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

Jason C Simeone1, Beth L Nordstrom2, Kwame Appenteng3

  • 1Real-World Evidence, Evidera, 500 Totten Pond Road, Fifth Floor, Waltham, MA, 02451, USA. jason.simeone@evidera.com.

Drugs - Real World Outcomes
|November 15, 2017
PubMed
Abstract

Insights

This study found no increased risk of heart attack or stroke with mirabegron compared to oxybutynin for overactive bladder treatment. Findings were consistent across multiple datasets, supporting safety for both new and existing users.

Area of Science:

  • Pharmacovigilance and drug safety research.
  • Cardiovascular and cerebrovascular event analysis in medication users.

Background:

  • The US Food and Drug Administration (FDA) initiated surveillance for acute myocardial infarction (AMI) and stroke risks associated with mirabegron for overactive bladder (OAB).
  • The Mini-Sentinel (M-S) program monitored mirabegron use against oxybutynin, a common OAB treatment.

Purpose of the Study:

  • To independently replicate the FDA's Mini-Sentinel analysis on mirabegron safety.
  • To utilize external healthcare claims datasets not included in the original M-S program.

Main Methods:

  • Two large claims databases (IMS PharMetrics Plus, Truven MarketScan) were converted to the M-S Common Data Model.
  • Propensity score matching (1:1) was used to compare new and non-new users of mirabegron and oxybutynin.
  • Incidence rates (IR) and adjusted hazard ratios (aHRs) for AMI and stroke were calculated using Cox regression.

Main Results:

  • In PharMetrics, adjusted hazard ratios for AMI and stroke with mirabegron versus oxybutynin were 0.67 (95% CI 0.33-1.37) and 0.62 (95% CI 0.34-1.13), respectively.
  • MarketScan data showed similar adjusted hazard ratios: 0.57 (95% CI 0.17-1.95) for AMI and 0.69 (95% CI 0.30-1.62) for stroke.
  • No increased risk of AMI or stroke was observed for mirabegron in non-new users in either dataset.

Conclusions:

  • Independent analysis using non-M-S data sources and the M-S protocol found no statistically significant increased risk of AMI or stroke with mirabegron.
  • These findings align with the original FDA M-S study, suggesting a consistent safety profile for mirabegron compared to oxybutynin.
  • The study supports the safety of mirabegron for both new and non-new users in the context of cardiovascular and cerebrovascular events.

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