Abstract | BACKGROUND: METHODS: In this multicenter, double-blind, double-dummy, randomized phase 2 study, we assigned patients who had ACE-inhibitor-induced angioedema of the upper aerodigestive tract to treatment with 30 mg of subcutaneous icatibant, a selective bradykinin B2 receptor antagonist, 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: All 27 patients in the per-protocol population had complete resolution of edema. The median time to complete resolution was 8.0 hours (interquartile range, 3.0 to 16.0) with icatibant as compared with 27.1 hours (interquartile range, 20.3 to 48.0) 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 had complete resolution of edema within 4 hours after treatment (5 of 13 vs. 0 of 14, P=0.02). The median time to the onset of symptom relief (according to a composite investigator-assessed symptom score) was significantly shorter with icatibant than with standard therapy (2.0 hours vs. 11.7 hours, P=0.03). The results were similar when patient-assessed symptom scores were used. CONCLUSIONS:
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Authors | Murat Baş, Jens Greve, Klaus Stelter, Miriam Havel, Ulrich Strassen, Nicole Rotter, Johannes Veit, Beate Schossow, Alexander Hapfelmeier, Victoria Kehl, Georg Kojda, Thomas K Hoffmann |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 372
Issue 5
Pg. 418-25
(Jan 29 2015)
ISSN: 1533-4406 [Electronic] United States |
PMID | 25629740
(Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Angiotensin-Converting Enzyme Inhibitors
- Bradykinin B2 Receptor Antagonists
- Glucocorticoids
- Histamine H1 Antagonists
- icatibant
- Clemastine
- Prednisolone
- Bradykinin
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Topics |
- Aged
- Angioedema
(chemically induced, drug therapy)
- Angiotensin-Converting Enzyme Inhibitors
(adverse effects)
- Bradykinin
(adverse effects, analogs & derivatives, therapeutic use)
- Bradykinin B2 Receptor Antagonists
(adverse effects, therapeutic use)
- Clemastine
(therapeutic use)
- Double-Blind Method
- Drug Therapy, Combination
- Female
- Glucocorticoids
(therapeutic use)
- Histamine H1 Antagonists
(therapeutic use)
- Humans
- Injections, Subcutaneous
(adverse effects)
- Male
- Middle Aged
- Prednisolone
(therapeutic use)
- Time Factors
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