Recombinant activated factor VII (eptacog alfa activated, NovoSeven ® ) in patients with rare congenital bleeding disorders. A systematic review on its use in surgical procedures

Matteo Nicola Dario Di Minno, Pasquale Ambrosino, Veronika A Myasoedova, Manuela Amato, Itala Ventre, Elena Tremoli, Alessandro Di Minno

Research output: Contribution to journalArticle

Abstract

In the absence of definite guidelines in the area, we have carried a systemic review to provide a thorough overview concerning the efficacy and safety of recombinant activated factor VII (rFVIIa, NovoSeven®, Novo Nordisk A/S, Bagsværd, Denmark) in patients with Glanzmann's thrombasthenia (GT) and FVII deficiency, undergoing surgical procedures. PubMed, Web of Science, Scopus and EMBASE databases was employed for the search. Three multicenter registries were identified: the Glanzmann's Thrombasthenia Registry (GTR), the Seven Treatment Evaluation Registry (STER), and a German post-marketing surveillance registry (the WIRK study). In addition, data from 10 case-series and/or single-center experiences have been summarized. We have found that the following; perioperatively, the hemostatic effectiveness of rFVIIa was high in GT patients and in those with FVII deficiency undergoing both minor and major surgical procedures. Moreover, in all studies , rFVIIa was well tolerated. Thus, the current evidence shows an optimal perioperative safety/efficacy profile of rFVIIa in the setting of these rare bleeding disorders, and provides the rationale for further studies aimed at evaluating the optimal perioperative anti-hemorrhagic prophylaxis with rFVIIa in GT and in FVII deficient patients.

Original languageEnglish
JournalCurrent Pharmaceutical Design
Publication statusE-pub ahead of print - Dec 30 2016

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Factor VIIa
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Thrombasthenia
Hemorrhage
Registries
Safety
Minor Surgical Procedures
Hemostatics
Denmark
Marketing
PubMed
recombinant FVIIa
Databases
Guidelines

Keywords

  • Journal Article

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Recombinant activated factor VII (eptacog alfa activated, NovoSeven ® ) in patients with rare congenital bleeding disorders. A systematic review on its use in surgical procedures. / Di Minno, Matteo Nicola Dario; Ambrosino, Pasquale; Myasoedova, Veronika A; Amato, Manuela; Ventre, Itala; Tremoli, Elena; Di Minno, Alessandro.

In: Current Pharmaceutical Design, 30.12.2016.

Research output: Contribution to journalArticle

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abstract = "In the absence of definite guidelines in the area, we have carried a systemic review to provide a thorough overview concerning the efficacy and safety of recombinant activated factor VII (rFVIIa, NovoSeven{\circledR}, Novo Nordisk A/S, Bagsv{\ae}rd, Denmark) in patients with Glanzmann's thrombasthenia (GT) and FVII deficiency, undergoing surgical procedures. PubMed, Web of Science, Scopus and EMBASE databases was employed for the search. Three multicenter registries were identified: the Glanzmann's Thrombasthenia Registry (GTR), the Seven Treatment Evaluation Registry (STER), and a German post-marketing surveillance registry (the WIRK study). In addition, data from 10 case-series and/or single-center experiences have been summarized. We have found that the following; perioperatively, the hemostatic effectiveness of rFVIIa was high in GT patients and in those with FVII deficiency undergoing both minor and major surgical procedures. Moreover, in all studies , rFVIIa was well tolerated. Thus, the current evidence shows an optimal perioperative safety/efficacy profile of rFVIIa in the setting of these rare bleeding disorders, and provides the rationale for further studies aimed at evaluating the optimal perioperative anti-hemorrhagic prophylaxis with rFVIIa in GT and in FVII deficient patients.",
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AU - Di Minno, Matteo Nicola Dario

AU - Ambrosino, Pasquale

AU - Myasoedova, Veronika A

AU - Amato, Manuela

AU - Ventre, Itala

AU - Tremoli, Elena

AU - Di Minno, Alessandro

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