Clinical efficacy and safety of fanhdi<sup>®</sup>, a plasma-derived VWF/Factor VIII concentrate, in von willebrand disease in Spain: a retrospective study
To evaluate the efficacy and safety of a plasma-derived factor VIII concentrate containing von Willebrand Factor (pdVWF/FVIII) in standard clinical practice in von Willebrand Disease (VWD) patients. Methods: A retrospective, multicentric, observational study of VWD patients treated with Fanhdi®, a p...
| Autores: | , , , , , , , , , , , , , , , |
|---|---|
| Tipo de documento: | artigo |
| Data de publicação: | 2022 |
| País: | España |
| Recursos: | Universidad Autónoma de Madrid |
| Repositório: | Biblos-e Archivo. Repositorio Institucional de la UAM |
| Idioma: | inglês |
| OAI Identifier: | oai:repositorio.uam.es:10486/706006 |
| Acesso em linha: | http://hdl.handle.net/10486/706006 https://dx.doi.org/10.1177/10760296221074348 |
| Access Level: | Acceso aberto |
| Palavra-chave: | bleeding plasma-derived von willebrand factor/factor VIII concentrate prophylaxis surgery von willebrand disease von willebrand factor Medicina |
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Clinical efficacy and safety of fanhdi<sup>®</sup>, a plasma-derived VWF/Factor VIII concentrate, in von willebrand disease in Spain: a retrospective studyJiménez Yuste, Víctor ManuelÁlvarez Roman, María TeresaPalomo Bravo, ÁngelesGalmes, Bernardo J.Nieto Hernández, Maria del MarBenítez Hidalgo, OlgaMarzo Alonso, CristinaPérez González, Noelia FlorenciaColl, JuliaNúñez, RamiroCarrasco, MarinaGarcía Candel, FaustinoGonzalez-Porras, Jose RamonHernández García, CarmenVaró Castro, Maria JoséMir, Roserbleedingplasma-derived von willebrand factor/factor VIII concentrateprophylaxissurgeryvon willebrand diseasevon willebrand factorMedicinaTo evaluate the efficacy and safety of a plasma-derived factor VIII concentrate containing von Willebrand Factor (pdVWF/FVIII) in standard clinical practice in von Willebrand Disease (VWD) patients. Methods: A retrospective, multicentric, observational study of VWD patients treated with Fanhdi®, a pdVWF/FVIII concentrate, from January 2011 to December 2017 was conducted at 14 centers in Spain. Efficacy and safety were evaluated for acute bleeding episodes, for prevention of bleeding in surgeries, and for secondary long-term prophylaxis. Seventy-two eligible patients, type 1, 2, 3 VWD (25%/38.9%/36.1%) were treated for spontaneous and traumatic bleeding (140 episodes, n = 41 patients), to prevent surgical bleeding (69 episodes, n = 43 patients); and for secondary long-term prophylaxis (18 programs, n = 13 patients). Replacement therapy with pdVWF/FVIII showed an excellent to good clinical efficacy in 96.7% of the bleeding episodes, 100% during surgical procedures and 100% during prophylaxis. No adverse events (AEs), nor serious AEs related to the product were observed. Conclusions: Fanhdi® was effective, safe and well tolerated in the management of bleeding episodes, the prevention of bleeding during surgeries, and for secondary long-term prophylaxis in VWD patientsThe author(s) disclosed receipt of the followingfinancial support forthe research, authorship, and/or publication of this article: This workwas supported by Grifols, manufacturer of the pdVWF/FVIII,Fanhdi®SAGEDepartamento de MedicinaFacultad de Medicina20222022-01-02research articlehttp://purl.org/coar/resource_type/c_2df8fbb1VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10486/706006https://dx.doi.org/10.1177/10760296221074348reponame:Biblos-e Archivo. Repositorio Institucional de la UAMinstname:Universidad Autónoma de MadridInglésengopen accesshttp://purl.org/coar/access_right/c_abf2info:eu-repo/semantics/openAccessoai:repositorio.uam.es:10486/7060062026-06-23T12:46:27Z |
| dc.title.none.fl_str_mv |
Clinical efficacy and safety of fanhdi<sup>®</sup>, a plasma-derived VWF/Factor VIII concentrate, in von willebrand disease in Spain: a retrospective study |
| title |
Clinical efficacy and safety of fanhdi<sup>®</sup>, a plasma-derived VWF/Factor VIII concentrate, in von willebrand disease in Spain: a retrospective study |
| spellingShingle |
Clinical efficacy and safety of fanhdi<sup>®</sup>, a plasma-derived VWF/Factor VIII concentrate, in von willebrand disease in Spain: a retrospective study Jiménez Yuste, Víctor Manuel bleeding plasma-derived von willebrand factor/factor VIII concentrate prophylaxis surgery von willebrand disease von willebrand factor Medicina |
| title_short |
Clinical efficacy and safety of fanhdi<sup>®</sup>, a plasma-derived VWF/Factor VIII concentrate, in von willebrand disease in Spain: a retrospective study |
| title_full |
Clinical efficacy and safety of fanhdi<sup>®</sup>, a plasma-derived VWF/Factor VIII concentrate, in von willebrand disease in Spain: a retrospective study |
