Effects of ezetimibe on cyclosporine pharmacokinetics in healthy subjects

J Clin Pharmacol. 2006 Mar;46(3):321-7. doi: 10.1177/0091270005284851.

Abstract

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 Cmax 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. Tmax (approximately 1.3 hours) was similar with and without EZE (P >.200). Mean CyA exposure slightly increased (approximately 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.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anticholesteremic Agents / pharmacology*
  • Area Under Curve
  • Azetidines / pharmacology*
  • Cross-Over Studies
  • Cyclosporine / pharmacokinetics*
  • Dose-Response Relationship, Drug
  • Drug Interactions
  • Drug Monitoring
  • Ezetimibe
  • Female
  • Humans
  • Immunosuppressive Agents / pharmacokinetics*
  • Male

Substances

  • Anticholesteremic Agents
  • Azetidines
  • Immunosuppressive Agents
  • Cyclosporine
  • Ezetimibe