A Database Cohort Study to Assess the Risk of Angioedema Among Patients with Heart Failure Initiating Angiotensin-Converting Enzyme Inhibitors in the USA
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Real-world evidence on the risk of angioedema associated with angiotensin-converting enzyme inhibitors (ACEIs) in patients with heart failure (HF) is scarce.
This non-interventional study aimed to estimate the incidence of and risk factors for angioedema in patients with HF initiating an ACEI in real-world practice.
This was a retrospective cohort study using claims data from the PharMetrics Plus database, supplemented with consumer health data, from 1 January 2007 to 31 March 2015. Patients with HF initiating an ACEI were followed up for a maximum of 1 year, until the first occurrence of angioedema or until cohort exit. Angioedema incidence rates were estimated and stratified by potential risk factors such as race, age, sex, and time from initiation of ACEI therapy. For each risk factor, the unadjusted and adjusted hazard ratio (HR) was calculated; exploratory analyses were carried out to account for all potential confounders.
We identified 21,639 patients with HF initiating an ACEI (mean age 58 years; 35.6% women; mean follow-up 205 days). The 1-year incidence of angioedema per 1000 patient-years was 3.3 [95% confidence interval (CI) 2.4–4.5]. The incidence was higher in Black [6.2 (95% CI 3.1–12.5)] than in non-black [2.9 (95% CI 2.1–4.1)] patients, higher in women [5.2 (95% CI 3.4–7.9)] than in men [2.3 (95% CI 1.5–3.6)], and greatest in the first 30 days of ACEI therapy.
The risk of angioedema in patients with HF initiating an ACEI observed in this study is in line with published estimates for the general patient population treated with ACEIs.
Medical writing support was provided by Noëlle L. O’Regan and Carly Sellick of PharmaGenesis London, London, UK, and was funded by Novartis Pharma AG.
Compliance with Ethical Standards
Conflict of interest
T. Do was an employee of Novartis at the time this study was conducted and is now an employee of Takeda Pharmaceutical International AG. R. Belleli was an employee of Novartis at the time this study was conducted and is now an employee of Numerus Analytics AG. H. Streefkerk was an employee of Novartis at the time this study was conducted and is now an employee of Piqur Therapeutics AG. A. Seetasith and C. Burudpakdee were contracted by Novartis Pharma AG to conduct this study. R. Schlienger, S. Corda, and S. Behr are employees of and stakeholders in Novartis Pharma AG.
This study was funded by Novartis Pharma AG, Basel, Switzerland.
- 3.Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016;37(27):2129–200.CrossRefPubMedGoogle Scholar
- 4.Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Colvin MM, et al. 2016 ACC/AHA/HFSA focused update on new pharmacological therapy for heart failure: an update of the 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the heart failure society of America. Circulation. 2016;134(13):e282–93.CrossRefPubMedGoogle Scholar
- 5.Sica DA, Black HR. Angioedema in heart failure: occurrence with ACE inhibitors and safety of angiotensin receptor blocker therapy. Congest Heart Fail. 2002;8(6):334–41, 45.Google Scholar
- 15.Hill A, Bigby JA. Databases to track use of preventive services after implementation of the affordable care act. Mathematica Policy Research. 2014. https://www.mathematica-mpr.com/our-publications-and-findings/publications/databases-to-track-use-of-preventive-services-after-implementation-of-the-affordable-care-act-ib. Accessed 9 Jun 2017.
- 21.The Henry J. Kaiser Family Foundation. Distribution of the nonelderly with Medicaid by race/ethnicity. 2016. http://kff.org/medicaid/state-indicator/distribution-by-raceethnicity-4/. Accessed 9 Jun 2017.
- 22.Centers for Medicare and Medicaid Services, Office of Enterprise Data and Analytics, CMS Chronic Conditions Data Warehouse. Total medicare enrollment. https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/CMSProgramStatistics/2013/Downloads/MDCR_ENROLL_AB/CPS_MDCR_ENROLL_AB_5.pdf. Accessed 16 Aug 2016.