Mizoribine versus mycophenolate mofetil in combination therapy with tacrolimus for de novo kidney transplantation: evaluation of efficacy and safety.

The present study compared the efficacy and safety of mizoribine (MZR) with mycophenolate mofetil (MMF) in kidney transplantation. This multicenter, randomized clinical trial. Employed doses of study drug tailored to the immunosuppressive need. The primary efficacy outcome was the incidence of biopsy-proven acute rejection episodes (BPAR). The safety of the study drug was assessed using the incidences of adverse events, drug discontinuations, and abnormal laboratory results. The 7 (6.4%) BPARs above grade II were observed in the MZR group noninferior to the 2 (1.8%) in the MMF group (95% confidence interval, -0.007-0.097 > noninferiority limit [-0.2]). BPAR was significantly decreased in the MZR group after the dose change (17/41 [41.4%] vs 8/69 [11.6%]; P < .0001) and the incidence of BPAR was similar between the MZR and MMF groups after the dose change (P = .592). The uric acid level was significantly elevated in the MZR group (P = .002). In conclusion, the efficacy and safety of MZR were similar and statistically noninferior to MMF in combination therapy with tacrolimus.

Ju MK ，Huh KH ，Park KT ，Kim SJ ，Cho BH ，Kim CD ，So BJ ，Kang CM ，Lee S ，Joo DJ ，Kim YS ... -  《-》

Randomized comparative trial of mizoribine versus mycophenolate mofetil in combination with tacrolimus for living donor renal transplantation.

Takahara S ，Takahashi K ，Akiyama T ，Uchida K ，Tanabe K ，Amada N ，Toma H ... -  《-》

Comparison of Mizoribine and Mycophenolate Mofetil With a Tacrolimus-Based Immunosuppressive Regimen in Living-Donor Kidney Transplantation Recipients: A Retrospective Study in China.

A retrospective study was conducted to investigate the prevalence of gastrointestinal (GI) symptoms as well as the efficacy and safety of mizoribine (MZR) and mycophenolate mofetil (MMF) in Chinese living-donor kidney transplantation (LDKT). Forty-two recipients enrolled between January 2012 and March 2014 were treated with either MZR (n = 22) or MMF (n = 20). All patients were treated in combination with a tacrolimus-based immunosuppressive regimen, besides the study drugs. GI symptoms were observed in 1 of 22 patients (4.5%) and 10 of 20 patients (50%) in MZR treatment group and MMF treatment group, respectively (P = .001), during the post-transplantation 1 year. No significant differences in the incidence of acid reflux, bloated stomach feeling, and constipation were observed between the two groups. No recipient developed diarrhea in the MZR treatment group, whereas 30% of the MMF treatment group developed diarrhea (P = .007). The averages of GI symptom severity total score and diarrhea score were significantly lower in the MZR treatment group compare with MMF treatment group. There were no inter-group differences in background characteristics. There were no significant differences in acute rejection rate and clinical findings between these two groups, whereas the prevalence of cytomegalovirus infection and leukopenia were significantly lower in the MZR treatment group. There was no significant difference on adverse events such as hyperuricemia or other adverse events. This study demonstrated a significantly lower incidence of GI symptoms for treatment with MZR compared with MMF and good efficacy and safety in Chinese LDKT with MZR.

Shi Y ，Liu H ，Chen XG ，Shen ZY ... -  《-》

Comparative efficacy and safety of mizoribine with mycophenolate mofetil for Asian renal transplantation--a meta-analysis.

Mizoribine (MZR) with its high safety and low cost has been widely used in Asia. It has been questioned whether high or low dose of MZR could obtain the efficacy and safety similar to mycophenolate mofetil (MMF) following renal transplantation. This meta-analysis was done to compare the efficacy and safety of high- or low-dose MZR with MMF for immunosuppressive therapy in renal transplantation. Available data comparing MZR with MMF in renal transplant recipients were searched. Subgroup analysis was conducted according to the administration dosage of MZR. Trials were pooled using Meta-analysis software and confidence intervals were set at 95%. Altogether 1149 Asian patients from 7 RCTs and 9 cohort studies were included. The efficacy of different MZR doses put on par with MMF, but the safety was better than MMF. Specifically, recipients taking MZR favor significantly fewer episodes of leucocytopenia [RR 0.40 (0.26, 0.60)], gastrointestinal disorder [RR 0.54 (0.40, 0.73)], CMV infection [RR 0.47 (0.34, 0.64)] and more favorable outcome of hepatic dysfunction, although the difference failed to reach a statistical significance [RR 0.67 (0.44, 1.00)]. Unfortunately, hyperuricemia was significantly obvious in MZR group [RR 1.96 (1.47, 2.61)]. MZR is an effective and safe immunosuppressive agent and high-dose MZR can be recommended as an alternative to MMF following adult renal transplantation in Asia, but hyperuricemia and liver damage should be closely monitored during the medication period.

Xing S ，Yang J ，Zhang X ，Zhou P ... -  《-》

A Prospective Randomized, Comparative Trial of High-Dose Mizoribine Versus Mycophenolate Mofetil in Combination With Tacrolimus and Basiliximab for Living Donor Renal Transplant: A Multicenter Trial.

Ishida H ，Takahara S ，Amada N ，Tomikawa S ，Chikaraishi T ，Takahashi K ，Uchida K ，Akiyama T ，Tanabe K ，Toma H ，Study Group for the Antimetabolite Comparison of Trial (AMCT) ... -  《-》