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(Circulation. 2004;109:e9004-e9005.)
© 2004 American Heart Association, Inc.

Report From the 100th Cardiovascular and Renal Drugs Advisory Committee Meeting

US Food and Drug Administration: December 8–9, 2003 Gaithersburg, Md

Thomas Fleming, PhD; Steven E. Nissen, MD; Jeffrey S. Borer, MD; Paul W. Armstrong, MD

Professor and Chair, Department of Biostatistics, University of Washington
Medical Director, Cleveland Clinic
Director, Division of Pathophysiology, Cornell University
Professor, Department of Medicine, University of Alberta

An extract of the first 250 words of the full text is provided, because this article has no abstract.

Day 1

The Committee was asked, through a citizen petition filed by Bayer Healthcare, to evaluate amending the professional labeling for the use of aspirin (ASA) to include primary prevention of myocardial infarction (MI). They cited evidence from 5 studies germane to this issue. Specifically, the request was to expand the current cardiovascular indications for daily ASA (75 to 325 mg) to include asymptomatic individuals with a 10% or greater risk of coronary heart disease over 10 years.

The Food and Drug Administration (FDA) and the Advisory Committee considered the use of ASA in primary prevention in 1998, when the Physicians Health Study (PHS) and the British Doctors Study (BDS) were reviewed. At that time, the FDA concluded that the data were insufficient to warrant a change identical to that requested in the current application. Since then, 3 new studies have been conducted and were provided for the current review: (1) the Thrombosis Prevention Trial (TPT), (2) the Hypertension Optima Trial (HOT), and (3) the Primary Prevention Project (PPP).

Overall, these 5 trials represent data from more than 55 000 patients in placebo-controlled trials from heterogeneous patient populations, using differing doses and formulations of ASA, and aimed towards differing primary end points. The 2 previously reviewed studies in male doctors account for more than 27 000 patients within the new pooled analysis supporting the claim. TPT, conducted between 1984 and 1989 in 5085 British males, was a factorial study involving ASA and warfarin that revealed a 32% reduction in nonfatal MI (. . . [Full Text of this Article]