Kidney diseases (Basel, Switzerland) · 2025
Comparative Effectiveness and Safety of Roxadustat versus Erythropoiesis-Stimulating Agents in Patients Receiving Maintenance Hemodialysis: A Real-World Cohort Study.
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Zhang Zhixi, Liu Jing, Kang Yingxi, Liu Ying, Fu Ping
Аннотация
INTRODUCTION: Renal anemia, a common complication of chronic kidney disease (CKD), is traditionally managed with erythropoiesis-stimulating agents (ESAs), which carry cardiovascular risks. Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, offers a novel mechanism by enhancing erythropoietin production and iron metabolism. While randomized controlled trials demonstrate its efficacy, real-world data on long-term safety and effectiveness remain limited.
METHODS: This retrospective study analyzed 6,414 hemodialysis patients with renal anemia from a single center (December 2018-December 2023), comparing roxadustat (n = 3,184) and ESA (n = 3,230) groups. Propensity score matching was used to balance the baseline characteristics. Efficacy outcomes included hemoglobin (Hb) changes (baseline to months 6-12 and 18-30) and Hb response rates. Safety endpoints assessed major adverse cardiovascular events (MACE), heart failure hospitalization (HHF), thromboembolism, and all-cause mortality. Sensitivity analyses addressed treatment crossover and confounding.
RESULTS: Roxadustat showed significantly greater Hb increases versus ESA at 6-12 months (least-squares mean difference: 0.46 g/dL, p = 0.04) and 18-30 months (0.26 g/dL, p = 0.01). Hb response rates were higher with roxadustat (84.0% vs. 76%, p < 0.01). No significant differences were observed in MACE (HR: 1.08, p = 0.12), HHF (HR: 0.88, p = 0.25), thromboembolism (HR: 1.05, p = 0.34), or mortality (HR: 0.94, p = 0.29). Subgroup analyses suggested that roxadustat elevated MACE risk in patients with baseline hypertension or cardiovascular history, but sensitivity analyses nullified this association.
CONCLUSION: Roxadustat demonstrated superior efficacy in elevating and sustaining Hb levels compared to ESA over a longer observation period, with comparable cardiovascular safety in hemodialysis-dependent CKD patients. Roxadustat represents a viable alternative to ESA for renal anemia management, though long-term multicenter studies are needed to validate safety and optimize clinical use.
METHODS: This retrospective study analyzed 6,414 hemodialysis patients with renal anemia from a single center (December 2018-December 2023), comparing roxadustat (n = 3,184) and ESA (n = 3,230) groups. Propensity score matching was used to balance the baseline characteristics. Efficacy outcomes included hemoglobin (Hb) changes (baseline to months 6-12 and 18-30) and Hb response rates. Safety endpoints assessed major adverse cardiovascular events (MACE), heart failure hospitalization (HHF), thromboembolism, and all-cause mortality. Sensitivity analyses addressed treatment crossover and confounding.
RESULTS: Roxadustat showed significantly greater Hb increases versus ESA at 6-12 months (least-squares mean difference: 0.46 g/dL, p = 0.04) and 18-30 months (0.26 g/dL, p = 0.01). Hb response rates were higher with roxadustat (84.0% vs. 76%, p < 0.01). No significant differences were observed in MACE (HR: 1.08, p = 0.12), HHF (HR: 0.88, p = 0.25), thromboembolism (HR: 1.05, p = 0.34), or mortality (HR: 0.94, p = 0.29). Subgroup analyses suggested that roxadustat elevated MACE risk in patients with baseline hypertension or cardiovascular history, but sensitivity analyses nullified this association.
CONCLUSION: Roxadustat demonstrated superior efficacy in elevating and sustaining Hb levels compared to ESA over a longer observation period, with comparable cardiovascular safety in hemodialysis-dependent CKD patients. Roxadustat represents a viable alternative to ESA for renal anemia management, though long-term multicenter studies are needed to validate safety and optimize clinical use.