(P-050) Cohort Study Assessing Angioedema Risk in Black Heart Failure Patients Using Angiotensin-converting Enzyme Inhibitors in the United States– Interim Results

Background: Heart failure (HF) affects approximately six million Americans and is a leading cause of hospital admission in older patients. Angiotensin-converting enzyme inhibitors (ACEI) are recommended to treat HF but are also known to increase the risk of angioedema, especially among Black patients. There is limited data quantifying angioedema risk among Black HF patients initiating ACEI. We present results from an interim analysis of an ongoing, multi-database, post-marketing safety study using various data sources under a common protocol.

Objectives: To estimate the angioedema incidence rate (IR) separately among Black and non-Black HF patients initiating ACEI in real-world settings.

Methods: We used claims data from eligible patients from the Innovation in Medical Evidence Development and Surveillance (IMEDS) Distributed Database Network between January 1, 2008 and September 30, 2019. Eligible patients met the following criteria: aged ≥18 years, known race, HF diagnosis within the prior year, and no prior angioedema diagnosis. Cohort entry was defined as a new dispensing (no dispensing in the prior year) of an ACEI after July 7, 2015. Patients were followed for angioedema for up to 365 days or until censoring. We calculated IRs per 1,000 patient-years (PY) of serious angioedema (recorded in an inpatient setting) and any angioedema (serious and non-serious) after treatment initiation among Black and non-Black patients separately. We also calculated IRs among ACEI initiators who had not previously used an angiotensin-receptor blocker (ARB).

Results: We identified 41,251 ACEI initiators, of whom 8,426 (20%) were Black. Among Black ACEI initiators, the IR per 1,000 PY for serious angioedema was 6.48 (95% CI: 3.90, 10.12) and for any angioedema was 21.53 (95% CI: 16.54, 27.54). Among the 33,095 non-Black ACEI initiators, the IR per 1,000 PY for serious angioedema was 1.06 (95% CI: 0.58, 1.78) and for any angioedema was 3.63 (95% CI: 2.68, 4.81). Among 6,301 ARB-naïve Black ACEI initiators, the IR per 1,000 PY for serious angioedema was 4.64 (95%CI: 2.32, 8.30) and for any angioedema was 19.46 (95%CI: 14.24, 25.95). Among 27,282 ARB-naïve non-Black ACEI initiators, the IR per 1,000 PY for serious angioedema was 0.79 (95%CI: 0.36, 1.50) and for any angioedema was 3.51 (95%CI: 2.51, 4.78).

Conclusions: In this interim analysis, we observed a higher IR for serious and any angioedema among Black HF patients who initiated an ACEI relative to non-Black patients, regardless of prior ARB use. For the final analysis, data will be combined with other sources, including Medicare.