| title_fullStr |
Clinical efficacy and safety of fanhdi<sup>®</sup>, a plasma-derived VWF/Factor VIII concentrate, in von willebrand disease in Spain: a retrospective study |
| title_full_unstemmed |
Clinical efficacy and safety of fanhdi<sup>®</sup>, a plasma-derived VWF/Factor VIII concentrate, in von willebrand disease in Spain: a retrospective study |
| title_sort |
Clinical efficacy and safety of fanhdi<sup>®</sup>, a plasma-derived VWF/Factor VIII concentrate, in von willebrand disease in Spain: a retrospective study |
| dc.creator.none.fl_str_mv |
Jiménez Yuste, Víctor Manuel Álvarez Roman, María Teresa Palomo Bravo, Ángeles Galmes, Bernardo J. Nieto Hernández, Maria del Mar Benítez Hidalgo, Olga Marzo Alonso, Cristina Pérez González, Noelia Florencia Coll, Julia Núñez, Ramiro Carrasco, Marina García Candel, Faustino Gonzalez-Porras, Jose Ramon Hernández García, Carmen Varó Castro, Maria José Mir, Roser |
| author |
Jiménez Yuste, Víctor Manuel |
| author_facet |
Jiménez Yuste, Víctor Manuel Álvarez Roman, María Teresa Palomo Bravo, Ángeles Galmes, Bernardo J. Nieto Hernández, Maria del Mar Benítez Hidalgo, Olga Marzo Alonso, Cristina Pérez González, Noelia Florencia Coll, Julia Núñez, Ramiro Carrasco, Marina García Candel, Faustino Gonzalez-Porras, Jose Ramon Hernández García, Carmen Varó Castro, Maria José Mir, Roser |
| author_role |
author |
| author2 |
Álvarez Roman, María Teresa Palomo Bravo, Ángeles Galmes, Bernardo J. Nieto Hernández, Maria del Mar Benítez Hidalgo, Olga Marzo Alonso, Cristina Pérez González, Noelia Florencia Coll, Julia Núñez, Ramiro Carrasco, Marina García Candel, Faustino Gonzalez-Porras, Jose Ramon Hernández García, Carmen Varó Castro, Maria José Mir, Roser |
| author2_role |
author author author author author author author author author author author author author author author |
| dc.contributor.none.fl_str_mv |
Departamento de Medicina Facultad de Medicina |
| dc.subject.none.fl_str_mv |
bleeding plasma-derived von willebrand factor/factor VIII concentrate prophylaxis surgery von willebrand disease von willebrand factor Medicina |
| topic |
bleeding plasma-derived von willebrand factor/factor VIII concentrate prophylaxis surgery von willebrand disease von willebrand factor Medicina |
| description |
To evaluate the efficacy and safety of a plasma-derived factor VIII concentrate containing von Willebrand Factor (pdVWF/FVIII) in standard clinical practice in von Willebrand Disease (VWD) patients. Methods: A retrospective, multicentric, observational study of VWD patients treated with Fanhdi®, a pdVWF/FVIII concentrate, from January 2011 to December 2017 was conducted at 14 centers in Spain. Efficacy and safety were evaluated for acute bleeding episodes, for prevention of bleeding in surgeries, and for secondary long-term prophylaxis. Seventy-two eligible patients, type 1, 2, 3 VWD (25%/38.9%/36.1%) were treated for spontaneous and traumatic bleeding (140 episodes, n = 41 patients), to prevent surgical bleeding (69 episodes, n = 43 patients); and for secondary long-term prophylaxis (18 programs, n = 13 patients). Replacement therapy with pdVWF/FVIII showed an excellent to good clinical efficacy in 96.7% of the bleeding episodes, 100% during surgical procedures and 100% during prophylaxis. No adverse events (AEs), nor serious AEs related to the product were observed. Conclusions: Fanhdi® was effective, safe and well tolerated in the management of bleeding episodes, the prevention of bleeding during surgeries, and for secondary long-term prophylaxis in VWD patients |
| publishDate |
2022 |
| dc.date.none.fl_str_mv |
2022 2022-01-02 |
| dc.type.none.fl_str_mv |
research article http://purl.org/coar/resource_type/c_2df8fbb1 VoR http://purl.org/coar/version/c_970fb48d4fbd8a85 |
| dc.type.openaire.fl_str_mv |
info:eu-repo/semantics/article |
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article |
| dc.identifier.none.fl_str_mv |
http://hdl.handle.net/10486/706006 https://dx.doi.org/10.1177/10760296221074348 |
| url |
http://hdl.handle.net/10486/706006 https://dx.doi.org/10.1177/10760296221074348 |
| dc.language.none.fl_str_mv |
Inglés eng |
| language_invalid_str_mv |
Inglés |
| language |
eng |
| dc.rights.none.fl_str_mv |
open access http://purl.org/coar/access_right/c_abf2 |
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info:eu-repo/semantics/openAccess |
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open access http://purl.org/coar/access_right/c_abf2 |
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openAccess |
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SAGE |
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SAGE |
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Universidad Autónoma de Madrid |
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