Efficacy and safety of vernakalant in recent-onset atrial fibrillation after the European medicines agency approval: systematic review and meta-analysis

Summary: Vernakalant is an emergent AAD that, in preclinical studies, has demonstrated high efficacy in restoring sinus rhythm and safety in patients with rapid recent-onset atrial fibrillation.

The aim of this work was to evaluate the efficacy and safety of vernakalant for cardioversion of recent-onset atrial fibrillation. PubMed, EMBASE, Clinical Trials Registry, and European Medicines Agency public reports were searched for RCTs, until May 2011, of Vernakalant compared with controls (placebo/other AAD) in enrolled patients with high ventricular rate AF.

Five RCTs that met inclusion criteria enrolled a total of 1099 patients. Among these, 810 had recent-onset AF. When compared with controls (placebo/other oral AAD), vernakalant was associated with a significant increase in cardioversion within 90 minutes from drug infusion (RR, 8.4; 95%; CI2, 4.4-16.3; P <.00001). Compared with controls, vernakalant was not associated with a significant difference in SAEs (RR, 0.9; 95%; CI2, 0.6-1.4; P = .64).

Conclusion: When compared with controls, vernakalant is effective and safe for rapidly converting recent-onset atrial fibrillation. Questions remain surrounding safety because 1 unpublished trial was discontinued for this reason. Further cost-effective analysis and comparison with other antiarrhythmic agents, such as class I antiarrhythmic agents, should be investigated, especially in the Emergency Department.

לקריאת המאמר:

Buccelletti F, Iacomini P, Botta G, Marsiliani D, Carroccia A, Gentiloni Silveri N, Franceschi F. Efficacy and safety of vernakalant in recent-onset atrial fibrillation after the European medicines agencyapproval: systematic review and meta-analysisJ Clin Pharmacol. 2012 Dec;52(12):1872-8.