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Angiotensin-Converting Enzyme (ACE) Inhibitors and Angiotensin II Receptor Blockers (ARBs) & Signal Identification

Basic Details
Status
Complete
Last Updated
Monday, March 18, 2024
Original Posting Date
Health Outcome(s)
signal identification
Purpose
Methods, Characterization, or Development
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
No
Study Summary

FDA initiated this feasibility study in the Sentinel System to explore the performance of TreeScan™ using International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) data. TreeScan™ is a signal identification approach that scans thousands of health outcomes simultaneously while adjusting for multiple scenarios that can be used to monitor the underlying assumption of no clinical differences.

The alert patterns observed in this feasibility study were highly similar to a prior analysis that evaluated Angiotensin-Converting Enzyme (ACE) Inhibitors and Angiotensin II Receptor Blockers (ARBs) using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) as the Tree and propensity score covariates. Based on these results, FDA determined the ICD-10-CM Tree and propensity score covariates are ready to use for signal identification (i.e., TreeScan analyses).