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Aspirin submission

This article was originally published in The Tan Sheet

Executive Summary

Aspirin "appears to be a significant player in the reduction in the incidence of CHD events and non-fatal myocardial infarction," according to a recent submission to FDA. Al Bartolucci, PhD, University of Alabama, et al., conducted a meta-analysis of the six major clinical trials on use of aspirin for primary prevention of heart attack, including the Women's Health Study. The researchers used data provided by the U.S. Preventive Services Task Force, finding that aspirin reduces incidence of cardiovascular events defined as a composite of CV deaths, MI and stroke. The drug had "no significant effect on stroke, fatal CHD or all-cause mortality," Bartolucci et al. add. The submission references Bayer's citizen petition submitted in 2003 seeking an indication on aspirin professional labeling for primary prevention of MI. Bartolucci et al. say their analysis is shorter version of a full-length manuscript they will submit to FDA in the future...

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