title: Repeat treatment of acute hereditary angioedema attacks with open-label icatibant in the FAST-1 trial.
abstract: 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.
authors.affiliation: Hospital Británico de Buenos Aires, Buenos Aires, Argentina.
authors.forename: A
authors.initials: A
authors.lastname: Malbrán
authors.forename: M
authors.initials: M
authors.lastname: Riedl
authors.forename: B
authors.initials: B
authors.lastname: Ritchie
authors.forename: W B
authors.initials: WB
authors.lastname: Smith
authors.forename: W
authors.initials: W
authors.lastname: Yang
authors.forename: A
authors.initials: A
authors.lastname: Banerji
authors.forename: J
authors.initials: J
authors.lastname: Hébert
authors.forename: G J
authors.initials: GJ
authors.lastname: Gleich
authors.forename: D
authors.initials: D
authors.lastname: Hurewitz
authors.forename: K W
authors.initials: KW
authors.lastname: Jacobson
authors.forename: J A
authors.initials: JA
authors.lastname: Bernstein
authors.forename: D A
authors.initials: DA
authors.lastname: Khan
authors.forename: C H
authors.initials: CH
authors.lastname: Kirkpatrick
authors.forename: D
authors.initials: D
authors.lastname: Resnick
authors.forename: H
authors.initials: H
authors.lastname: Li
authors.forename: D S
authors.initials: DS
authors.lastname: Fernández Romero
authors.forename: W
authors.initials: W
authors.lastname: Lumry
mesh_terms: D000328:Adult; D054179:Angioedemas, Hereditary / Q000175:diagnosis / Q000188:drug therapy*; D001920:Bradykinin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D065168:Bradykinin Receptor Antagonists; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019233:Retreatment; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D065168:Bradykinin Receptor Antagonists; C065679:icatibant; D001920:Bradykinin
keywords: C1-inhibitor deficiency; FAST-1; OLE phase; bradykinin B2 receptor antagonist; hereditary angioedema; icatibant
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