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CLINICAL STUDIES |
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 acidstimulated 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: Lumiracoxib aspirin platelet aggregation
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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