The onerous task of comparing treatments in inhibitor patients

• References

• 1 Hedner U. Recombinant factor VIIa: its background, development and clinical use.. Curr Opin Hematol 2007; 14: 225-229.
• 2 Hedner U, Glazer S, Pingel K. et al. Successful use of recombinant factor VIIa in a patient with severe haemophilia A during synovectomy.. Lancet 1988; 2: 1193.
• 3 Villar A, Aronis S, Morfini M. et al. Pharmacokinetics of activated recombinant coagulation factor VII (NovoSeven) in children vs. adults with haemophilia A.. Haemophilia 2004; 10: 352-359.
• 4 Shapiro AD, Gilchrist GS, Hoots WK. et al. Prospective, randomised trial of two doses of rFVIIa (Novo-Seven) in haemophilia patients with inhibitors undergoing surgery.. Thromb Haemost 1998; 80: 773-778.
• 5 Lusher JM, Roberts HR, Davignon G. et al. A randomized, double-blind comparison of two dosage levels of recombinant factor VIIa in the treatment of joint, muscle and mucocutaneous haemorrhages in persons with haemophilia A and B, with and without inhibitors. rFVIIa Study Group.. Haemophilia 1998; 4: 790-798.
• 6 Kavakli K, Makris M, Zulfikar B. et al. Home treatment of haemarthroses using a single dose regimen of recombinant activated factor VII in patients with haemophilia and inhibitors. A multi-centre, randomised, double-blind, cross-over trial.. Thromb Haemost 2006; 95: 600-605.
• 7 Santagostino E, Mancuso ME, Rocino A. et al. A prospective randomized trial of high and standard dosages of recombinant factor VIIa for treatment of hemarthroses in haemophiliacs with inhibitors.. J Thromb Haemost 2006; 4: 367-371.
• 8 Schulman S, Bech Jensen M, Varon D. et al. Feasibility of using recombinant factor VIIa in continuous infusion.. Thromb Haemost 1996; 75: 432-436.
• 9 Bonde C, Jensen MB. Continuous infusion of recombinant activated factor VII: stability in infusion pump systems.. Blood Coagul Fibrinolysis 1998; 9 (Suppl. 01) S103-105.
• 10 Schulman S. the rFVIIa-CI group.. Safety, efficacy and lessons from continuous infusion with rFVIIa.. Haemophilia 1998; 4: 564-567.
• 11 Ludlam CA, Smith MP, Morfini M. et al. A prospective study of recombinant activated factor VII administered by continuous infusion to inhibitor patients undergoing elective major orthopaedic surgery: a pharmacokinetic and efficacy evaluation.. Br J Haematol 2003; 120: 808-813.
• 12 Smith MP, Ludlam CA, Collins PW. et al. Elective surgery on factor VIII inhibitor patients using continuous infusion of recombinant activated factor VII: plasma factor VII activity of 10 IU/ml is associated with an increased incidence of bleeding.. Thromb Haemost 2001; 86: 949-953.
• 13 Mauser-Bunschoten EP, Koopman MM, Goede-Bolder AD. et al. Efficacy of recombinant factor VIIa administered by continuous infusion to haemophilia patients with inhibitors.. Haemophilia 2002; 8: 649-656.
• 14 Santagostino E, Morfini M, Rocino A. et al. Relationship between factor VII activity and clinical efficacy of recombinant factor VIIa given by continuous infusion to patients with factor VIII inhibitors.. Thromb Haemost 2001; 86: 954-958.
• 15 Schulman S, d’Oiron R, Martinowitz U. et al. Experiences with continuous infusion of recombinant activated factor VII.. Blood Coagul Fibrinolysis 1998; 9 (Suppl. 01) S97-S101.
• 16 Pruthi RK, Mathew P, Valentino LA. et al. Hemostatic efficacy and safety of bolus and continuous infusion of recombinant factor VIIa are comparable in haemophilia patients with inhibitors undergoing major surgery: results from an open-label, randomized, multicenter trial.. Thromb Haemost 2007; 98: 726-732.
• 17 Mauser-Bunschoten EP, de Goede-Bolder A, Wielenga JJ. et al. Continuous infusion of recombinant factor VIIa in patients with haemophilia and inhibitors. Experience in The Netherlands and Belgium.. Neth J Med 1998; 53: 249-255.