Mirabegron is used to treat overactive bladder, a condition in which a person may have a strong and/or frequent urge to urinate (in the absence of urinary tract infections) or in which he or she may involuntarily leak urine. A few studies conducted while mirabegron was being developed have raised concern that this drug may be associated with cardiovascular (heart) problems. The objective of this research is to evaluate, in real-world practice in the United Kingdom, if there is an association between mirabegron use and heart problems. In this study, we will calculate and compare the occurrence of several cardiovascular outcomes, including heart attack, stroke, and death, among new users of mirabegron and new users of several other medications commonly used to treat overactive bladder.
This will be a cohort study comparing the incidence of cardiovascular (CV) outcomes among new users of mirabegron and new users of any comparator antimuscarinic medication, as a group, used in the treatment of overactive bladder (OAB). Incidence rates for the following CV outcomes will be calculated: Acute myocardial infarction (AMI); Stroke; CV mortality (comprised of coronary heart disease [CHD] death and cerebrovascular disease death); All-cause mortality; and a composite measure of major adverse cardiovascular events (MACE), defined as the first of AMI, stroke, or CV mortality. The incidence of these CV outcomes will be estimated within each of two exposure cohorts and additional analyses of comparisons of mirabegron to individual antimuscarinic medications will be conducted. We will compare CV incidence after exposure to mirabegron and to antimuscarinics. Potential confounders will be addressed and the outcomes will be modelled, accounting for differences in follow-up time between the cohorts. Adjustment for potential confounders will be performed by matching on propensity score (PS) to balance cohorts with respect to factors present at or before the time of cohort entry. Results will be expressed as estimated adjusted hazard ratios (HRs) of the study outcomes along with confidence intervals (CIs).
Cardiovascular outcomes: acute myocardial infarction, stroke, CV mortality, all-cause mortality and a composite measure of major adverse cardiovascular events (MACE), defined as the first of AMI, stroke, or CV mortality.
Alejandro Arana Navarro - Chief Investigator - RTI Health Solutions ( USA )
Alejandro Arana Navarro - Corresponding Applicant - RTI Health Solutions ( USA )
Andrea Margulis - Collaborator - RTI Health Solutions ( USA )
Billy Franks - Collaborator - Astellas Pharmaceuticals
Christine Bui - Collaborator - RTI Health Solutions ( USA )
David Martinez - Collaborator - RTI Health Solutions ( USA )
Diana Eid - Collaborator - RTI Health Solutions ( USA )
Jamie Robinson - Collaborator - Astellas Pharmaceuticals
Kenneth Rothman - Collaborator - RTI Health Solutions ( USA )
Kwame Appenteng - Collaborator - Astellas Pharmaceuticals
Lisa McQuay - Collaborator - RTI Health Solutions ( USA )
Maria Reynolds - Collaborator - RTI Health Solutions ( USA )
Martin Backhouse - Collaborator - RTI Health Solutions ( USA )
Miguel Cainzos-Achirica - Collaborator - RTI Health Solutions ( USA )
Milbhor D'Silva - Collaborator - Astellas Pharmaceuticals
Ryan Ziemiecki - Collaborator - RTI Health Solutions ( USA )
Stefan de Vogel - Collaborator - Astellas Pharmaceuticals
Susana Perez-Gutthann - Collaborator - RTI Health Solutions ( USA )
Willem Jan Atsma - Collaborator - Astellas Pharmaceuticals
Alicia Gilsenan - Collaborator - RTI Health Solutions ( USA )
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