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Cohort study of the relative incidence of major cardiovascular events (MACE) among patients initiating prucalopride versus a matched comparator cohort
Prucalopride (Resolor®) is a new selective 5-HAT4 agonist and was approved in Europe in October 2009 as first agent of its drug class for the treatment of chronic constipation in women in which traditional laxatives did not show sufficient therapeutic response. Since two other laxatives (cisapride and tegaserod) with a similar mechanism of action were withdrawn from the market due to possible cardiovascular adverse events, the U.S Food and Drug Administration (FDA) demands further studies about the cardiovascular safety of all 5-HT4 agonists, including prucalopride.
The aim of this study is to compare the drug use patterns and the risk of major cardiovascular events (e.g. hospitalization caused by myocardial infarction or stroke) in new users of prucalopride and new users of other drugs for chronic constipation. Based on data of the German Pharmacoepidemiological Research Database (GePaRD) for the years 2010 to 2015, a retrospective and matched cohort study will be conducted.
The non-profit organization RTI Health Solutions will evaluate the results of this and four simultane-ous studies in England, Scotland and Sweden.