News and Views ; Atrial ﬁbrillation associated with ivabradine treatment: meta-analysis of randomised controlled trials
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 For studies where AF data were unpublished, safety data were obtained from the European Medicines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. Metaanalyses 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.
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. Ivabradine treatment is associated with a 15% increase in the RR of AF. We estimate that 208 patient-years of treatment with ivabradine would be required to cause one new case of AF.