Angioedema following Sacubitril/Valsartan Use in Patients with Heart Failure: A Propensity Score Analysis

    Basic Details
    Date Posted
    Wednesday, April 21, 2021
    Status
    In progress
    Medical Product
    sacubitril/valsartan
    Health Outcome(s)
    angioedema
    Description

    This analysis investigates 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 included data from July 7, 2015 to February 29, 2020.

    The analytic packages associated with this analysis can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.

    Additional Details
    FDA Center
    CDER
    Time Period
    July 7, 2015 - February 29, 2020
    Study Type
    Modular Program
    Assessment Type
    Safety Analyses
    Population / Cohort
    Individuals 18 years of age and older
    Data Sources
    Sentinel Distributed Database (SDD)