Abstract
BACKGROUND: The use of generic formulations of immunosuppressive drugs in place of brand name drugs offers considerable cost savings. Brand name tacrolimus (Prograf(®)) came off patent in April 2008. However, published evidence supporting therapeutic equivalence of generic formulations of tacrolimus in solid organ transplantation is lacking. The South West Transplant Centre switched from administering Prograf(®) to a generic formulation (Adoport(®)) for de novo transplant recipients in November 2010. This study sought to compare the clinical outcomes of renal transplant recipients administered Prograf(®) with those receiving Adoport(®). METHODS: Data regarding patient characteristics and clinical outcomes were collected retrospectively for all patients undergoing renal transplantation at the South West Transplant Centre between 8 November 2009 and 8 November 2011 to whom tacrolimus was prescribed. RESULTS: A total of 48 patients received Prograf(®) and 51 received Adoport(®). At 6 months, no statistically significant differences were identified in the rates of patient survival, graft survival, acute allograft rejection, delayed graft function, calcineurin inhibitor toxicity or cytomegalovirus infection occurring within the two groups. CONCLUSIONS: This is the first study to compare the clinical outcomes of patients receiving Adoport(®) with those receiving brand name tacrolimus. We report comparable clinical outcomes at 6 months in patients receiving either Prograf(®) or Adoport(®) from the time of renal transplantation. These early outcome data therefore support the use of Adoport(®) in place of Prograf(®) as a potential cost-saving measure.