A randomised, cross-over study comparing injection site pain with subcutaneous epoetin beta and subcutaneous darbepoetin alfa in patients with chronic kidney disease

Roger, Simon D., Suranyi, Michael G., Walker, Rowan G., Isbel, Nicole M. and COMFORT study group (2008) A randomised, cross-over study comparing injection site pain with subcutaneous epoetin beta and subcutaneous darbepoetin alfa in patients with chronic kidney disease. Current Medical Research and Opinion, 24 8: 2181-2187. doi:10.1185/03007990802240552


Author Roger, Simon D.
Suranyi, Michael G.
Walker, Rowan G.
Isbel, Nicole M.
COMFORT study group
Title A randomised, cross-over study comparing injection site pain with subcutaneous epoetin beta and subcutaneous darbepoetin alfa in patients with chronic kidney disease
Journal name Current Medical Research and Opinion   Check publisher's open access policy
ISSN 0300-7995
1473-4877
Publication date 2008
Sub-type Article (original research)
DOI 10.1185/03007990802240552
Volume 24
Issue 8
Start page 2181
End page 2187
Total pages 7
Place of publication London, United Kingdom
Publisher Informa Healthcare
Language eng
Subject 110312 Nephrology and Urology
1103 Clinical Sciences
Formatted abstract
 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 30μg or weekly sc epoetin beta 6000IU for 2 weeks and were then crossed over to the alternative treatment for 2 weeks. Injection site pain was assessed using a 10cm 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.

Keyword Darbepoetin alfa
Epoetin beta
Pain
Subcutaneous injections
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Excellence in Research Australia (ERA) - Collection
School of Medicine Publications
 
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Created: Tue, 19 Jan 2010, 09:02:47 EST by Maria Campbell on behalf of Faculty Of Health Sciences