Noyola-Villalobos HF, Espinoza-Mercado F, Jiménez-Chavarría E, Ramos-Díaz E, Loera-Torres MA, Rivera-Navarrete E

Language: Spanish
References: 22
Page: 57-65
PDF size: 281.97 Kb.

ABSTRACT

Background: Chronic allograft nephropathy is the main obstacle to long-term survival of renal allografts involving acute rejection, vascular remodeling, nephrotoxicity associated with calcineurin-inhibitors and cytomegalovirus. Recently there has been an increasingly growing interest in the use of inhibitors of the mammalian target of rapamycin (mTOR) such as everolimus and sirolimus with demonstrated efficacy in allograft survival rates. Methodology: Non-inferiority, non-randomized controlled trial, open-label and unicentric study from June 2010 to June 2013. Using a systematic sampling, renal transplant patients were assigned to the everolimus and control group, respectively. Both groups were initially treated with a calcineurin inhibitor, MMF and prednisone during the first three months post-transplant; then the everolimus group suspended calcineurin-inhibitor and were converted to everolimus 1.5 mg/24 hours; control group received standard immunosuppressive regimen. During an 18-month-follow-up serum creatinine, glucose, triglycerides, cholesterol, LDL, hemoglobin, platelets, total leucocyte count were measured, estimated glomerular filtration rate was calculated and adverse reactions were registered. Primary outcomes measures were allograft survival, rejection and mortality. Results: A total of 58 renal allograft patients were sampled, 30 complied with inclusion criteria and 2 groups were formed with 15 patients each. Everolimus group received 1.5 mg/day (0.75 mg bid po); Control group received Cys (80%), Pred (100%) MMF (53.3%) AZA (46.6%) and Tac (20%). Evl group had 100% allograft survival rate, 0% rejection rate and 1 death with functional allograft. Control group 91.7% renal allograft survival at 18 months (8.3% allograft loss), acute rejection 8.3% and 0% mortality. Statistical analysis for primary outcome measures were not statistically significant for survival (p = 0.35), rejection (p = 0.54) and mortality (p = 0.45). Conclusions: Early conversion to everolimus is efficient and safe with no increase in clinical rejection rates.

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