| Anti-inhibitor coagulant complex prophylaxis in hemophilia with inhibitors. | |
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MedLine Citation:
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PMID: 22047559 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Patients with severe hemophilia A and factor VIII inhibitors are at increased risk for serious bleeding complications and progression to end-stage joint disease. Effective strategies to prevent bleeding in such patients have not yet been established. METHODS: We enrolled patients with hemophilia A who were older than 2 years of age, had high-titer inhibitors, and used concentrates known as bypassing agents for bleeding in a prospective, randomized, crossover study comparing 6 months of anti-inhibitor coagulant complex (AICC), infused prophylactically at a target dose of 85 U per kilogram of body weight (±15%) on 3 nonconsecutive days per week, with 6 months of on-demand therapy (AICC at a target dose of 85 U per kilogram [±15%] used for bleeding episodes). The two treatment periods were separated by a 3-month washout period, during which patients received on-demand therapy for bleeding. The primary outcome was the number of bleeding episodes during each 6-month treatment period. RESULTS: Thirty-four patients underwent randomization; 26 patients completed both treatment periods and could be evaluated per protocol for the efficacy analysis. As compared with on-demand therapy, prophylaxis was associated with a 62% reduction in all bleeding episodes (P<0.001), a 61% reduction in hemarthroses (P<0.001), and a 72% reduction in target-joint bleeding (≥3 hemarthroses in a single joint during a 6-month treatment period) (P<0.001). Thirty-three randomly assigned patients received at least one infusion of the study drug and were evaluated for safety. One patient had an allergic reaction to the study drug. CONCLUSIONS: AICC prophylaxis at the dosage evaluated significantly and safely decreased the frequency of joint and other bleeding events in patients with severe hemophilia A and factor VIII inhibitors. (Funded by Baxter BioScience; Pro-FEIBA ClinicalTrials.gov number, NCT00221195.). |
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Authors:
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Cindy Leissinger; Alessandro Gringeri; Bülent Antmen; Erik Berntorp; Chiara Biasoli; Shannon Carpenter; Paolo Cortesi; Hyejin Jo; Kaan Kavakli; Riitta Lassila; Massimo Morfini; Claude Négrier; Angiola Rocino; Wolfgang Schramm; Margit Serban; Marusia Valentina Uscatescu; Jerzy Windyga; Bülent Zülfikar; Lorenzo Mantovani |
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Publication Detail:
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Type: Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: The New England journal of medicine Volume: 365 ISSN: 1533-4406 ISO Abbreviation: N. Engl. J. Med. Publication Date: 2011 Nov |
Date Detail:
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Created Date: 2011-11-03 Completed Date: 2011-11-23 Revised Date: 2011-12-22 |
Medline Journal Info:
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Nlm Unique ID: 0255562 Medline TA: N Engl J Med Country: United States |
Other Details:
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Languages: eng Pagination: 1684-92 Citation Subset: AIM; IM |
Affiliation:
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Louisiana Center for Bleeding and Clotting Disorders, Tulane University, New Orleans, LA, USA. cleissi@tulane.edu |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00221195 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Aged Blood Coagulation Factors / administration & dosage*, adverse effects Child Child, Preschool Cross-Over Studies Drug Administration Schedule Factor VIII / administration & dosage, antagonists & inhibitors Female Hemophilia A / complications, drug therapy* Hemorrhage / prevention & control* Humans Male Middle Aged Prospective Studies Statistics, Nonparametric Young Adult |
| Chemical | |
Reg. No./Substance:
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0/Blood Coagulation Factors; 78690-39-8/Feiba; 9001-27-8/Factor VIII |
| Comments/Corrections | |
Erratum In:
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N Engl J Med. 2011 Dec 22;365(25):2441 |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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