title: Pain comparison after subcutaneous administration of single-dose formulation versus multidose formulation of epogen in hemodialysis patients.
abstract: Subcutaneous (s.c.) injection is an approved route of administration for recombinant human erythropoietin (epoetin alfa). However, pain at the injection site with the single-dose formulation has limited its use. With the recent development of a multidose formulation containing benzyl alcohol as a preservative, anecdotal reports have emerged that suggest this product causes less stinging. Using a randomized, triple-blind, placebo-controlled crossover design, this study compared pain perception, intensity, and duration after s.c. injection with a multidose formulation versus single-dose formulation using visual analogue (VAS) and verbal descriptive pain scales (VDS). Twenty-eight hemodialysis patients received s.c. injections of placebo (normal saline) in one arm and either the multidose or single-dose formulation in the opposite arm. One week later, the subjects again received placebo in one arm and the other epoetin alfa formulation in the opposite arm. The VAS and VDS measurements were obtained at time 0 and then every 5 minutes for a period of 30 minutes. Results showed a statistically significant difference in pain perception between formulations at times 0, 10, and 15 minutes for both the VAS and VDS. In conclusion, there was a significant difference in pain perception between formulations with the multidose formulation causing less pain than the single-dose formulation. However, it should be noted that several patients reported no pain with the single-dose formulation. This indicates that individual patient response could be considered when deciding which formulation to use, although it may be difficult to implement an error-free distribution and administration system using the two different formulations.
authors.affiliation: Division of Nephrology, Hennepin County Medical Center and University of Minnesota College of Pharmacy, Minneapolis, USA. stpet002@tc.umn.edu
authors.forename: W L
authors.initials: WL
authors.lastname: St Peter
authors.forename: M J
authors.initials: MJ
authors.lastname: Lewis
authors.forename: M G
authors.initials: MG
authors.lastname: Macres
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D011994:Recombinant Proteins; D006435:Renal Dialysis; D012107:Research Design
chemical_list: D003692:Delayed-Action Preparations; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa