Recombinant Factor VIIa concentrate versus plasma derived concentrates for the treatment of acute bleeding episodes in people with haemophilia and inhibitors.

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. OBJECTIVES 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. SEARCH STRATEGY 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. SELECTION CRITERIA 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. DATA COLLECTION AND ANALYSIS 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. MAIN 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. AUTHORS' 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.