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John B. Kostis, MD; Harold J. Kim, MD; James Rusnak, MD, PhD; Thomas Casale, MD; Allen Kaplan, MD; Jonathan Corren, MD; Elliott Levy, MD

Arch Intern Med. 2005;165:1637-1642.

Background  Angioedema is a rare but potentially serious adverse event of angiotensin-converting enzyme inhibitor therapy. However, no prospective, controlled studies have reported on its incidence and clinical characteristics.

Methods  We studied the occurrence of angioedema in a randomized, double-blind, controlled trial of 12 557 persons with hypertension treated with enalapril maleate, 5 to 40 mg/d, using a prospective ascertainment and adjudication of angioedema by an expert committee.

Results  Angioedema occurred in 86 (0.68%) of the subjects. Stepwise logistic regression identified black race (odds ratio [OR], 2.88; 95% confidence interval [CI], 1.72-4.82), history of drug rash (OR, 3.78; 95% CI, 1.80-7.92), age greater than 65 years (OR, 1.60; 95% CI, 1.02-2.53), and seasonal allergies (OR, 1.79; 95% CI, 1.06-3.00) as independent risk factors for angioedema. The incidence of angioedema was higher after initiation of therapy (3.6/1000 patients per month) and declined to 0.4/1000 patients per month. Treatment was not given in 44 (51%) of the cases; antihistamines were administered in 35 (41%); corticosteroids, in 20 (23%); and epinephrine, in 1 (1%). Two patients were hospitalized but none had airway compromise.

Conclusions  Enalapril-related angioedema is uncommon. Although it is most likely to occur early after initiation of therapy, it may occur at any time. It is more likely to occur in black patients, those older than 65 years, and those with a history of drug rash or seasonal allergies. Fatal angioedema or angioedema requiring airway protection did not occur in this study.

Author Affiliations: Department of Medicine, University of Medicine and Dentistry of New Jersey–Robert Wood Johnson Medical School, New Brunswick (Drs Kostis and Kim); Bristol-Myers Squibb, Princeton, NJ (Drs Rusnak and Levy); Department of Medicine, Creighton University, Omaha, Neb (Dr Casale); Medical University of South Carolina, Charleston (Dr Kaplan); and Department of Medicine, Allergy Research Foundation, Inc, Los Angeles, Calif (Dr Corren).

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