Safety, tolerability, and efficacy of everolimus in de novo liver transplant recipients: 12- and 36-month results.
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Safety, tolerability, and efficacy of everolimus in de novo liver transplant recipients: 12- and 36-month results. / Levy, Gary; Schmidli, Heinz; Punch, Jeffrey; Tuttle-Newhall, Elizabeth; Mayer, David; Neuhaus, Peter; Samuel, Didier; Nashan, Björn; Klempnauer, Juergen; Langnas, Alan; Calmus, Yvon; Rogiers, Xavier; Abecassis, Michael; Freeman, Richard; Sloof, Maarten; Roberts, John; Fischer, Lutz.
In: LIVER TRANSPLANT, Vol. 12, No. 11, 11, 2006, p. 1640-1648.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Safety, tolerability, and efficacy of everolimus in de novo liver transplant recipients: 12- and 36-month results.
AU - Levy, Gary
AU - Schmidli, Heinz
AU - Punch, Jeffrey
AU - Tuttle-Newhall, Elizabeth
AU - Mayer, David
AU - Neuhaus, Peter
AU - Samuel, Didier
AU - Nashan, Björn
AU - Klempnauer, Juergen
AU - Langnas, Alan
AU - Calmus, Yvon
AU - Rogiers, Xavier
AU - Abecassis, Michael
AU - Freeman, Richard
AU - Sloof, Maarten
AU - Roberts, John
AU - Fischer, Lutz
PY - 2006
Y1 - 2006
N2 - Everolimus is a macrolide immunosuppressive agent with known consistent absorption. In this double-blind study, we examined the safety and tolerability of everolimus vs. placebo in de novo liver transplant recipients. One hundred and nineteen liver allograft recipients were randomized to 1 of 4 groups: everolimus 0.5 mg bid, everolimus 1.0 mg bid, everolimus 2 mg bid, or placebo. Patients received oral cyclosporine to achieve a target trough level of 150-400 ng/mL in combination with prednisone. Primary and secondary endpoints of safety, tolerability, and efficacy were determined at 12 months, and patients were followed through 36 months. There was a trend toward fewer treated acute rejections in the everolimus group than in the placebo group: everolimus 0.5 mg: 39.3%; everolimus 1.0 mg: 30.0%; everolimus 2 mg: 29.0%; placebo: 40.0% (P = not significant). Adverse events were higher in everolimus-treated patients especially at the 4-mg/day dose, but there was no difference in the incidence of thrombocytopenia or leukopenia between all groups and renal function as determined by serum creatinine, and creatinine clearance remained stable to 36 months in everolimus-treated patients. Mean cholesterol and triglycerides increased from baseline in all treatment groups, and maximum levels were seen at 6 months. In conclusion, this study demonstrates that everolimus in combination with oral cyclosporine had an acceptable safety and tolerability profile, paving the way for additional studies in this transplant indication.
AB - Everolimus is a macrolide immunosuppressive agent with known consistent absorption. In this double-blind study, we examined the safety and tolerability of everolimus vs. placebo in de novo liver transplant recipients. One hundred and nineteen liver allograft recipients were randomized to 1 of 4 groups: everolimus 0.5 mg bid, everolimus 1.0 mg bid, everolimus 2 mg bid, or placebo. Patients received oral cyclosporine to achieve a target trough level of 150-400 ng/mL in combination with prednisone. Primary and secondary endpoints of safety, tolerability, and efficacy were determined at 12 months, and patients were followed through 36 months. There was a trend toward fewer treated acute rejections in the everolimus group than in the placebo group: everolimus 0.5 mg: 39.3%; everolimus 1.0 mg: 30.0%; everolimus 2 mg: 29.0%; placebo: 40.0% (P = not significant). Adverse events were higher in everolimus-treated patients especially at the 4-mg/day dose, but there was no difference in the incidence of thrombocytopenia or leukopenia between all groups and renal function as determined by serum creatinine, and creatinine clearance remained stable to 36 months in everolimus-treated patients. Mean cholesterol and triglycerides increased from baseline in all treatment groups, and maximum levels were seen at 6 months. In conclusion, this study demonstrates that everolimus in combination with oral cyclosporine had an acceptable safety and tolerability profile, paving the way for additional studies in this transplant indication.
M3 - SCORING: Zeitschriftenaufsatz
VL - 12
SP - 1640
EP - 1648
JO - LIVER TRANSPLANT
JF - LIVER TRANSPLANT
SN - 1527-6465
IS - 11
M1 - 11
ER -