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Less-frequent dosing of epoetin alfa efficacious in treating anemia in patients with CKD, new data reveal

Monday, November 17 2008 | Comments
Evidence Grade 7 What's This?
By Hunter Kaller

Once-weekly and biweekly regimens of epoetin alfa appear to be statistically noninferior to the Food and Drug Administration-approved thrice-weekly regimen in treating anemia in subjects with stage III-IV chronic kidney disease (CKD), according to study data.

The open-label study included 375 subjects (average age, 70 years) with stage III-IV CKD who were randomized to 1 of the 3 dosing groups (once weekly, biweekly, and the FDA-approved thrice-weekly regimens) and treated for 44 weeks. The patients in the thrice-weekly group were changed to once-weekly dosing after 22 weeks.

Change in hemoglobin (Hb) from baseline to the average of the last 8 weeks of treatment through week 22 was the primary endpoint. Data were also analyzed through week 44.

The mean baseline Hb was 9.6 g/dL, 9.7 g/dL, and 9.8 g/dL for the thrice-weelkly group, once-weekly group, and biweekly group, respectively. The mean final Hb was 11.4 g/dL, 11.3 g/dL, and 11.1 g/dL, representing a mean Hb increase of 1.8 g/dL, 1.6 g/dL, and 1.3 g/dL, respectively. Based on these increases in Hb, the once-weekly and biweekly regimens were statistically noninferior to the approved thrice-weekly regimen, as the lower limits of the 95% CIs were within the prespecified noninferiority margin of -1 g/dL.

The thrice-weekly group had a higher percentage of patients exceeding Hb 11.9 g/dL during the first 22 weeks of treatment (86.2%) than did the once-weekly (78.4%) and biweekly groups (71.2%).

In the thrice-weekly group, 15% of the patients experienced serious adverse events compared with 22% of the patients in the other 2 groups who experienced these events. Investigator-confirmed thromboembolic vascular events during the first 22 weeks were seen in 2 patients in the thrice-weekly group, in 2 patients in the once-weekly group, and in 3 patients in the biweekly group.

No subjects died in the first 22 weeks in the thrice-weekly group compared with 6 subjects in the once-weekly group and 3 in the biweekly group. By 44 weeks, 4, 6, and 4 patients, respectively, died. The deaths were not considered to be related to the study drug.

"These data provide important insights into the potential use of extended-dosing regimens of epoetin alfa in this patient population," said Dr. Pablo Pergola, the study's lead researcher. (Poster F-PO1833.)


Press release by Ortho Biotech Products LP

View abstract posted on ASN's site

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