PMID- 19878338
OWN - NLM
STAT- MEDLINE
DCOM- 20110105
LR  - 20180823
IS  - 1365-2516 (Electronic)
IS  - 1351-8216 (Linking)
VI  - 16
IP  - 1
DP  - 2010 Jan
TI  - Postmarketing surveillance study of KOGENATE Bayer with Bio-Set in patients with 
      haemophilia A: evaluation of patients' satisfaction after switch to the new 
      reconstitution system.
PG  - 66-71
LID - 10.1111/j.1365-2516.2009.02113.x [doi]
AB  - KOGENATE Bayer (rFVIII-FS) with Bio-Set is designed to prevent patient contact 
      with exposed needles during recombinant factor VIII reconstitution. This 
      postmarketing surveillance study evaluated patient satisfaction before and after 
      switching to the new Bio-Set reconstitution method. Male children and adults with 
      haemophilia A were enrolled from nine European countries. A preference 
      questionnaire was administered to patients after Bio-Set training and at the end 
      of the observation period (> or =20 exposure days or 3 months). Physician 
      assessments of patient compliance and satisfaction were conducted at the end of 
      the observation period. Patients (N = 306) received a mean +/- SD of 28 +/- 23 
      infusions of rFVIII-FS with Bio-Set. A majority of patients (82%) preferred the 
      Bio-Set method, with domain scores for ease of use, safety from needlesticks, and 
      speed of reconstitution being highest after training and at the end of the 
      observation period. The Bio-Set method received higher mean scores than previous 
      reconstitution methods for worry/safety and ease/confidence domains at both time 
      points. Physician-reported patient compliance with the Bio-Set method was similar 
      or greater compared with the previous method for 94% of the patients, with 
      physicians reporting that 92% of the patients were satisfied or very satisfied 
      with Bio-Set. Thirteen adverse events (AEs) occurred in nine patients, and five 
      serious AEs occurred in five patients; none was related to rFVIII-FS. No de novo 
      or recurrent inhibitor development was observed during the observation period. 
      rFVIII-FS with Bio-Set was well tolerated and well accepted by haemophilia A 
      patients, which may improve treatment compliance.
FAU - Vidovic, N
AU  - Vidovic N
AD  - Institut fuer Experimentelle Haematologie und Transfusionsmedizin, Universitaet 
      Bonn, Bonn, Germany.
FAU - Musso, R
AU  - Musso R
FAU - Klamroth, R
AU  - Klamroth R
FAU - Enriquez, M M
AU  - Enriquez MM
FAU - Achilles, K
AU  - Achilles K
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20091029
PL  - England
TA  - Haemophilia
JT  - Haemophilia : the official journal of the World Federation of Hemophilia
JID - 9442916
RN  - 0 (Recombinant Proteins)
RN  - 839MOZ74GK (F8 protein, human)
RN  - 9001-27-8 (Factor VIII)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Child
MH  - Child, Preschool
MH  - Factor VIII/*administration & dosage/therapeutic use
MH  - Hemophilia A/*drug therapy
MH  - Home Infusion Therapy/*methods
MH  - Humans
MH  - Infant
MH  - Male
MH  - Medication Adherence
MH  - Middle Aged
MH  - *Patient Satisfaction
MH  - Product Surveillance, Postmarketing
MH  - Recombinant Proteins/administration & dosage/therapeutic use
MH  - Surveys and Questionnaires
MH  - Young Adult
EDAT- 2009/11/03 06:00
MHDA- 2011/01/06 06:00
CRDT- 2009/11/03 06:00
PHST- 2009/11/03 06:00 [entrez]
PHST- 2009/11/03 06:00 [pubmed]
PHST- 2011/01/06 06:00 [medline]
AID - HAE2113 [pii]
AID - 10.1111/j.1365-2516.2009.02113.x [doi]
PST - ppublish
SO  - Haemophilia. 2010 Jan;16(1):66-71. doi: 10.1111/j.1365-2516.2009.02113.x. Epub 
      2009 Oct 29.