Premium
Efficacy and Safety of Vernakalant in Recent‐Onset Atrial Fibrillation After the European Medicines Agency Approval: Systematic Review and Meta‐Analysis
Author(s) -
Buccelletti Francesco,
Iacomini Paolo,
Botta Gianfranco,
Marsiliani Davide,
Carroccia Annarita,
Silveri Nicolò Gentiloni,
Franceschi Francesco
Publication year - 2012
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/0091270011426876
Subject(s) - medicine , atrial fibrillation , cardioversion , placebo , cardiology , amiodarone , sinus rhythm , randomized controlled trial , adverse effect , clinical trial , anesthesia , alternative medicine , pathology
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 Questions remain surrounding safety because 1 unpublished trial was discontinued for this reason.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.