High doses of aspirin tied to poor Brilinta response

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Seeking the data needed to remove the regulatory cloud hovering above the potential blockbuster Brilinta, a new analysis of a late-stage study shows that heart patients taking high doses of aspirin did worse than the patients on low doses. AstraZeneca will use this new analysis in its response to the FDA, which had been troubled to see data indicating that patients in the U.S. did not do as well on Brilinta as the European arm of the study. One possible reason for that, AstraZeneca had noted, could be the higher doses of aspirin used in the U.S. "While the regional interaction could arise from chance alone, two independently performed analyses identified a statistical interaction with aspirin maintenance dose that may explain the regional difference," said the researchers. Report

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