SAFETY AND EFFICACY OF TWO TACROLIMUS FORMULATIONS (PROGRAF® AND ADVAGRAF®) IN MALAYSIAN RENAL TRANSPLANT PATIENTS: A COMPARATIVE STUDY

Abstract

Aim: A once-daily formulation of tacrolimus, Advagraf®, is increasingly being used in place of twice-daily tacrolimus, Prograf®, as a standard immunosuppressive agent for transplant patients. In this study, the clinical safety and efficacy of Advagraf® were compared with Prograf®, among multi-ethnic Malaysian renal transplanted population. Method: This retrospective study identified renal transplant patients who were converted from Prograf® to Advagraf® at the University Malaya Medical Centre (UMMC) (n=69). Clinical notes and laboratory records, including tacrolimus daily dose and trough levels, were obtained for one-year, pre-and post-conversion. Causality assessment of suspected adverse events were based on the WHO-Uppsala Monitoring Center criteria. Renal biopsy records were re-evaluated based on the updated Banff 2007 classification for biopsy-confirmed acute rejection (BPAR). Results: Following conversion to Advagraf®, the mean tacrolimus trough level and daily dose decreased significantly (p<0.01) from 6.11±2.15 to 4.91±1.25 ng/mL and 4.08±2.19 to 3.48±1.79 mg/day, respectively. There was no significant difference in serum creatinine and estimated glomerular function. HDL was significantly increased (p=0.005) while triglycerides was significantly decreased following conversion to Advagraf® (p=0.003). The incidence of BPAR was 16% (4 cases in Prograf® and 7 cases in Advagraf®). No patients died or lost their grafts during the study period. There were 34 cases of adverse events which were classified as certain (5%), probable (36%), possible (23%) and unlikely (36%) with no significant difference between groups. Conclusion: Prograf® and Advagraf® tacrolimus formulations have comparable safety and efficacy profiles among Malaysian renal transplant patients. Advagraf® may have an advantage in terms of lipid profile. Keywords: Prograf®, Renal Transplant, Advagraf®, Acute Rejection, Safety