PMID- 17602979 OWN - NLM STAT- MEDLINE DCOM- 20070719 LR - 20231024 IS - 1532-8414 (Electronic) IS - 1071-9164 (Linking) VI - 13 IP - 5 DP - 2007 Jun TI - The safety of amiodarone in patients with heart failure. PG - 340-5 AB - BACKGROUND: Uncertainty persists about the safety and efficacy of amiodarone for the management of heart failure. METHODS AND RESULTS: We randomized 3029 patients with chronic heart failure to receive carvedilol or metoprolol and followed patients for a median of 58 months. One hundred fifty-five of 1466 patients in New York Heart Association (NYHA) Class II and 209 of 1563 in Class III or IV received amiodarone at baseline. Persistence with amiodarone treatment was high and 66% received amiodarone after 4 years. During follow-up, 38.7% and 58.9% of patients receiving amiodarone in NYHA Classes II and III + IV died versus 26.2% and 43.3% not receiving amiodarone (P < .001). This difference was maintained in multivariable analysis (hazard ratio [HR] 1.5, 95% confidence interval [CI] 1.2-1.7, P < .001). The difference was explained by an increased risk of death due to circulatory failure (HR 2.4, CI 1.9-3.1, P < .001) in patients receiving amiodarone. Sudden death was not different (HR 1.07, CI 0.8-1.4, P = .7). The increased risk was similar across NYHA classes with HR of 1.60 (CI 1.2-2.1, P < .001) in NYHA Class II versus 1.58 (CI 1.3-1.9, P < .001) in Classes III + IV. CONCLUSIONS: Treatment with amiodarone was associated with an increased risk of death from circulatory failure independent of functional class. FAU - Torp-Pedersen, Christian AU - Torp-Pedersen C AD - Department of Cardiology, Bispebjerg University Hospital, Copenhagen, Denmark. FAU - Metra, Marco AU - Metra M FAU - Spark, Philip AU - Spark P FAU - Lukas, Mary Ann AU - Lukas MA FAU - Moullet, Christine AU - Moullet C FAU - Scherhag, Armin AU - Scherhag A FAU - Komajda, Michel AU - Komajda M FAU - Cleland, John G F AU - Cleland JG FAU - Remme, Willem AU - Remme W FAU - Di Lenarda, Andrea AU - Di Lenarda A FAU - Swedberg, Karl AU - Swedberg K FAU - Poole-Wilson, Philip A AU - Poole-Wilson PA CN - COMET Investigators LA - eng PT - Journal Article PT - Randomized Controlled Trial PL - United States TA - J Card Fail JT - Journal of cardiac failure JID - 9442138 RN - 0 (Adrenergic alpha-Antagonists) RN - 0 (Adrenergic beta-Antagonists) RN - 0 (Anti-Arrhythmia Agents) RN - 0 (Carbazoles) RN - 0 (Propanolamines) RN - 0K47UL67F2 (Carvedilol) RN - GEB06NHM23 (Metoprolol) RN - N3RQ532IUT (Amiodarone) SB - IM MH - Adrenergic alpha-Antagonists/therapeutic use MH - Adrenergic beta-Antagonists/therapeutic use MH - Aged MH - Amiodarone/*adverse effects/therapeutic use MH - Anti-Arrhythmia Agents/*adverse effects/therapeutic use MH - Atrial Fibrillation/prevention & control MH - Carbazoles/therapeutic use MH - Carvedilol MH - Death, Sudden, Cardiac/prevention & control MH - Female MH - Heart Failure/*drug therapy/*mortality MH - Humans MH - Male MH - Metoprolol/therapeutic use MH - Middle Aged MH - Multivariate Analysis MH - Propanolamines/therapeutic use EDAT- 2007/07/03 09:00 MHDA- 2007/07/20 09:00 CRDT- 2007/07/03 09:00 PHST- 2006/10/26 00:00 [received] PHST- 2007/02/23 00:00 [revised] PHST- 2007/02/28 00:00 [accepted] PHST- 2007/07/03 09:00 [pubmed] PHST- 2007/07/20 09:00 [medline] PHST- 2007/07/03 09:00 [entrez] AID - S1071-9164(07)00069-3 [pii] AID - 10.1016/j.cardfail.2007.02.009 [doi] PST - ppublish SO - J Card Fail. 2007 Jun;13(5):340-5. doi: 10.1016/j.cardfail.2007.02.009.