Effectiveness and safety of roxadustat in the treatment of anemia of kidney disease: a systematic review and meta-analysis.

Background: Chronic kidney disease is a global public health problem, anemia is the most common complication of chronic kidney disease. Roxadustat is a new drug that can be used to treat renal anemia by oral administration.

Methods: We conducted a comprehensive computerized search of the China Knowledge Network (CNKI), VIP (VIP), Wanfang, China Biomedical (CBM), PubMed, Embase, and the Cochrane Library databases. We collected clinical randomized controlled trials (RCTs) published on roxadustat in the treatment of anemia of kidney disease. According to the inclusion and exclusion criteria, the included studies were subject to screening and quality evaluation, and RevMan 5.3 software was used for meta-analysis.

Results: A total of 7 RCTs involving 997 patients with anemia of kidney disease were included. The results of meta-analysis showed that compared with the treatment effect of the erythropoietin (EPO) group, in the roxadustat group there were significant increases in the amount of hemoglobin [mean difference (MD) =11.70, 95% confidence interval (CI): 0.41 to 22.99, P=0.04], hemoglobin overall response rate [odds ratio (OR) =1.97, 95% CI: 1.7 to 3.33, P=0.01], serum iron [standardized mean difference (SMD) =0.39, 95% CI: 0.23 to 0.55, P<0.00001], transferrin saturation (MD =6.09, 95% CI: 5.36 to 6.82, P<0.0001), transferrin (MD =0.36, 95% CI: 0.28 to 0.44, P<0.00001], total iron binding capacity (SMD =0.63, 95% CI: 0.47 to 0.79, P<0.00001) and significantly reduced hepcidin (MD =-29.04, 95% CI: -51.61 to -6.47, P=0.01). There was no significant difference in adverse reactions between groups (OR =1.06, 95% CI: 0.30 to 3.74, P=0.93).

Discussion: Roxadustat can effectively improve the anemia status of patients with CKD without increasing adverse reactions. Due to limitations of the number and quality of the included studies, further verification is required through the multi-center, large sample-sized, and high-quality RCTs in the future.