Comparison of efficacy,safety and cost analysis between generic and branded enteric-coated myco-phenolate sodium in adult recipients of renal transplantation
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 ×109/L,P=0.045)and platelet count at W1(158.5±51.5 vs 185.8±46.8 ×109/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.
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