Hoffman V, Hallas J, Linder M, Margulis AV, Suehs BT, Arana A, Enger C, Horter L, Odsbu I, Olesen M, Perez-Gutthann S, Xu Y, Kristiansen NS, Appenteng K, de Vogel S, Seeger JD. Cardiovascular risk in users of mirabegron relative to users of antimuscarinic treatments for overactive bladder: findings from a non-interventional, real-world data safety study. Presented at the Virtual ICPE 2021 Conference; August 24, 2021. Previously presented at the 2020 Virtual American Heart Association’s Scientific Sessions.

BACKGROUND: During clinical trials, mirabegron, a β3-adrenoreceptor agonist, was associated with increased heart rate and systolic/diastolic blood pressure compared with placebo in patients with overactive bladder (OAB).

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

METHODS: This was an observational post-marketing safety study that utilized real-world data. The study population was identified within five data sources: Danish and Swedish National Registers, Clinical Practice Research Datalink (UK), Optum (US), and Humana (US). Episodes of time when patients were new users of mirabegron or antimuscarinic medications from 2012 to 2018 were sourced from prescription/dispensing information and matched on propensity scores. Major adverse cardiovascular events (MACE), acute myocardial infarction (AMI), stroke, CV mortality, and all-cause mortality were identified from register linkage, validated through medical record review, or confirmed from physician questionnaires. Incidence rates of these outcomes during follow-up of current use of mirabegron or antimuscarinics were estimated along with hazard ratios (HRs) from Cox models.

RESULTS: In total, 152 026 mirabegron episodes were matched to an equal number of antimuscarinic episodes. Women represented 63% of the study population and 73% of the patients were ≥65 years old. Baseline CV disease risk factors were similar between matched groups. There were no appreciable differences in the incidence rates of MACE, AMI, and stroke among current users of mirabegron relative to antimuscarinics. The incidence rates of CV mortality (HR: 0.83, 95% confidence interval [CI]: 0.73, 0.95) and all-cause mortality (HR: 0.80, CI: 0.76, 0.84) were no higher following the use of mirabegron versus antimuscarinics. Results restricted to episodes at high risk for CV events, split by age (<65, ≥65 years), or split by 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 current users of mirabegron relative to current users of antimuscarinics.

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