved in 19 patients, and had worsened in 2 patients. The two valves on the right side of the heart (tricuspid and pulmonic) were less commonly affected. Tricuspid abnormality was found initially in 29 patients; during follow-up, 9 patients had no change, 18 had improved, and 1 had worsened. Pulmonic abnormality was found initially in 11 patients; 1 had no change and 9 improved during follow-up.

What were the limitations of the study?

Patients in the study had echocardiograms because problems suggesting heart disease had developed. People who took the drug but did not develop symptoms suggesting heart problems were not studied. Moreover, for the many patients who initially had severe valve abnormalities, the only change that could be observed was improvement. The researchers also could not tell if the patients had heart valve damage before they took the diet drugs. Finally, the follow-up period was relatively short.

What are the implications of the study?

Most heart valve abnormalities that developed in people who took the diet drugs fenfluramine and dexfenfluramine improved or remained stable over time after they stopped taking the drug, although a few became worse.

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