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A new microemulsion formula (Sandimmun Neoral: SIM-NO) was developed to solve the problem of variable absorption and lower bioavailability of conventional Sandimmune (SIM), showed 74 to 139% better bioavailability, and was efficacious and safe in studies up to 12 weeks.
In this multicenter, prospective and randomized study, efficacy and tolerability of SIM-NO was evaluated in 44 renal recipients (RTR) from 3 centers (25 male, 19 female; age 18- 58 years). SIM-NO was started with a dose of 10 mg/kg preoperatively, by the day of operation one-third of the dose was given intravenously, then the dose was adjusted according to the Cs levels (target levels were between 200- 300 ng/ml for the first 3 months, and 150-200 ng/ml for the second 3 months). All the patients were also administered prednisolone and azathioprine. The study was continued for 24 months.
Forty patients completed the study; one patient died from bleeding following liver biopsy, one lost his graft with acute rejection following graft infection in the first week. Cs was stopped in another patient who developed Kaposi's sarcoma, and one other was lost to follow-up.
Six steroid sensitive acute rejection episodes were noted. The mean creatinine level was 1.51±0.47 mg/dl, the mean Cs dose was 238±76 mg/day, the mean Cs level was 215±88 ng/ml at the end of the study. The tolerability of SIMNO was good or very good in 93% and 91%, at the 12th and 24th weeks, respectively.
SIM-NO is shown to be efficacious and tolerable in rejection prophylaxis in de novo RTR,