S. Snel et al., TIAGABINE, A NOVEL ANTIEPILEPTIC AGENT - LACK OF PHARMACOKINETIC INTERACTION WITH DIGOXIN, European Journal of Clinical Pharmacology, 54(4), 1998, pp. 355-357
Objective: To assess the possibility of any clinically relevant pharma
cokinetic interactions between tiagabine, a novel antiepileptic drug,
and digoxin. Methods: Potential pharmacokinetic interactions between t
iagabine and digoxin were investigated in an open-label, two-period cr
oss-over study in healthy male volunteers. Thirteen volunteers, aged b
etween 18 and 43 years, were randomised to receive digoxin (0.5 mg twi
ce a day for 1 day, then 0.25 mg once a day for 8 days) either alone o
r co-administered with tiagabine (4 mg three times daily for 9 days).
Following a 7-day washout period, volunteers crossed over to the other
dosing regimen. Peak serum concentration, time to maximum serum conce
ntration, area under the serum concentration-time curve from zero to 2
4 h and steady state serum concentration were calculated for digoxin a
nd compared between treatment groups. Results: No statistically signif
icant differences between treatment groups were observed for any of th
e derived digoxin pharmacokinetic parameters. The most common adverse
events reported during digoxin alone;Ind in combination with tiagabine
were somnolence and headache; an overall greater frequency of adverse
events was reported during combined treatment. Adverse events were ge
nerally mild in nature; no serious adverse events were reported. Concl
usions: At the doses administered, there is 30 evidence of a pharmacok
inetic interaction between digoxin and tiagabine in healthy male volun
teers.