The Effect Of Roxadustat On Anemia In Patients With Diabetic Kidney Disease

Background:Renal anemia secondary to diabetic kidney disease(DKD)is earlier and graver than that in other chronic kidney disease,Increasing the risk of kidney injury and cardiovascular events.The traditional drug EPO has disadvantages such as erythropoietin hypo-responsiveness,and will increase the risk of hypertension and thromboembolism.roxadustat is an oral drug for the treatment of renal anemia,which can induce the physiological adaptive response to hypoxia,comprehensive regulate erythropoiesis by multiple targets.The efficacy and safety of Roxadustat in DKD patients has been partially proved in previous study as a subgroup.However,no specific study in this population has been carried out yet.Objective:To evaluate the effect of Roxadustat on renal anemia caused by DKD.Methods:In the first part,we conducted a retrospective study.Patients diagnosed as DKD renal anemia were included in this study.There were a total of 61 patients treated with roxadustat,so we randomly included in 61 patients treated by EPO.We evaluated the efficacy by comparing the difference in blood routine between the two groups before and after 3months’ treatment.Logistic regression analysis and least squares principle were used to compare the efficacy of roxadustat with EPO,and subgroup analysis was conducted to explore whether the efficacy was affected by baseline i PTH,CRP,ALB level and DKD stage.In the second part,we conducted a prospective study and enroll 12non-dialysis DKD patients with anemia.Efficacy and safety of all subjects are assessed at week 0,2,4,8,12.The laboratory variables include blood routine,UACR,iron metabolic parameters,Hb A1 C,LDL,Potassium,Creatine kinase,liver and renal function.Results:Part one:1.After 3 months’ of treatment,Hb and Hct in both groups were significantly higher than before.Response rate of Hb,ΔHb,ΔHct and Hb in roxadustat group were significantly higher than EPO group.After adjusting confounding factors,Hb response rate in roxadustat group was 3.3 times higher than EPO group(P=0.0251).The difference in ΔHb LSM Changes was(-2.4,12.1),indicating the noninferiority of roxadustat to EPO.2.Subgroup analysis results show there was no difference between the two groups in normal CRP,i PTH,ALB,DKD G3-4 subgroup.While in high CRP,i PTH,low ALB,DKD G5 subgroups,indicators such as ΔHb in roxadustat group were significantly higher than EPO group.Part two:1.Hb,Hct and RBC increased significantly with the prolongation of treatment time.Hb response and compliance rate were on the rise.2.After 12 weeks’ treatment,TIBC increased significantly and ferritin decreased significantly,while other variables had no significant changes.3.After 12 weeks’ treatment,LDL-C decreased(P=0.054);4.We found 5 cases with hyperkalemia,5 cases with increased blood pressure.After 2 weeks’ treatment,potassium and calcium levels were significantly higher than baseline,while other variables had no significant change.Conclusion:1.Roxadustat can effectively correct anemia in patients with diabetic kidney disease and the efficacy is slightly better than EPO.2.The effect of roxadustat on anemia in patients with diabetic kidney disease is not affected by inflammatory status,parathyroid function,nutritional status and DKD stage.3.Roxadustat is safe and well toleranced.In addition,it can improve iron metabolism and lipid metabolism.