Safety of dronedarone in treating cardiovascular disease:A Meta-analysis
ZHANG Changjiang
MA Ruisong
ZHANG Xutao
LI Yuanhong
Abstract：Objective To systemic review the safety of dronedarone therapy on cardiovascular diseases .Methods Using computer retrieval PubMed , Embase, Cochrane Collaboration database to find out published randomized controlled trials (RCT) of dronedarone therapy for cardiovascular diseases and search from start of the database to August 31, 2014.Accor-ding to the inclusion and exclusion criteria for quality evaluation of literature screening , data extraction method , Meta-analysis was carried out using RevMan 5.2 software.Results Ultimately this study included 7 RCT with 10 205 cases.The Meta-anal-ysis results showed that:(1) hospitalization and mortality rate, compared with placebo, dronedarone may increase cardiovas-cular events hospitalization rate (OR=1.82, 95%CI 1.42-2.34, P <0.000 01), incident of heart failure hospitalization rate (OR=1.50, 95%CI 1.05-2.14, P =0.03), the total mortality (OR=1.95, 95%CI 1.25-3.04, P =0.03), car-diovascular events and mortality (OR=2.44, 95%CI 1.44-4.14, P =0.000 9) and arrhythmia mortality (OR=3.21, 95%CI 1.28-8.07, P =0.01).(2) the incidence of adverse reaction: compared with placebo, dronedarone will increase the overall incidence of adverse reaction (OR=1.34, 95%CI 0.97-1.86, P =0.08), serious adverse reaction incidence (OR=1.25, 95%CI 0.92-1.70, P =0.16) and serious cardiovascular adverse reaction rate (OR=1.37,95%CI 0.98-1.91, P =0.07), but there were no significant differences of these indices .Conclusion Dronedarone may increase the risk of cardiovascular events , while not significantly increase the adverse reactions of patients .
Keywords：DronedaronePlaceboCardiovascular diseaseSafetyMeta-analysisRandomized controlled trial
Publication Date：2015-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：5( 64-68 )