JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL

Icatibant, a new bradykinin-receptor antagonist, in hereditary angioedema

Marco Cicardi, Aleena Banerji, Francisco Bracho, Alejandro Malbrán, Bernd Rosenkranz, Marc Riedl, Konrad Bork, William Lumry, Werner Aberer, Henning Bier, Murat Bas, Jens Greve, Thomas K Hoffmann, Henriette Farkas, Avner Reshef, Bruce Ritchie, William Yang, Jürgen Grabbe, Shmuel Kivity, Wolfhart Kreuz, Robyn J Levy, Thomas Luger, Krystyna Obtulowicz, Peter Schmid-Grendelmeier, Christian Bull, Brigita Sitkauskiene, William B Smith, Elias Toubi, Sonja Werner, Suresh Anné, Janne Björkander, Laurence Bouillet, Enrico Cillari, David Hurewitz, Kraig W Jacobson, Constance H Katelaris, Marcus Maurer, Hans Merk, Jonathan A Bernstein, Conleth Feighery, Bernard Floccard, Gerald Gleich, Jacques Hébert, Martin Kaatz, Paul Keith, Charles H Kirkpatrick, David Langton, Ludovic Martin, Christiane Pichler, David Resnick, Duane Wombolt, Diego S Fernández Romero, Andrea Zanichelli, Francesco Arcoleo, Jochen Knolle, Irina Kravec, Liying Dong, Jens Zimmermann, Kimberly Rosen, Wing-Tze Fan
New England Journal of Medicine 2010 August 5, 363 (6): 532-41
20818888

BACKGROUND: Hereditary angioedema is characterized by recurrent attacks of angioedema of the skin, larynx, and gastrointestinal tract. Bradykinin is the key mediator of symptoms. Icatibant is a selective bradykinin B2 receptor antagonist.

METHODS: In two double-blind, randomized, multicenter trials, we evaluated the effect of icatibant in patients with hereditary angioedema presenting with cutaneous or abdominal attacks. In the For Angioedema Subcutaneous Treatment (FAST) 1 trial, patients received either icatibant or placebo; in FAST-2, patients received either icatibant or oral tranexamic acid, at a dose of 3 g daily for 2 days. Icatibant was given once, subcutaneously, at a dose of 30 mg. The primary end point was the median time to clinically significant relief of symptoms.

RESULTS: A total of 56 and 74 patients underwent randomization in the FAST-1 and FAST-2 trials, respectively. The primary end point was reached in 2.5 hours with icatibant versus 4.6 hours with placebo in the FAST-1 trial (P=0.14) and in 2.0 hours with icatibant versus 12.0 hours with tranexamic acid in the FAST-2 trial (P<0.001). In the FAST-1 study, 3 recipients of icatibant and 13 recipients of placebo needed treatment with rescue medication. The median time to first improvement of symptoms, as assessed by patients and by investigators, was significantly shorter with icatibant in both trials. No icatibant-related serious adverse events were reported.

CONCLUSIONS: In patients with hereditary angioedema having acute attacks, we found a significant benefit of icatibant as compared with tranexamic acid in one trial and a nonsignificant benefit of icatibant as compared with placebo in the other trial with regard to the primary end point. The early use of rescue medication may have obscured the benefit of icatibant in the placebo trial. (Funded by Jerini; ClinicalTrials.gov numbers, NCT00097695 and NCT00500656.)

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