Daprodustat noninferior to darbepoetin alfa for anemia in CKD patients on dialysis: JAMA
USA: Results from a recent study in JAMA Internal Medicine show that daprodustat is noninferior to darbepoetin alfa for treating anemia of chronic kidney disease (CKD) in incident dialysis (ID) patients. Based on this, the authors suggest that daprodustat may represent an oral alternative to a conventional erythropoiesis-stimulating agent in ID patients.
Daprodustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor. It is being evaluated as an oral alternative to conventional erythropoiesis-stimulating agent (ESA) therapy. However, not many studies of anemia treatment in an ID population have been reported. Considering this, Ajay K. Singh, Brigham and Women's Hospital, Boston, Massachusetts, and colleagues aimed to evaluate the safety and efficacy of daprodustat vs darbepoetin alfa in treating anemia of CKD in ID patients in a prospective, randomized, open-label clinical trial.
The trial was conducted from May 11, 2017, through September 24, 2020, in 90 centers across 14 countries. Eligibility criteria were patients with advanced CKD if they planned to start dialysis within 6 weeks from screening or had started and received hemodialysis (HD) or peritoneal dialysis (PD) within 90 days before randomization, had screening hemoglobin (Hb) concentration of 8.0 to 10.5 g/dL (to convert to grams per liter, multiply by 10) and a randomization Hb of 8.0 to 11.0 g/dL, were ESA-naive or had received limited ESA treatment, and were iron-replete.
Patients were randomized in a ratio of 1:1 to receive daprodustat or darbepoetin alfa. The mean change in Hb concentration from baseline to evaluation period (weeks 28-52) was evaluated in the primary analysis in the intent-to-treat population to assess the noninferiority of daprodustat vs darbepoetin alfa. The principal secondary endpoint was the mean monthly intravenous (IV) iron dose from baseline to week 52. A comparison was made between rates of treatment-emergent and serious adverse events (AEs) among treatment groups to assess safety and tolerability.
The study included a total of 312 patients (median age, 55 years; 62% were male). They were randomized to receive either (157 patients; median age, 52.0 years; 61% male) or darbepoetin alfa (155 patients; median age, 56.0 years; 63% male). The trial was completed by 306 patients (98%).
Based on the study, the researchers reported the following findings:
- The mean Hb concentration during the evaluation period was 10.5 g/dL for the daprodustat and 10.6 g/dL for the darbepoetin alfa group, with an adjusted mean treatment difference of −0.10 g/dL, indicating noninferiority.
- There was a reduction in mean monthly IV iron use from baseline to week 52 in both treatment groups; however, daprodustat was not superior compared with darbepoetin alfa in reducing monthly IV iron use (adjusted mean treatment difference, 19.4 mg).
- Adverse event rates were 76% for daprodustat vs 72% for darbepoetin alfa.
"The findings showed that daprodustat is noninferior to darbepoetin alfa in treating anemia of CKD and may represent a potential oral alternative to a conventional ESA in the ID population," the authors wrote in their study.
Reference:
Singh AK, Cizman B, Carroll K, et al. Efficacy and Safety of Daprodustat for Treatment of Anemia of Chronic Kidney Disease in Incident Dialysis Patients: A Randomized Clinical Trial. JAMA Intern Med. Published online April 04, 2022. doi:10.1001/jamainternmed.2022.0605
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