This analysis investigated the risk of angioedema associated with sacubitril/valsartan (SV) compared to angiotensin-converting enzyme inhibitors (ACEI) or to angiotensin II receptor blockers (ARBs, excluding SV) in patients with heart failure in the Sentinel Distributed Database (SDD). The analysis was divided into two parts:
- Part 1: We used a pure new user design to identify individuals with incident use of SV, ACEI, and ARBs and conducted a Propensity Score Analysis (PSA) comparing the SV users to the ACEI or ARB users, matching on and stratifying by propensity score.
- Part 2: We modified the new user design in Part 1 by allowing re-entry from ACEI or ARB cohort to SV cohort.
The study period includes data from July 7, 2015 to February 29, 2020. We distributed Part 1 of this request to seven Sentinel Data Partners on November 13, 2020. We distributed Part 2 of this request to five Sentinel Data Partners on January 13, 2021.
The analytic packages associated with analysis can be found externally in Sentinel's Git Repository located here: Part 1 and Part 2. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.