Hemoglobin maintenance with use of extended dosing of epoetin alfa in patients with diabetes and anemia of chronic kidney disease.

OBJECTIVE

To compare the efficacy of extended epoetin alfa dosing in maintaining hemoglobin (Hb) concentrations in patients with and without diabetes as the primary cause of chronic kidney disease.

METHODS

We undertook a post hoc analysis of the Clinical Evaluation of PROCRIT(R) for Maintenance Phase Treatment of Patients With Anemia Due to Chronic Kidney Disease (PROMPT) study. The study patients had chronic kidney disease but were not receiving dialysis, had stable Hb levels of >or= 11.0 g/dL, and had been receiving epoetin alfa for >or= 2 months. Patients received 1 of 4 epoetin alfa dosing regimens administered subcutaneously for up to 16 weeks: 10,000 U once weekly (QW), 20,000 U every 2 weeks (Q2W), 30,000 U every 3 weeks (Q3W), or 40,000 U every 4 weeks (Q4W). The primary end point was the percentage of patients able to achieve Hb maintenance, defined as a mean Hb level of >or= 11.0 g/dL from week 2 to final measurement.

RESULTS

Among 445 evaluable patients, 201 had diabetes and 244 did not have diabetes. Mean baseline Hb was 11.9 g/dL in both groups. The percentage of patients achieving Hb maintenance, stratified by epoetin alfa dosing regimen, was similar in patients with and those without diabetes: QW (90.2% versus 96.5%), Q2W (91.1% versus 87.9%), Q3W (80.0% versus 75.7%), or Q4W (79.2% versus 72.5%). The incidence of adverse events was low and comparable between patients with and those without diabetes.

CONCLUSION

Approximately 90% of patients with and without diabetes in the QW and Q2W groups and more than 70% in the Q3W and Q4W groups maintained mean Hb levels of >or= 11.0 g/dL from week 2 to final measurement. These results demonstrated that patients with diabetes responded in a similar manner as patients without diabetes to extended dosing of epoetin alfa up to Q4W.