Cardiovascular Risk in Users of Mirabegron Compared with Users of Antimuscarinic Treatments for Overactive Bladder: Findings from a Non-Interventional, Multinational, Cohort Study

Veena Hoffman, Jesper Hallas, Marie Linder, Andrea V. Margulis, Brandon T. Suehs, Alejandro Arana, Kelesitse Phiri, Cheryl Enger, Libby Horter, Ingvild Odsbu, Morten Olesen, Susana Perez-Gutthann, Yihua Xu, Nina Sahlertz Kristiansen, Kwame Appenteng, Stefan de Vogel and John D. Seeger ()
Additional contact information
Veena Hoffman: Optum
Jesper Hallas: University of Southern Denmark
Marie Linder: Karolinska Institutet
Andrea V. Margulis: RTI Health Solutions
Brandon T. Suehs: Humana Healthcare Research
Alejandro Arana: RTI Health Solutions
Kelesitse Phiri: Optum
Cheryl Enger: Optum
Libby Horter: Humana Healthcare Research
Ingvild Odsbu: Karolinska Institutet
Morten Olesen: University of Southern Denmark
Susana Perez-Gutthann: RTI Health Solutions
Yihua Xu: Humana Healthcare Research
Nina Sahlertz Kristiansen: University of Southern Denmark
Kwame Appenteng: Astellas Pharma US
Stefan de Vogel: Astellas Pharma Europe B.V.
John D. Seeger: Optum

Drug Safety, 2021, vol. 44, issue 8, No 8, 899-915

Abstract: Abstract Introduction During clinical trials, mirabegron, a β3-adrenoreceptor agonist, was associated with increased vital signs vs placebo in patients with overactive bladder. Objective The purpose of this study was to compare incidence rates of adverse cardiovascular (CV) outcomes following mirabegron or antimuscarinic use. Methods We conducted an 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 (October 2012–December 2018) 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 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 (hazard ratio 0.83, 95% confidence interval 0.73–0.95) and all-cause mortality (hazard ratio 0.80, 95% confidence interval 0.76–0.84) were no higher with mirabegron vs antimuscarinics. Results restricted to episodes at high risk for CV events or stratified by age (

Date: 2021
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DOI: 10.1007/s40264-021-01095-7

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