title: Celivarone in patients with an implantable cardioverter-defibrillator: adjunctive therapy for the reduction of ventricular arrhythmia-triggered implantable cardioverter-defibrillator interventions.
abstract: BACKGROUND
  Implantable cardioverter-defibrillators (ICDs) remain the treatment of choice for the prevention of life-threatening arrhythmias. However, many patients with ICDs require additional antiarrhythmic therapy to reduce the morbidity associated with recurrent arrhythmia-triggered ICD interventions.
  
  
  OBJECTIVE
  Our study aimed to evaluate the safety and efficacy of celivarone in reducing these interventions.
  
  
  METHODS
  A total of 153 eligible ICD recipients were randomized to receive either placebo or celivarone 100 or 300 mg once daily for 6 months. The primary end point was the prevention of arrhythmia-triggered ICD therapies.
  
  
  RESULTS
  Fewer ventricular tachycardia and ventricular fibrillation episodes were observed in the 300-mg celivarone group than in the placebo group, with a relative risk reduction of 46%, which was not statistically significant. The analysis of all-cause shocks showed a trend toward a decreased number of events in the celivarone 300-mg group. A post hoc analysis of the primary end point in a subgroup of patients in the celivarone 300-mg group, who had received ICD therapy within 1 month of randomization, showed a significant benefit (P = .032). Celivarone was not associated with an increased risk of torsades de pointes, thyroid dysfunction, or pulmonary events. More heart failure events were reported in the celivarone groups than in the placebo group, but the difference was not statistically significant.
  
  
  CONCLUSIONS
  Celivarone tends to reduce ventricular tachycardia-/ventricular fibrillation-triggered ICD therapies. This effect was not statistically significant. There was a trend toward greater efficacy in the 300-mg group, especially in patients undergoing ICD therapy within 30 days prior to randomization. Overall, celivarone was well tolerated.
authors: Lankenau Hospital and Institute of Medical Research, Wynnewood, Philadelphia, Pennsylvania, USA.
authors: Olivera
authors: O
authors: Gojkovic
authors: Etienne M
authors: EM
authors: Aliot
authors: Alessandro
authors: A
authors: Capucci
authors: Stuart J
authors: SJ
authors: Connolly
authors: Harry
authors: H
authors: Crijns
authors: Stefan H
authors: SH
authors: Hohnloser
authors: Piotr
authors: P
authors: Kulakowski
authors: Denis
authors: D
authors: Roy
authors: David
authors: D
authors: Radzik
authors: Bramah N
authors: BN
authors: Singh
authors: Peter R
authors: PR
authors: Kowey
mesh_terms: D000368:Aged; D000889:Anti-Arrhythmia Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001145:Arrhythmias, Cardiac / Q000188:drug therapy / Q000209:etiology / Q000517:prevention & control*; D001572:Benzofurans / Q000009:adverse effects / Q000627:therapeutic use*; D017147:Defibrillators, Implantable; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006352:Heart Ventricles / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D017180:Tachycardia, Ventricular / Q000209:etiology / Q000517:prevention & control*; D014693:Ventricular Fibrillation / Q000209:etiology / Q000517:prevention & control*
chemical_list: D000889:Anti-Arrhythmia Agents; D001572:Benzofurans; C499879:celivarone