| Autor: |
Simeone, Jason C., Nordstrom, Beth L., Appenteng, Kwame, Huse, Samuel, D’Silva, Milbhor |
| Předmět: |
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| Zdroj: |
Drugs - Real World Outcomes; Mar2018, Vol. 5 Issue 1, p25-34, 10p |
| Abstrakt: |
Background: 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 oxybutynin.Purpose: To replicate the FDA M-S analysis of mirabegron using datasets that did not contribute to the M-S program.Methods: 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.Results: In PharMetrics, 12,429 new mirabegron users and 61,548 new oxybutynin users were identified. The aHR was 0.67 (95% confidence interval (CI)] 0.33–1.37) for AMI (mirabegron IR 4.4/1000 PY), and 0.62 (95% CI 0.34–1.13) for stroke (mirabegron IR 6.3/1000 PY). In MarketScan, 17,182 new mirabegron users and 63,962 new oxybutynin users were identified. The aHR was 0.57 (95% CI 0.17–1.95) for AMI, and 0.69 (95% CI 0.30–1.62) for stroke; IRs were similar to those from PharMetrics. Neither dataset suggested an increased risk of AMI or stroke associated with mirabegron in non-new users.Conclusions: Using the publicly-available M-S protocol and analysis programs with alternative (non M-S) data sources, no statistically significant increased risk of AMI or stroke was found among new or non-new users of mirabegron compared with oxybutynin. These findings were consistent with the FDA M-S mirabegron study. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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