• Richard Sinert, Phillip Levy, Jonathan A Bernstein, and Richard Body.
• Department of Emergency Medicine, SUNY Downstate Medical Center/Kings County Hospital Medical Center, Brooklyn, NY. Electronic address: Richard.Sinert@downstate.edu.
• J Allergy Clin Immunol Pract. 2017 Sep 1; 5 (5): 1402-1409.e3.

BackgroundUpper airway angioedema is a rare, unpredictable, and at times life-threatening adverse effect of angiotensin-converting enzyme inhibitors (ACE-Is) with no existing effective pharmacologic treatment. Icatibant is a bradykinin B2 receptor antagonist that may be beneficial in patients with ACE-I-induced angioedema.ObjectiveWe aimed to evaluate the efficacy of icatibant in subjects with ACE-I-induced angioedema.MethodsAt 31 centers in 4 countries, adults on ACE-Is who presented within 12 hours of the onset of at least moderately severe angioedema were randomized 1:1 to icatibant 30 mg or placebo administered subcutaneously. The primary efficacy end point was time to meeting discharge criteria after study drug administration, based on the severity of airway symptoms assessed hourly by a blinded physician using clinical ratings across 4 domains.ResultsA total of 121 subjects were randomized (icatibant, n = 61; placebo, n = 60); 118 received treatment a median of 7.8 hours from symptom onset. We observed no difference in time to meeting discharge criteria between groups (median, 4.0 hours in each group; P = .63). There also was no difference in time to onset of symptom relief (median, icatibant, 2.0 hours; placebo, 1.6 hours; P = .57) or any other secondary end point. Similar findings were noted in prespecified and post hoc subgroup analyses stratified by symptom severity, time interval to treatment, age, and other clinical covariates. No new safety signals were detected.ConclusionsIcatibant was no more efficacious than placebo in at least moderately severe ACE-I-induced angioedema of the upper airway.Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

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