Hyon J. Kwon, PharmD, MPH; Timothy R. Cot, MD, MPH; Michael S. Cuffe, MD; Judith M. Kramer, MD, MS; M Miles Braun, MD, MPH
Acknowledgments: The authors thank Ellis Unger, MD, and Jeffrey N. Siegel, MD, for their help and advice in reviewing the manuscript.
Grant Support: In part by Dr. Kwon's appointment to the Research Fellowship Program at the Center for Biologics Evaluation and Research, administered by Oak Ridge Associated Universities through a contract with the U.S. Food and Drug Administration.
Potential Financial Conflicts of Interest:Consultancies: M.S. Cuffe (Wyeth); Honoraria: M.S. Cuffe (Wyeth).
Requests for Single Reprints: Hyon J. Kwon, PharmD, MPH, Division of Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Suite 200S, HFM-224, Rockville, MD 20852; e-mail, email@example.com.
Current Author Addresses: Drs. Kwon, Cot, and Braun: Division of Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Suite 200S, HFM-224, Rockville, MD 20852.
Dr. Cuffe: Duke University Medical Center, Box 3850, Durham, NC 27710.
Dr. Kramer: Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715.
Author Contributions: Conception and design: H.J. Kwon, M.S. Cuffe, M.M. Braun.
Analysis and interpretation of the data: H.J. Kwon, T.R. Cot, M.S. Cuffe, J.M. Kramer, M.M. Braun.
Drafting of the article: H.J. Kwon, M.S. Cuffe.
Critical revision of the article for important intellectual content: H.J. Kwon, T.R. Cot, M.S. Cuffe, J.M. Kramer, M.M. Braun.
Final approval of the article: H.J. Kwon, T.R. Cot, M.S. Cuffe, J.M. Kramer, M.M. Braun.
Administrative, technical, or logistic support: H.J. Kwon.
Collection and assembly of data: H.J. Kwon.
Etanercept and infliximab are U.S. Food and Drug Administrationapproved tumor necrosis factor (TNF) antagonists.
To describe adverse event reports of heart failure after TNF antagonist therapy.
The U.S. Food and Drug Administration's MedWatch program.
47 patients who developed new or worsening heart failure during TNF antagonist therapy.
Clinical and laboratory reports.
After TNF antagonist therapy, 38 patients developed new-onset heart failure and 9 patients experienced heart failure exacerbation. Of the 38 patients with new-onset heart failure, 19 (50%) had no identifiable risk factors. Ten patients younger than 50 years of age developed new-onset heart failure after receiving TNF antagonists. After TNF antagonist therapy was discontinued and heart failure therapy was started in these 10 patients, 3 had complete resolution of heart failure, 6 improved, and 1 died.
In a fraction of patients, TNF antagonists might induce new-onset heart failure or exacerbate existing disease.
Although tumor necrosis factor (TNF) antagonists were once considered as a possible treatment for heart failure, recent trials showed no benefit, and one trial showed worsening heart failure with TNF antagonist treatment.
This analysis of data from the U.S. Food and Drug Administration's MedWatch program on 47 patients who developed heart failure while receiving long-term TNF antagonist therapy showed that 81% had never experienced heart failure before taking TNF antagonists. Half of the patients with new-onset heart failure had no identifiable heart failure risk factors, and 10 patients were younger than 50 years of age.
Clinicians should be aware that heart failure may occur in patients receiving TNF antagonists.
Table 1. Summary Characteristics of Heart Failure Reported with Use of Tumor Necrosis Factor Antagonists
Table 2. Characteristics of New-Onset Heart Failure in Patients Younger Than 50 Years of Age
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Hyon J. Kwon, Timothy R. Cot, Michael S. Cuffe, Judith M. Kramer, M Miles Braun. Case Reports of Heart Failure after Therapy with a Tumor Necrosis Factor Antagonist. Ann Intern Med. 2003;138:807–811. doi: 10.7326/0003-4819-138-10-200305200-00008
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Published: Ann Intern Med. 2003;138(10):807-811.
Cardiology, Heart Failure.
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