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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Background  Fenfluramine hydrochloride was withdrawn from the market in September 1997 after reports of heart valve abnormalities in patients who used it.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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