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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
immunology and microbiology
Randomized placebo-controlled trial of the bradykinin B
2
receptor antagonist icatibant for the treatment of acute attacks of hereditary angioedema: The FAST-3 trial
Annals of Allergy, Asthma and Immunology, Volume 107, No. 6, Year 2011
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Description
The For Angioedema Subcutaneous Treatment (FAST)-3 study was a phase III, randomized, double-blind, placebo-controlled study of icatibant (bradykinin B2 receptor antagonist) in subjects with hereditary angioedema (HAE) resulting from C1-INH deficiency or dysfunction (type I/II). To investigate icatibant efficacy and safety in subjects with acute HAE attacks. Subjects with moderate to very severe cutaneous or abdominal symptoms received icatibant (n = 43) or placebo (n = 45). Five subjects with laryngeal (mild-to-moderate) first attacks received icatibant (n = 3) or placebo (n = 2), and 5 subjects with severe laryngeal first attacks received open-label icatibant. Cutaneous or abdominal attacks: icatibant significantly reduced median times (vs placebo) to 50% or more reduction in symptom severity (2.0 vs 19.8 hours; P <.001, primary endpoint), onset of primary symptom relief (1.5 vs 18.5 hours; P <.001, key secondary endpoint), or almost complete symptom relief (8.0 vs 36.0 hours; P =.012) and provided a shorter time to initial symptom relief (0.8 vs 3.5 hours; P <.001). For laryngeal attacks, median time to 50% or more reduction in symptom severity was 2.5 hours (icatibant) and 3.2 hours (placebo). No icatibant-treated subject required rescue medication before symptom relief occurred. The incidence of adverse events (AEs) was similar in icatibant- and placebo-treated subjects (41% and 52%, respectively). All icatibant-treated subjects experienced injection site reactions, but none reported clinically relevant changes in safety parameters or serious AEs. FAST-3 demonstrated that icatibant was effective and generally well tolerated in subjects with acute HAE attacks. Clinicaltrials.gov Identifier: NCT00912093. © 2011 American College of Allergy, Asthma & Immunology.
Authors & Co-Authors
Lumry, William Raymond
United States, Dallas
Allergy and Asthma Research Associates, Texas
Li, Huamin Henry
United States, Chevy Chase
Institute for Asthma and Allergy
Levy, Robyn J.
United States, Atlanta
Family Allergy and Asthma Center
Potter, Paul C.
South Africa, Cape Town
University of Cape Town
Farkas, Henriette
Hungary, Budapest
Általános Orvostudományi Kar
Moldovan, Dumitru
Romania, Targu Mures
George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures
Riedl, Marc A.
United States, Los Angeles
David Geffen School of Medicine at Ucla
Li, Hongbin
United States, Cambridge
Shire Usa
Craig, Timothy J.
United States, Hershey
Penn State Health Milton S. Hershey Medical Center
Bloom, Bradley J.
United States, Cambridge
Shire Usa
Reshef, Avner
Israel, Tel Hashomer Tel Aviv
Chaim Sheba Medical Center Israel
Statistics
Citations: 199
Authors: 11
Affiliations: 10
Identifiers
Doi:
10.1016/j.anai.2011.08.015
ISSN:
10811206
e-ISSN:
15344436
Research Areas
Disability
Study Design
Cohort Study