No Pharmacokinetic or Pharmacodynamic Interaction Between Atorvastatin and the Oral Direct Thrombin Inhibitor Ximelagatran

In this randomized, 2‐way crossover study, the potential for interaction was investigated between atorvastatin and ximelagatran, an oral direct thrombin inhibitor. Healthy female and male volunteers (n = 16) received atorvastatin 40 mg as a single oral dose and, in a separate study period, ximelagat...

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Bibliographic Details
Published in:Journal of clinical pharmacology 2004-08, Vol.44 (8), p.928-934
Main Authors: Sarich, Troy C., Schützer, Kajs-Marie, Dorani, Hassan, Wall, Ulrika, Kalies, Inge, Ohlsson, Lis, Eriksson, Ulf G.
Format: Article
Language:English
Subjects:
Administration, Oral
Adult
Anticholesteremic Agents - pharmacokinetics
Anticholesteremic Agents - pharmacology
Anticoagulants - pharmacokinetics
Anticoagulants - pharmacology
Area Under Curve
Atorvastatin
Atorvastatin Calcium
Azetidines - pharmacokinetics
Azetidines - pharmacology
Benzylamines
Cross-Over Studies
Drug Combinations
Drug Interactions
Female
Glycine - analogs & derivatives
Glycine - blood
Half-Life
Heptanoic Acids - pharmacokinetics
Heptanoic Acids - pharmacology
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors - blood
Male
oral direct thrombin inhibitors
Partial Thromboplastin Time
Prodrugs - pharmacokinetics
Prodrugs - pharmacology
Pyrroles - pharmacokinetics
Pyrroles - pharmacology
thromboembolic disease
ximelagatran
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Summary:In this randomized, 2‐way crossover study, the potential for interaction was investigated between atorvastatin and ximelagatran, an oral direct thrombin inhibitor. Healthy female and male volunteers (n = 16) received atorvastatin 40 mg as a single oral dose and, in a separate study period, ximelagatran 36 mg twice daily for 5 days plus a 40‐mg oral dose of atorvastatin on the morning of day 4. In the 15 subjects completing the study, no pharmacokinetic interaction was detected between atorvastatin and ximelagatran for all parameters investigated, including melagatran (the active form of ximelagatran) area under the plasma concentration versus time curve (AUC) and maximum plasma concentration, atorvastatin acid AUC, and AUC of active 3‐hydroxy‐3‐methylglutaryl‐coenzyme‐A (HMG‐CoA) reductase inhibitors. Atorvastatin did not alter the melagatran‐induced prolongation of the activated partial thromboplastin time, and both drugs were well tolerated when administered in combination. In conclusion, no pharmacokinetic or pharmacodynamic interaction between atorvastatin and ximelagatran was observed in this study.
ISSN:0091-2700
1552-4604
DOI:10.1177/0091270004268047