At. Melia et al., THE INFLUENCE OF REDUCED DIETARY-FAT ABSORPTION INDUCED BY ORLISTAT ON THE PHARMACOKINETICS OF DIGOXIN IN HEALTHY-VOLUNTEERS, Journal of clinical pharmacology, 35(8), 1995, pp. 840-843
To assess the influence of an orlistat-induced reduction in dietary fa
t absorption on the pharmacokinetics of digoxin, an open-label, placeb
o-controlled, randomized, two-way crossover study was performed in 12
healthy volunteers. Each subject received single 0.4-mg doses of digox
in (soft gelatin capsules) administered orally on the fourth day of or
listat (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 p
eriod. Serial blood samples were collected before and at appropriate i
ntervals after each digoxin dose to determine plasma concentrations of
unchanged digoxin. The 90% confidence intervals for the ratio of geom
etric least-squares means (for C-max,C- AUC(0-48,) AUCo(0-t,) and AUC)
and for the difference of arithmetic least-squares means (for t(max)
and lambda(z)) indicate that the pharmacokinetics of digoxin was not a
ltered by treatment with orlistat. This result suggests that a similar
to 30% reduction in dietary fat absorption will not change the effica
cy of digoxin in cardiac patients.