TY - JOUR
T1 - Randomized placebo-controlled trial of the bradykinin B2 receptor antagonist icatibant for the treatment of acute attacks of hereditary angioedema
T2 - The FAST-3 trial
AU - Lumry, William R.
AU - Li, H. Henry
AU - Levy, Robyn J.
AU - Potter, Paul C.
AU - Farkas, Henriette
AU - Moldovan, Dumitru
AU - Riedl, Marc
AU - Li, Hongbin
AU - Craig, Timothy
AU - Bloom, Bradley J.
AU - Reshef, Avner
N1 - Funding Information:
Robyn Levy speaks for CSL Behring. She has received research grant support from CSL Behring, Dyax, Shire HGT, Pharming Technologies BV, and Viropharma , Inc. She is a medical consultant for CSL Behring and Shire HGT.
Funding Information:
Avner Reshef has received research grants from CSL Behring, Jerini AG/Shire HGT, and Pharming NV . Dr. Reshef is a member of the Global Advisory Board for Shire HGT.
Funding Information:
Disclosures: William Lumry speaks for CSL Behring, Dyax, and Viropharma. He has received research grant support from CSL Behring, Dyax, Shire HGT/Jerini AG, Pharming NV, and Viropharma . He is an advisor to CSL Behring, Dyax, Shire HGT/Jerini AG, and Viropharma.
PY - 2011/12
Y1 - 2011/12
N2 - 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.
AB - 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.
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U2 - 10.1016/j.anai.2011.08.015
DO - 10.1016/j.anai.2011.08.015
M3 - Article
C2 - 22123383
AN - SCOPUS:82955233701
SN - 1081-1206
VL - 107
SP - 529-537.e2
JO - Annals of Allergy, Asthma and Immunology
JF - Annals of Allergy, Asthma and Immunology
IS - 6
ER -