A trial comparing local pain after subcutaneous injection of epoetin-beta versus darbepoetin-alpha in healthy volunteers.
BACKGROUND
The aim of this study was to compare local pain experienced with subcutaneous (s.c.) injection of epoetin-beta vs. darbepoetin-alpha.


METHODS
40 healthy volunteers were enrolled into this single-blind, crossover study. After receiving an injection of placebo, individuals were randomized to receive s.c. injections of epoetin-beta 6,000 IU (0.3 ml) or darbepoetin-alpha 30 mg (0.3 ml), with a 1-week washout period between injections. Local pain was evaluated using a Visual Analog Scale (VAS) and a 6-item Verbal Rating Scale (VRS) immediately after (T0) and 1 h after injection (T1).


RESULTS
The respective mean (standard deviation) and median (range) VAS values at T0 were 1.2 (1.7) and 0.5 (0.0 - 6.9) for epoetin-beta vs. 2.8 (2.4) and 1.9 (0.0 - 9.0) for darbepoetin-alpha (p < 0.0001). At T0, VRS scores demonstrated that 51% of individuals experienced no pain after epoetin- injection compared with 16% of those receiving darbepoetin-alpha. The percentage of individuals perceiving moderate or important pain was significantly greater with darbepoetin-alpha (38%) compared with epoetin-beta (5%, p = 0.0005) and placebo (14%). Pain evaluation at T1 showed no difference between treatment groups. Local tolerance was excellent except for a small hematoma with epoetin- at T1 and with darbepoetin-alpha at T0 which persisted at T1.


CONCLUSIONS
In healthy volunteers, s.c. injection of epoetin-beta was significantly less painful than with darbepoetin-alpha and comparable with placebo. No significant pain was apparent at T1 in any group.
Berthoux
F
F
Department of Nephrology, Dialysis and Renal Transplantation, North University Hospital Saint-Etienne, France. francois.berthoux@chu-st-etienne.fr
Ryckelynck
J-P
JP
Rouanet
S
S
Gelu-Mantoulet
S
S
Montestruc
F
F
Mouchel
P
P
Choukroun
G
G
D000293:Adolescent; D000328:Adult; D018592:Cross-Over Studies; D000068256:Darbepoetin alfa; D004921:Erythropoietin / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D006397:Hematinics / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007279:Injections, Subcutaneous / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000209:etiology*; D010147:Pain Measurement; D011994:Recombinant Proteins; D016037:Single-Blind Method
D006397:Hematinics; D011994:Recombinant Proteins; C103998:epoetin beta; D004921:Erythropoietin; D000068256:Darbepoetin alfa