This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Shively, B. K. Articles by Loar, S. B. Search for Related Content PubMed PubMed Citation Articles by Shively, B. K. Articles by Loar, S. B. Related Collections Obesity Echocardiography CV surgery: valvular disease

(Circulation. 1999;100:2161.)
© 1999 American Heart Association, Inc.

Clinical Investigation and Reports

Prevalence and Determinants of Valvulopathy in Patients Treated With Dexfenfluramine

Bruce K. Shively, MD; Carlos A. Roldan, MD; Edward A. Gill, MD; Thomas Najarian, MD; Sonja Barton Loar, PharmD

From the Cardiology Divisions of Oregon Health Sciences University (B.K.S.), Portland, Ore; the University of New Mexico (C.A.R.), Albuquerque; the University of Colorado Health Sciences Center (E.A.G.), Denver, Co; and Research and Development, Interneuron Pharmaceuticals, Inc (T.N., S.B.L.).

Correspondence to: Bruce K. Shively, MD, Division of Cardiology UHN-62, Oregon Health Sciences University, 3181 SW Sam Jackson Park Blvd, Portland, OR 97221. E-mail shivelyb{at}ohsu.edu

Background—Valve regurgitation has been associated with dexfenfluramine, but its prevalence and severity are uncertain. Additional factors that may contribute to valve regurgitation in patients exposed to this drug are poorly understood.

Methods and Results—Echocardiography was performed on subjects recruited from 26 prescribing sites in 15 states. The total sample of 412 subjects included 172 dexfenfluramine patients and 172 unexposed controls matched for age, sex, and body mass index and 68 unmatched subjects meeting the same entry criteria (51 dexfenfluramine patients and 17 controls). Mean treatment duration was 6.9 months; mean interval from treatment discontinuation to echocardiogram was 8.5 months. Each echocardiogram was interpreted independently by 3 echocardiographers. FDA-grade regurgitation (at least mild aortic regurgitation or at least moderate mitral regurgitation) was significantly more frequent in dexfenfluramine patients (7.6% versus 2.1% for controls; P=0.01; odds ratio, 3.82). This difference was primarily due to more frequent mild aortic regurgitation in dexfenfluramine patients (6.3% versus 1.6% in controls; P<0.02; odds ratio, 4.15). No differences were found in sclerosis or mobility for either the aortic or mitral valve. Factors independently related to FDA-grade regurgitation or any grade of aortic regurgitation were older age, higher diastolic blood pressure at the time of echocardiography, and shorter time from drug discontinuation to echocardiogram.

Conclusions—Dexfenfluramine use is associated with an increase in the prevalence of abnormal valve regurgitation. Age and blood pressure may also affect the prevalence of regurgitation. Dexfenfluramine-related valve regurgitation may regress after drug discontinuation.

Key Words: dexfenfluramine • drugs • echocardiography • regurgitation • valves

This article has been cited by other articles:

				J. M. Gardin, N. J. Weissman, C. Leung, J. A. Panza, D. Fernicola, K. D. Davis, G. D. Constantine, and C. L. Reid Clinical and Echocardiographic Follow-up of Patients Previously Treated With Dexfenfluramine or Phentermine/Fenfluramine JAMA, October 24, 2001; 286(16): 2011 - 2014. [Abstract] [Full Text] [PDF]

				G. Glazer Long-term Pharmacotherapy of Obesity 2000: A Review of Efficacy and Safety Arch Intern Med, August 13, 2001; 161(15): 1814 - 1824. [Abstract] [Full Text] [PDF]

				R. Davidoff, A. McTiernan, G. Constantine, K. D. Davis, G. J. Balady, L. A. Mendes, R. E. Rudolph, and D. J. Bowen Echocardiographic Examination of Women Previously Treated With Fenfluramine: Long-term Follow-up of a Randomized, Double-blind, Placebo-Controlled Trial Arch Intern Med, June 11, 2001; 161(11): 1429 - 1436. [Abstract] [Full Text] [PDF]

				T. O. Cheng Reversibility of anorexigenic valvulopathy Ann. Thorac. Surg., January 1, 2001; 71(1): 397 - 397. [Full Text] [PDF]

				T. O. Cheng Fen/Phen and Valvular Heart Disease: The Final Link Has Now Been Established Circulation, December 12, 2000; 102 (24): e180 - e180. [Full Text] [PDF]

				R. B. Rothman, M. H. Baumann, J. E. Savage, L. Rauser, A. McBride, S. J. Hufeisen, and B. L. Roth Evidence for Possible Involvement of 5-HT2B Receptors in the Cardiac Valvulopathy Associated With Fenfluramine and Other Serotonergic Medications Circulation, December 5, 2000; 102(23): 2836 - 2841. [Abstract] [Full Text] [PDF]

				H. Jick Heart Valve Disorders and Appetite-Suppressant Drugs JAMA, April 5, 2000; 283(13): 1738 - 1740. [Full Text] [PDF]

				Dexfenfluramine and Valve Regurgitation Journal Watch Cardiology, January 14, 2000; 2000(114): 2 - 2. [Full Text]

				More on Diet Drugs and Aortic Regurgitation Journal Watch (General), December 14, 1999; 1999(1214): 6 - 6. [Full Text]