Once-weekly compared with three-times-weekly subcutaneous epoetin β: Results from a randomized, multicenter, therapeutic-equivalence study

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 β 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 β (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 β dose during the study. The ratio of mean weekly epoetin β 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 β administrations are statistically equivalent in terms of maintaining both stable hematocrits and epoetin β dose requirements in HD patients. These findings may improve compliance among patients. © 2002 by the National Kidney Foundation, Inc.