Objectives To observe the efficacy, safety and economy of roxadustat in the treatment of renal anemia in peritoneal dialysis patients. Methods We collected peritoneal dialysis patients with renal anemia in Longyan Second Hospital from January 2020 to December 2021. 32 patients treated with roxadustat selected as the roxadustat group, and 32 patients treated with recombinant human erythropoietin (rHuEPO) were randomly selected as the EPO group. The changes of hemoglobin, iron metabolism indexes and adverse reactions of the patients before and at the first, third and sixth months of the treatment were observed. Cost-effectiveness analysis and incremental analysis were used to evaluate the economy of drug treatment and conduct single actor sensitivity analysis. Results The hemoglobin level of the two groups both increased after treatment, but it was higer in roxadustat group than EPO group (the first month: t=0.025,P=0.616;the third month: t=0.286,P=0.136,the sixth month: t=0.417,P=0.045). After treatment, the ferroprotein of the two groups (the first month:t= -0.319,P=0.137;the third month:t=-0.254,P=0.096;the sixth month:t=-0.645, P=0.064)、transferin saturation (the first month::t=0.241,P=0.314;the third month:t=0.354,P=0.216;the sixth month:t=0.415,P=0.335), and the total iron binding capacity (the first month: t=6.272,P=0.235;the third month: t=2.334,P=0.327;the sixth month: t=2.696,P=0.284) were no significant differences between the two groups. Meanwhile, there were no serious adverse reactions in the two groups. The cost of roxadustat group were higher than EPO group (t=29.150,P<0.001). The incremental cost-effectiveness ratio (ICER) is 51049.58, which was 1-3 times of per capita gross domestic product (GDP),so the increased cost was acceptable. Single factor sensitivity analysis based on the decline of drug cost shown that when the drug price decreases by 25%, ICER was less than 1 time of per capita GDP, indicating that its economy was better. Conclusions Roxadustat is effective in the treatment of renal anemia in peritoneal dialysis patients and can improve iron metabolism safety. And roxadustat cost higher but the increased cost is acceptable, with better economy when drug prices decrease by 25%.
QIU Mei-Lan
,
CHEN Yong-Ping
. Efficacy and economic evaluation of roxadustat in the treatment of anemia in peritoneal dialysis patients[J]. Chinese Journal of Blood Purification, 2022
, 21(12)
: 873
-877
.
DOI: 10.3969/j.issn.1671-4091.2022.12.003
[1] Besarab A, Chernyavskaya E, Motylev I, et al. Roxadustat (FG-4592): Correction of Anemia in Incident Dialysis Patients[J]. J Am Soc Nephrol, 2016,27:1225-33.
[2] Stauffer ME, Fan T. Prevalence of anemia in chronic kidney disease in the United States[J]. PLoS One, 2014,9:e84943.
[3] Nakhoul G, Simon JF. Anemia of chronic kidney disease: Treat it, but not too aggressively[J]. Cleve Clin J Med, 2016,83:613-24.
[4] Cockwell P, Fisher LA. The global burden of chronic kidney disease[J]. Lancet, 2020,395:662-664.
[5] Hoshino J, Muenz D, Zee J, et al. Associations of Hemoglobin Levels With Health-Related Quality of Life, Physical Activity, and Clinical Outcomes in Persons With Stage 3-5 Nondialysis CKD[J]. J Ren Nutr, 2020,30:404-414.
[6] 中国医师协会肾脏内科医师分会肾性贫血指南工作组. 中国肾性贫血诊治临床实践指南[J]. 中华医学杂志, 2021,101:1463-1502.
[7] 《中国药物经济学评价指南》课题组, 刘国恩, 胡善联, 等. 中国药物经济学评价指南(2011版)[J]. 中国药物经济学, 2011:6-9+11-48.
[8] Ogawa T, Nitta K. Erythropoiesis-stimulating agent hyporesponsiveness in end-stage renal disease patients[J]. Contrib Nephrol, 2015,185:76-86.
[9] 董建华, 范文静, 吴边, 等. 罗沙司他治疗血液透析患者红细胞生成素低反应性贫血的疗效观察[J]. 肾脏病与透析肾移植杂志, 2021,30:211-216.
[10] 孙凌霜, 薛瑾虹, 魏萌, 等. 罗沙司他替代大剂量重组人红细胞生成素治疗维持性血液透析患者贫血的疗效[J]. 肾脏病与透析肾移植杂志, 2021,30:217-221.
[11] Chen N, Hao C, Liu BC, et al. Roxadustat Treatment for Anemia in Patients Undergoing Long-Term Dialysis[J]. N Engl J Med, 2019,381:1011-1022.
[12] Provenzano R, Besarab A, Wright S, et al. Roxadustat (FG-4592) Versus Epoetin Alfa for Anemia in Patients Receiving Maintenance Hemodialysis: A Phase 2, Randomized, 6- to 19-Week, Open-Label, Active-Comparator, Dose-Ranging, Safety and Exploratory Efficacy Study[J]. Am J Kidney Dis, 2016,67:912-24.
[13] Xu B, Liu S, Li Y, et al. Roxadustat in the treatment of a hemodialysis patient with anti-erythropoietin antibody-mediated pure red cell aplasia[J]. Clin Kidney J, 2021,14:2444-2445.
[14] Akizawa T, Tsubakihara Y, Nangaku M, et al. Effects of Daprodustat, a Novel Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor on Anemia Management in Japanese Hemodialysis Subjects[J]. Am J Nephrol, 2017,45:127-135.
[15] Holdstock L, Meadowcroft AM, Maier R, et al. Four-Week Studies of Oral Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor GSK1278863 for Treatment of Anemia[J]. J Am Soc Nephrol, 2016,27:1234-44.
[16] Abdelazeem B, Abbas KS, Shehata J, et al. The efficacy of Roxadustat for the treatment of anemia in dialysis dependent chronic kidney disease patients: an updated systematic review and meta-analysis of randomized clinical trials[J]. Ann Transl Med, 2021,9:1714.
[17] Grzeszczak W, Szczyra D, ?nit M. Whether Prolyl Hydroxylase Blocker-Roxadustat-In the Treatment of Anemia in Patients with Chronic Kidney Disease Is the Future?[J]. Int J Environ Res Public Health, 2021,18.
[18] Hwang S, Nguyen AD, Jo Y, et al. Hypoxia-inducible factor 1α activates insulin-induced gene 2 (Insig-2) transcription for degradation of 3-hydroxy-3-methylglutaryl (HMG)-CoA reductase in the liver[J]. J Biol Chem, 2017,292:9382-9393.
[19] Charytan C, Manllo-Karim R, Martin ER, et al. A Randomized Trial of Roxadustat in Anemia of Kidney Failure: SIERRAS Study[J]. Kidney Int Rep, 2021,6:1829-1839.
[20] Provenzano R, Shutov E, Eremeeva L, et al. Roxadustat for anemia in patients with end-stage renal disease incident to dialysis[J]. Nephrol Dial Transplant, 2021,36:1717-1730.