AMelioration of Angiotensin Converting Enzyme Inhibitor Induced Angioedema Study

Summary

This is a multicenter study recruiting patients with angioedema induced by ACEI. Open-label treatment with subcutaneous Icatibant compared to a historic group of 47 patients with ACE inhibitor induced angioedema which the investigators have been previously treated in the investigators centers with current "standard" therapy (250 mg methylprednisolon and 2 mg clemastine). In cases with fast progression of edema after application the study-drug, a second application with icatibant could be necessary. Rescue medication and intervention.

Timeline

Start

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Primary completion

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Completion

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Outcome

Met primary endpoint

paper 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 PMID 25629740 ↗

paper the time to complete resolution of edema was significantly shorter with icatibant than with combination therapy with a glucocorticoid and an antihistamine. PMID 25629740 ↗

Publications

• Bas M, Greve J, Stelter K, Havel M, Strassen U, Rotter N, Veit J, Schossow B, Hapfelmeier A, Kehl V, Kojda G, Hoffmann TK. A randomized trial of icatibant in ACE-inhibitor-induced angioedema. N Engl J Med. 2015 Jan 29;372(5):418-25. doi: 10.1056/NEJMoa1312524.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Clemastine	Small molecule	2 mg	Intravenous
Comparator	Cortisone acetate	Other / unclassified	—	Intravenous
Subject	Icatibant	Peptide	30 mg	Subcutaneous

Indications