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PHARMACOKINETICS |
From the Department of Pharmacy (Dr Hebert) and the Department of Pharmaceutics (Dr H. E. Smith), University of Washington, Seattle; Orlando Clinical Research Center, Orlando, Florida (Dr Marbury); DaVita Clinical Research & Hennepin County Medical Center, Minneapolis, Minnesota (Dr Swan); New Orleans Center for Clinical Research, New Orleans, Louisiana (Dr W. B. Smith); and Fujisawa Healthcare, Inc, Deerfield, Illinois (Dr Townsend, Dr Buell, Dr Keirns, Dr Bekersky). Dr Townsend is currently at Kos Pharmaceuticals, Inc, Weston, Florida. Dr Bekersky is currently at Quark Biotech, Inc, Pleasanton, California.
Micafungin is an antifungal agent metabolized by arylsulfatase with secondary metabolism by catechol-O-methyltransferase. The objectives of this study were to estimate the pharmacokinetic parameters and plasma protein binding of micafungin in volunteers with moderate hepatic dysfunction (n = 8), volunteers with creatinine clearance <30 mL/min (n = 9), and matched controls (n = 8 and n = 9, respectively). Single-dose micafungin pharmacokinetics were estimated using noncompartmental techniques. There was a statistically lower area under the observed micafungin concentration-time curve (AUC) from time 0 to infinity for subjects with moderate hepatic dysfunction as compared to control subjects (97.5 ± 19 µg·h/mL vs 125.9 ± 26.4 µg·h/mL, P = .03), although there was no difference in micafungin weight-adjusted clearance (10.9 ± 1.7 mL/h/kg vs 9.8 ± 1.8 mL/h/kg, P = .2). The difference in area under the concentration-time curve may be explained by the differences in body weight between subjects and controls. Renal dysfunction did not alter micafungin pharmacokinetics.
Key Words: Micafungin • liver disease • renal disease • pharmacokinetics
Address for reprints: Mary F. Hebert, PharmD, Professor, University of Washington, Department of Pharmacy, H-375 Health Sciences Center, Box 357630, Seattle, WA 98195-7630; e-mail: mhebert{at}u.washington.edu.
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