A trial comparing local pain after subcutaneous injection of epoetin-beta versus darbepoetin-alpha in healthy volunteers.

Abstract

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.

CONCLUSION:

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.

• Authors: F Berthoux, J-P Ryckelynck, S Rouanet, S Gelu-Mantoulet, F Montestruc, P Mouchel, G Choukroun, Painless Investigators Coordinators
• Journal: Clinical nephrology (Clin Nephrol) Vol. 70 Issue 1 Pg. 33-40 (Jul 2008) ISSN: 0301-0430 [Print] Germany
• PMID: 18793546 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Hematinics
• Recombinant Proteins
• epoetin beta
• Erythropoietin
• Darbepoetin alfa

Topics

• Adolescent
• Adult
• Cross-Over Studies
• Darbepoetin alfa
• Erythropoietin (administration & dosage, adverse effects, analogs & derivatives)
• Female
• Hematinics (administration & dosage, adverse effects)
• Humans
• Injections, Subcutaneous (adverse effects)
• Male
• Middle Aged
• Pain (etiology)
• Pain Measurement
• Recombinant Proteins
• Single-Blind Method