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CKD Screening in Type 2 DM When, Why, and How? by Dr. Jay Singh Arora

Discussion about role of DPO in Anemia management

22 Aug 2024
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CKD Screening in Type 2 DM When, Why, and How? by Dr. Isha Tiwari Arora

Discussion about role of DPO in Anemia management

22 Aug 2024
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Anemia in CKD by Dr. Gaurav Singla

Discussion about role of DPO in Anemia management

22 Aug 2024
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Medshorts

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2Min Read

Efficacy of darbepoetin alfa administered subcutaneously every other week in maintaining hemoglobin in Chronic Kidney Disease

According to a recent study, chronic kidney disease patients who received once-weekly (QW) recombinant human erythropoietin (rHuEPO), effectively converted to darbepoetin alfa administered subcutaneously every other week (Q2W), which was well tolerated. This study was published in the American Journal of Nephrology .

The STAAR (Simplify the Treatment of Anemia with Aranesp) was a multicenter, 52-week study that enrolled 524 subjects. The subgroup analysis of subjects who were on QW rHuEPO, were converted to 52-weeks of darbepoetin alfa therapy, administered subcutaneously. These subjects had either creatinine clearance < or = 70 ml/min or transferrin saturation > or = 20% and an estimated glomerular filtration rate < or = 60 ml/min. The primary endpoint of the study was mean Hb during evaluation.

It was found that the mean Hb +/- standard deviation was 11.2 +/- 1.27 g/dl at baseline while the least squares mean +/- SE was 11.4 +/- 0.04 during evaluation. Also, the mean +/- SD Q2W darbepoetin alfa dose was 49.7 +/- 21.9 microg and 48.9 +/- 35.5 microg at baseline and evaluation, respectively.

From the above results, it can be concluded that darbepoetin alfa was well tolerated in subjects who had chronic kidney disease, who were receiving QW rHuEPO and were effectively converted to Q2W darbepoetin alfa.

04 Jan 2024

Efficacy of darbepoetin alfa administered subcutaneously every other week in maintaining hemoglobin in Chronic Kidney Disease

According to a recent study, chronic kidney disease patients who received once-weekly (QW) recombinant human erythropoietin (rHuEPO), effectively converted to darbepoetin alfa administered subcutaneously every other week (Q2W), which was well tolerated. This study was published in the American Journal of Nephrology .

The STAAR (Simplify the Treatment of Anemia with Aranesp) was a multicenter, 52-week study that enrolled 524 subjects. The subgroup analysis of subjects who were on QW rHuEPO, were converted to 52-weeks of darbepoetin alfa therapy, administered subcutaneously. These subjects had either creatinine clearance < or = 70 ml/min or transferrin saturation > or = 20% and an estimated glomerular filtration rate < or = 60 ml/min. The primary endpoint of the study was mean Hb during evaluation.

It was found that the mean Hb +/- standard deviation was 11.2 +/- 1.27 g/dl at baseline while the least squares mean +/- SE was 11.4 +/- 0.04 during evaluation. Also, the mean +/- SD Q2W darbepoetin alfa dose was 49.7 +/- 21.9 microg and 48.9 +/- 35.5 microg at baseline and evaluation, respectively.

From the above results, it can be concluded that darbepoetin alfa was well tolerated in subjects who had chronic kidney disease, who were receiving QW rHuEPO and were effectively converted to Q2W darbepoetin alfa.

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Efficacy of darbepoetin alfa administered subcutaneously every other week in maintaining hemoglobin in Chronic Kidney Disease

According to a recent study, chronic kidney disease patients who received once-weekly (QW) recombinant human erythropoietin (rHuEPO), effectively converted to darbepoetin alfa administered subcutaneously every other week (Q2W), which was well tolerated. This study was published in the American Journal of Nephrology .

The STAAR (Simplify the Treatment of Anemia with Aranesp) was a multicenter, 52-week study that enrolled 524 subjects. The subgroup analysis of subjects who were on QW rHuEPO, were converted to 52-weeks of darbepoetin alfa therapy, administered subcutaneously. These subjects had either creatinine clearance < or = 70 ml/min or transferrin saturation > or = 20% and an estimated glomerular filtration rate < or = 60 ml/min. The primary endpoint of the study was mean Hb during evaluation.

It was found that the mean Hb +/- standard deviation was 11.2 +/- 1.27 g/dl at baseline while the least squares mean +/- SE was 11.4 +/- 0.04 during evaluation. Also, the mean +/- SD Q2W darbepoetin alfa dose was 49.7 +/- 21.9 microg and 48.9 +/- 35.5 microg at baseline and evaluation, respectively.

