Trial reportClinical and experimental immunology2014
Repeat treatment of acute hereditary angioedema attacks with open-label icatibant in the FAST-1 trial.
Trial report in Clinical and experimental immunology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00097695 (Randomized, Double Blind, Placebo-Controlled, Multicenter Study of a Subcutaneous Formulation of Icatibant for the Treatment of Hereditary Angioedema), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Randomized, Double Blind, Placebo-Controlled, Multicenter Study of a Subcutaneous Formulation of Icatibant for the Treatment of Hereditary Angioedema
Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 41 citations in OpenAlex.
- Diverse Trial Designs, Populations, and Outcomes: A Systematic Literature Review of Trials for the Treatment of Hereditary Angioedema Attacks.Advances in therapy · 2026Pooled it
- Acquired Angioedema-A Challenge in Medical Practice: A Narrative Review.Journal of clinical medicine · 2026Review
- A Comprehensive Management Approach in Pediatric and Adolescent Patients With Hereditary Angioedema.Clinical pediatrics · 2023Review
- The Role of Bradykinin Receptors in Hereditary Angioedema Due to C1-Inhibitor Deficiency.International journal of molecular sciences · 2022Article
- Orphan Drug Use in Patients With Rare Diseases: A Population-Based Cohort Study.Frontiers in pharmacology · 2022Article
- Continued icatibant use across recurrent attacks in adolescents with hereditary angioedema.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2021Article
- Population Pharmacokinetics and Exposure-Response Analyses to Guide Dosing of Icatibant in Pediatric Patients With Hereditary Angioedema.Journal of clinical pharmacology · 2021Article
- Therapeutic management of hereditary angioedema: past, present, and future.Balkan medical journal · 2021Article
- Modeling Cost-Effectiveness of On-Demand Treatment for Hereditary Angioedema Attacks.Journal of managed care & specialty pharmacy · 2020Article
- Article
- Fresh frozen plasma for on-demand hereditary angioedema treatment in South Africa and Iran.The World Allergy Organization journal · 2019Article
- The Icatibant Outcome Survey: experience of hereditary angioedema management from six European countries.Journal of the European Academy of Dermatology and Venereology : JEADV · 2017Article
- Long-term safety of icatibant treatment of patients with angioedema in real-world clinical practice.Allergy · 2017Observational
- Optimum Use of Acute Treatments for Hereditary Angioedema: Evidence-Based Expert Consensus.Frontiers in medicine · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 15 institutions in 4 countries.
Funding
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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.