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The Influence of Reduced Dietary Fat Absorption Induced by Orlistat on the Pharmacokinetics of Digoxin in Healthy Volunteers
Author(s) -
Melia Angela T.,
Zhi Jianguo,
KossTwardy Susan G.,
Min Bo H.,
Smith Bettye L.,
Freundlich Nancy L.,
Arora Sujata,
Passe Sharon M.
Publication year - 1995
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1002/j.1552-4604.1995.tb04128.x
Subject(s) - digoxin , pharmacokinetics , orlistat , crossover study , cmax , medicine , placebo , pharmacology , confidence interval , volunteer , absorption (acoustics) , obesity , weight loss , heart failure , physics , alternative medicine , pathology , acoustics , agronomy , biology
To assess the influence of an orlistat‐induced reduction in dietary fat absorption on the pharmacokinetics of digoxin, an open‐label, placebo‐controlled, randomized, two‐way crossover study was performed in 12 healthy volunteers. Each subject received single 0.4‐mg doses of digoxin (soft gelatin capsules) administered orally on the fourth day of orlistat (120 mg three times daily for 6 days) and placebo (three times daily for 6 days) treatment, separated by at least an 11‐day washout period. Serial blood samples were collected before and at appropriate intervals after each digoxin dose to determine plasma concentrations of unchanged digoxin. The 90% confidence intervals for the ratio of geometric least‐squares means (for C max , AUC 0–48 , AUC 0‐t , and AUC) and for the difference of arithmetic least‐squares means (for t max and Λ z ) indicate that the pharmacokinetics of digoxin was not altered by treatment with orlistat. This result suggests that a ∼30% reduction in dietary fat absorption will not change the efficacy of digoxin in cardiac patients.