A Randomized Placebo-Controlled Study of Vernakalant (Oral) for the Prevention of Atrial Fibrillation Recurrence Post-Cardioversion.
Circ Arrhythm Electrophysiol. 2011 Aug 14;
Authors: Torp-Pedersen C, Raev DH, Dickinson G, Butterfield NN, Mangal B, Beatch GN
BACKGROUND: -Vernakalant, a relatively atrial-selective antiarrhythmic drug, has previously demonstrated efficacy for the acute conversion of atrial fibrillation (AF) to sinus rhythm. This study was designed to determine the most appropriate oral dose of vernakalant for the prevention of AF recurrence post-cardioversion. METHODS AND RESULTS: -Patients with non-permanent AF were randomized to 150, 300, or 500 mg vernakalant or placebo twice daily (BID) for up to 90 days. The efficacy analysis was conducted on 605 of 735 patients who entered the maintenance phase on Day 3 following cardioversion. The time to the first recurrence of symptomatic sustained AF was significantly longer in the 500 mg vernakalant group, with a median of >90 days versus 29 days in the placebo group (hazard ratio 0.735, P = 0.0275). No significant effect was seen at the lower doses. The percent of patients in sinus rhythm at Day 90 was 41%, 39%, and 49% in the 150 mg (N=147), 300 mg (N=148), and 500 mg (N=150) vernakalant groups, respectively, compared to 36% in the placebo group (N=160). There were no vernakalant-related proarrhythmic events. Related serious adverse events occurred in two patients in the 150 mg vernakalant group and in one patient in each of the other groups. CONCLUSIONS: -Vernakalant, 500 mg BID, appears to be effective and safe for the prevention of AF recurrence after cardioversion. The absence of proarrhythmia and favorable safety profile is an important finding for the drug. Clinical Trial Registration Information-Clinical trial registered with www.clinicaltrials.gov (NCT00526136).
PMID: 21841207 [PubMed - as supplied by publisher]