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Echocardiographic Examination of Women Previously Treated With Fenfluramine
Long-term Follow-up of a Randomized, Double-blind, Placebo-Controlled Trial
Ravin Davidoff, MB, BCh;
Anne McTiernan, MD, PhD;
Ginger Constantine, MD;
Kelly D. Davis, MD;
Gary J. Balady, MD;
Lisa A. Mendes, MD;
Rebecca E. Rudolph, MD, MPH;
Deborah J. Bowen, PhD
Arch Intern Med. 2001;161:1429-1436.
Background Fenfluramine hydrochloride was withdrawn from the market in September
1997 after reports of heart valve abnormalities in patients who used it. The
prevalence of echocardiographic abnormalities and the clinical cardiovascular
status of patients who received fenfluramine monotherapy remains uncertain.
Methods A long-term, follow-up evaluation was undertaken in subjects who were
randomly assigned to receive either fenfluramine hydrochloride (60 mg daily)
or placebo as part of a double-blind smoking cessation therapy study. Cardiovascular
status was evaluated by echocardiography, medical history, and physical examination.
Results From the group of 720 smokers who had originally participated in the
smoking cessation therapy trial, 619 women were enrolled; data from 530 (276
in the fenfluramine group and 254 in the placebo group) were evaluable. No
statistically significant differences were identified in the prevalence of
aortic or mitral regurgitation by Food and Drug Administration criteria or
by grade, aortic or mitral valve leaflet mobility restriction or thickening,
elevated pulmonary artery systolic pressure, or abnormal left ventricular
ejection fraction. No significant differences were demonstrated in cardiovascular
status by physical examination, and no serious cardiac events were noted among
fenfluramine-treated subjects.
Conclusion There was no evidence of drug-related heart disease up to 4.9 years
after anorexigen therapy in subjects who were randomly assigned to receive
fenfluramine at the recommended dose for up to 3 months.
From the Section of Cardiology, Evans Department of Medicine, Boston
University Medical Center, Boston, Mass (Drs Davidoff, Balady, and Mendes);
Cancer Prevention Research Program and Women's Health Initiative, Fred Hutchinson
Cancer Research Center, Seattle, Wash (Drs McTiernan, Rudolph, and Bowen);
and Wyeth-Ayerst Research, Philadelphia, Pa (Drs Constantine and Davis).
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Fenfluramine and Valvular Heart Disease
Journal Watch Cardiology 2001;2001:10-10.
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Fenfluramine and Valvular Heart Disease
JWatch General 2001;2001:2-2.
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