OBJECTIVES: The introduction of mycophenolate mofetil has proven itself effective in preventing acute rejection in renal transplant recipients. However, this cost is ineffective with countries with a limited income. This study sought to compare the clinical and therapeutic profiles of a generic formulation with mycophenolate mofetil. MATERIALS AND METHODS: This 2-year, single-center, prospective, randomized, open-label study investigated the efficacy and safety of a new mycophenolate mofetil generic formulation compared with mycophenolaterenal transplant recipients. The study divided patients in 2 groups: 8 patients in G1 received mycophenolate mofetil 500 and 10 patients in G2 received mycophenolate. Their demographics were similar: mean age, 36.6±7.1 and 33.3±11.7 years; sex M/F: 2/6 and 5/5; mean donor age, 42.6±11.1 and 43.6±13.9 years; mean HLA mismatches, 2.7±1.2 and 3.3±1.5; deceased donors, 25% and 20%; and warm ischemia time, 40.2±11.9 and 38.7±10.5 minutes. All patients received 2 g daily of mycophenolate mofetil 500 or mycophenolate with initial dosage of 0.1 mg/kg/d and prednisolone. RESULTS: One patient of 7 in the mycophenolate mofetil group and 4 of 6 in the mycophenolate group had 1 episode of acute tubular necrosis, and 1 patient in each group had an acute rejection with no significant differences between the groups. The area under the curve of the mycophenolate mofetil did not show any difference between the 2 groups. The values of serum creatinine were also comparable. Patient survival rate at 6, 12, and 24 months was 100% in the groups. The frequencies of digestive and hematologic adverse effects were comparable in the groups with no significant differences. CONCLUSIONS: Use of mycophenolate mofetil 500 provided safe and effective immunosuppressive therapy compared with mycophenolate. However, as the duration of the study was short, these results need to be confirmed in a long-term study.
RCT Entities:
OBJECTIVES: The introduction of mycophenolate mofetil has proven itself effective in preventing acute rejection in renal transplant recipients. However, this cost is ineffective with countries with a limited income. This study sought to compare the clinical and therapeutic profiles of a generic formulation with mycophenolate mofetil. MATERIALS AND METHODS: This 2-year, single-center, prospective, randomized, open-label study investigated the efficacy and safety of a new mycophenolate mofetil generic formulation compared with mycophenolate renal transplant recipients. The study divided patients in 2 groups: 8 patients in G1 received mycophenolate mofetil 500 and 10 patients in G2 received mycophenolate. Their demographics were similar: mean age, 36.6±7.1 and 33.3±11.7 years; sex M/F: 2/6 and 5/5; mean donor age, 42.6±11.1 and 43.6±13.9 years; mean HLA mismatches, 2.7±1.2 and 3.3±1.5; deceased donors, 25% and 20%; and warm ischemia time, 40.2±11.9 and 38.7±10.5 minutes. All patients received 2 g daily of mycophenolate mofetil 500 or mycophenolate with initial dosage of 0.1 mg/kg/d and prednisolone. RESULTS: One patient of 7 in the mycophenolate mofetil group and 4 of 6 in the mycophenolate group had 1 episode of acute tubular necrosis, and 1 patient in each group had an acute rejection with no significant differences between the groups. The area under the curve of the mycophenolate mofetil did not show any difference between the 2 groups. The values of serum creatinine were also comparable. Patient survival rate at 6, 12, and 24 months was 100% in the groups. The frequencies of digestive and hematologic adverse effects were comparable in the groups with no significant differences. CONCLUSIONS: Use of mycophenolate mofetil 500 provided safe and effective immunosuppressive therapy compared with mycophenolate. However, as the duration of the study was short, these results need to be confirmed in a long-term study.
Authors: Amber O Molnar; Dean Fergusson; Anne K Tsampalieros; Alexandria Bennett; Nicholas Fergusson; Timothy Ramsay; Greg A Knoll Journal: BMJ Date: 2015-06-22