PMID- 35108125
OWN - NLM
STAT- MEDLINE
DCOM- 20220324
LR  - 20220324
IS  - 1938-2723 (Electronic)
IS  - 1076-0296 (Print)
IS  - 1076-0296 (Linking)
VI  - 28
DP  - 2022 Jan-Dec
TI  - Clinical Efficacy and Safety of Fanhdi((R)), a Plasma-Derived VWF/Factor VIII 
      Concentrate, in von Willebrand Disease in Spain: A Retrospective Study.
PG  - 10760296221074348
LID - 10.1177/10760296221074348 [doi]
LID - 10760296221074348
AB  - 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.
FAU - Jimenez-Yuste, Victor
AU  - Jimenez-Yuste V
AD  - Department of Hematology and Hemotherapy, Hospital Universitario La Paz, Autonoma 
      University, Madrid, Spain.
FAU - Alvarez-Roman, Maria Teresa
AU  - Alvarez-Roman MT
AD  - Department of Hematology and Hemotherapy, Hospital Universitario La Paz, Autonoma 
      University, Madrid, Spain.
FAU - Palomo Bravo, Angeles
AU  - Palomo Bravo A
AD  - Hematology Service, Hospital Materno-Infantil de Malaga, Malaga, Spain.
FAU - Galmes, Bernardo J
AU  - Galmes BJ
AD  - Hematology Service, Hospital Universitario Son Espases, Palma de Mallorca, Spain.
FAU - Nieto Hernandez, Maria Del Mar
AU  - Nieto Hernandez MDM
AD  - Hematology and Hemotherapy Service, Complejo Universitario de Jaen, Jaen, Spain.
FAU - Benitez Hidalgo, Olga
AU  - Benitez Hidalgo O
AD  - Hematology and Hemotherapy Department, Hospital Vall d'Hebron, Barcelona, Spain.
FAU - Marzo Alonso, Cristina
AU  - Marzo Alonso C
AD  - Hematology and Hemotherapy Service, Hospital Universitari Arnau de Vilanova, 
      Lleida, Spain.
FAU - Perez Gonzalez, Noelia Florencia
AU  - Perez Gonzalez NF
AD  - Hematology and Hemotherapy Service, Complejo Universitario Torrecardenas, 
      Almeria, Spain.
FAU - Coll, Julia
AU  - Coll J
AD  - Hematology Service, Complejo Hospitalario de Navarra, Pamplona, Spain.
FAU - Nunez, Ramiro
AU  - Nunez R
AD  - Hematology Service, Hospital Virgen del Rocio, Sevilla, Spain.
FAU - Carrasco, Marina
AU  - Carrasco M
AD  - Thrombosis and Hemostasis Unit, Hospital de la Santa Creu i Sant Pau, Barcelona, 
      Spain.
FAU - Garcia Candel, Faustino
AU  - Garcia Candel F
AD  - Hematology and Hemotherapy Service, Hospital Clinico Universitario Virgen 
      Arrixaca, Murcia, Spain.
FAU - Gonzalez-Porras, Jose Ramon
AU  - Gonzalez-Porras JR
AD  - Department of Hematology, Hospital Universitario de Salamanca-IBSAL-USAL, 
      Salamanca, Spain.
FAU - Hernandez Garcia, Carmen
AU  - Hernandez Garcia C
AD  - Hematology and Hemotherapy Service, Hospital de Don Benito-Villanueva, Badajoz, 
      Spain.
FAU - Varo Castro, Maria Jose
AU  - Varo Castro MJ
AD  - Hematology Service, Hospital Universitario de Albacete, Albacete, Spain.
FAU - Mir, Roser
AU  - Mir R
AD  - Scientific and Medical Affairs Department, Grifols, Barcelona, Spain.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PL  - United States
TA  - Clin Appl Thromb Hemost
JT  - Clinical and applied thrombosis/hemostasis : official journal of the 
      International Academy of Clinical and Applied Thrombosis/Hemostasis
JID - 9508125
RN  - 0 (Drug Combinations)
RN  - 0 (Hemostatics)
RN  - 0 (von Willebrand Factor)
RN  - 9001-27-8 (Factor VIII)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Blood Loss, Surgical/prevention & control
MH  - Child
MH  - Drug Combinations
MH  - Factor VIII/administration & dosage/*therapeutic use
MH  - Female
MH  - Hemorrhage/*drug therapy/*etiology
MH  - Hemostatics/administration & dosage/*therapeutic use
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Retrospective Studies
MH  - Spain
MH  - Young Adult
MH  - von Willebrand Diseases/*complications
MH  - von Willebrand Factor/administration & dosage/*therapeutic use
PMC - PMC8814963
OTO - NOTNLM
OT  - bleeding
OT  - plasma-derived von willebrand factor/factor VIII concentrate
OT  - prophylaxis
OT  - surgery
OT  - von willebrand disease
OT  - von willebrand factor
COIS- Declaration of Conflicting Interests: The author(s) declared the following 
      potential conflicts of interest with respect to the research, authorship, and/or 
      publication of this article: R. Mir is full-time employee of Grifols and has no 
      other competing interests to declare. V. Jimenez-Yuste received reimbursement for 
      attending symposia/congresses and/or honoraria for speaking and/or honoraria for 
      consulting, and/or funds for research from Shire, Bayer, CSL-Behring, Grifols, 
      Novo Nordisk, Sobi, Octapharma, BioMarin, Sanofi and Pfizer. M.T. Alvarez-Roman 
      received reimbursement for attending symposia and/or honoraria for speaking 
      and/or honoraria for consulting, and/or funds for research from Takeda, Bayer, 
      CSL-Behring, Grifols, Novo Nordisk, Sobi, Octapharma, BioMarin, Novartis, Amgen 
      and Pfizer. O. Benitez Hidalgo received reimbursement for attending 
      symposia/congresses and/or honoraria for speaking and/or advisory boards from 
      Bayer, CSL-Behring, Takeda, Sobi and Pfizer. R. Nunez reports personal fees or 
      consulting services for Novonordisk, Bayer, Takeda, Roche, Pfizer, CSL Behring 
      and Sobi. J.R. Gonzalez-Porras reports financial activities outside the submitted 
      work: fees for consulting services by Amgen, Novartis, Sobi, Grifols, and CSL 
      Behring, and speaking honoraria from NovoNordisk, Shire, Sobi, Roche, Daiichi 
      Sankyo, Pfizer, Amgen, Novartis. N.F. Perez Gonzalez, C. Marzo Alonso, A. Palomo 
      Bravo, C. Hernandez Garcia, J. Coll, M. Carrasco, M.M. Nieto Hernandez, B. J 
      Galmes, M.J. Varo Castro and F. Garcia Candel have no conflict of interest to 
      declare.
EDAT- 2022/02/03 06:00
MHDA- 2022/03/25 06:00
PMCR- 2022/02/02
CRDT- 2022/02/02 17:14
PHST- 2022/02/02 17:14 [entrez]
PHST- 2022/02/03 06:00 [pubmed]
PHST- 2022/03/25 06:00 [medline]
PHST- 2022/02/02 00:00 [pmc-release]
AID - 10.1177_10760296221074348 [pii]
AID - 10.1177/10760296221074348 [doi]
PST - ppublish
SO  - Clin Appl Thromb Hemost. 2022 Jan-Dec;28:10760296221074348. doi: 
      10.1177/10760296221074348.