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A comparison of efficacy between recombinant activated factor VII (Aryoseven) and Novoseven in patients with hereditary FVIII deficiency with inhibitor

Faranoush, M. and Abolghasemi, H. and Mahboudi, F. and Toogeh, G. and Karimi, M. and Eshghi, P. and Managhchi, M. and Hoorfar, H. and Dehdezi, B.K. and Mehrvar, A. and Khoeiny, B. and Vaziri, B. and Kamyar, K. and Heshmat, R. and Baghaeipour, M.R. and Mirbehbahani, N.B. and Fayazfar, R. and Ahmadinejad, M. and Naderi, M. (2016) A comparison of efficacy between recombinant activated factor VII (Aryoseven) and Novoseven in patients with hereditary FVIII deficiency with inhibitor. Clinical and Applied Thrombosis/Hemostasis, 22 (2). pp. 184-190.

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Abstract

Introduction: This study compared the efficacy of Aryoseven with Novoseven to control bleeding episodes in patients with hemophilia A with inhibitors. Methods: Sixty-six patients were randomized into 2 groups, with 4 consecutive block randomization. These groups received Aryoseven and Novoseven dosages of 90 to 120 μg/kg intravenously every 2 hours. Results: Median (interquartile range) level of factor VIII (FVIII) inhibitor in groups A and B was 15.0 and 19.0 Bethesda Unit (BU) preadministration. Bleeding onset in group A was 1246 ± 1104 minutes and in group B was 2301 ± 1693 minutes (P =.311). The Kavakli global response scores and treatment success rate was comparable in both the groups. The side effects in groups A (9.7%) and B (2.9%) were comparable. Conclusion: Biosimilar recombinant activated FVII is found to be as effective as Novoseven in the treatment of acute joint bleeding in patients with hemophilia with inhibitors. Its usage will decrease the gaps in hemophilia. © SAGE Publications.

Item Type: Article
Additional Information: cited By 0
Uncontrolled Keywords: blood clotting factor; recombinant activated factor VII; recombinant blood clotting factor 7a; recombinant protein; unclassified drug, adolescent; adult; analgesia; Article; child; controlled study; diagnostic procedure; double blind procedure; drug blood level; drug efficacy; drug safety; female; headache; hemarthrosis; hemophilia A; human; major clinical study; male; multicenter study; nausea; outcome assessment; priority journal; randomized controlled trial; rash; scoring system; time to treatment; treatment response
Subjects: مقالات نمایه شده محققین دانشگاه در سایت ,Web of Science ,Scopus
Divisions: معاونت تحقیقات و فناوری
Depositing User: GOUMS
Date Deposited: 08 Sep 2016 04:49
Last Modified: 08 Sep 2016 06:02
URI: http://eprints.goums.ac.ir/id/eprint/4584

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