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AF associated with ivabradine treatment

Atrial fibrillation (AF) is a substantially more common side-effect of ivabradine treatment than one patient in 10,000, which is the risk presently reported in the product literature, and AF incidence has not routinely been reported in clinical trials of the drug, according to a study published recently in Heart.1

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 four 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 For studies where AF data were unpublished, safety data were obtained from the European Medicines Agency (EMeA) website and personal communications.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.

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 the authors estimated that the number needed to harm for ivabradine would be 208 (95% CI 122 to 667) per year of treatment.

References

1. Martin RIR, Pogoryelova O, Koref MS, Bourke JP, Teare MD, Keavney BD. Atrial fibrillation associated with ivabradine treatment: meta-analysis of randomised controlled trials. Heart 2014. http://dx.doi.org/10.1136/heartjnl-2014-305482

Published on: June 26, 2014

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ENDORSED BY

  • ArrhythmiaAlliance
  • Stars
  • Anticoagulation Europe
  • Atrial Fibrillation Association
 

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