Clinical Efficacy and Safety of Fanhdi(R), a Plasma-Derived VWF/Factor VIII Concentrate, in von Willebrand Disease in Spain: A Retrospective Study
Por:
Jimenez-Yuste, V, Alvarez-Roman, MT, Bravo, AP, Galmes, BJ, Hernandez, MDN, Hidalgo, OB, Alonso, CM, Gonzalez, NFP, Coll, J, Nunez, R, Carrasco, M, Candel, FG, Gonzalez-Porras, JR, Garcia, CH, Castro, MJV, Mir, R
Publicada:
1 feb 2022
Resumen:
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(R), 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(R) 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.
Filiaciones:
Jimenez-Yuste, V:
Univ Autonoma Madrid, Hosp Univ La Paz, Dept Hematol & Hemotherapy, Madrid, Spain
Alvarez-Roman, MT:
Univ Autonoma Madrid, Hosp Univ La Paz, Dept Hematol & Hemotherapy, Madrid, Spain
Bravo, AP:
Hosp Materno Infantil Malaga, Hematol Serv, Malaga, Spain
Galmes, BJ:
Hosp Univ Son Espases, Hematol Serv, Palma De Mallorca, Spain
Hernandez, MDN:
Complejo Univ Jaen, Hematol & Hemotherapy Serv, Jaen, Spain
Hidalgo, OB:
Hosp Valle De Hebron, Hematol & Hemotherapy Dept, Barcelona, Spain
Alonso, CM:
Hosp Arnau Vilanova, Hematol & Hemotherapy Serv, Lleida, Spain
Gonzalez, NFP:
Complejo Univ Torrecardenas, Hematol & Hemotherapy Serv, Almeria, Spain
Coll, J:
Complejo Hosp Navarra, Hematol Serv, Pamplona, Spain
Nunez, R:
Hosp Virgen Rocio, Hematol Serv, Seville, Spain
Carrasco, M:
Hosp Santa Creu & Sant Pau, Thrombosis & Hemostasis Unit, Barcelona, Spain
Candel, FG:
Hosp Clin Univ Virgen Arrixaca, Hematol & Hemotherapy Serv, Murcia, Spain
Gonzalez-Porras, JR:
Hosp Univ Salamanca, Dept Hematol, USAL, IBSAL, Salamanca, Spain
Garcia, CH:
Hosp Don Benito Villanueva, Hematol & Hemotherapy Serv, Badajoz, Spain
Castro, MJV:
Hosp Univ Albacete, Hematol Serv, Albacete, Spain
Mir, R:
Grifols, Sci & Med Affairs Dept, Barcelona, Spain
Green Published, gold
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