Echocardiographic improvement over time after cessation of use of fenfluramine
and phentermine.
Author(s): Hensrud DD, Connolly HM, Grogan M, Miller FA, Bailey KR, Jensen MD.
Affiliation(s): Division of Preventive and Occupational Medicine and Internal Medicine, Mayo
Clinic Rochester, Minn 55905, USA.
Publication date & source: 1999, Mayo Clin Proc. , 74(12):1191-7
OBJECTIVE: To determine the echocardiographic changes over time of valvular heart
lesions in patients who took the weight loss drugs fenfluramine and phentermine.
SUBJECTS AND METHODS: This prospective cohort study began at the termination of a
randomized, double-blind, placebo-controlled weight loss trial of 18 obese women
and 13 obese men (mean age, 42 years; mean body mass index, 33.4 kg/m2) who had
been assigned randomly to treatment with fenfluramine and phentermine or to
placebo. Echocardiograms were obtained at termination of the trial when
fenfluramine was withdrawn from the market and 6 months later. They were
interpreted independently by 3 cardiologists blinded to treatment assignment and
temporal sequence of the echocardiograms. The main outcome measure was the change
in drug-related valvular disease over time.
RESULTS: One subject assigned to receive the drugs was lost to follow-up, and 3
subjects who did not meet a weight loss goal of 10 kg crossed over from placebo
to drug treatment. Echocardiograms were obtained in 19 subjects who received the
drugs and 11 subjects who received placebo, and 6-month follow-up echocardiograms
were obtained in 15 subjects who received the drugs and 3 who received placebo.
Subjects had taken fenfluramine and phentermine a mean of 41 weeks (range, 8-73
weeks). Five of 19 subjects who received the drugs (26%; 95% confidence interval,
7%-46%) and 1 of 11 who received placebo (9%) (odds ratio, 3.6; 95% confidence
interval, 0.4-35.6) had findings that met criteria established for drug-related
valvular disease. All 5 subjects (4 women and 1 man) receiving the drugs had mild
aortic regurgitation, and 1 also had pulmonary hypertension (estimated pulmonary
artery pressure, 59 mm Hg). Six months later, the echocardiographic findings had
improved in all 5 subjects (P=.06), and 3 no longer met the criteria for
drug-related valvular disease. Pulmonary artery pressures decreased to near
normal in the subject with pulmonary hypertension (37 mm Hg). Overall, the
echocardiographic valvular features improved in 8 of 15 subjects who received the
drugs and had echocardiograms performed at both time periods (P=.008).
CONCLUSIONS: Valvular heart disease did not appear to progress after cessation of
use of fenfluramine and phentermine, and echocardiographic valvular features
appeared to improve over time.
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