The efficacy and safety of roxadustat for anemia in patients with chronic kidney disease: a meta-analysis

被引:28
作者
Zheng, Qiyan [1 ,2 ,3 ]
Yang, Huisheng [4 ]
Fu, Xinwen [1 ,2 ,3 ]
Huang, Yishan [1 ,2 ,3 ]
Wei, Ruojun [1 ,2 ]
Wang, Yahui [1 ,2 ,3 ]
Liu, Yu Ning [1 ,2 ,3 ]
Liu, Wei Jing [1 ,3 ,5 ]
机构
[1] Beijing Univ Chinese Med, Key Lab Chinese Internal Med, Dongzhimen Hosp Affiliated, Minist Educ & Beijin, Beijing, Peoples R China
[2] Beijing Univ Chinese Med, Renal Res Inst, Beijing, Peoples R China
[3] Beijing Univ Chinese Med, Dongzhimen Hosp, Dept Endocrinol Nephropathy, Beijing, Peoples R China
[4] China Acad Chinese Med Sci, Inst Acupuncture & Moxibust, Beijing, Peoples R China
[5] Guangdong Med Univ, Zhanjiang Key Lab Prevent & Management Chron Kidn, Zhanjiang, Peoples R China
基金
中国国家自然科学基金;
关键词
anemia; chronic kidney disease; meta-analysis; roxadustat; EPOETIN-ALPHA; IRON-METABOLISM; HYPOXIA; FG-4592; HEPCIDIN; LEVEL; ERYTHROPOIETIN; REGULATOR; PHASE-2; TRIAL;
D O I
10.1093/ndt/gfaa110
中图分类号
R3 [基础医学]; R4 [临床医学];
学科分类号
1001 ; 1002 ; 100602 ;
摘要
Background. Chronic kidney disease (CKD) is an increasing public health issue. Anemia, which is a complication of CKD, is associated with reduced quality of life and increased morbidity and mortality. Currently quite a few clinical studies have been conducted to compare roxadustat with epoetin alfa [all for dialysis-dependent (DD) patients] or placebo [all for nondialysis-dependent (NDD) patients]. Our meta-analysis aimed to investigate the efficacy and safety of roxadustat for anemia in patients with CKD. Methods. We thoroughly searched eight electronic resource databases for randomized controlled trials (RCTs) comparing the efficacy and safety between roxadustat versus epoetin alfa or placebo for the treatment of anemia in patients with CKD. Results. Four Phase 2 and two Phase 3 studies with 1010 participants were included. Hemoglobin (Hb) and transferrin levels were increased significantly in the roxadustat group versus those in the placebo {standard mean difference [SMD] 1.57 [95% confidence interval (CI) 1.17-1.98]; SMD 1.81 [95% CI 1.53-2.08]; respectively, both low-quality evidence} or epoetin alfa group [SMD 0.47 (95% CI 0.02-0.93), very low-quality evidence; SMD 1.05 (95% CI 0.81-1.29), low-quality evidence; respectively]. Hepcidin levels were reduced significantly in the roxadustat group versus those in the placebo [SMD -1.72 (95% CI -3.03 to -0.41), very low-quality evidence] or epoetin alfa group [SMD -0.23 (95% CI -0.43 to -0.02), low-quality evidence]. Ferritin and serum transferrin saturation (TSAT) levels were reduced significantly in the roxadustat group versus those in the placebo group [SMD -0.82 (95% CI -1.31 to -0.33); SMD -0.54 (95% CI -0.76 to -0.32), respectively; both low-quality evidence] and ferritin and TSAT levels in the roxadustat group were comparable to those in the epoetin alfa group [SMD 0.02 (95% CI -0.18-0.21); SMD 0.15 (95% CI -0.04-0.35), respectively, both low-quality evidence]. As for safety, the incidence of adverse events (AEs) in the roxadustat group was insignificantly different from that of the placebo group [risk ratio (RR)0.99 (95% CI 0.83-1.18); P=0.89, very low-quality evidence]. But the incidence of AEs in the roxadustat group was significantly higher than that in the epoetin alfa group [RR1.25 (95% CI 1.01-1.54); P=0.04, low-quality evidence]. There was no significant association between roxadustat and the incidence of serious AEs (SAEs) for both NDD and DD patients [RR1.08 (95% CI 0.51-2.28) and RR1.43 (95% CI 0.85-2.40), respectively, both very low-quality evidence]. Conclusion. In this meta-analysis of RCTs, we found evidence that after the oral administration of roxadustat, NDD patients' Hb levels were increased effectively and DD patients' Hb levels were maintained effectively. The risk of SAEs was not observed with the short-term use of roxadustat. These findings support roxadustat for the treatment of anemia in patients with CKD.
引用
收藏
页码:1603 / 1615
页数:13
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