Clinical Efficacy and Safety of Fanhdi, a Plasma-Derived VWF/Factor VIII Concentrate, in von Willebrand Disease in Spain: A Retrospective Study

Autor: Víctor Jiménez-Yuste MD, PhD, María Teresa Alvarez-Román MD, Ángeles Palomo Bravo MD, Bernardo J. Galmes MD, Maria del Mar Nieto Hernández MD, Olga Benítez Hidalgo MD, Cristina Marzo Alonso MD, Noelia Florencia Pérez González MD, Julia Coll MD, Ramiro Núñez MD, Marina Carrasco MD, Faustino García Candel MD, Jose Ramon Gonzalez-Porras MD, Carmen Hernández García MD, Maria José Varó Castro MD, Roser Mir PhD
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: Clinical and Applied Thrombosis/Hemostasis, Vol 28 (2022)
Druh dokumentu: article
ISSN: 1938-2723
10760296
DOI: 10.1177/10760296221074348
Popis: 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.
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