Clinical and echocardiographic follow-up of patients previously treated with dexfenfluramine or phentermine/fenfluramine

Context Use of anorexigen therapy is associated with valvular abnormalities , although there is limited information on long-term changes in valvular re gurgitation following discontinuation of these agents. Objective To evaluate changes in valvular regurgitation, valve morphology, and clinical parameters 1 year after an initial echocardiogram in patients previously treated with dexfenfluramine or phentermine/fenfluramine and in untreated controls. Design and Setting A reader-blinded, multicenter, echocardiographic and cli nical 1-year follow-up study at 25 outpatient clinical sites. Patients A total of 1142 obese patients (1466 participated in the initial s tudy) who had follow-up echocardiogram; all but 4 had a follow-up medical h istory and physical examination. Follow-up time from discontinuation of dru g to follow-up echocardiogram for 371 dexfenfluramine patients was 17.5 mon ths (range, 13-26 months) and for 340 phentermine/fenfluramine patients was 18.7 months (range, 13-26 months) after discontinuation of drug therapy. Main Outcome Measure Change in grade of valvular regurgitation and valve mo rphology and mobility. Results Echocardiographic changes in aortic regurgitation were observed in 8 controls (7 [1.7%] had decreases; 1 [0.2%]had an increase); 29 dexfenflur amine patients (23 [6.4%] had decreases; 6 [1.7%] had increases; P<.001 vs controls); and 15 phentermine/fenfluramine patients (4.5% all decreases; P= .03 vs controls). No statistically significant differences were observed wh en treated patients were compared with controls for changes in medical hist ory, physical findings, mitral regurgitation, aortic or mitral leaflet mobi lity or thickness, pulmonary artery systolic pressure, ejection fraction, v alve surgery, or cardiovascular events. Conclusion Progression of valvular abnormalities is unlikely in patients 1 year after an initial echocardiogram and 13 to 26 months after discontinuat ion of dexfenfluramine and phentermine/fenfluramine.