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| |  Preliminary Results Show Excellent Patient, Graft Survival With Sirolimus Plus Tacrolimus Regimen in Renal Transplant Recipients: Presented at TTS By Rachel Parratt SYDNEY, Australia -- August 14, 2008 -- Preliminary 2-year data from the Optimizing Renal Transplant Immunosuppression to Overcome Nephrotoxicity (ORION) study show similar rates of patient and graft survival between 3 different calcineurin-inhibitor sparing regimens. Lead investigator Stuart Flechner, MD, Cleveland Clinic Foundation, Cleveland, Ohio, presented the 2-year preliminary findings here on August 13 at the 22nd International Congress of the Transplantation Society (TTS 2008). The randomised, open-label, comparative study compared the efficacy of 2 sirolimus regimens versus mycophenolate mofetil (MMF) plus tacrolimus. The study included 451 renal transplant recipients who were randomised to sirolimus plus tacrolimus (group 1, n = 155), sirolimus plus MMF (group 2, n = 155), or tacrolimus plus MMF (control group, n = 141). At week 13, tacrolimus was eliminated in group 1. Corticosteroids and daclizumab were given to all patients. Because of increased acute rejection rates, group 2 was terminated in June 2006 (after all patients were accrued), and data were collected for 30 days beyond termination. Patient survival was similar between both treatment groups (94.8%) and the control group (97.1%). There was no significant difference in graft survival at 2 years between group 1 (88.8%), group 2 (90.1%), or the control group (95%). Patients in group 2 had a significantly higher rate of biopsy-confirmed acute rejection (BCAR) at 28.3% compared with group 1 (13.5%) and the control group (9.4%), P < .0001 (group 2 vs control group). All acute rejections were grades 1 and 2, and the majority occurred within the first 3 months before tacrolimus elimination. Furthermore, group 2 had a significantly higher proportion of rejectors (56.4%) compared with nonrejectors (24.3%) for subtherapeutic levels of sirolimus. Subtherapeutic levels were defined as 2 or more sirolimus trough levels <40 ng/mL or 1 level <40 ng/mL with 14 days of BCAR. Renal function, measured by mean creatinine clearance, was similar among all groups, despite the higher BCAR rates in group 2. Dr. Flechner commented that "early adequate exposure to sirolimus is necessary to achieve desired and low BCAR rates." Funding for this study was provided by Wyeth. [Presentation title: Preliminary Two-Year Efficacy Results From a Randomized, Open-Label, Comparative Study of Two Different Sirolimus (SRL) Regimens Versus a Tacrolimus (TAC) + Mycophenolate Regimen (MMF) in De Novo Renal Allograft Recipients. Mini-Oral Session 18 WMO18]
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