A recent study found that darbepoetin alfa dosed every-other-week (Q2W) is safe and efficacious in treating anemia in chronic kidney disease patients. This study was published in the journal, Current medical research and opinion.

This open-label, multicenter, single-arm study included 128 subjects with ESA-naïve chronic kidney disease (CKD), with baseline hemoglobin (Hb) < 11.0 g/dL. Darbepoetin alfa was dosed every-other-week at an initial dose of 0.75 microg/kg and titrated to achieve and maintain Hb levels at 11.0-13.0 g/dL. Treatment was given from week 1 to week 19. The primary endpoint of the study was the proportion of subjects who achieved Hb > or = 11 g/dL at any study visit, with the exception of week 1.

Out of 128 subjects, 118 received at least one dose of darbepoetin alfa and 112 of the subjects completed the study, achieved a Hb > or = 11 g/dL in a median time of 5 weeks. The median dose of darbepoetin alfa was 60 microg at week 1 and 80 microg at the time of Hb > or = 11 g/dL.

From the above results, it can be concluded that de novo Q2W darbepoetin alfa was well-tolerated and effective in correcting and maintaining Hb levels in ESA-naïve subjects with CKD who were not undergoing dialysis.

A recent study suggests that darbepoetin-α (DPO-α) is more advantageous than recombinant human erythropoietin (rHuEPO) in improving anemia in hemodialysis (HD) patients. This study was published in the European Journal of Haematology.

This study included a long-term crossover study for 3 years to compare the effects of the two erythropoiesis-stimulating agents (ESA) on serum iron, transferrin saturation (TSAT), and ferritin, as well as a short-term crossover study for 8 weeks to examine their effects on serum hepcidin-25 in HD patients.

From the long-term crossover study, it was demonstrated that the change of ESA from rHuEPO to DPO-α significantly decreased serum ferritin while serum iron and TSAT remained unchanged. On the other hand, DPO-α as well as rHuEPO maintained hemoglobin levels between 10.0 and 11.0 g/dL, which was the target range. In the short-term crossover study, area under the percent suppression of serum hepcidin-25 time curve for the first 7 days during the DPO-α treatment period was significantly greater than that during the rHuEPO period. Also, the greater suppression of hepcidin-25 by DPO-α may facilitate iron mobilization, resulting in a diminution of body iron stores without any significant effect on serum iron utilizable for erythropoiesis.

From the above results, it can be concluded that DPO-α has a greater advantage than rHuEPO in that it facilitates iron mobilization from body stores into the bone marrow to induce effective erythropoiesis.

A recent study suggests that darbepoetin alfa (DA) acts as an effective treatment for anaemia in chronic kidney disease (CKD) patients not on dialysis (NoD) when administered once biweekly (Q2W) or weekly (QM). The results of this study were published in the journal, Nephrology, dialysis, transplantation.

The EXTEND study was an observational cohort study of extended dosing regimens of DA that included data obtained from 4278 patients. Data included haemoglobin levels and erythropoiesis-stimulating agent (ESA) dosing that were collected 6 months before and 12 months after DA initiation.

At the end of the study, it was seen that patients receiving ESA treatment before DA Q2W/QM initiation had a mean Hb level of 11.9 g/dL at initiation and 11.6 g/dL at Months 10-12. The mean ESA dose was 22 μg/week before initiation, 16 μg/week at initiation and 16 μg/week at Month 12. Hb levels increased from 10.3 g/dL at initiation to 11.7 g/dL at Months 4-6 in ESA-naive patients. The Hb levels were maintained at a mean level of 11.7 g/dL at Months 10-12, with mean ESA dose of 16 μg/week at initiation and 16 μg/week at Month 12.

From the above results, it can be concluded that DA Q2W/QM may be an effective treatment of anaemia in the general CKD-NoD patient population, without the need for a dose increase in patients switching from a previous ESA regimen.

A recent study suggests the effect of switching from erythropoiesis-stimulating agent (ESA) treatment from darbepoetin alfa (DA) to methoxy polyethylene glycol-epoetin beta (PEG-Epo) in treating anemia associated with chronic kidney disease (CKD). This study was published in the journal, Advances in Therapy.

The AFFIRM study was a retrospective, multi-site, observational study that included 206 patients who had received hemodialysis for ≥ 12 months and DA for ≥ 7 months. The dose conversion ratio (DCR) was calculated for patients with hemoglobin level (Hb) and ESA data for the pre-switch evaluation period (months 1 and 2) and post-switch EP (months 6 and 7). Red blood cell transfusions during both evaluation periods were noted.

The results showed a geometric mean DCR of 1.17. DCR showed a decrease with increasing pre-switch DA dose. The geometric mean weekly ESA doses in the pre-switch and post-switch EP were 24.1 μg DA and 28.6 μg PEG-Epo, respectively. Mean Hb in the pre-switch EP and post-switch EP were found to be 11.5 g/dL and 11.4 g/dL, respectively. Overall, 16 transfusions and 34 units were transfused in the pre-switch EP whereas 48 transfusions and 95 units were transfused in the post-switch EP.

It may be concluded that in hemodialysis patients switched from DA to PEG-Epo, the DCR was 1.17 and 1.21. Thus, the number of transfusions and units transfused increased three-fold times from the pre to post-switch period.