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A Comparison of Efficacy Between Recombinant Activated Factor Vii (Aryoseven) and Novoseven in Patients With Hereditary Fviii Deficiency With Inhibitor Publisher Pubmed



Faranoush M1 ; Abolghasemi H2 ; Mahboudi F3 ; Toogeh G4 ; Karimi M5 ; Eshghi P2 ; Managhchi M4 ; Hoorfar H6 ; Dehdezi BK7 ; Mehrvar A8 ; Khoeiny B9 ; Vaziri B3 ; Kamyar K9 ; Heshmat R4 Show All Authors
Authors
  1. Faranoush M1
  2. Abolghasemi H2
  3. Mahboudi F3
  4. Toogeh G4
  5. Karimi M5
  6. Eshghi P2
  7. Managhchi M4
  8. Hoorfar H6
  9. Dehdezi BK7
  10. Mehrvar A8
  11. Khoeiny B9
  12. Vaziri B3
  13. Kamyar K9
  14. Heshmat R4
  15. Baghaeipour MR10
  16. Mirbehbahani NB11
  17. Fayazfar R12
  18. Ahmadinejad M13
  19. Naderi M14
Show Affiliations
Authors Affiliations
  1. 1. Iran University of Medical Sciences, Rasool Akram Hospital, Tehran, Iran
  2. 2. Pediatric Congenital Hematologic Disorders Research Center, Shahid Beheshti University of Medical Sciences, Mofid Children's Hospital, Tehran, Iran
  3. 3. Biotechnology Research Center, Pasteur Institute of Iran, Tehran, Iran
  4. 4. Thrombosis and Hemostasis Research Center, Tehran University of Medical Sciences, Imam Khomeini Hospital, Tehran, Iran
  5. 5. Hematology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
  6. 6. Isfahan University of Medical Sciences, Isfahan, Iran
  7. 7. Ahwaz University of Medical Sciences, Ahwaz, Iran
  8. 8. MAHAK Children's Hospital, Tehran, Iran
  9. 9. Aryogen Zist Darou Company, Karaj, Iran
  10. 10. Iranian Comprehensive Hemophilia Care Center, Tehran, Iran
  11. 11. Golestan University of Medical Sciences, Gorgan, Iran
  12. 12. MD, Kerman University of Medical Sciences, Kerman, Iran
  13. 13. High Institute of Research, Iranian Blood Transfusion Organization, Tehran, Iran
  14. 14. Zahedan University of Medical Sciences, Ahwaz, Iran

Source: Clinical and Applied Thrombosis/Hemostasis Published:2016


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.
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