Everolimus, a mammalian target of rapamycin (mTOR) inhibitor, is licensed for the prevention of acute rejection in heart or kidney transplant recipients. Based on the mechanism of action of the drug, everolimus-based immunosuppressive regimen may display some important benefits, such as lower incidence of malignancies and CMV infections, and better preservation of renal function when associated with low dose calcineurin inhibitors. To gain information on the safety and efficacy of long-term use of everolimus in de novo and maintenance patients in the clinical practice, we designed the CERTIC observational study. Between 2008 and 2010, 783 kidney and heart transplant recipients who were on therapy with everolimus since at least 6 months were enrolled into a 5-year follow-up registry. Death, graft loss, major cardiovascular events (MACE), malignancies, acute rejections, glomerular filtration rate, and main clinical and biological parameters were recorded. Of the 382 enrolled kidney transplant patients, the majority (88%) received everolimus within three months from transplant (de novo group) and were transplanted a mean of two years before entering the registry, for a total of four years of everolimus treatment. In this group, the patients survival rate was 96%, 2 patients lost the graft (0.6%) and 3 went back to dialysis. Six patients in the first year and 7 patients in the second year developed neoplasms (1.8% yearly rate), accounting for 6 solid organ tumors and 14 non melanoma skin cancer (NMSC). No PTLDs and Kaposi’s sarcoma were recorded. Estimated glomerular filtration rate (eGFR), calculated with the MDRD formula, remained stable from the beginning of the study (from 54.5 ± 22.8 to 53.9 ± 25.4 ml/min/1.73 m²).

By picturing real-life clinical practice, this large prospective registry shows promising outcome in de novo patients in treatment with everolimus for four years, with good survival rate of patients and grafts, low incidence of malignancies and renal function seems to be effectively preserved.

Carmellini, M.: Grant/Research Support, Novartis. Federico, S.: Grant/Research Support, Novartis. Messa, P.: Grant/Research Support, Novartis. Gubbiotti, G.: Grant/Research Support, Novartis. Colombo, D.: Employee, Novartis. Brusa, R.: Employee, Novartis.

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