J Clin Pharmacol
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CLINICAL STUDIES

Lumiracoxib Does Not Affect the Ex Vivo Antiplatelet Aggregation Activity of Low-Dose Aspirin in Healthy Subjects

J. Jermany, PhD, J. Branson, MSc, R. Schmouder, MD, M. Guillaume, MD and C. Rordorf, MD

From Novartis Institutes for BioMedical Research, Inc, Cambridge, Massachusetts (Dr Jermany); Novartis Pharma AG, Basel, Switzerland (Ms Branson, Dr Rordorf); Novartis Pharmaceuticals Corporation, East Hanover, New Jersey (Dr Schmouder); and Aster, Paris, France (Dr Guillaume).

This randomized, double-blind, placebo-controlled study evaluated the pharmacodynamic effects of concomitant low-dose aspirin and lumiracoxib in healthy subjects. Participants received lumiracoxib 400 mg once daily (n = 14) or placebo (n = 14) for 11 days, with concomitant low-dose aspirin (75 mg once daily) from days 5 to 11. Ex vivo pharmacodynamic assessments included assays of platelet aggregation and urinary thromboxane and prostacyclin metabolite profile. Arachidonic acid–stimulated platelet aggregation was reduced from 76.3% on day 4 to 4.8% on day 11 in the placebo group and from 75.8% on day 4 to 5.1% on day 11 in the lumiracoxib group. Collagen-induced platelet aggregation was reduced from 77.5% on day 4 to 52.8% on day 11 in the placebo group and from 79.5% on day 4 to 55.9% on day 11 in the lumiracoxib group. Urinary thromboxane and prostacyclin were unaffected by lumiracoxib. In conclusion, concomitant lumiracoxib did not interfere with the cyclooxygenase-1-mediated antiplatelet effects of low-dose aspirin.


Key Words: Lumiracoxibaspirinplateletaggregation

Address for reprints: Christiane Rordorf, Novartis Pharma AG, Exploratory Clinical Development, WSJ-103-4 D, CH-4002 Basel, Switzerland; e-mail: christiane.rordorf{at}novartis.com.







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