A comparison between recombinant activated factor VII (Aryoseven) and Novoseven in patients with congenital factor VII deficiency
| Autor: | M. R. Baghaeipour, Hamid Hoorfar, Peyman Eshghi, Majid Naderi, Gh. Toogeh, Minoo Ahmadinejad, Mohammadreza Managhchi, Azim Mehrvar, N B Mirbehbahani, B. khoeiny, R. Heshmat, Mohammad Faranoush, B. Keikhaei Dehdezi, Mehran Karimi, Hassan Abolghasemi, K. Kamyar, R. Fayazfar |
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| Rok vydání: | 2014 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent Factor VII Deficiency Hemorrhage Factor VIIa Gastroenterology law.invention chemistry.chemical_compound Double-Blind Method Interquartile range law hemic and lymphatic diseases Internal medicine Activated factor VII medicine Humans In patient cardiovascular diseases Factor VII deficiency Child Blood Coagulation Factor VII business.industry Hematology General Medicine Plasma levels Recombinant Proteins Surgery Coagulation chemistry Recombinant DNA Female business |
| Zdroj: | Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis. 21(8) |
| ISSN: | 1938-2723 |
| Popis: | In order to establish the efficacy and biosimilar nature of AryoSeven to NovoSeven in the treatment of congenital factor VII (FVII) deficiency, patients received either agent at 30 μg/kg, intravenously per week for 4 weeks, in a randomized fashion. The primary aim was to compare FVII:coagulation activity (FVII:C), 20 minutes after recombinant activated FVII (rFVIIa) injection, in the 2 groups. A secondary measure was self-reported bleeding. The median interquartile baseline range of the plasma level of activated FVII (FVIIa) activity in the 2 groups was 1.6 (1.1-14.0) IU/dL and 5.0 (1.1-25.5) IU/dL. All patients achieved levels of FVIIa (FVII:C) >30 IU/dL, 20 minutes after the injection of rFVIIa. Bleeding was similar between the 2 groups, with a comparable decrease in severity and frequency compared to the last month prior to treatment. AryoSeven is similar to NovoSeven in increasing postinjection FVIIa activity as well as in clinical safety and efficacy. |
| Databáze: | OpenAIRE |
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