TY - JOUR
T1 - Pain comparison after subcutaneous administration of single-dose formulation versus multidose formulation of epogen in hemodialysis patients
AU - St Peter, Wendy L
AU - Lewis, Matthew J.
AU - Macres, Mark G.
N1 - Copyright:
Copyright 2017 Elsevier B.V., All rights reserved.
PY - 1998/9
Y1 - 1998/9
N2 - Subcutaneous (SC) 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 SC injection with a multidose formulation versus single-dose formulation using visual analogue (VAS) and verbal descriptive pain scales (VDS). Twenty-eight hemodialysis patients received SC 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.
AB - Subcutaneous (SC) 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 SC injection with a multidose formulation versus single-dose formulation using visual analogue (VAS) and verbal descriptive pain scales (VDS). Twenty-eight hemodialysis patients received SC 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.
KW - Erythropoietin alfa
KW - Pain
KW - Subcutaneous administration
UR - http://www.scopus.com/inward/record.url?scp=0031682322&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0031682322&partnerID=8YFLogxK
U2 - 10.1053/ajkd.1998.v32.pm9740164
DO - 10.1053/ajkd.1998.v32.pm9740164
M3 - Article
C2 - 9740164
AN - SCOPUS:0031682322
SN - 0272-6386
VL - 32
SP - 470
EP - 474
JO - American Journal of Kidney Diseases
JF - American Journal of Kidney Diseases
IS - 3
ER -