Low prevalence of valvular heart disease in 226 phentermine-fenfluramine protocol subjects prospectively followed for up to 30 months

• Published in: Journal of the American College of Cardiology Vol. 34; no. 4; pp. 1153 - 1158
• Main Authors: Burger, Andrew J, Sherman, Howard B, Charlamb, Mark J, Kim, Juhee, Asinas, Laura A, Flickner, Stacy R, Blackburn, George L
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.10.1999
• Subjects: Adult; Appetite Depressants - adverse effects; Appetite Depressants - therapeutic use; Echocardiography, Transesophageal; Female; Fenfluramine - adverse effects; Fenfluramine - therapeutic use; Follow-Up Studies; Heart Valve Diseases - chemically induced; Heart Valve Diseases - diagnostic imaging; Heart Valve Diseases - epidemiology; Humans; Male; Middle Aged; Phentermine - adverse effects; Phentermine - therapeutic use; Risk; ECG; FDA; phen-fen
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/S0735-1097(99)00321-6

OBJECTIVES This investigation sought to determine the effect of phentermine-fenfluramine (phen-fen) on the prevalence of valvular heart disease in 226 obese subjects enrolled in a prospective, strict weight loss, research protocol. BACKGROUND Early reports have suggested that the use of phen-fen for weight loss may be associated with increased valvular heart disease. Such reports were based on small numbers of patients, limited data on dose and duration of phen-fen therapy, and no correlation with matched controls. METHODS All subjects underwent transthoracic echocardiography for significant valvular lesions within a mean of 97 days from the manufacturer’s announcement of the voluntary withdrawal of fenfluramine and dexfenfluramine. All echocardiograms were interpreted by two independent readers. RESULTS The study population included 183 women and 43 men with a mean age of 46.9 ± 8.9 years and mean starting body mass index of 39.8 ± 7.7 kg/m2. Using the Food and Drug Administration criteria, significant aortic regurgitation was detected in 15 subjects (6.6%) and mitral regurgitation in 3 subjects (1.3%). Only one patient had significant regurgitation of both aortic and mitral valves. No valves had severe regurgitation. Significant valvular disease did not correlate with the dose or duration of phen-fen therapy. Furthermore, the prevalence of valvular regurgitation is comparable to the normal offspring in the Framingham Heart Study, who are similar in age, gender, and geographical location. CONCLUSIONS Phen-fen therapy is associated with a low prevalence of significant valvular regurgitation. Valvular regurgitation in our subjects may reflect age-related degenerative changes.