Absence of cardiac valve dysfunction in obese patients treated with sibutramine

Objective: Serotonin-releasing agents prescribed as weight-loss medications have been implicated as a cause of acquired aortic and mitral valve abnorm alities. Sibutramine hydrochloride (MERIDIA(R)) is a serotonin and norepine phrine reuptake inhibitor with proven efficacy of weight reduction. The pur pose of this study was to determine the incidence of cardiac valve disease in sibutramine-treated patients. Research Methods and Procedures: Obese patients with type 2 diabetes mellit us enrolled in an ongoing double-blind, placebo-controlled, parallel-arm, 1 2-month study of sibutramine (followed by a 12-month open label extension) underwent transthoracic echocardiographic imaging and color Doppler interro gation for assessment of cardiac valve anatomy and function. Results: A total of 210 patients were evaluated. Of these, 133 were receivi ng sibutramine (72 in the double-blind period), and 77 were receiving place bo. The mean +/- Standard Deviation age was 54 +/- 9 years, and the mean du ration of treatment was 229 +/- 117 days (approximately 7.6 months). The pr evalence of left-sided cardiac valve dysfunction was low and similar for th e two treatment groups (sibutramine 3/133, or 2.3%; placebo 2/77, or 2.6%). All five cases were cases of aortic insufficiency; four were mild, one was severe (in a placebo patient). All three sibutramine cases were patients o ver age 50; two had a history of systemic hypertension. Conclusion: The prevalence of left-sided cardiac valve dysfunction was not higher than background in obese patients treated with sibutramine for an av erage of 7.6 months.