Clinical Comprehensive Evaluation Of Roxadustat In The Treatment Of Renal Anemia

Objective: To comprehensively evaluate the safety,effectiveness,economy and innovation of roxadustat in the treatment of renal anemia,and to provide reference for national and regional medical institutions to use roxadustat in the treatment of renal anemia.Methods: Literature review,retrospective cohort study and pharmacoeconomic model were used to compare the safety,efficacy,economics,and innovation of the placebo and erythropoiesis-stimulating agents（ESA）in the treatment of renal anemia.Results:1.Safety and effectiveness evaluation-literature review: a total of 1 300 literatures were obtained after preliminary retrieval,and 16 literatures were finally included,including 14 meta-analyses,including 9 English literatures,5 Chinese literatures and 2 randomized controlled studies.Efficacy evaluation results:（1）effect on hemoglobin（Hb）levels: Compared with placebo or ESA,roxadustat significantly increased Hb levels in patients with non-dialysis-dependent chronic kidney disease（NDD-CKD）compared with placebo and ESA,and was no less effective than ESA in correcting anemia in patients with dialysis-dependent chronic kidney disease（DD-CKD）.（2）Effects on iron metabolism indexes: For NDD-CKD patients,roxadustat decreased Hepcidin（Hepc）,ferritin（SF）levels,transferrin saturation（TSAT）,and increased transferrin（TRF）and total ferritin binding force（TIBC）levels,but had no significant difference in serum iron（SI）level.For DD-CKD patients,roxadustat reduced the level of Hepc and SI higher than that of ESA,but decreased the level of SF without significant difference,and increased the level of TIBC higher than that of ESA.（3）The effect on cholesterol level.Compared with ESA,roxadustat can reduce LDL level in DD-CKD patients.The safety evaluation showed that there is no significant difference in the incidence of adverse events beteated with placebo and ESA.However,the serious adverse events was higher in the roxadustat group compared with placebo and ESA.2.Safety and efficacy evaluation-retrospective analysis: Retrospective analysis showed that the total effective rate of roxadustat group was higher than that of ESA group（P<0.05）,and there was no statistical significance in the incidence of adverse reactions between the two groups（P>0.05）.3.Economic evaluation:The cumulative cost of roxadustat treatment group was44 940.33 yuan,and the cumulative cost of ESA group was 18 732.60 yuan,9.51 QALYs for roxadustat patients,9.38 QALYs for ESA patients,and 201 597.92 yuan /QALY for incremental cost-effectiveness ratio（ICER）.4.Innovation evaluation: The mechanism of action and administration of roxadustat in the treatment of renal anemia were different from that of ESA.Conclusions:1.Compared with placebo and ESA,roxadustat had better safety and efficacy.2.In China’s current economic situation,compared with ESA and placebo,roxadustat had a cost-utility advantage in the treatment of patients with renal anemia.3.Roxadustat was innovative in its mechanism of action and in optimizing delivery.