1. Repeat treatment of acute hereditary angioedema attacks with open-label icatibant in the FAST-1 trial.
- Author
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Malbrán, A., Riedl, M., Ritchie, B., Smith, W. B., Yang, W., Banerji, A., Hébert, J., Gleich, G. J., Hurewitz, D., Jacobson, K. W., Bernstein, J. A., Khan, D. A., Kirkpatrick, C. H., Resnick, D., Li, H., Fernández Romero, D. S., and Lumry, W.
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ANGIONEUROTIC edema , *GENETIC disorders , *EDEMA , *SUBCUTANEOUS infusions , *RANDOMIZED controlled trials , *CLINICAL trials - 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. [ABSTRACT FROM AUTHOR]
- Published
- 2014
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