A Comparison of Efficacy Between Recombinant Activated Factor VII (Aryoseven) and Novoseven in Patients With Hereditary FVIII Deficiency With Inhibitor
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 dosa...
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| Veröffentlicht in: | Clinical and applied thrombosis/hemostasis 2016-03, Vol.22 (2), p.184-190 |
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| creator | Faranoush, M. Abolghasemi, H. Mahboudi, F. Toogeh, Gh Karimi, M. Eshghi, P. Managhchi, M. Hoorfar, H. Dehdezi, B. Keikhaei Mehrvar, A. khoeiny, B. Vaziri, B. Kamyar, K. Heshmat, R. Baghaeipour, M. R. Mirbehbahani, N. B. Fayazfar, R. Ahmadinejad, M. Naderi, M. |
| description | 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. |
| doi_str_mv | 10.1177/1076029614555902 |
| format | Article |
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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.</description><identifier>ISSN: 1076-0296</identifier><identifier>EISSN: 1938-2723</identifier><identifier>DOI: 10.1177/1076029614555902</identifier><identifier>PMID: 25343955</identifier><language>eng</language><publisher>Los Angeles, CA: SAGE Publications</publisher><subject>Adolescent ; Adult ; Biosimilar Pharmaceuticals - administration & dosage ; Blood Coagulation Factor Inhibitors - blood ; Child ; Factor VIIa - administration & dosage ; Female ; Hemophilia ; Hemophilia A - blood ; Hemophilia A - drug therapy ; Hemorrhage - blood ; Hemorrhage - drug therapy ; Humans ; Male ; Recombinant Proteins - administration & dosage ; Time Factors</subject><ispartof>Clinical and applied thrombosis/hemostasis, 2016-03, Vol.22 (2), p.184-190</ispartof><rights>The Author(s) 2014</rights><rights>The Author(s) 2014.</rights><rights>The Author(s) 2014. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the associated terms available at: https://uk.sagepub.com/en-gb/eur/reusing-open-access-and-sage-choice-content</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c398t-e6257c5d841f84dd139b5e9c3c9312f14ded09dcfd60ae72d6b973c5abdc50a73</citedby><cites>FETCH-LOGICAL-c398t-e6257c5d841f84dd139b5e9c3c9312f14ded09dcfd60ae72d6b973c5abdc50a73</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://journals.sagepub.com/doi/pdf/10.1177/1076029614555902$$EPDF$$P50$$Gsage$$H</linktopdf><linktohtml>$$Uhttps://journals.sagepub.com/doi/10.1177/1076029614555902$$EHTML$$P50$$Gsage$$H</linktohtml><link.rule.ids>314,776,780,21945,27830,27901,27902,44921,45309</link.rule.ids><linktorsrc>$$Uhttps://journals.sagepub.com/doi/full/10.1177/1076029614555902?utm_source=summon&utm_medium=discovery-provider$$EView_record_in_SAGE_Publications$$FView_record_in_$$GSAGE_Publications</linktorsrc><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25343955$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Faranoush, M.</creatorcontrib><creatorcontrib>Abolghasemi, H.</creatorcontrib><creatorcontrib>Mahboudi, F.</creatorcontrib><creatorcontrib>Toogeh, Gh</creatorcontrib><creatorcontrib>Karimi, M.</creatorcontrib><creatorcontrib>Eshghi, P.</creatorcontrib><creatorcontrib>Managhchi, M.</creatorcontrib><creatorcontrib>Hoorfar, H.</creatorcontrib><creatorcontrib>Dehdezi, B. Keikhaei</creatorcontrib><creatorcontrib>Mehrvar, A.</creatorcontrib><creatorcontrib>khoeiny, B.</creatorcontrib><creatorcontrib>Vaziri, B.</creatorcontrib><creatorcontrib>Kamyar, K.</creatorcontrib><creatorcontrib>Heshmat, R.</creatorcontrib><creatorcontrib>Baghaeipour, M. R.</creatorcontrib><creatorcontrib>Mirbehbahani, N. B.</creatorcontrib><creatorcontrib>Fayazfar, R.</creatorcontrib><creatorcontrib>Ahmadinejad, M.</creatorcontrib><creatorcontrib>Naderi, M.</creatorcontrib><title>A Comparison of Efficacy Between Recombinant Activated Factor VII (Aryoseven) and Novoseven in Patients With Hereditary FVIII Deficiency With Inhibitor</title><title>Clinical and applied thrombosis/hemostasis</title><addtitle>Clin Appl Thromb Hemost</addtitle><description>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.