PMID- 18565240
OWN - NLM
STAT- MEDLINE
DCOM- 20081229
LR  - 20151119
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 24
IP  - 8
DP  - 2008 Aug
TI  - A randomised, cross-over study comparing injection site pain with subcutaneous 
      epoetin beta and subcutaneous darbepoetin alfa in patients with chronic kidney 
      disease.
PG  - 2181-7
LID - 10.1185/03007990802240552 [doi]
AB  - OBJECTIVE: To compare injection site pain of subcutaneous (sc) epoetin beta and 
      darbepoetin alfa in adult patients with chronic kidney disease. RESEARCH DESIGN 
      AND METHODS: This was a multi-centre, randomised, two-arm, single-blind, 
      cross-over study. Patients were randomised to receive weekly sc darbepoetin alfa 
      30 mug or weekly sc epoetin beta 6000 IU for 2 weeks and were then crossed over 
      to the alternative treatment for 2 weeks. Injection site pain was assessed using 
      a 10 cm ungraduated visual analogue scale (0 = no pain, 10 = worst pain) and a 
      six-point verbal rating scale. Patient preference for treatment was also 
      assessed. TRIAL REGISTRATION: http://clinicaltrials. gov/(NCT00377481). RESULTS: 
      All randomised patients (N = 48) completed the study. The sample comprised 29 
      chronic kidney disease patients (Stage 3 or Stage 4), 11 peritoneal dialysis 
      patients and 8 renal transplant patients. Patients perceived significantly less 
      pain with epoetin beta than darbepoetin alfa, using the visual analogue scale 
      (relative pain score = 2.75, darbepoetin alfa:epoetin beta, 95% CI: 1.85, 4.07; p 
      < 0.0001) and the verbal rating scale (median: 0.5, 95% CI: 0.5, 1.0 vs. median: 
      1.5, 95% CI: 1.0, 2.0; p < 0.0001). Epoetin beta was preferred by significantly 
      more patients (65%) than darbepoetin alfa (10%) (p < 0.001); 25% of patients 
      reported no preference. CONCLUSIONS: Limitations included lack of an epoetin alfa 
      comparator and limited blinding (patients were blinded to treatment, however, an 
      unblinded nurse administered treatment). We show that sc injection of epoetin 
      beta is significantly less painful than darbepoetin alfa and patient preference 
      for epoetin beta confirms that the difference is clinically meaningful.
FAU - Roger, Simon D
AU  - Roger SD
AD  - Renal Research, Gosford, Australia. sroger@nsccahs.health.nsw.gov.au
FAU - Suranyi, Michael G
AU  - Suranyi MG
FAU - Walker, Rowan G
AU  - Walker RG
FAU - Disney, Alex
AU  - Disney A
FAU - Isbel, Nicole M
AU  - Isbel NM
FAU - Kairaitis, Lukas
AU  - Kairaitis L
FAU - Pollock, Carol A
AU  - Pollock CA
FAU - Brown, Fiona G
AU  - Brown FG
FAU - Chow, Josephine
AU  - Chow J
FAU - Truman, Matt I
AU  - Truman MI
FAU - Ulyate, Kellie A
AU  - Ulyate KA
CN  - COMFORT study group
LA  - eng
SI  - ClinicalTrials.gov/NCT00377481
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20080618
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Recombinant Proteins)
RN  - 0 (epoetin beta)
RN  - 11096-26-7 (Erythropoietin)
RN  - 15UQ94PT4P (Darbepoetin alfa)
SB  - IM
MH  - Aged
MH  - Darbepoetin alfa
MH  - Erythropoietin/administration & dosage/*adverse effects/*analogs & 
      derivatives/therapeutic use
MH  - Female
MH  - Humans
MH  - Injections, Subcutaneous
MH  - Kidney Failure, Chronic/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Pain/*etiology
MH  - Pain Measurement
MH  - Recombinant Proteins
EDAT- 2008/06/21 09:00
MHDA- 2008/12/30 09:00
CRDT- 2008/06/21 09:00
PHST- 2008/06/21 09:00 [pubmed]
PHST- 2008/12/30 09:00 [medline]
PHST- 2008/06/21 09:00 [entrez]
AID - 4555 [pii]
AID - 10.1185/03007990802240552 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2008 Aug;24(8):2181-7. doi: 10.1185/03007990802240552. Epub 
      2008 Jun 18.