The A-COMET-II ( Azimilide-CardiOversion MaintEnance Trial-II ) trial evaluated the efficacy of Azimilide ( Stedicor ), a new class III anti-arrhythmic drug, in atrial fibrillation.
Researchers, led by Federico Lombardi of University of Milan ( Italy ), studied 658 patients with symptomatic persistent atrial fibrillation, adequate anticoagulant therapy, and planned electrical cardioversion.
Patients were randomized to placebo, Azimilide ( 125 mg o.d. ), or Sotalol ( 160 mg b.i.d; Sotalex. ).
Primary efficacy analysis was based on event recurrence, which was defined as atrial fibrillation lasting more than 24 h, or requiring DC cardioversion.
Median time to recurrence was 14 days for Azimilide, 12 days for placebo, and 28 days for Sotalol. The placebo-to-Azimilide hazard ratio was 1.291 and the Sotalol-to-Azimilide hazard ratio was 0.652.
Adverse events causing patient withdrawal were more frequent ( P less than 0.01 ) in patients on Azimilide ( 12.3% ) and on Sotalol ( 13.9% ) than on placebo ( 5.4% ).
Eight patients in the Sotalol ( 3.5% ) and 16 in the Azimilide ( 7.6% ) group interrupted the study because of QTc prolongation. torsade de pointes was reported in five patients of the Azimilide group.
This study has demonstrated that the anti-arrhythmic efficacy of Azimilide is slightly superior to placebo but significantly inferior to Sotalol in patients with persistent atrial fibrillation.
The modest anti-arrhythmic efficacy and high rate of torsade de pointes and marked QTc prolongation limit Azimilide utilization for the treatment of atrial fibrillation. ( Xagena )
Source: European Heart Journal, 2006