Darbepoetin alfa 150micrograms/0.3ml solution for injection pre-filled syringes

ObjectivesTo compare the efficacy and safety of daprodustat (DPD) versus darbepoetin alfa (DBPA) in patients with anemia in chronic renal failure.Materials and methodsRandomized controlled trials (RCTs) of DPD and DBPA in anemia were retrieved from PubMed, Embase, Cochrane library, and Web of Science from inception to August 1, 2023. The collected data were analyzed using Stata 15.0.ResultsFour RCTs involving 7419 patients (3717 in the DPD group and 3702 in the DBPA group) were included in the study. Meta-analysis revealed that there were no significant differences in the change in hemoglobin level [Standardized Mean Difference (SMD) = 3.23, 95 % CI (-0.25, 6.70)], transferrin saturation [SMD = -0.07, 95 % CI (-0.31, 0.17)], total iron [SMD = 0.24, 95 % CI (-0.05, 0.53))], and incidence of adverse events [ RR = 1.02, 95 % CI (0.98, 1.06)] between the two groups. However, DPD was superior in lowering ferritin level [SMD = -0.05, 95 % CI (-0.10, -0.01)] and improving total iron-binding capacity [SMD = 0.57, 95 % CI (0.46, 0.68)] than DBPA.ConclusionsDPD is not inferior to DBPA in the treatment of anemia in chronic renal failure.

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Rationale & objectiveIn the PRO2TECT trials, vadadustat was found to be noninferior to darbepoetin alfa in hematologic efficacy but not for major adverse cardiovascular events (MACE; all-cause death or nonfatal myocardial infarction or stroke) in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD). We investigated the regional differences in MACE in the PRO2TECT trials.Study designPhase 3, global, open-label, randomized, active-controlled clinical trial.Setting & participantsA total of 1,725 erythropoiesis-stimulating agent (ESA)-treated patients with anemia and NDD-CKD.Intervention1:1 randomization to receive vadadustat or darbepoetin alfa.OutcomesThe primary safety end point was the time to first MACE.ResultsAt baseline, patients in Europe (n=444) were primarily treated with darbepoetin alfa, showed higher proportions on low ESA doses (P = 0.07). In Europe, ESA rescue was associated with a higher risk of MACE in both groups.LimitationsSeveral analyses are exploratory.ConclusionsIn this trial, there was a low risk of MACE in the darbepoetin alfa group in Europe. Patients in Europe were generally on low doses of ESA, with hemoglobin already within target range. The low risk of MACE may have been related to a limited need to switch and titrate darbepoetin alfa compared with the non-US/non-Europe group.FundingAkebia Therapeutics, Inc.Trial registrationClinicalTrials.gov identifier: NCT02680574.

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[This corrects the article DOI: 10.1002/cdt3.23.].

Abstract licence: CC BY