OBJECTIVES

: Patients with anemia of CKD are at increased risk of major adverse cardiovascular events (MACE), which have been associated with significant costs and loss of quality of life. Higher hemoglobin levels in the CKD population have been associated with improved outcomes and decreased costs. Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates a coordinated erythropoietic response that includes the increase of plasma endogenous erythropoietin levels and reduction of hepcidin.

METHODS

: In the global roxadustat phase 3 program, MACE was a composite endpoint defined as myocardial infarction (MI), stroke, and all-cause mortality. MACE-plus included the 3 MACE components as well as hospitalized congestive heart failure (CHF) and hospitalized unstable angina. Data from three pivotal, randomized studies were pooled to compare roxadustat to epoetin alfa in patients with dialysis-dependent chronic kidney disease (DD CKD). Patients who were on dialysis for less than 4 months were part of the incident dialysis (ID) population. Costs of MACE and MACE-plus were estimated using data from the 2016 Healthcare Cost and Utilization Project and the literature. Costs were translated to 2020 dollars using the Consumer Price Index inflation calculator. ICD-10 codes were used to identify MACE and MACE-plus events.

RESULTS

: The average cost per episode of MI, stroke, CHF, unstable angina, and mortality were $24,030, $18,674, $14,358, $8,224, and $52,297, respectively. In the ID CKD study population, MACE and MACE-plus rates in the roxadustat as compared to epoetin alfa arms were HR=0.70; 95% CI: 0.51, 0.96; and HR=0.66; 95% CI: 0.50, 0.89. In the DD CKD study population, MACE rates in the roxadustat arm were non-inferior to epoetin alfa (HR=0.96; 95% CI: 0.82, 1.13) and lower for MACE-plus (HR=0.86; 95% CI: 0.74, 0.98).

CONCLUSIONS

: Anemia management in CKD may reduce cardiovascular event rates and subsequently lower associated costs and healthcare resource utilization.