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No Pharmacokinetic or Pharmacodynamic Interaction Between Atorvastatin and the Oral Direct Thrombin Inhibitor Ximelagatran
Author(s) -
Sarich Troy C.,
Schützer KajsMarie,
Dorani Hassan,
Wall Ulrika,
Kalies Inge,
Ohlsson Lis,
Eriksson Ulf G.
Publication year - 2004
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 - 10.1177/0091270004268047
Subject(s) - atorvastatin , ximelagatran , pharmacology , pharmacodynamics , pharmacokinetics , direct thrombin inhibitor , discovery and development of direct thrombin inhibitors , thrombin , medicine , warfarin , atrial fibrillation , dabigatran , platelet
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.