PROGRAF VS

prograf prescribing information

DIABETES MELLITUS WITH NEORAL (CYCLOSPORINE) VS. PROGRAF (TACROLIMUS) BASED REGIMENS AFTER KIDNEY TRANSPLANT DIABETES MELLITUS WITH NEORAL (CYCLOSPORINE) VS. PROGRAF (TACROLIMUS) BASED REGIMENS AFTER KIDNEY TRANSPLANT A randomized, three arm, parallel group, open label, prospective study of 3 immunosuppressive regimens [Prograf+azatioprine(AZA) vs Neoral+mycophenolate mofetil(MMF) vs Prograf +MMF] was performed in adult recipients of first cadaver kidney transplants at 15 sites. Prograf was initially dosed at 0.15-0.20 mg/kg/day orally to achieve target trough levels of 8-16ng/ml for the first 3 months and 5-15ng/mL thereafer. Neoral was initially dosed at 8-10 mg/kg/day orally to achieve-target trough levels of 200-4Oong/ml for the first 3 months and 100-3OOng/mL thereafter. All patients received the same maintenance corticosteroid regimens. Antilymphocyte induction was used only in patients with delayed graft function. 224 patients were randomized and transplanted. 156 patients have completed 6 months post-transplant follow-up of whom 105 patients did not have diabetes mellitus pre-transplant The incidence of post-transplant diabetes mellitus (PTDM), defined as new insulin use for 30days was: Prograf +AZA 10.5%(n=4). Neoral+MMF 6.5%(n=2) Prograf+MMF 0%(n=0). The percentage of patients on insulin at 6 months post-transplant was: Prograf+AZA 7.9% (n=3), Neoral+MMF 6.5%(n=2), Prograf+MMF 2.8%(n=1).