Objective: To quantify any risk of atrial fibrillation (AF) associated with ivabradine treatment by meta-analysis of clinical trial data. Methods: Medline, Embase, Web of Knowledge and the Cochrane central register of controlled trials were searched for double-blinded randomised controlled trials of ivabradine with a minimum follow-up period of 4 weeks. For studies where AF data were unpublished, safety data were obtained from the European Medicines Agency (EMeA) website and personal communications. Studies were appraised for risk of bias using components recommended by the Cochrane Collaboration. Meta-analyses were performed of relative risk of AF and absolute risk difference of AF per year of treatment. The main outcome measure was incident AF during the follow-up period. Results: AF data were available from 11 studies: one from the published report, six from the EMeA and four from personal communications. Ivabradine treatment was associated with a relative risk of AF of 1.15 (95% CI 1.07 to 1.24, p=0.0027) among 21 571 patients in the meta-analysis. From this we estimated that the number needed to harm for ivabradine would be 208 (95% CI 122 to 667) per year of treatment. Conclusions: AF is a substantially more common side effect of ivabradine treatment than one patient in 10 000, the risk presently reported in the product literature. The incidence of AF has not routinely been reported in clinical trials of ivabradine.
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机译:目的:通过临床试验数据的荟萃分析,量化与伊伐布雷定治疗相关的房颤(AF)的任何风险。方法:检索Medline,Embase,Web of Knowledge和Cochrane对照试验中心注册资料库,以追踪伊伐布雷定的双盲随机对照试验,至少随访4周。对于未公布房颤数据的研究,可从欧洲药品管理局(EMeA)网站和个人通讯获得安全性数据。使用Cochrane合作组织推荐的成分对研究的偏倚风险进行了评估。对每年治疗的房颤的相对风险和房颤的绝对风险差异进行荟萃分析。主要结果指标是随访期间的房颤事件。结果:AF数据来自11项研究:一项来自已发表的报告,六项来自EMeA,四项来自个人通讯。在荟萃分析中,伊伐布雷定治疗与21 571例患者的房颤相对风险为1.15(95%CI 1.07至1.24,p = 0.0027)相关。据此,我们估计每年治疗伊伐布雷定所需的伤害数量为208(95%CI 122至667)。结论:房颤是伊伐布雷定治疗的副作用,远比万分之一的患者更为常见,该风险目前在产品文献中已有报道。伊伐布雷定的临床试验中未常规报道房颤的发生。
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