Neil J. Weissman, MD; Julio A. Panza, MD; John F. Tighe, MD; John T. Gwynne, MD
Disclaimer:Dr. Panza's work in this study, including the preparation of the manuscript, was completed in his private capacity. The views expressed in this article do not necessarily represent those of the National Institutes of Health, the Department of Health and Human Services, or the United States.
Acknowledgments:The authors thank Susan Perras, MSN, Maria Mattern, RN, and Jan Kitzen, PhD, for coordination of the clinical trial, assistance with the literature review, and technical preparation of the manuscript; John Vance, MD, for thoughtful review of the manuscript; Harvey Kushner, PhD, for assistance in developing the statistical analysis plan and providing statistical support during the data analysis and manuscript preparation; and Jonathan Tall, CNMT, CCRC, and Kenneth Horton, RDCS, for coordination of the central echocardiography laboratory.
Grant Support:By a research grant from the Wyeth-Ayerst Research Division of Wyeth Laboratories, Philadelphia, Pennsylvania. Dexfenfluramine hydrochloride capsules (Redux) were manufactured and distributed by Wyeth Laboratories, Inc., a Wyeth-Ayerst Company, under license from Interneuron Pharmaceuticals, Inc., Lexington, Massachusetts.
Requests for Single Reprints:Neil J. Weissman, MD, Cardiovascular Research Institute, Washington Hospital Center, 110 Irving Street NW, Suite 4B-1, Washington, DC 20010.
Current Author Addresses:Dr. Weissman: Cardiovascular Research Institute, Washington Hospital Center, 110 Irving Street NW, Suite 4B-1, Washington, DC 20010.
Dr. Panza: Cardiology Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Building 10, Room 7B-15, Bethesda, MD 20892.
Dr. Tighe: Cardiology Consultants of Westchester, 3078 Route 9W South, Suite 100, New Windsor, NY 12553.
Dr. Gwynne: Department of Clinical Research, Wyeth-Ayerst Research, Wyeth-Ayerst, 145 King of Prussia Road, Radnor, PA 19087.
Author Contributions:Conception and design: N.J. Weissman, J.A. Panza, J.F. Tighe, J.T. Gwynne.
Analysis and interpretation of the data: N.J. Weissman, J.A. Panza, J.F. Tighe, J.T. Gwynne.
Drafting of the article: N.J. Weissman, J.A. Panza, J.F. Tighe, J.T. Gwynne.
Critical revision of the article for important intellectual content: N.J. Weissman, J.A. Panza, J.F. Tighe, J.T. Gwynne.
Final approval of the article: N.J. Weissman, J.A. Panza, J.F. Tighe, J.T. Gwynne.
Provision of study materials or patients: N.J. Weissman.
Statistical expertise: N.J. Weissman.
Obtaining of funding: N.J. Weissman, J.T. Gwynne.
Administrative, technical, or logistic support: N.J. Weissman, J.T. Gwynne.
Collection and assembly of data: N.J. Weissman, J.A. Panza, J.F. Tighe, J.T. Gwynne.
Weissman N., Panza J., Tighe J., Gwynne J.; Natural History of Valvular Regurgitation 1 Year after Discontinuation of Dexfenfluramine Therapy: A Randomized, Double-Blind, Placebo-Controlled Trial. Ann Intern Med. 2001;134:267-273. doi: 10.7326/0003-4819-134-4-200102200-00009
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Published: Ann Intern Med. 2001;134(4):267-273.
Many studies have reported an association between use of appetite suppressants and cardiac valvular abnormalities (1-6). After the initial reports (1, 7), dexfenfluramine and fenfluramine were withdrawn from the market. Now that these drugs are no longer available, the most clinically relevant question is whether progression, regression, or latent development of valvular regurgitation is associated with appetite suppressants.
We previously reported echocardiographic results from a randomized, double-blind, placebo-controlled study comparing dexfenfluramine, an investigational sustained-release formulation of dexfenfluramine, and placebo (6). Patients took study medication for 2 to 3 months. Analysis of echocardiograms obtained 1 month after discontinuation of therapy with the study drug found no statistical difference among the groups, according to U.S. Food and Drug Administration criteria for significant valvular regurgitation (aortic regurgitation mild or worse and/or mitral regurgitation moderate or worse). However, when all degrees of valvular regurgitation were considered and when the two dexfenfluramine groups were combined, a higher prevalence of any degree of aortic regurgitation, a higher prevalence of any degree of mitral regurgitation, and restriction of posterior mitral leaflet mobility were seen in the treated patients. On repeated evaluation 3 to 5 months later (8), the differences between the treated and placebo groups were no longer significant in 941 patients. This study was solely an evaluation of valvular regurgitation prevalence and did not directly assess change. The purpose of the present study was to assess change in valvular regurgitation by using a side-by-side reading method 1 year after dexfenfluramine therapy was discontinued.
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Cardiology, Valvular Heart Disease, Cardiac Diagnosis and Imaging.
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