Kwon Hyon J, Coté Timothy R, Cuffe Michael S, Kramer Judith M, Braun M Miles
Division of Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland 20852, USA.
Ann Intern Med. 2003 May 20;138(10):807-11. doi: 10.7326/0003-4819-138-10-200305200-00008.
Etanercept and infliximab are U.S. Food and Drug Administration-approved tumor necrosis factor (TNF) antagonists.
To describe adverse event reports of heart failure after TNF antagonist therapy.
Case series.
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.
依那西普和英夫利昔单抗是美国食品药品监督管理局批准的肿瘤坏死因子(TNF)拮抗剂。
描述TNF拮抗剂治疗后心力衰竭的不良事件报告。
病例系列。
美国食品药品监督管理局的MedWatch项目。
47例在TNF拮抗剂治疗期间出现新发或加重心力衰竭的患者。
临床和实验室报告。
TNF拮抗剂治疗后,38例患者出现新发心力衰竭,9例患者心力衰竭加重。在38例新发心力衰竭患者中,19例(50%)无明确危险因素。10例年龄小于50岁的患者在接受TNF拮抗剂治疗后出现新发心力衰竭。在这10例患者停用TNF拮抗剂治疗并开始心力衰竭治疗后,3例心力衰竭完全缓解,6例有所改善,1例死亡。
在部分患者中,TNF拮抗剂可能诱发新发心力衰竭或加重现有疾病。