Introduction. The half-life of everolimus is approximately 28 hours, but everolimus is generally administered twice a day. The aim of this prospective, single-center, exploratory study was to compare the efficacy and safety of a once a day everolimus (OD) with the standard twice a day administration regimen (BID) as immunosuppressive therapy in renal transplantation. Methods. Forty-one de novo renal transplant recipients prospectively assigned to OD (n = 21) or BID (n = 20) treatment were followed for 1 year. In the OD group, everolimus was orally administered targeting a trough blood level of 2 to 5 ng/mL. In the BID group, everolimus was given twice a day targeting a trough blood level of 3 to 12 ng/mL. All patients also received induction with basiliximab and low-dose calcineurin inhibitor immunosuppression. Results. At 1 year follow-up patient and graft survivals were 100%. The intention-to-treat analysis showed similar renal function between the two regimens: serum creatinine values for OD 1.54 +/- 0.6 versus BID 1.48 +/- 0.53 mg/dL (P = NS). Also the occurrence of acute rejection episodes was not significantly different: 4.8% in the OD versus 15% in the BID group, (P = NS). The median trough blood levels were significantly lower among the OD group: OD 4.5 versus BID 7.2 ng/mL (P < .001). Discussion. This study demonstrated that once a day administration of everolimus achieved excellent patient and graft survival and good renal function without an increased incidence of acute rejection episodes.

Spagnoletti, G., Favi, E., Gargiulo, A., Salerno, M., Citterio, F., Once-a-Day Administration of Everolimus Is Safe in De Novo Renal Transplant Recipients: 1-Year Results of a Pilot Study, <<TRANSPLANTATION PROCEEDINGS>>, 2011; 43 (Maggio): 1010-1012. [doi:10.1016/j.transproceed.2011.03.018] [http://hdl.handle.net/10807/11494]

Once-a-Day Administration of Everolimus Is Safe in De Novo Renal Transplant Recipients: 1-Year Results of a Pilot Study

Spagnoletti, Gionata;Favi, Evaldo;Gargiulo, Antonio;Citterio, Franco
2011

Abstract

Introduction. The half-life of everolimus is approximately 28 hours, but everolimus is generally administered twice a day. The aim of this prospective, single-center, exploratory study was to compare the efficacy and safety of a once a day everolimus (OD) with the standard twice a day administration regimen (BID) as immunosuppressive therapy in renal transplantation. Methods. Forty-one de novo renal transplant recipients prospectively assigned to OD (n = 21) or BID (n = 20) treatment were followed for 1 year. In the OD group, everolimus was orally administered targeting a trough blood level of 2 to 5 ng/mL. In the BID group, everolimus was given twice a day targeting a trough blood level of 3 to 12 ng/mL. All patients also received induction with basiliximab and low-dose calcineurin inhibitor immunosuppression. Results. At 1 year follow-up patient and graft survivals were 100%. The intention-to-treat analysis showed similar renal function between the two regimens: serum creatinine values for OD 1.54 +/- 0.6 versus BID 1.48 +/- 0.53 mg/dL (P = NS). Also the occurrence of acute rejection episodes was not significantly different: 4.8% in the OD versus 15% in the BID group, (P = NS). The median trough blood levels were significantly lower among the OD group: OD 4.5 versus BID 7.2 ng/mL (P < .001). Discussion. This study demonstrated that once a day administration of everolimus achieved excellent patient and graft survival and good renal function without an increased incidence of acute rejection episodes.
2011
Inglese
Spagnoletti, G., Favi, E., Gargiulo, A., Salerno, M., Citterio, F., Once-a-Day Administration of Everolimus Is Safe in De Novo Renal Transplant Recipients: 1-Year Results of a Pilot Study, <<TRANSPLANTATION PROCEEDINGS>>, 2011; 43 (Maggio): 1010-1012. [doi:10.1016/j.transproceed.2011.03.018] [http://hdl.handle.net/10807/11494]
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