A Randomized Trial of Icatibant in ACE-Inhibitor–Induced Angioedema
Monday, March 7, 2016
South Exhibit Hall H (Convention Center)
Ulrich Strassen, Jens Greve, Klaus Stelter, Miriam Havel, Nicole Rotter, Johannes Veit, Beate Schossow, Alexander Hapfelmeier, Victoria Kehl, Georg Kojda, Thomas K. Hoffmann, Murat Bas, MD

Angioedema induced by treatment with angiotensin-converting-enzyme (ACE) inhibitors is estimated to occur in up to 0.68% of patients receiving ACE inhibitors and usually are located in the upper airway and the head and neck region. There is no approved treatment for this potentially life-threatening condition. The study objective was to evaluate the effectiveness and safety of the selective B2-receptor-antagonist icatibant in the treatment of this condition.


Patients (n = 30) who had been diagnosed with ACE-inhibitor-induced angioedema of the upper aerodigestive tract were randomly assigned to treatment with 30 mg of subcutaneous icatibant or to the current off-label standard therapy consisting of intravenous prednisolone (500 mg) plus clemastine (2 mg). The primary efficacy end point was the median time to complete resolution of edema.


The median time to complete resolution was 8.0 hours with icatibant as compared to 27.1 hours with standard therapy (P = 0.002). Three patients receiving standard therapy required rescue intervention with icatibant and prednisolone; 1 patient required tracheotomy. Significantly more patients in the icatibant group than in the standard-therapy group showed  complete resolution of edema within 4 hours after treatment (5 of 13 vs. 0 of 14, P = 0.02). 


Among patients with ACE-inhibitor-induced angioedema, the time to complete resolution of edema was significantly shorter with icatibant than with combination therapy with a glucocorticoid and an antihistamine. Icatibant therefore seems to be an effective and safe therapeutic option in patients suffering from ACE-inhibitor-induced angioedema.