BACKGROUND: The ability to reduce the administration frequency of subcutaneous (SC) epoetin could provide benefits. This multicenter open-label study investigated the therapeutic equivalence of SC epoetin beta once-weekly and thrice-weekly administration regimens in maintaining anemia correction in stable hemodialysis (HD) patients. METHODS:One hundred seventy-three patients were randomly assigned to either once-weekly epoetin beta (n = 84) or their original thrice-weekly regimen (n = 89) for 24 weeks. All patients were administered intravenous iron supplementation, as required. RESULTS: The per-protocol analysis included 134 patients (69 patients, once-weekly group; 65 patients, thrice-weekly group). Mean hematocrits in both groups remained stable throughout the study. The difference in mean time-adjusted area under the curve for hematocrits between the once-weekly and thrice-weekly groups (-0.54 vol%) and 90% confidence intervals (-1.27 to 0.19) were within the prespecified equivalence range (-2 to +2 vol%). There was no significant change in epoetin beta dose during the study. The ratio of mean weekly epoetin beta doses in the once-weekly and thrice-weekly groups (1.11) and 90% confidence interval (0.99 to 1.23) also remained within the prespecified range (0.8 to 1.25). Intention-to-treat analysis results were similar to per-protocol analysis results. Both regimens were well tolerated. CONCLUSION: Once-weekly and thrice-weekly SC epoetin beta administrations are statistically equivalent in terms of maintaining both stable hematocrits and epoetin beta dose requirements in HD patients. These findings may improve compliance among patients. Copyright 2002 by the National Kidney Foundation, Inc.
RCT Entities:
BACKGROUND: The ability to reduce the administration frequency of subcutaneous (SC) epoetin could provide benefits. This multicenter open-label study investigated the therapeutic equivalence of SC epoetin beta once-weekly and thrice-weekly administration regimens in maintaining anemia correction in stable hemodialysis (HD) patients. METHODS: One hundred seventy-three patients were randomly assigned to either once-weekly epoetin beta (n = 84) or their original thrice-weekly regimen (n = 89) for 24 weeks. All patients were administered intravenous iron supplementation, as required. RESULTS: The per-protocol analysis included 134 patients (69 patients, once-weekly group; 65 patients, thrice-weekly group). Mean hematocrits in both groups remained stable throughout the study. The difference in mean time-adjusted area under the curve for hematocrits between the once-weekly and thrice-weekly groups (-0.54 vol%) and 90% confidence intervals (-1.27 to 0.19) were within the prespecified equivalence range (-2 to +2 vol%). There was no significant change in epoetin beta dose during the study. The ratio of mean weekly epoetin beta doses in the once-weekly and thrice-weekly groups (1.11) and 90% confidence interval (0.99 to 1.23) also remained within the prespecified range (0.8 to 1.25). Intention-to-treat analysis results were similar to per-protocol analysis results. Both regimens were well tolerated. CONCLUSION: Once-weekly and thrice-weekly SC epoetin beta administrations are statistically equivalent in terms of maintaining both stable hematocrits and epoetin beta dose requirements in HDpatients. These findings may improve compliance among patients. Copyright 2002 by the National Kidney Foundation, Inc.