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Alendronate and atrial fibrillation: A meta-analysis of randomized placebo-controlled clinical trials
Osteoporosis International, 03/11/2011
Clinical Article
Barrett-Connor E et al. – In this meta-analysis of all Merck-conducted, placebo-controlled clinical trials of alendronate, the occurrence of atrial fibrillation (AF) was uncommon, with most studies reporting two or fewer events. Across all studies, no clear association between overall bisphosphonate exposure and the rate of serious or non-serious AF was observed.
Methods- All double-blind, placebo-controlled studies of alendronate 5, 10, or 20 mg daily, 35 mg once-weekly, 35 mg twice-weekly, and 70 mg once-weekly of at least 3 months duration conducted by Merck were included in this meta-analysis
- Primary method of analysis was exact Poisson regression
- Estimated relative risk (RR) of alendronate versus placebo and associated 95% CI derived from model that included number of episodes with factors for treatment group and study and an offset parameter for number of person-years on study
- Of 41 studies considered, 32 met all criteria for inclusion in analysis (participants—9,518 alendronate, 7,773 placebo)
- Estimated RR for all AF events was 1.16 (95% CI?=?0.87, 1.55; p?=?0.33)
- Most trials had 2 or fewer AF events
- RR of AF classified as serious AE 1.25 (95% CI?=?0.82, 1.93; p?=?0.33), but became 0.97 (95% CI?=?0.51, 1.85) when clinical fracture cohort of Fracture Intervention Trial was excluded, indicating that results by events in that study
- Estimated RRs for other cardiovascular endpoints less than 1
