J Clin Pharmacol
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DRUG INTERACTIONS

Influence of Everolimus on Steady-State Pharmacokinetics of Cyclosporine in Maintenance Renal Transplant Patients

Klemens Budde, Gustav Lehne, Michael Winkler, Lutz Renders, Arno Lison, Lutz Fritsche, Jean-Paul Soulillou, Per Fauchald, Hans-Hellmut Neumayer, Jaques Dantal RADW 102 Renal Transplant Study Group

From the University Clinic Charité, Berlin, Germany (Dr Budde, Dr Fritsche, Dr Neumayer); Nephrology Service, CHU Hotel Dieu, Nantes, France (Dr Soulillou, Dr Dantal); Rikshospitalet, Oslo, Norway (Dr Lehne, Dr Fauchald); Medizinische Hochschule, Hannover, Germany (Dr Winkler); Universitätsklinikum Kiel, Germany (Dr Renders); and Zentral-krankenhaus, Bremen, Germany (Dr Lison).

To investigate possible interactions of the novel immunosuppressant everolimus with cyclosporine, a multicenter, randomized, double-blind, placebo-controlled, dose-escalating phase I study was performed. Everolimus regimens (0.75-10 mg/d) were administered for 28 days to stable renal allograft recipients receiving the microemulsion form of cyclosporine. Steady-state cyclosporine profiles were assessed at baseline on day 0 (cyclosporine alone) and on day 21 with everolimus on steady state. By day 21, mean dose-normalized cyclosporine AUC0-12 increased by 15% in patients receiving placebo. In everolimus-treated patients, mean increases in cyclosporine AUC0-12 ranged from 7% to 43%, which were not significantly different across all dosing cohorts including placebo. Linear regression of everolimus AUC on day 21 versus the increase in cyclosporine AUC0-12 yielded a slope not significantly different from a horizontal line (P = ns). In conclusion, these results suggest that steady-state everolimus exposure over the wide range assessed in this study did not affect steady-state cyclosporine pharmacokinetics.

Key Words: Cyclosporine • everolimus • pharmacokinetics • renal transplantation

Address for reprints: Klemens Budde, University Clinic Charité, Schumannstr. 20/21, Berlin 10098, Germany.


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