title: Recombinant Factor VIIa concentrate versus plasma derived concentrates for the treatment of acute bleeding episodes in people with haemophilia and inhibitors.
abstract: BACKGROUND
  In people with haemophilia, therapeutic clotting agents might be recognised as a foreign protein and induce anti-FVIII antibodies, known as 'inhibitors'. Drugs insensitive to such antibodies, either recombinant or plasma-derived, are called factor VIII "by-passing" agents and used for treatment of bleeding in people with inhibitors.
  
  
  OBJECTIVE
  To determine the clinical effectiveness of recombinant FVIIa concentrate in comparison to plasma-derived concentrates for the treatment of acute bleeding episodes in people with haemophilia and inhibitors.
  
  
  METHODS
  We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Coagulopathies Trials Register which comprises references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings.Date of the most recent search of the Group's Trials Register: 07 July 2010.
  
  
  METHODS
  Randomised (RCTs) and quasi-randomised controlled clinical trials comparing recombinant FVIIa concentrate (rFVIIa) to human plasma-derived concentrates (high-dose human or recombinant FVIII or FIX concentrate; prothrombin complex concentrates (PCCs); activated prothrombin complex concentrate (aPCC)) in persons with haemophilia. Comparisons with animal derived products were excluded.
  
  
  METHODS
  Two authors independently assessed trials (eligibility and risk of bias) and extracted data. No meta-analysis was performed due to unavailability of outcomes and comparisons common to the included studies.
  
  
  RESULTS
  A total of ten trials were identified, two of which (total of 69 participants) were eligible for analysis. Both trials showed methodological flaws and did not show superiority of one treatment over the other. Both the treatments showed that (rFVIIa and aPCC appeared to have a similar haemostatic effect in both studies, without increasing thromboembolic risk.
  
  
  CONCLUSIONS
  Although the main conclusion should be the need for further randomised controlled trials, we conclude that both rFVIIa and aPCC can be used to treat bleeding in haemophiliacs with inhibitors.
authors.affiliation: Department of Internal Medicine, University of Perugia, Ospedale Santa Maria della Misericordia, Località Sant'Andrea delle Fratte, Perugia, Italy, 06126.
authors.forename: Alfonso
authors.initials: A
authors.lastname: Iorio
authors.forename: Davide
authors.initials: D
authors.lastname: Matino
authors.forename: Roberto
authors.initials: R
authors.lastname: D'Amico
authors.forename: Michael
authors.initials: M
authors.lastname: Makris
mesh_terms: D000208:Acute Disease; D001779:Blood Coagulation Factors / Q000627:therapeutic use*; D005169:Factor VIII / Q000276:immunology / Q000627:therapeutic use; D015942:Factor VIIa / Q000627:therapeutic use*; D006467:Hemophilia A / Q000097:blood / Q000188:drug therapy*; D002836:Hemophilia B / Q000097:blood / Q000188:drug therapy*; D006470:Hemorrhage / Q000188:drug therapy*; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins / Q000627:therapeutic use
chemical_list: D001779:Blood Coagulation Factors; D011994:Recombinant Proteins; C078147:F8 protein, human; D005169:Factor VIII; C103587:recombinant FVIIa; C065655:anti-inhibitor coagulant complex; D015942:Factor VIIa