6/28/23, 11:40 PM Icatibant in ACEI-Induced Angioedema Pathway Feedback Search Clinical Topics Home Studies Icatibant in ACEI Induced Angioedema Icatibant in ACEI Induced Angioedema Disease Hypertension Trial question What is the role of icatibant in patients who had ACE-inhibitor-induced angioedema? Study design Multi-center Double blinded RCT Population Characteristics of study participants 37.0% female N = 27 63.0% male 27 patients (10 female, 17 male) Inclusion criteria: patients who had ACE-inhibitor-induced angioedema of the upper aerodigestive tract Key exclusion criteria: causes other than ACE inhibitors, history of angioedema before the initiation of ACE-inhibitor therapy, acute urticaria, unstable angina, acute myocardial ischemia, acute HF with a NYHA class of III or IV, pregnancy, and lactation Interventions N=13 icatibant (at a dose of 30 mg SC) N=14 standard therapy (intravenous 500 mg prednisolone plus 2 mg clemastine) Primary outcome Median time to complete resolution of edema 27.1 hours 27.1 https://web.pathway.md/studies/recr8fuzeWK1rXZTe 1/2 6/28/23, 11:40 PM Icatibant in ACEI-Induced Angioedema Pathway 20.3 hours 13.6 hours 8 6.8 hours Significant decrease 0.0 hours Icatibant Standard therapy Significant decrease in median time to complete resolution of edema (8 hours vs. 27.1 hours; AD -19.1 hours, 95% CI -31.18 to -7.02) Secondary outcomes Significant increase in complete resolution within 4 hours (AD 38%, 95% CI 5.95 to 70.05) Significant decrease in median time to the onset of symptom relief (2 hours vs. 11.7 hours; AD -9.7 hours, 95% CI -18.47 to -0.93) Safety outcomes No significant difference in drug-related adverse event. Significant differences in adverse events (7% vs. 27%), redness at injection site (80% vs. 27%), swelling at injection site (53% vs. 20%), pain at injection site (47% vs. 13%). Conclusion In patients who had ACE-inhibitor-induced angioedema of the upper aerodigestive tract, icatibant was superior to standard therapy with respect to median time to complete resolution of edema. Reference Bas M, Greve J, Stelter K et al. A randomized trial of icatibant in ACE-inhibitor-induced angioedema. N Engl J Med. 2015 Jan 29;372(5):418-25. Open reference URL https://web.pathway.md/studies/recr8fuzeWK1rXZTe 2/2