Efficacy of intravenous and subcutaneous darbepoetin alfa in maintaining haemoglobin levels and doses

According to a recent study, mean haemoglobin levels and mean weekly darbepoetin alfa dose did not differ significantly in the subcutaneous and the intravenous groups. The study’s findings were published in the journal, Nephrology, dialysis, transplantation.

A multicenter, prospective, randomized trial included 114 patients, who were treated with subcutaneous darbepoetin alfa for at least 6 months. These participants were randomized in a 1:1 ratio to either continue with subcutaneous treatment of darbepoetin alfa (n=61) or were switched to the intravenous administration route (n=53). The darbepoetin dose and haemoglobin concentrations were assessed as per patient average taken at baseline i.e., Week -3 +/- 1, followed by Week 24 +/- 3 and Week 48 +/- 3.

It was observed that there were no significant changes in mean haemoglobin levels and mean weekly darbepoetin alfa dose in either of the treatment groups. From the above results, it may be concluded that darbepoetin alfa dose can be kept constant if patients are switched from subcutaneous to intravenous treatment.

Darbepoetin alfa administered once monthly non-inferior to once every two weeks dosage for anemia correction

According to a recent study, darbepoetin alfa (DA) administered once monthly (QM) to maintain haemoglobin (Hb) concentrations in anaemic patients was non-inferior and with a similar safety profile to DA every 2 weeks (Q2W) in anaemic patients with chronic kidney disease not on dialysis (CKD-ND). The results of this study were published in the journal, Nephrology.

This randomized, non-inferiority, active-controlled, double-blind trial included 355 adult subjects with CKD-ND and having Hb levels <10 g/dL, who were not treated with an erythropoiesis-stimulating agent. These subjects were randomized in a 1:1 ratio to receive initial doses of 0.75 μg/kg DA every 2 weeks (Q2W) or 1.5 μg/kg DA once monthly (QM) for 33 weeks. The primary end-point of the study was the Hb change between baseline and weeks 29-33 (evaluation period), where the non-inferiority margin was -0.5 g/dL.

It was observed that the mean change in Hb between baseline and the evaluation period was 2.16 and 1.97 for the Q2W and QM groups, respectively. 97.9% of the subjects in Q2W and 98.1% subjects in QM group achieved a Hb level ≥10.0 g/dL and ≥1.0 g/dL increase in Hb from baseline. Over weeks 29-33, mean DA (SD) weekly equivalent doses were 0.20 and 0.27 μg/kg per week for the Q2W and QM groups, respectively, with both groups showing similar safety profiles.

Thus, it can be concluded that darbepoetin alfa administered once a month may be non-inferior and having similar safety profile as DA administered every 2 weeks for anemia correction in patients with CKD-ND.

Dose equivalence and hemoglobin stability on conversion from epoetin to darbepoetin alfa in hemodialysis patients

In a recent study, it was suggested that in patients undergoing hemodialysis, the conversion of epoetin alfa to darbepoetin alfa meant that achieving hemoglobin (Hb) stability was possible at a conversion ratio of 300:1 for patients receiving low doses of epoetin alfa and 350:1 for those receiving higher doses. This study was published in the International Journal of Nephrology and Renovascular Disease.

In this multicenter, observational, retrospective study, 125 patients above 18 years of age, who were switched from intravenous (IV) epoetin alfa to IV darbepoetin alfa, were included. They were on hemodialysis from month 0 to at least 24 months. The dose conversion was adjusted to maintain Hb within 1.0 g/dL of baseline.

At the end of the study, it was observed that there were no significant changes in Hb levels. The erythropoiesis-stimulating agent (ESA) dose decreased significantly after conversion from epoetin to darbepoetin alfa. With epoetin, an annual mean of 174.7 international units (IU)/kg/week was achieved while it was 95.7 and 91.4 IU/kg/week during the first and second year, respectively for darbepoetin.

Based on the above results, it can be concluded that to maintain Hb stability, a conversion ratio of 300:1 may seem appropriate for patients who received low doses of epoetin while a ratio of 350:1 may seem better for those receiving higher doses.

Maintenance of hemoglobin concentrations in dialysis patients with darbepoetin alfa once every two weeks

A recent study found that hemoglobin concentrations were effectively maintained with darbepoetin alfa (DA) given once every two weeks (Q2W) in dialysis patients. This study was published in the journal, Clinical Nephrology.

The ALTERNATE was an observational study that included 6,104 adult dialysis patients initiating treatment with darbepoetin alfa administered Q2W. Data obtained was from 6 months prior and 12 months post Q2W initiation. The primary endpoint of the study was hemoglobin (Hb) concentration, one year after initiation.

It was found that before initiation, 77.3%, 8.8%, and 7.8% of patients were on DA, epoetin beta, and epoetin alpha, respectively. Mean Hb (g/dl) and geometric mean weekly ESA dose (µg/wk) 6 months before initiation, at initiation, and 12 months after initiation were 11.68, 12.00, and 11.62, respectively and 27.27, 23.69, and 26.80, respectively. A total of 77.3% of patients were found to be receiving DA Q2W at the end of the study (12 months).

From the above results, it can be concluded that Hb concentrations can be effectively maintained over 12 months in dialysis patients without the need for an increase in the Erythropoiesis-stimulating agents (ESAs) dose.