Trial reportThe New England journal of medicine2010
Icatibant, a new bradykinin-receptor antagonist, in hereditary angioedema.
Trial report in The New England journal of medicine, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 4 registered trials, which are not on this map. Cited by 183 papers, 7 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
Randomised Double Blind, Controlled, Parallel Group, Multicentre Study of a Subcutaneous Formulation of Icatibant Versus Oral Tranexamic Acid for the Treatment of Hereditary Angioedema (HAE)
Determination of Specific Biomarkers of Angioneurotic Crisis
Randomized, Open, Multicenter Phase II Clinical Trial, Proof of Concept, to Evaluate Efficacy and Safety of Icatibant in Hospitalized Patients With SARS-COV-2 (COVID-19) Without Assisted Ventilation Compared With Standard Care
Who cites it
183 citing papers in PubMed, 7 syntheses or guidelines pooled it, 548 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
- International Guideline on the Diagnosis and Management of Pediatric Patients With Hereditary Angioedema.Allergy · 2026Guideline
- Discovery of Novel Inhibitors of Cruzain Cysteine Protease ofCurrent medicinal chemistry · 2024Pooled it
- Efficacy of Treatment of Non-hereditary Angioedema.Clinical reviews in allergy & immunology · 2018Pooled it
- Brazilian Guidelines for Hereditary Angioedema Management - 2017 Update Part 1: Definition, Classification and Diagnosis.Clinics (Sao Paulo, Brazil) · 2018Guideline
- A consensus parameter for the evaluation and management of angioedema in the emergency department.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2014Guideline
- Brazilian guidelines for the diagnosis and treatment of hereditary angioedema.Clinics (Sao Paulo, Brazil) · 2011Guideline
- Post Hoc Analysis of Recombinant C1 Inhibitor Clinical Data Using Contemporary Endpoints for Hereditary Angioedema.Advances in therapy · 2026Trial
- Endogenous bradykinin and B1-B5 during angiotensin-converting enzyme inhibitor-associated angioedema.The Journal of allergy and clinical immunology · 2018Trial
- Effect of bradykinin receptor antagonism on ACE inhibitor-associated angioedema.The Journal of allergy and clinical immunology · 2017Trial
- Dedicated call center (SOS-HAE) for hereditary angioedema attacks: study protocol for a randomised controlled trial.Trials · 2016Trial
- Repeat treatment of acute hereditary angioedema attacks with open-label icatibant in the FAST-1 trial.Clinical and experimental immunology · 2014Trial
- Icatibant, an inhibitor of bradykinin receptor 2, for hereditary angioedema attacks: prospective experimental single-cohort study.Sao Paulo medical journal = Revista paulista de medicina · 2014Trial
- Risk of angioedema following invasive or surgical procedures in HAE type I and II--the natural history.Allergy · 2013Trial
- Review
- Registry-Based Analysis of Treatment and Retreatment Attacks of Hereditary Angioedema.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2026Article
- Therapeutic Targeting of the Bradykinin B2 Receptor in Immunological and Vascular Diseases: Insights from Kinin Biology to Clinical Outcomes.Clinical reviews in allergy & immunology · 2026Review
- Molecular mechanisms for subtype selectivity of kinin receptors' antagonists.Nature communications · 2026Article
- The 2025 WAO Guidelines for the classification, diagnosis, and treatment of hereditary angioedema, with consideration of worldwide disparities.The World Allergy Organization journal · 2026Article
- Assessing Patient-Reported Outcomes in Acute Attacks of Hereditary Angioedema: Insights from a Mixed Methods Study of Participants Receiving Standard-of-Care Treatments in a Real-World Setting.Clinical reviews in allergy & immunology · 2026Article
123 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
- Commented on by
- Commented on by
- Erratum issued
Authors and funding
60 authors at 17 institutions in 12 countries.
Funding
Abstract
backgroundHereditary angioedema is characterized by recurrent attacks of angioedema of the skin, larynx, and gastrointestinal tract. Bradykinin is the key mediator of symptoms. Icatibant is a selective bradykinin B2 receptor antagonist.
methodsIn two double-blind, randomized, multicenter trials, we evaluated the effect of icatibant in patients with hereditary angioedema presenting with cutaneous or abdominal attacks. In the For Angioedema Subcutaneous Treatment (FAST) 1 trial, patients received either icatibant or placebo; in FAST-2, patients received either icatibant or oral tranexamic acid, at a dose of 3 g daily for 2 days. Icatibant was given once, subcutaneously, at a dose of 30 mg. The primary end point was the median time to clinically significant relief of symptoms.
resultsA total of 56 and 74 patients underwent randomization in the FAST-1 and FAST-2 trials, respectively. The primary end point was reached in 2.5 hours with icatibant versus 4.6 hours with placebo in the FAST-1 trial (P=0.14) and in 2.0 hours with icatibant versus 12.0 hours with tranexamic acid in the FAST-2 trial (P<0.001). In the FAST-1 study, 3 recipients of icatibant and 13 recipients of placebo needed treatment with rescue medication. The median time to first improvement of symptoms, as assessed by patients and by investigators, was significantly shorter with icatibant in both trials. No icatibant-related serious adverse events were reported.
conclusionsIn patients with hereditary angioedema having acute attacks, we found a significant benefit of icatibant as compared with tranexamic acid in one trial and a nonsignificant benefit of icatibant as compared with placebo in the other trial with regard to the primary end point. The early use of rescue medication may have obscured the benefit of icatibant in the placebo trial. (Funded by Jerini; ClinicalTrials.gov numbers, NCT00097695 and NCT00500656.)
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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.