A Comparative Study of Once Daily Versus Twice Daily Tacrolimus in Liver Transplantation

Abstract

Background: Once daily (OD) tacrolimus, recently launched for post liver transplant immunosuppression might offer better compliance and efficacy compared to standard twice daily (BID) tacrolimus. Data from India, however is sparse. Aim: The aim of our study was to compare the efficacy and adverse effects of OD versus BID tacrolimus formulation in liver transplant recipients. Methods: This was a retrospective, observational, comparative study of 115 patients who were on tacrolimus based regimens (tacrolimus BID: 92; M: F-75:17 and tacrolimus OD: 23; M: F-22:1). Total daily dose and trough levels of tacrolimus were recorded at 1, 3, 6, 12 and 24 months after transplantation. Results: Median age in tacrolimus BID and OD groups were 45 years (6-64 years) and 50 years (1-70 years), respectively. The median tacrolimus dose was significantly lower in the tacrolimus OD arm at all the time points studied. Tacrolimus trough levels were significantly lower in the tacrolimus OD group at 3 and 6 months. The biopsy proven rejection rate was 15.2% and 0% in the tacrolimus BID and OD groups, respectively. Two year patient and graft survival rate was 89.4% in the tacrolimus BID and 87.5% in the tacrolimus OD group. The incidence of new onset diabetes, renal dysfunction, dyslipidemia, neurotoxicity, hyperkalemia and weight gain were comparable between the two arms. Conclusion: Tacrolimus OD has a lower rejection rate compared to its BID formulation. However, this does not translate into better patient or graft survival. Both the formulations appear to be comparable with respect to the adverse effect and tolerability profile. Key words: Biopsy Proven Acute Rejection, Graft Survival, Patient Survival, Liver Transplantation, Tacrolimus Once Daily, Tacrolimus Twice Daily.