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Replication of Mini-Sentinel Study Assessing Mirabegron and Cardiovascular Risk in Non-Mini-Sentinel Databases

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    In 2014, the US Food and Drug Administration (FDA) initiated a prospective routine surveillance using the Mini-Sentinel (M-S) program to assess potential signals of acute myocardial infarction (AMI) and stroke, with use of mirabegron, indicated for the treatment of overactive bladder (OAB), compared with use of oxybutynin. The purpose was to replicate the FDA M-S analysis of mirabegron using datasets that did not contribute to the M-S program. IMS PharMetrics Plus and Truven MarketScan claims data from 2012-2015 were converted to the M-S Common Data Model. New and non-new users of mirabegron and oxybutynin were analyzed per the publicly available M-S protocol, and propensity score-matched 1:1 using the M-S PROMPT 2 module. Incidence rates (IR) were calculated per 1000 person-years (PY). Adjusted hazard ratios (aHRs) for mirabegron versus oxybutynin were calculated using Cox regression models.


    Jason Simeone, Beth Nordstrom, Kwame Appenteng, Samuel Huse, Milbhor D’Silva