title: Efficacy and safety of vernakalant in recent-onset atrial fibrillation after the European medicines agency approval: systematic review and meta-analysis.
abstract: Vernakalant is an emergent antiarrhythmic drug 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 randomized clinical trials, until May 2011, of vernakalant compared with controls (placebo/other antiarrhythmic drug) in enrolled patients with high ventricular rate atrial fibrillation. Five randomized trials that met inclusion criteria enrolled a total of 1099 patients. Among these, 810 had recent-onset atrial fibrillation. When compared with controls (placebo/other oral antiarrhythmic drugs), vernakalant was associated with a significant increase in cardioversion within 90 minutes from drug infusion (relative risk, 8.4; 95% confidence interval, 4.4-16.3; P < .00001). Compared with controls, vernakalant was not associated with a significant difference in serious adverse events (relative risk, 0.9; 95% confidence interval, 0.6-1.4; P = .64). The authors conclude that 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 Questions remain surrounding safety because 1 unpublished trial was discontinued for this reason.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.
authors.affiliation: Department of Emergency Medicine, Catholic University of the Sacred Heart Largo F. Vito 1, 00168, Rome, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Buccelletti
authors.forename: Paolo
authors.initials: P
authors.lastname: Iacomini
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Botta
authors.forename: Davide
authors.initials: D
authors.lastname: Marsiliani
authors.forename: Annarita
authors.initials: A
authors.lastname: Carroccia
authors.forename: Nicolò
authors.initials: N
authors.lastname: Gentiloni Silveri
authors.forename: Francesco
authors.initials: F
authors.lastname: Franceschi
mesh_terms: D000840:Anisoles / Q000627:therapeutic use*; D000889:Anti-Arrhythmia Agents / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000188:drug therapy*; D017277:Drug Approval; D005062:European Union; D033161:Government Regulation; D006801:Humans; D049990:Membrane Transport Modulators / Q000627:therapeutic use*; D011759:Pyrrolidines / Q000627:therapeutic use*
chemical_list: D000840:Anisoles; D000889:Anti-Arrhythmia Agents; D049990:Membrane Transport Modulators; D011759:Pyrrolidines; C524581:vernakalant