Efficacy and safety of roxadustat for the treatment of renal anemia in patients undergoing peritoneal dialysis: a systematic review and meta-analysis.
TL;DR
Evidence concerning hemoglobin target attainment, high-density lipoprotein cholesterol, and long-term safety remains insufficient, and comparative clinical superiority of roxadustat-based over ESA-based strategies in PD is insufficient.
Abstract
Renal anemia is a prevalent complication in patients undergoing peritoneal dialysis (PD). Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, but comparisons with erythropoiesis-stimulating agents (ESAs) require consideration of the specific regimens used. We systematically searched PubMed, Embase, the Cochrane Library, Web of Science, CNKI, Wanfang, VIP, and SinoMed from inception to December 2025 for randomized controlled studies comparing roxadustat-based regimens with ESA-based regimens in adults receiving PD. Eligible evidence was restricted to PD-only randomized studies after rechecking dialysis modality and study design. Nineteen studies involving 1,636 participants were included. The average post-treatment hemoglobin level was higher in the roxadustat-based groups than in the study-specific ESA comparator groups (mean difference = 7.30 g/L, 95% CI: 5.43 to 9.16; I2 = 62.6%). However, hemoglobin target-attainment data were not defined or reported consistently enough for quantitative synthesis. Post-treatment hematocrit and red blood cell count also differed between groups, with substantial heterogeneity. The pooled reported adverse-event rate yielded an RR of 0.45 (95% CI: 0.27 to 0.74), but definitions and ascertainment were not standardized. Effects on iron indices, inflammatory markers, lipid indices, and cardiovascular outcomes were exploratory. Grading of Recommendations Assessment, Development and Evaluation certainty was low for hemoglobin and low to very low for most secondary outcomes. Available evidence is insufficient to determine the comparative clinical superiority of roxadustat-based over ESA-based strategies in PD because final values were pooled and comparator regimens were heterogeneous. Evidence concerning hemoglobin target attainment, high-density lipoprotein cholesterol, and long-term safety remains insufficient.