Pharmacokinetic characterization of baclofen in patients with chronic kidney disease: dose adjustment recommendations

摘要: The pharmacokinetics of baclofen is well delineated in subjects with normal kidney function (KF); however, data patients chronic disease (CKD) are not and dosage recommendations remain empirical. effects CKD on were assessed through a multi-center, open-label, single 5-mg dose, study. KF was measured as the creatinine clearance (CrCL) calculated Cockroft-Gault (C-G) equation or estimated glomerular filtration rate (eGFR) using subjects' CKD-EPI equation. Subjects assigned to 1 4 groups based their CrCL (>80 mL/min, 50-80 mL/min; 30-50 mL/min <30 mL/min). Cmax statistically different between groups, while AUC T1/2el increased, CL/F decreased, increasing severity CKD. Baclofen's oral significantly correlated, trend same when classifying either C-G equations. Linear equations variable set recommend individual dose reduction patients. Results suggest mean 1/3, 1/2, 2/3 mild, moderate, severe respectively, order achieve exposure comparable that observed healthy subjects.