Echocardiographic examination of women previously treated with fenfluramine: long-term follow-up of a randomized, double-blind, placebo-controlled trial.
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Fenfluramine hydrochloride was withdrawn from the market in September 1997 after reports of heart valve abnormalities in patients who used it.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.


CONCLUSIONS
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.
Davidoff
R
R
Section of Cardiology C8, Boston University Medical Center, 88 E Newton St, Boston, MA 02118-2393, USA. ravin.davidoff@bmc.org
McTiernan
A
A
Constantine
G
G
Davis
K D
KD
Balady
G J
GJ
Mendes
L A
LA
Rudolph
R E
RE
Bowen
D J
DJ
D000293:Adolescent; D000328:Adult; D000368:Aged; D015992:Body Mass Index; D004311:Double-Blind Method; D004452:Echocardiography / Q000379:methods; D005260:Female; D005277:Fenfluramine / Q000008:administration & dosage / Q000009:adverse effects*; D005500:Follow-Up Studies; D006349:Heart Valve Diseases / Q000139:chemically induced* / Q000175:diagnosis; D006801:Humans; D008875:Middle Aged; D018490:Serotonin Agents / Q000008:administration & dosage / Q000009:adverse effects*; D012720:Severity of Illness Index; D016540:Smoking Cessation / Q000379:methods
D018490:Serotonin Agents; D005277:Fenfluramine