dc.contributor | Vall d'Hebron Barcelona Hospital Campus |
dc.contributor.author | Jiménez-Yuste, Víctor |
dc.contributor.author | Palomo Bravo, Ángeles |
dc.contributor.author | Galmes, Bernardo J. |
dc.contributor.author | Nieto Hernández, Maria del Mar |
dc.contributor.author | Benitez Hidalgo, Olga |
dc.contributor.author | Álvarez Román, María Teresa |
dc.date.accessioned | 2022-08-11T06:09:06Z |
dc.date.available | 2022-08-11T06:09:06Z |
dc.date.issued | 2022-01 |
dc.identifier.citation | Jiménez-Yuste V, Alvarez-Román MT, Palomo Bravo Á, Galmes BJ, Nieto Hernández MDM, Benítez Hidalgo O, et al. Clinical Efficacy and Safety of Fanhdi®, a Plasma-Derived VWF/Factor VIII Concentrate, in von Willebrand Disease in Spain: A Retrospective Study. Clin Appl Thromb Hemost. 2022 Jan;28:1–11. |
dc.identifier.issn | 1938-2723 |
dc.identifier.uri | https://hdl.handle.net/11351/7986 |
dc.description | Prophylaxis; Von willebrand disease |
dc.description.abstract | Objective
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.
Results
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. |
dc.language.iso | eng |
dc.publisher | SAGE Publications |
dc.relation.ispartofseries | Clinical and Applied Thrombosis/Hemostasis;28 |
dc.rights | Attribution-NonCommercial 4.0 International |
dc.rights.uri | http://creativecommons.org/licenses/by-nc/4.0/ |
dc.source | Scientia |
dc.subject | Malaltia de von Willebrandt - Tractament |
dc.subject | Sang - Coagulació - Factor VIII |
dc.subject.mesh | von Willebrand Diseases |
dc.subject.mesh | von Willebrand Factor |
dc.subject.mesh | /therapeutic use |
dc.title | Clinical Efficacy and Safety of Fanhdi®, a Plasma-Derived VWF/Factor VIII Concentrate, in von Willebrand Disease in Spain: A Retrospective Study |
dc.type | info:eu-repo/semantics/article |
dc.identifier.doi | 10.1177/10760296221074348 |
dc.subject.decs | enfermedades de von Willebrand |
dc.subject.decs | factor de von Willebrand |
dc.subject.decs | /uso terapéutico |
dc.relation.publishversion | https://doi.org/10.1177/10760296221074348 |
dc.type.version | info:eu-repo/semantics/publishedVersion |
dc.audience | Professionals |
dc.contributor.organismes | Institut Català de la Salut |
dc.contributor.authoraffiliation | [Jiménez-Yuste V, Alvarez-Román MT] Department of Hematology and Hemotherapy, Hospital Universitario La Paz, Autónoma University, Madrid, Spain. [Palomo Bravo Á] Hematology Service, Hospital Materno-Infantil de Málaga, Málaga, Spain. [Galmes BJ] Hematology Service, Hospital Universitario Son Espases, Palma de Mallorca, Spain. [Nieto Hernández MDM] Hematology and Hemotherapy Service, Complejo Universitario de Jaén, Jaén, Spain. [Benítez Hidalgo O] Servei d’Hematologia i Hemoteràpia, Vall d’Hebron Hospital Universitari, Barcelona, Spain |
dc.identifier.pmid | 35108125 |
dc.identifier.wos | 000751874100001 |
dc.rights.accessrights | info:eu-repo/semantics/openAccess |