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Efficacy and Safety of Celivarone, With Amiodarone as Calibrator, in Patients With an Implantable Cardioverter-Defibrillator for Prevention of Implantable Cardioverter-Defibrillator Interventions or Death: The ALPHEE Study
Study Questions:
Does celivarone prevent malignant ventricular arrhythmias?
Methods:
In this double-blind study, 486 patients (mean age 64 years) with an ejection fraction ≤40% who received an implantable cardioverter-defibrillator (ICD) for primary or secondary prevention of sudden death (SD) were randomly assigned to treatment with placebo (n = 109); celivarone, 50 mg/day (n = 109); celivarone, 100 mg/day (n = 102); celivarone, 300 mg/day (n = 113); or amiodarone, 600 mg/day for 10 days then 200 mg/day (n = 53). The median duration of follow-up was 9 months. The primary endpoint was the occurrence of an appropriate ICD therapy or SD.
Results:
The incidence of the primary endpoint was 61.5% in the placebo group; 67%, 58.8%, and 54.9% in the celivarone 50-, 100-, and 300-mg groups; and 45.3% in the amiodarone group. There were no significant differences in the primary endpoint between the celivarone groups and placebo, or between the amiodarone group and placebo. Amiodarone significantly reduced appropriate ICD therapies by 40%. Celivarone, regardless of dosage, did not reduce appropriate ICD therapies.
Conclusions:
The authors concluded that celivarone does not prevent malignant ventricular arrhythmias.
Perspective:
Celivarone is a noniodinated benzofuran derivative that is similar to amiodarone in that it blocks sodium, calcium and potassium channels, and beta-receptors. As is the case with dronedarone, celivarone has less organ toxicity and faster onset of action than amiodarone. A prior study demonstrated that celivarone does not prevent atrial fibrillation (AF), and this study demonstrates that celivarone also does not prevent serious ventricular arrhythmias. Dronedarone clearly is inferior to amiodarone for preventing AF and is not as risk-free as originally thought. The search for a ‘safe amiodarone’ continues.
Keywords: Defibrillators, Potassium Channels, Follow-Up Studies, Death, Secondary Prevention, Sodium, Benzofurans, Calcium
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