The purpose of this study is to explore the cardiovascular safety of antimuscarinic drugs to treat overactive bladder (OAB) in Denmark.
This was a cohort study using data recorded in Danish registries from patients newly exposed to darifenacin, fesoterodine, oxybutynin, solifenacin, tolterodine, or trospium in 2004-2012. We estimated crude and standardized incidence rates (IRs) for acute myocardial infarction (AMI); stroke; cardiovascular mortality; major adverse cardiac events (MACE, a combined endpoint of the previous three outcomes); and all-cause death for the individual and combined drugs. We also estimated crude, standardized, and propensity score-stratified incidence rate ratios (IRRs) comparing individual antimuscarinic drugs to tolterodine as the reference.
Among 72,917 new users of OAB drugs (mean age, 66 years; 60% women), the standardized IR (95% confidence interval) per 1000 person-years for current use of any OAB drug was 2.7 (2.5-2.9) for AMI, 1.3 (1.2-1.5) for stroke, 7.8 (7.5-8.1) for MACE, 4.8 (4.5-5.0) for cardiovascular mortality, and 15.2 (14.8-15.6) for all-cause mortality. Propensity score-stratified IRRs for current use (reference, tolterodine) were close to the null for all drugs and endpoints.
We did not identify differences in the risk of cardiovascular events or mortality among users of individual antimuscarinic OAB drugs.
European journal of clinical pharmacology. 2017 Nov 13 [Epub ahead of print]
Andrea V Margulis, Jesper Hallas, Anton Pottegård, Nina Sahlertz Kristiansen, Willem Jan Atsma, Billy Franks, Milbhor D'Silva, Cristina Varas-Lorenzo, Susana Perez-Gutthann, Alejandro Arana
RTI Health Solutions, Av. Diagonal, 605, 9-1, 08028, Barcelona, Spain., University of Southern Denmark, J. B. Winsløws Vej 19, 2., 5000, Odense, Denmark. ., University of Southern Denmark, J. B. Winsløws Vej 19, 2., 5000, Odense, Denmark., Astellas Pharma B.V., PO Box 344, 2300 AH, Leiden, The Netherlands., Astellas Pharma Global Development Inc., 1 Astellas Way, Northbrook, IL, 60062, USA.