Atrial fibrillation associated with ivabradine treatment: meta-analysis of randomised controlled trials.
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ABSTRACT: 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 For studies where AF data were unpublished, safety data were obtained from the European Medicines Agency (EMeA) website and personal communications.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.
SUBMITTER: Martin RI
PROVIDER: S-EPMC4174120 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:The aim of the present study was to compare the health outcomes of catheter ablation therapy against those of antiarrhythmic drugs (AADs) in the management of atrial fibrillation (AF). The effects of catheter ablation and AADs on a number of parameters were compared, including AF recurrence, all-cause mortality, stroke/transient ischemic attack (TIA) and quality of life (QoL). A systematic literature search of PubMed, Embase and the Cochrane Central Register of Controlled Trials was conducted to obtain relevant randomized controlled trials. The relative risks (RRs) and 95% confidence intervals (CIs) of AF recurrence, all-cause mortality and stroke/TIA between catheter ablation and AADs were subsequently calculated. Weighted mean differences (WMDs) and 95% CIs were used to evaluate the QoL between the two therapy groups. In total, 11 randomized trials, which included 1,763 AF patients, were eligible for the meta-analysis. Overall, the results indicated that catheter ablation produces superior outcomes compared with AADs in reducing AF recurrence (RR, 0.47; 95% CI, 0.38-0.58; P<0.001) and improving the QoL (physical component summary: WMD, 2.23; 95% CI, 0.24-4.21; P=0.03; mental component summary: WMD, 2.69; 95% CI, 0.04-5.35; P=0.05). However, no statistically significant difference was identified between the two groups with regard to the incidence of all-cause mortality (RR, 0.87; 95% CI, 0.37-2.06; P=0.76) and stroke/TIA (RR, 1.83; 95% CI, 0.73-4.55; P=0.20). In summary, catheter ablation was demonstrated to markedly reduce AF recurrence and improve QoL when compared with AAD therapy. However, the incidence rates of all-cause mortality and stroke/TIA were comparable between catheter ablation and AAD therapy.
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