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

• DOI: 10.1002/jcph.247
• Publication Date: 2014-01-10T17:46:40Z
• Authors: Raphaël Vlavonou; Marc M. Perreault; Olivier Barrière; Eric Shink; Pierre-Olivier Tr...; Richard Larouche; Vincent Pichette; Mario Tanguay
• Keywords: Baclofen

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.