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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Icatibant, a new bradykinin-receptor antagonist, in hereditary angioedema
New England Journal of Medicine, Volume 363, No. 6, Year 2010
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Description
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. Copyright © 2010 Massachusetts Medical Society.
Authors & Co-Authors
Banerji, Aleena Suryadevara
United States, Boston
Harvard Medical School
Malbrán, Alejandro
Argentina, Buenos Aires
Hospital Britanico de Buenos Aires
Rosenkranz, Bernd
Unknown Affiliation
Riedl, Marc A.
United States, Los Angeles
David Geffen School of Medicine at Ucla
Bork, Konrad
Germany, Mainz
Johannes Gutenberg-universität Mainz
Lumry, William Raymond
Unknown Affiliation
Aberer, Werner
Austria, Graz
Medizinische Universität Graz
Baş, Murat
Germany, Munich
Technische Universität München
Farkas, Henriette
Hungary, Budapest
Semmelweis Egyetem
Reshef, Avner
Israel, Tel Hashomer Tel Aviv
Chaim Sheba Medical Center Israel
Ritchie, Bruce C.
Canada, Edmonton
University of Alberta
Yang, William Ho Ching
Unknown Affiliation
Levy, Robyn J.
United States, Atlanta
Family Allergy and Asthma Center
Luger, Thomas Anton
Germany, Munster
Universitätsklinikum Münster
Schmid-Grendelmeier, Peter D.
Switzerland, Zurich
Universitatsspital Zurich
Sitkauskiene, Brigita
Lithuania, Kaunas
Kaunas University of Medicine
Smith, William Bernard
Australia, Adelaide
Royal Adelaide Hospital
Toubi, Elias
Israel, Haifa
Bnai Zion Medical Center
Bouillet, Laurence
France, Grenoble
Centre Hospitalier Universitaire de Grenoble
Katelaris, Constance Helen
Unknown Affiliation
Maurer, Marcus S.
Germany, Berlin
Charité – Universitätsmedizin Berlin
Merk, Hans Friedrich
Germany, Aachen
Uniklinik Rwth Aachen
Bernstein, Jonathan A.
United States, Cincinnati
University of Cincinnati
Feighery, Conleth F.
Ireland, Dublin
St James's Hospital
Floccard, Bernard
France, Lyon
Hopital Edouard Herriot
Gleich, Gerald J.
United States, Salt Lake City
University of Utah Health Sciences
Hébert, Jacques R.
Canada, Quebec
Centre de Recherche Appliquée en Allergie de Québec
Keith, Paul Kevin
Canada, Hamilton
Hamilton Health Sciences
Langton, David
Australia, Frankston
Frankston Hospital
Martin, Ludovic
France, Orleans
Chr D'orléans
Zanichelli, Andrea
Italy, Milan
Università Degli Studi Di Milano
Statistics
Citations: 469
Authors: 31
Affiliations: 40
Identifiers
Doi:
10.1056/NEJMoa0906393
ISSN:
00284793
Research Areas
Disability
Health System And Policy
Study Design
Randomised Control Trial