From the above results, it can be concluded that darbepoetin alfa was well tolerated in subjects who had chronic kidney disease, who were receiving QW rHuEPO and were effectively converted to Q2W darbepoetin alfa.

04 Jan 2024
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2Min Read

Dose reduction conversion from epoetin to darbepoetin alfa in patients undergoing dialysis

According to a recent study conducted in patients undergoing dialysis, a dose reduction conversion from epoetin to darbepoetin alfa using the starting dose conversion of 200:1, helped achieve a 30% dose savings. This study was published in the journal, NDT Plus.

This meta-analysis was done after sourcing articles from Medline and EmBase in order to find out all published trials investigating Erythropoiesis-stimulating agents (ESAs) for treatment in anaemic patients receiving dialysis. Prospective randomized controlled, non-randomized and observational studies that included patients on dialysis and which compared epoetin and darbepoetin alfa dosing were selected. Out of 573 articles, 9 studies fulfilled the eligibility criteria and were included in the analysis. Target haemoglobin levels were maintained before and after conversion in all the studies.

From the meta-analysis, it was found out that overall percentage dose savings attained was 30% when dialysis patients were converted from epoetin to darbepoetin alfa. Intravenous administration (33%) showed greater dose savings when compared to subcutaneous (27%) and between switch-over studies (31%) and RCTs (27%).

Based on the findings, it can be concluded that using an initial 200:1 conversion ratio, as indicated by the European Medicines Agency, after conversion from epoetin to darbepoetin alfa, an average 30% dose savings could be achieved through subsequent reduction in dose.

02 Jan 2024

Dose reduction conversion from epoetin to darbepoetin alfa in patients undergoing dialysis

According to a recent study conducted in patients undergoing dialysis, a dose reduction conversion from epoetin to darbepoetin alfa using the starting dose conversion of 200:1, helped achieve a 30% dose savings. This study was published in the journal, NDT Plus.

This meta-analysis was done after sourcing articles from Medline and EmBase in order to find out all published trials investigating Erythropoiesis-stimulating agents (ESAs) for treatment in anaemic patients receiving dialysis. Prospective randomized controlled, non-randomized and observational studies that included patients on dialysis and which compared epoetin and darbepoetin alfa dosing were selected. Out of 573 articles, 9 studies fulfilled the eligibility criteria and were included in the analysis. Target haemoglobin levels were maintained before and after conversion in all the studies.

From the meta-analysis, it was found out that overall percentage dose savings attained was 30% when dialysis patients were converted from epoetin to darbepoetin alfa. Intravenous administration (33%) showed greater dose savings when compared to subcutaneous (27%) and between switch-over studies (31%) and RCTs (27%).

Based on the findings, it can be concluded that using an initial 200:1 conversion ratio, as indicated by the European Medicines Agency, after conversion from epoetin to darbepoetin alfa, an average 30% dose savings could be achieved through subsequent reduction in dose.

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Dose reduction conversion from epoetin to darbepoetin alfa in patients undergoing dialysis

According to a recent study conducted in patients undergoing dialysis, a dose reduction conversion from epoetin to darbepoetin alfa using the starting dose conversion of 200:1, helped achieve a 30% dose savings. This study was published in the journal, NDT Plus.

This meta-analysis was done after sourcing articles from Medline and EmBase in order to find out all published trials investigating Erythropoiesis-stimulating agents (ESAs) for treatment in anaemic patients receiving dialysis. Prospective randomized controlled, non-randomized and observational studies that included patients on dialysis and which compared epoetin and darbepoetin alfa dosing were selected. Out of 573 articles, 9 studies fulfilled the eligibility criteria and were included in the analysis. Target haemoglobin levels were maintained before and after conversion in all the studies.

From the meta-analysis, it was found out that overall percentage dose savings attained was 30% when dialysis patients were converted from epoetin to darbepoetin alfa. Intravenous administration (33%) showed greater dose savings when compared to subcutaneous (27%) and between switch-over studies (31%) and RCTs (27%).

Based on the findings, it can be concluded that using an initial 200:1 conversion ratio, as indicated by the European Medicines Agency, after conversion from epoetin to darbepoetin alfa, an average 30% dose savings could be achieved through subsequent reduction in dose.

02 Jan 2024
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1Min Read

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.

28 Dec 2024

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.

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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.

28 Dec 2024
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2Min Read

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.

27 Dec 2024

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.

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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.

27 Dec 2024
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