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Cardiovascular safety of denosumab across multiple indications: A systematic review and meta‐analysis of randomized trials

Journal of Bone and Mineral Research Aug 18, 2020

Seeto AH, Abrahamsen B, Ebeling PR, et al. - In this systematic review and meta‐analysis, researchers sought to quantify the number of randomized controlled trials (RCTs) of denosumab (against comparators) reporting cardiovascular adverse events (CAEs) and explore the balance of CAEs between treatment arms. MEDLINE, Embase, and clinicaltrials.gov have been searched from inception to October 26, 2019, for RCTs of denosumab vs comparators for any indication. Using the Cochrane risk‐of‐bias tool, the risk of bias was evaluated. Of 554 records screened, 49 were involved, whereas 36 reported CAEs. Twenty‐seven involved trials (twelve eligible for meta‐analysis) were carried out in 13,202 post‐menopausal women. The excess CAEs in denosumab-treated postmenopausal women compared with bisphosphonates but not placebo implicitly support claims that bisphosphonates that suppress CAEs. Future studies should use standardized CAE reporting to better describe the cardiovascular effects of bone-active drugs.

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