Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:dateCreated
1999-12-10
pubmed:abstractText
The safety, and the pharmacodynamic and pharmacokinetic compatibility of clopidogrel, 75 mg daily, with the cardiac glycoside digoxin, were assessed in 12 healthy male subjects who took digoxin 0.25 mg once daily for 20 days and, in addition, clopidogrel 75 mg once daily from day 11 to day 20, so as to achieve steady-state conditions with both drugs. The drugs were taken after an overnight fast, and a standardized breakfast was served 30 minutes later. Blood samples for digoxin determination were drawn pre-dose on days 1, 8, 9, 10, 18, 19, and 20 of the schedule, and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, and 24 hours post-dose on days 10 and 20. Urine samples were collected pre-dose and from 0-4, 4-8, 8-12, and 12-24 hours post-dose on days 10 and 20. Platelet aggregation studies were carried out using ADP at 5 micromol/L final concentration as an agonist. Establishment of steady-state plasma concentrations of digoxin on days 8-11 and 18-21 was confirmed by application of Dunnett's test on the trough plasma concentrations. The plasma pharmacokinetics and urinary excretions of digoxin for day 10 and day 20 were very similar: the day 20/day 10 ratios (90% Cl) were 1.1 (0.99; 1.24) for Cmax, 1.0 (0.92; 1.08) for Cmin, 1.02 (0.96; 1.07) for AUC(0-24), and 0.99 (0.94; 104) for urinary excretion. Mean inhibition of ADP-induced platelet aggregation at the end of the clopidogrel treatment period was 34%. The clinical, cardiac, and biological evidence from the study indicated that clopidogrel administration does not enhance digoxin's cardiac effects. Overall, the data indicated that there is no reason to anticipate an interaction when clopidogrel is added to digoxin for long-term management of patients with cardiac disease.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:issn
0094-6176
pubmed:author
pubmed:issnType
Print
pubmed:volume
25 Suppl 2
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
51-4
pubmed:dateRevised
2006-3-7
pubmed:meshHeading
pubmed:year
1999
pubmed:articleTitle
Clopidogrel, a novel antiplatelet agent, and digoxin: absence of pharmacodynamic and pharmacokinetic interaction.
pubmed:affiliation
N.V. Organon, Oss, The Netherlands.
pubmed:publicationType
Journal Article, Clinical Trial, Clinical Trial, Phase III