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Biosimilar Pharmaceuticals - administration & dosage</subject><subject>Blood Coagulation Factor Inhibitors - blood</subject><subject>Child</subject><subject>Factor VIIa - administration & dosage</subject><subject>Female</subject><subject>Hemophilia</subject><subject>Hemophilia A - blood</subject><subject>Hemophilia A - drug therapy</subject><subject>Hemorrhage - blood</subject><subject>Hemorrhage - drug therapy</subject><subject>Humans</subject><subject>Male</subject><subject>Recombinant Proteins - administration & dosage</subject><subject>Time Factors</subject><issn>1076-0296</issn><issn>1938-2723</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNqFkUtvEzEUhUcIREthzwpZYlMWA357vAyhoSNVgBCP5chj36GuMnZqO0H5JfxdXFJAqoRY2db9zjm6Pk3zlOCXhCj1imAlMdWScCGExvRec0w061qqKLtf73Xc3syPmkc5X2FMtNTyYXNEBeNMC3Hc_FigZZw3JvkcA4oTOpsmb43do9dQvgME9BFsnEcfTChoYYvfmQIOrYwtMaEvfY9OF2kfM-wgvEAmOPQu7g5P5AP6YIqHUDL66sslOocEzheT9mhVpT16AzWtAjXvF9CHSz_66vy4eTCZdYYnt-dJ83l19ml53l68f9svFxetZborLUgqlBWu42TquHOE6VGAtsxqRuhEuAOHtbOTk9iAok6OWjErzOiswEaxk-b04LtJ8XoLuQyzzxbWaxMgbvNAOkU71nHN_48qSWWHOSYVfX4HvYrbFOoiA2Wc146I6iqFD5RNMecE07BJfq6fMxA83PQ73O23Sp7dGm_HGdwfwe9CK9AegGy-wd_Ufxr-BMWMrNU</recordid><startdate>201603</startdate><enddate>201603</enddate><creator>Faranoush, M.</creator><creator>Abolghasemi, H.</creator><creator>Mahboudi, F.</creator><creator>Toogeh, Gh</creator><creator>Karimi, M.</creator><creator>Eshghi, P.</creator><creator>Managhchi, M.</creator><creator>Hoorfar, H.</creator><creator>Dehdezi, B. Keikhaei</creator><creator>Mehrvar, A.</creator><creator>khoeiny, B.</creator><creator>Vaziri, B.</creator><creator>Kamyar, K.</creator><creator>Heshmat, R.</creator><creator>Baghaeipour, M. R.</creator><creator>Mirbehbahani, N. B.</creator><creator>Fayazfar, R.</creator><creator>Ahmadinejad, M.</creator><creator>Naderi, M.</creator><general>SAGE Publications</general><general>SAGE PUBLICATIONS, INC</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>8FD</scope><scope>FR3</scope><scope>P64</scope><scope>RC3</scope></search><sort><creationdate>201603</creationdate><title>A Comparison of Efficacy Between Recombinant Activated Factor VII (Aryoseven) and Novoseven in Patients With Hereditary FVIII Deficiency With Inhibitor</title><author>Faranoush, M. ; Abolghasemi, H. ; Mahboudi, F. ; Toogeh, Gh ; Karimi, M. ; Eshghi, P. ; Managhchi, M. ; Hoorfar, H. ; Dehdezi, B. Keikhaei ; Mehrvar, A. ; khoeiny, B. ; Vaziri, B. ; Kamyar, K. ; Heshmat, R. ; Baghaeipour, M. R. ; Mirbehbahani, N. 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B.</creatorcontrib><creatorcontrib>Fayazfar, R.</creatorcontrib><creatorcontrib>Ahmadinejad, M.</creatorcontrib><creatorcontrib>Naderi, M.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><jtitle>Clinical and applied thrombosis/hemostasis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext_linktorsrc</fulltext></delivery><addata><au>Faranoush, M.</au><au>Abolghasemi, H.</au><au>Mahboudi, F.</au><au>Toogeh, Gh</au><au>Karimi, M.</au><au>Eshghi, P.</au><au>Managhchi, M.</au><au>Hoorfar, H.</au><au>Dehdezi, B. Keikhaei</au><au>Mehrvar, A.</au><au>khoeiny, B.</au><au>Vaziri, B.</au><au>Kamyar, K.</au><au>Heshmat, R.</au><au>Baghaeipour, M. R.</au><au>Mirbehbahani, N. B.</au><au>Fayazfar, R.</au><au>Ahmadinejad, M.</au><au>Naderi, M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Comparison of Efficacy Between Recombinant Activated Factor VII (Aryoseven) and Novoseven in Patients With Hereditary FVIII Deficiency With Inhibitor</atitle><jtitle>Clinical and applied thrombosis/hemostasis</jtitle><addtitle>Clin Appl Thromb Hemost</addtitle><date>2016-03</date><risdate>2016</risdate><volume>22</volume><issue>2</issue><spage>184</spage><epage>190</epage><pages>184-190</pages><issn>1076-0296</issn><eissn>1938-2723</eissn><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.</abstract><cop>Los Angeles, CA</cop><pub>SAGE Publications</pub><pmid>25343955</pmid><doi>10.1177/1076029614555902</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 1076-0296 |
| ispartof | Clinical and applied thrombosis/hemostasis, 2016-03, Vol.22 (2), p.184-190 |
| issn | 1076-0296 1938-2723 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_1872838494 |
| source | Sage Journals GOLD Open Access 2024 |
| subjects | Adolescent Adult Biosimilar Pharmaceuticals - administration & dosage Blood Coagulation Factor Inhibitors - blood Child Factor VIIa - administration & dosage Female Hemophilia Hemophilia A - blood Hemophilia A - drug therapy Hemorrhage - blood Hemorrhage - drug therapy Humans Male Recombinant Proteins - administration & dosage Time Factors |
| title | A Comparison of Efficacy Between Recombinant Activated Factor VII (Aryoseven) and Novoseven in Patients With Hereditary FVIII Deficiency With Inhibitor |
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