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Moderate Liver Impairment Has No Influence on Daptomycin Pharmacokinetics

From Cubist Pharmaceuticals, Inc., Lexington, Massachusetts. Dr. Dvorchik's current affiliation is Barry Dvorchik and Associates, Inc., Tampa, Florida.

Daptomycin (N-decanoyl-L-tryptophyl-L-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine-lactone) is a novel cyclic lipopeptide antibiotic derived from the fermentation of Streptomyces roseosporus. Daptomycin was recently approved for the treatment of complicated skin and skin structure infections caused by aerobic gram-positive bacteria, including those caused by methicillin-resistant and methicillin-susceptible Staphylococcus aureus. This single-dose, parallel-design, matched-controlled study was designed to evaluate the pharmacokinetics of daptomycin in subjects between ages 18 and 80 years with moderately impaired hepatic function (Child-Pugh Class B, n = 10). Subjects were administered a single intravenous dose (6 mg/kg total body weight) over 30 minutes using a syringe pump. A normal volunteer control group matched by weight (±25 lb/11 kg), age (±10 years), and sex was included in this study for comparison to the hepatic-impaired group. The pharmacokinetic parameters of daptomycin were similar in both groups. Adverse events occurred only in the hepatic-impaired patients and were consistent with the subjects' disease state. In conclusion, subjects with moderate hepatic impairment receiving daptomycin do not require an adjustment in daptomycin dose or dose regimen.

Key Words: Daptomycin • liver impairment • hepatic function • pharmacokinetics • complicated skin and skin structure infections

Address for reprints: Megan Robertson, Cubist Pharmaceuticals, Inc., 65 Hayden Avenue, Lexington, MA 02421.

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