Hoffman V, Hallas J, Linder M, Margulis AV, Suehs BT, Arana A, Phiri K, Enger C, Horter L, Odsbu I, Olesen M, Perez-Gutthann S, Xu Y, Kristiansen NS, Appenteng K, de Vogel S, Seeger JD, mirabegron PMR-PASS study group. Cardiovascular risk in users of mirabegron compared with users of antimuscarinic treatments for overactive bladder: findings from a non-interventional, multinational, cohort study. Drug Saf. 2021 Aug;44(8):899-915. doi: 10.1007/s40264-021-01095-7.


OBJECTIVES: To compare incidence rates of adverse cardiovascular (CV) outcomes following mirabegron or antimuscarinic use.

METHODS: Observational post-marketing safety study utilising real-world data. The study population was identified within five sources: Danish and Swedish National Registers, Clinical Practice Research Datalink (UK), Optum (USA), and Humana (USA). Episodes of time when patients were new users of mirabegron or antimuscarinics (Oct2012–Dec2018) were sourced from prescriptions and matched on propensity scores. Occurrences of major adverse cardiovascular events (MACE), acute myocardial infarction (AMI), stroke, CV mortality, and all-cause mortality were identified. Outcome incidence rates and hazard ratios (HRs) from Cox models were estimated.

RESULTS: Overall, 152,026 mirabegron and 152,026 antimuscarinic episodes were matched. The population consisted of 63.1% women and 72.6% were ≥ 65 years old. There were no appreciable differences in the incidence rates of MACE, AMI, or stroke between users of mirabegron and antimuscarinics. Incidence rates of CV mortality (HR 0.83, 95% confidence interval [CI] 0.73–0.95) and all-cause mortality (HR 0.80, 95% CI 0.76–0.84) were no higher with mirabegron versus antimuscarinics. Results restricted to episodes at high risk for CV events or stratified by age (< 65, ≥ 65 years) or prior OAB medication use were consistent with overall findings.

CONCLUSIONS: This large, multinational study found no higher risk of MACE, AMI, stroke, CV mortality, or all-cause mortality among users of mirabegron relative to users of antimuscarinics.

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