Pharmacokinetic of Everolimus and Atorvastatin Co-administration

Population : Thai postrenal transplantation recipient who received everolimus and have hypercholesterolemia in posttransplantation clinic at Faculty of Medicine, Chulalongkorn University.

Study Design : Experimental study, Two-sample crossover study Sample size calculation :N = 18 Primary outcome : 12-hour area under the time concentration curve of everolimus Secondary outcome : renal function (serum creatinine, creatinine clearance)

Method :

• Patients will random to everolimus or everolimus with atorvastatin 20 mg arm for 1 month.
• Take blood sample for everolimus concentration at time 0,0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 hour
• After first blood sample, patients will received everolimus only for 1 month (wash out period)
• Patients will switch to another arm eg.patient who had received everolimus will switch to everolimus with atorvastatin 20 mg for 1 month
• Take blood sample for everolimus concentration at time 0,0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 hour
• Everolimus level will analyse for 12-hour AUC of everolimus.

Inclusion criteria

• Post renal transplantation recipient who received immunosuppressive drug Everolimus and has hypercholesterolemia
• Co everolimus level within 3-12 ng/mL
• Informed consent
• Patient can follow research methodology

Exclusion criteria

• Patient don't want to participate in the study
• Post renal transplantation recipient who have normal lipid profile