THE PREVALENCE OF CARDIAC VALVULAR INSUFFICIENCY ASSESSED BY TRANSTHORACIC ECHOCARDIOGRAPHY IN OBESE PATIENTS TREATED WITH APPETITE-SUPPRESSANT DRUGS

Background. After case reports of cardiac-valve abnormalities related to the use of appetite suppressants were published, we undertook a stu dy to determine the prevalence of the problem using transthoracic echo cardiography. Methods. We examined patients who had taken dexfenfluram ine alone, dexfenfluramine and phentermine, or fenfluramine and phente rmine for various periods. We enrolled obese patients who had taken or were taking these agents during open-label trials from January 1994 t hrough August 1997. We also recruited subjects who had not taken appet ite suppressants and who were matched to the patients for sex, height, and pretreatment age and body-mass index. The presence of cardiac-val ve abnormalities, defined by the Food and Drug Administration and Cent ers for Disease Control and Prevention as at least mild aortic-valve o r moderate mitral-valve insufficiency, was determined independently by at least two cardiologists. Multivariate logistic-regression analysis was used to identify factors associated with cardiac-valve abnormalit ies. Results. Echocardiograms were available for 257 patients and 239 control subjects. The association between the use of any appetite supp ressant and cardiac-valve abnormalities was analyzed in a final matche d group of 233 pairs of patients and controls. A total of 1.3 percent of the controls (3 of 233) and 22.7 percent of the patients (53 of 233 ) met the case definition for cardiac-valve abnormalities (odds ratio, 22.6; 95 percent confidence interval, 7.1 to 114.2; P < 0.001). The o dds ratio for such cardiac-valve abnormalities was 12.7 (95 percent co nfidence interval, 2.9 to 56.4) with the use of dexfenfluramine alone, 24.5 (5.9 to 102.2) with the use of dexfenfluramine and phentermine, and 26.3 (7.9 to 87.1) with the use of fenfluramine and phentermine. C onclusions. Obese patients who took fenfluramine and phentermine, dexf enfluramine alone, or dexfenfluramine and phentermine had a significan tly higher prevalence of cardiac valvular insufficiency than a matched group of control subjects. (N Engl J Med 1998;339:713-8.) (C) 1998, M assachusetts Medical Society.