Comparison of efficacy, safety and cost analysis between generic and branded enteric-coated mycophenolate sodium in adult recipients of renal transplantation
10.3760/cma.j.cn421203-20240331-00077
- VernacularTitle:麦考酚钠肠溶片仿制药与原研药在成人肾移植受者免疫抑制治疗中的对比分析
- Author:
Haoyu CHEN
1
;
Lizhi LI
1
;
Pingping SUN
1
;
Jiali WANG
1
;
Wei WANG
1
;
Zhixiang JIA
1
;
Hua ZHOU
1
Author Information
1. 山西省第二人民医院肾移植透析中心，太原 030012
- Publication Type:Journal Article
- Keywords:
Kidney transplantation;
Immunosuppressant;
Generic drug;
Innovator drug;
Efficacy;
Safety;
Mycophenolate Sodium Enteric-coated Tablets
- From:
Chinese Journal of Organ Transplantation
2024;45(12):885-891
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To compare the therapeutic efficacy, safety and drug cost between generic enteric-coated mycophenolate sodium (EC-MPS) and branded EC-MPS in immunosuppressive treatment for adult recipients of renal transplantation (RT) .Methods:From January, 2022 to October, 2023, 60 adult RT patients were continuously enrolled and randomized into two groups. Patients receiving generic EC-MPS were selected as cohort 1 (n=30) while those taking branded EC-MPS designated as cohort 2 (n=30). Hepatic/renal function, blood routine parameters, drug concentrations, adverse events (AEs) and drug costs were recorded and compared between two cohorts at baseline (<3 days before/after day of RT, W0), week 1 (W1), week 4 (W4), week 8 (W8), week 12 (W12) and week 24 (W24) post-RT.Results:Only urine protein was elevated at W24[0.4 (0-0.6) vs 0 (0-0.2) g/24 h, P=0.049]in cohort 1 as compared with cohort 2. Aspartate aminotransferase at W12 (15.6±3.3 vs 20.3±9.7 U/L, P=0.010), leucocyte count at W1 (8.4±2.3 vs 10.1±3.8 ×10 9/L, P=0.045) and platelet count at W1 (158.5±51.5 vs 185.8±46.8 ×10 9/L, P=0.036) all declined in cohort 1 as compared with cohort 2. However, these parameters at other timepoints did not vary between two cohorts (all P>0.050). In addition, blood concentration of MPS after dosing, area under the concentration-time curve and trough concentration of tacrolimus at different timepoints were not different between two cohorts (all P>0.050). Similarly, helper T cells (Th), suppressor T cells (Ts), Th/Ts and B cells at W4/12 did not vary between two cohorts (all P>0.050). Concerning drug cost, no difference existed in the number of tablets or length of stay between two cohorts (both P>0.050). However, cost of EC-MPS (￥1 333.5±419.6 vs ￥2 368.6±596.0, P<0.001) and total cost during hospitalization (￥96 403.3±29 159.8 vs ￥117 062.8±28 782.1, P=0.001) were lower in cohort 1 than cohort 2. The most common AEs in cohort 1 included acid regurgitation (n=19, 63.3%), hypoalbuminemia (n=16, 53.3%), anemia (n=12, 40.0%) and hypokalemia (n=11, 36.7%). And the most common AEs in cohort 2 included acid regurgitation (n=20, 66.7%), anemia (n=14, 46.7%) and hypoalbuminemia (n=9, 30.0%). Notably, the incidence of all AEs was not different between two cohorts (all P>0.050) . Conclusion:Generic EC-MPS has comparable therapeutic efficacy and safety profile with lower drug cost in adult RT patients. It provides more options for maintenance treatment in RT patients.
