Key result
ACE inhibitors were associated with a significantly higher risk of angioedema compared to beta-blockers (HR 3.14), successfully replicating findings from a customized protocol-driven assessment.
Why the study?
Does the Sentinel Propensity Score Matching tool produce similar results to customized protocol-driven assessments in quantifying the risk of angioedema with ACE inhibitors versus beta-blockers?
Cohort (n=3,884,897)
Yes
Does the Sentinel Propensity Score Matching tool produce similar results to customized protocol-driven assessments in quantifying the risk of angioedema with ACE inhibitors versus beta-blockers?
Hazard Ratio: 3.14 (95% CI 2.86–3.44)
Absolute Event Rate: 7.31% vs 2.33%
p-value: p=<0.0001
The FDA Sentinel Propensity Score Matching tool can successfully produce safety signal findings similar to highly customized protocol-driven assessments.
Sentinel PSM tool replicates known ACEI-angioedema risk; supports validation for safety signals but leaves open equivalence to customized protocols.
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.
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Gagne et al. (2016) conducted a cohort in Angioedema (n=3,884,897). ACE inhibitors vs. Beta-blockers was evaluated on Angioedema (inpatient, outpatient, or emergency department claim with ICD-9-CM code 995.1) (HR 3.14, 95% CI 2.86 to 3.44, p=<0.0001). ACE inhibitors were associated with a significantly higher risk of angioedema compared to beta-blockers (HR 3.14), successfully replicating findings from a customized protocol-driven assessment.
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