Data published last week in the American Journal of Transplantation (AJT) demonstrate that in liver transplant patients, initiating lower dose Japanese pharma major Astellas Pharma’s (TYO: 4503) Advagraf capsules (prolonged-release tacrolimus) therapy immediately post transplant, in combination with basiliximab, results in significantly better renal function and a lower incidence of acute organ rejection when compared with patients starting at the maximum recommended dose of Advagraf therapy.
Pavel Trunečka, lead author of the publication, said: “Renal function is a vital predictor of long-term transplant success; the DIAMOND study suggests potential for balancing the risk of rejection, whilst minimizing the risk of renal damage and potentially reducing the risk of long-term complications. This study shows that lower dose Advagraf, given immediately post-transplantation, offers the potential advantages of an immunosuppressive regimen which minimizes risk of graft rejection whilst preserving renal function without the need for maintenance steroids. In turn, this offers the real possibility of simplifying immunosuppression in the early post- transplant period for most liver transplant recipients.
Study details
Results from the DIAMOND (Advagraf studied In combinAtion with MycOphenolate mofetil [MMF] aND basiliximab in liver transplantation) study show that during the immediate post-transplant period, initial administration of Advagraf in mid-range of recommended dose which is up to 25% lower than the maximum recommended dose (0.15–0.175mg/kg/day) plus basiliximab (without maintenance corticosteroids) and MMF was associated with lower tacrolimus exposure, and significantly reduced renal function impairment and acute rejection incidence compared to prolonged-release tacrolimus administered at maximum recommended dose (0.2mg/kg/day) with the same concomitant medications.
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