Repeat treatment of acute hereditary angioedema attacks with open-label icatibant in the FAST-1 trial

Clin Exp Immunol. 2014 Aug;177(2):544-53. doi: 10.1111/cei.12358.


Hereditary angioedema (HAE) is characterized by potentially life-threatening recurrent episodes of oedema. The open-label extension (OLE) phase of the For Angioedema Subcutaneous Treatment (FAST)-1 trial (NCT00097695) evaluated the efficacy and safety of repeated icatibant exposure in adults with multiple HAE attacks. Following completion of the randomized, controlled phase, patients could receive open-label icatibant (30 mg subcutaneously) for subsequent attacks. The primary end-point was time to onset of primary symptom relief, as assessed by visual analogue scale (VAS). Descriptive statistics were reported for cutaneous/abdominal attacks 1-10 treated in the OLE phase and individual laryngeal attacks. Post-hoc analyses were conducted in patients with ≥ 5 attacks across the controlled and OLE phases. Safety was evaluated throughout. During the OLE phase, 72 patients received icatibant for 340 attacks. For cutaneous/abdominal attacks 1-10, the median time to onset of primary symptom relief was 1·0-2·0 h. For laryngeal attacks 1-12, patient-assessed median time to initial symptom improvement was 0·3-1·2 h. Post-hoc analyses showed the time to onset of symptom relief based on composite VAS was consistent across repeated treatments with icatibant. One injection of icatibant was sufficient to treat 88·2% of attacks; rescue medication was required in 5·3% of attacks. No icatibant-related serious adverse events were reported. Icatibant provided consistent efficacy and was well tolerated for repeated treatment of HAE attacks.

Keywords: C1-inhibitor deficiency; FAST-1; OLE phase; bradykinin B2 receptor antagonist; hereditary angioedema; icatibant.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Angioedemas, Hereditary / diagnosis
  • Angioedemas, Hereditary / drug therapy*
  • Bradykinin / administration & dosage
  • Bradykinin / adverse effects
  • Bradykinin / analogs & derivatives*
  • Bradykinin / therapeutic use
  • Bradykinin Receptor Antagonists
  • Female
  • Humans
  • Male
  • Middle Aged
  • Retreatment
  • Treatment Outcome
  • Young Adult


  • Bradykinin Receptor Antagonists
  • icatibant
  • Bradykinin

Associated data