December 09, 2003

FDA Advisory Committee underscores need for greater understanding of Aspirin's benefit in appropriate patient populations

Bayer committed to ongoing work with FDA to advance public health goal of broader Aspirin use in appropriate patients to reduce burden of heart disease

Gaithersburg, USA
- The U.S. Food and Drug Administration (FDA) Cardiovascular & Renal Drugs Advisory Committee convened today to consider broadening the professional labeling of aspirin to include an indication for prevention of first heart attack (primary prevention) in individuals at moderate risk of coronary heart disease (CHD). While the committee expressed a desire for additional supporting data, the members broadly recognized the life-saving benefits of aspirin in patients for whom it is currently indicated, and reiterated the public health potential of its broader use. Bayer Consumer Care acknowledged the committee's vote with a reaffirmation of its commitment to continue working with the FDA to advance the broader appropriate use of aspirin in the prevention of coronary events.

Committee members who voted in favor of approving aspirin for primary prevention cited the totality of the evidence, and acknowledged the public health imperative of reducing the burden of cardiovascular disease in this country. Representatives of medical organizations such as the American Heart Association (AHA), the U.S. Preventive Health Services Task Force (USPSTF), the American College of Cardiology, the American Diabetes Association and the American Academy of Family Physicians spoke out in strong support of approval. Several FDA committee members acknowledged that they themselves take aspirin and recommend it to their patients for primary prevention.

Earlier this year, Bayer filed a Citizen's Petition requesting expanded labeling for the use of low dose (75-325 mg) aspirin in the prevention of a first heart attack in patients at moderate risk (defined as a 10 year risk of CHD that equals or exceeds 10%). The basis of the Petition was a systematic evidence review that provided the foundation for recently (2002) published clinical primary prevention guidelines from the USPSTF and the AHA - which advise that individuals with a 10-year risk of CHD in the range of 6-10% and above should be considered as candidates for aspirin therapy. Today, approximately 100 million people may be at risk of developing CHD and as many as 62 million Americans already have some form of heart disease and may be at risk of experiencing a coronary event. Yet, only a fraction of those that could benefit from a physician-directed aspirin regimen are on one.

"We believe it is ultimately important that professional labeling be aligned with widely recognized guidelines, while acknowledging that sound clinical judgment is the basis for recommending aspirin to appropriate patients," said Thomas Pearson, MD, MPH, PhD, Department Chair, Albert D. Kaiser Professor, Division of Epidemiology, Community & Preventive Medicine at the University of Rochester and first author of the American Heart Association Guidelines for Primary Prevention of Cardiovascular Disease and Stroke. "What we're trying to do is to get the right people taking aspirin for prevention of a first heart attack. What we learned today is that the exact groups need to be further defined."

Presented at today's meeting were important new findings by Randall Stafford, MD, PhD, assistant professor of medicine at Stanford University Medical School, which highlighted the underutilization of aspirin across the strata of risk profiles. "These findings confirm the dramatic underutilization of aspirin. For example, only 25 percent of those at highest risk of heart attack - patients with prior history of heart attack for whom aspirin's lifesaving benefits are well-recognized - were recommended to take it by their physician," he said. "This clearly underscores the critical need for a broadened professional aspirin label."

The recommendation today by the committee does not change the medical community's view of aspirin's multitude of professional cardiovascular indications already approved by the FDA. Specifically, aspirin's benefit has been clearly proven and is widely recognized in prevention of recurrent heart attacks (MI), death during a suspected acute MI, recurrent ischemic strokes and ischemic strokes after temporary ischemic attacks (TIAs) as well as heart attacks among patients with unstable angina pectoris and chronic stable angina pectoris.

"Today's discussions underscore the incontrovertible evidence to support the current use of aspirin for prevention of recurrent heart attacks," said C. Noel Bairey Merz, MD, Women's Guild Endowed Chair in Women's Health and the medical director of the Cedars-Sinai Women's Health Program, who also presented at the meeting. "We must be vigilant that our patients who are already on aspirin therapy remain so, and must continue to conduct careful risk assessments, ensuring sound clinical decisions for those patients at risk."

"Bayer commends the committee for its careful consideration of aspirin's role in reducing the risk of first heart attack," said Erica Peitler, Senior Vice President of Global Strategic Initiatives in the Bayer Consumer Care Division. "We appreciate the important feedback provided today and we're encouraged that the committee is willing to consider professional labeling based on global - rather than event-based - risk. This is a big step forward in identifying a broader group of appropriate patients that can benefit from aspirin therapy. Bayer remains committed to partnering with the FDA in advancing comprehensive educational and scientific initiatives that enhance the current understanding of aspirin's role in reducing the burden of heart disease."

Bayer Consumer Care, a division of Bayer HealthCare, is headquartered in Morristown, N.J. Bayer Consumer Care is among the largest marketers of over-the-counter medications in the world. Some of the most trusted and recognizable brands in the world today come from the Bayer portfolio of products. These include Bayer Aspirin, Aleve, Phillips' Milk of Magnesia, Midol, Alka-Seltzer, Alka-Seltzer Plus, Bactine, RID, and One-A-Day and Flintstones vitamins. Bayer HealthCare combines the global activities of the Animal Health, Biological Products, Consumer Care, Diagnostics and Pharmaceuticals divisions. A subgroup of Bayer AG, Bayer HealthCare has annual sales of approximately 10 billion Euro and employs more than 34,000 people worldwide.

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