title: The safety of amiodarone in patients with heart failure.
abstract: BACKGROUND
  Uncertainty persists about the safety and efficacy of amiodarone for the management of heart failure.
  
  
  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.
authors.affiliation: Department of Cardiology, Bispebjerg University Hospital, Copenhagen, Denmark.
authors.forename: Christian
authors.initials: C
authors.lastname: Torp-Pedersen
authors.forename: Marco
authors.initials: M
authors.lastname: Metra
authors.forename: Philip
authors.initials: P
authors.lastname: Spark
authors.forename: Mary Ann
authors.initials: MA
authors.lastname: Lukas
authors.forename: Christine
authors.initials: C
authors.lastname: Moullet
authors.forename: Armin
authors.initials: A
authors.lastname: Scherhag
authors.forename: Michel
authors.initials: M
authors.lastname: Komajda
authors.forename: John G F
authors.initials: JG
authors.lastname: Cleland
authors.forename: Willem
authors.initials: W
authors.lastname: Remme
authors.forename: Andrea
authors.initials: A
authors.lastname: Di Lenarda
authors.forename: Karl
authors.initials: K
authors.lastname: Swedberg
authors.forename: Philip A
authors.initials: PA
authors.lastname: Poole-Wilson
mesh_terms: D000317:Adrenergic alpha-Antagonists / Q000627:therapeutic use; D000319:Adrenergic beta-Antagonists / Q000627:therapeutic use; D000368:Aged; D000638:Amiodarone / Q000009:adverse effects* / Q000627:therapeutic use; D000889:Anti-Arrhythmia Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001281:Atrial Fibrillation / Q000517:prevention & control; D002227:Carbazoles / Q000627:therapeutic use; D000077261:Carvedilol; D016757:Death, Sudden, Cardiac / Q000517:prevention & control; D005260:Female; D006333:Heart Failure / Q000188:drug therapy* / Q000401:mortality*; D006801:Humans; D008297:Male; D008790:Metoprolol / Q000627:therapeutic use; D008875:Middle Aged; D015999:Multivariate Analysis; D011412:Propanolamines / Q000627:therapeutic use
chemical_list: D000317:Adrenergic alpha-Antagonists; D000319:Adrenergic beta-Antagonists; D000889:Anti-Arrhythmia Agents; D002227:Carbazoles; D011412:Propanolamines; D000077261:Carvedilol; D008790:Metoprolol; D000638:Amiodarone