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Successful Comparison of US Food and Drug Administration Sentinel Analysis Tools to Traditional Approaches in Quantifying a Known Drug‐Adverse Event Association

2016; Wiley; Volume: 100; Issue: 5 Linguagem: Inglês

10.1002/cpt.429

1532-6535

JJ Gagne, Xiaopeng Han, Sean Hennessy, Leonard Ce, Elizabeth A. Chrischilles, Ryan M. Carnahan, SV Wang, Candace C. Fuller, Aarthi Iyer, Hannah Katcoff, TS Woodworth, Patrick Archdeacon, T. E. Meyer, Sebastian Schneeweiß, Sengwee Toh,

Atrial Fibrillation Management and Outcomes

The US Food and Drug Administration's Sentinel system has developed the capability to conduct active safety surveillance of marketed medical products in a large network of electronic healthcare databases. We assessed the extent to which the newly developed, semiautomated Sentinel Propensity Score Matching (PSM) tool could produce the same results as a customized protocol‐driven assessment, which found an adjusted hazard ratio (HR) of 3.04 (95% confidence interval [CI], 2.81–3.27) comparing angioedema in patients initiating angiotensin‐converting enzyme (ACE) inhibitors vs. beta‐blockers. Using data from 13 Data Partners between 1 January 2008, and 30 September 2013, the PSM tool identified 2,211,215 eligible ACE inhibitor and 1,673,682 eligible beta‐blocker initiators. The tool produced an HR of 3.14 (95% CI, 2.86–3.44). This comparison provides initial evidence that Sentinel analytic tools can produce findings similar to those produced by a highly customized protocol‐driven assessment.