A Randomized Trial of Icatibant in ACE-Inhibitor–Induced Angioedema

Rationale:

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.

Methods:

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.

Results:

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). 

Conclusions:

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.