Thromb Haemost 2006; 95(02): 224-228
DOI: 10.1160/TH05-08-0592
Blood Coagulation, Fibrinolysis and Cellular Haemostasis
Schattauer GmbH

Anticoagulant and anti-platelet effects are maintained following coadministration of otamixaban, a direct factor Xa inhibitor, and acetylsalicylic acid

Markus Hinder
1   Sanofi-Aventis, Science and Medical Affairs, Frankfurt, Germany
,
Annke Frick
1   Sanofi-Aventis, Science and Medical Affairs, Frankfurt, Germany
,
Ronald Rosenburg
1   Sanofi-Aventis, Science and Medical Affairs, Frankfurt, Germany
,
Galina Hesse
1   Sanofi-Aventis, Science and Medical Affairs, Frankfurt, Germany
,
Marie-Laure Ozoux
2   Sanofi-Aventis, Science and Medical Affairs, Antony, France
,
Volker Laux
1   Sanofi-Aventis, Science and Medical Affairs, Frankfurt, Germany
,
Herman Scholtz
3   Sanofi-Aventis, Science and Medical Affairs, Farmovs-Parexel, Bloemfontein, South Africa
,
Alexander Gebauer
1   Sanofi-Aventis, Science and Medical Affairs, Frankfurt, Germany
,
Anne Paccaly
4   Sanofi-Aventis, Science and Medical Affairs, Bridgewater, NJ, USA
› Institutsangaben

Financial support: This study was supported by sanofi-aventis.
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Publikationsverlauf

Received 31. August 2005

Accepted after resubmission 27. Januar 2005

Publikationsdatum:
28. November 2017 (online)

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Summary

The pharmacokinetics, pharmacodynamics and safety of the direct factor Xa inhibitor, otamixaban, with and without concomitant acetylsalicylic acid (ASA) were investigated in healthy volunteers. The study was a double-blind, placebo-controlled 3-way crossover study. Sixty-eight male volunteers in total were randomised to otamixaban, ASA, or otamixaban with ASA. ASA (300 mg once a day) was started2 days before and continued on the day of the otamixaban 6-hour IV infusion (0.3 and 0.5 mg/kg). Pharmacokinetic and pharmacodynamic parameters (coagulation markers, platelet function tests and skin bleeding time) were determined. Drug interaction was assessed by the ratios of geometric means and 90 confidence intervals (90% CI)of the parameter estimates.

Pharmacokinetic parameters of otamixaban remain ed unchanged with ASA. Ratios of geometric means (90% CI) were for Ceoi 96.54 (91.21–102.19) and 95. 04 (90. 10–100. 24) and for AUC 98. 0 (93. 92–102. 25) and 95. 90 (92. 61–99. 31), for 0. 3 and 0. 5 mg/kg, respectively. No drug interaction was observed between otamixaban andASA on the coagulation and platelet function parameters. Neither otamixaban nor ASA had an effect on skin bleeding time; their co-administration led toa slight prolongation of skin bleeding time above the normal range without any clinically relevant bleeding. This study demonstrated that the desired effects of otamixaban and ASA, namely anticoagulation and platelet inhibition, respectively, are maintained during co-administration of both drugs.