PMID- 22123383
OWN - NLM
STAT- MEDLINE
DCOM- 20120209
LR  - 20220409
IS  - 1534-4436 (Electronic)
IS  - 1081-1206 (Linking)
VI  - 107
IP  - 6
DP  - 2011 Dec
TI  - 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.
PG  - 529-37
LID - 10.1016/j.anai.2011.08.015 [doi]
AB  - BACKGROUND: The For Angioedema Subcutaneous Treatment (FAST)-3 study was a phase 
      III, randomized, double-blind, placebo-controlled study of icatibant (bradykinin 
      B(2) receptor antagonist) in subjects with hereditary angioedema (HAE) resulting 
      from C1-INH deficiency or dysfunction (type I/II). OBJECTIVE: To investigate 
      icatibant efficacy and safety in subjects with acute HAE attacks. METHODS: 
      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. 
      RESULTS: 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. CONCLUSIONS: FAST-3 
      demonstrated that icatibant was effective and generally well tolerated in 
      subjects with acute HAE attacks. TRIAL REGISTRATION: Clinicaltrials.gov 
      Identifier: NCT00912093.
CI  - Copyright (c) 2011 American College of Allergy, Asthma & Immunology. Published by 
      Elsevier Inc. All rights reserved.
FAU - Lumry, William R
AU  - Lumry WR
AD  - Allergy and Asthma Research Associates Research Center, Dallas, Texas 75081, USA. 
      LumryMD@AllergySpecialists.us
FAU - Li, H Henry
AU  - Li HH
FAU - Levy, Robyn J
AU  - Levy RJ
FAU - Potter, Paul C
AU  - Potter PC
FAU - Farkas, Henriette
AU  - Farkas H
FAU - Moldovan, Dumitru
AU  - Moldovan D
FAU - Riedl, Marc
AU  - Riedl M
FAU - Li, Hongbin
AU  - Li H
FAU - Craig, Timothy
AU  - Craig T
FAU - Bloom, Bradley J
AU  - Bloom BJ
FAU - Reshef, Avner
AU  - Reshef A
LA  - eng
SI  - ClinicalTrials.gov/NCT00912093
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20111005
PL  - United States
TA  - Ann Allergy Asthma Immunol
JT  - Annals of allergy, asthma & immunology : official publication of the American 
      College of Allergy, Asthma, & Immunology
JID - 9503580
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Bradykinin B2 Receptor Antagonists)
RN  - 7PG89G35Q7 (icatibant)
RN  - S8TIM42R2W (Bradykinin)
SB  - IM
MH  - Adult
MH  - Angioedemas, Hereditary/*drug therapy
MH  - Anti-Inflammatory Agents, Non-Steroidal/*administration & dosage
MH  - Bradykinin/administration & dosage/*analogs & derivatives
MH  - *Bradykinin B2 Receptor Antagonists
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Injections, Subcutaneous
MH  - Kaplan-Meier Estimate
MH  - Male
EDAT- 2011/11/30 06:00
MHDA- 2012/02/10 06:00
CRDT- 2011/11/30 06:00
PHST- 2011/06/07 00:00 [received]
PHST- 2011/08/09 00:00 [revised]
PHST- 2011/08/30 00:00 [accepted]
PHST- 2011/11/30 06:00 [entrez]
PHST- 2011/11/30 06:00 [pubmed]
PHST- 2012/02/10 06:00 [medline]
AID - S1081-1206(11)00658-2 [pii]
AID - 10.1016/j.anai.2011.08.015 [doi]
PST - ppublish
SO  - Ann Allergy Asthma Immunol. 2011 Dec;107(6):529-37. doi: 
      10.1016/j.anai.2011.08.015. Epub 2011 Oct 5.