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Effects of Ezetimibe on Cyclosporine Pharmacokinetics in Healthy Subjects

From Merck Research Laboratories, Rahway, New Jersey, and West Point, Pennsylvania (Dr Bergman, Ms Burke, Mr Larson, Dr Johnson-Levonas, Dr Murphy, Dr Gottesdiener, Dr Paolini); Schering-Plough Research Institute, Kenilworth, New Jersey (Dr Reyderman, Dr Statkevich, Dr Kosoglou); and the Clinical Research Unit, Division of Clinical Pharmacology, Department of Medicine, Thomas Jefferson University, Philadelphia, Pennsylvania (Dr Greenberg, Dr Kraft, Dr Frick).

This single-center, open-label, 2-period crossover study investigated the effects of multiple-dose ezetimibe (EZE) on a single dose of cyclosporine (CyA). Healthy subjects received 2 treatments in random order with a 14-day washout: (1) CyA 100 mg alone and (2) EZE 20 mg for 7 days with CyA 100 mg coadministered on day 7; EZE 20 mg alone was administered on day 8. AUC_(0-last) and C_max geometric mean ratios (90% confidence interval) for ([CyA + EZE]/CyA alone) were 1.15 (1.07, 1.25) and 1.10 (0.97, 1.26), respectively. T_max (1.3 hours) was similar with and without EZE (P >.200). Mean CyA exposure slightly increased (15%) with multiple-dose EZE 20 mg; however, this value was contained within (0.80, 1.25). The implications for chronic EZE dosing within the usual clinical paradigm of chronic CyA dosing have not been established; caution is recommended when using these agents concomitantly. CyA concentrations should be monitored in patients receiving EZE and CyA.

Key Words: Ezetimibe • cyclosporine • interaction

Address for reprints: Arthur J. Bergman, Clinical Drug Metabolism, Merck & Co, Inc, WP 75-100, Sumneytown Pike, PO Box 4, West Point, PA 19486.

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