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| |  FDA Urged to Expand Uses for Aspirin MORRISTOWN, N.J., Jan. 23, 1997 -- Bayer Corporation says two FDA advisory committees confirmed the value of aspirin in heart attack and stroke prevention and recommended to the FDA its use in broader patient populations, which could save the lives of millions of Americans whose doctors determine they are at high risk for cardiovascular disease. A joint meeting of the FDA's Cardiovascular-Renal and Non-Prescription Drugs advisory committees acknowledged aspirin's preventive benefits in numerous groups of patients at high risk for heart attack and stroke. The recommendation includes people who have undergone procedures to restore blood flow in arteries and veins, and other patients with clinically manifested symptoms of blocked or narrowed blood vessels. Specific recommendations include use in patients at risk of heart attack and stroke because of a condition called stable angina. The committee members also suggested that the FDA approve the use of lower doses of aspirin for cardiovascular disease prevention than are currently recommended, as well as in the treatment of all forms of stroke caused by obstructions of blood flow to the brain, based on studies confirming efficacy at these levels. According to evidence presented at the meeting, aspirin's benefits far outweigh any risk of gastrointestinal bleeding or stomach upset, which were deemed to be relatively rare and insignificant side effects when compared to aspirin's lifesaving potential. The advisory committee members also concluded that aspirin may play a role in the treatment of peripheral vascular disease, and even recommend its use in many of their own practices, but felt the weight of evidence was insufficient to warrant making specific recommendations about aspirin's role and requested additional research in this area. Also today, the FDA signaled that it intends to broaden aspirin's currently approved indications and will begin encouraging physicians to administer aspirin for: (1) prevention of stroke in women after a transient ischemic attack, also called TIA or "mini-stroke," and often a precursor of full stroke, and (2) prevention of stroke in men and women who previously have suffered a minor stroke. "Women, often relied on as family caregivers, are highly susceptible to stroke, which can strip them of their ability to take care of themselves and their families," said Debra R. Judelson, M.D., FACC, FACP, president of the American Medical Women's Association, director, Women's Cardiovascular Institute of Southern California and senior partner of the Cardiovascular Medical Group of Southern California. "With aspirin, we're now aware of a new way to help fight this debilitating disease and reduce the toll it takes on American women." Since the 1980s, aspirin's role in stroke prevention has been acknowledged in men only. However, as many as 228,000 women in the U.S. suffer stroke annually, and more women than men die from stroke each year, according to the American Heart Association. In total, about 500,000 Americans suffer stroke each year. Today's announcement marks another demonstration of the FDA's intent to expand aspirin's professional labeling, where the FDA guides physicians on administering medications to patients. In June 1996, the FDA proposed aspirin for use during a suspected heart attack. Under physician supervision, as little as one-half (162.5 mg) of a regular strength tablet taken as soon as a heart attack is suspected and continued for 30 days reduces risk of death by 23 percent. Heart attack is the nation's leading killer, striking 1.5 million Americans annually and killing nearly one-third of them. A 25 percent reduction in the number of heart attacks can save between 10,000-20,000 people annually. aspirin's new uses have been based on more than 100 clinical trials involving aspirin -- many of which used Bayer Aspirin. Some of the more important published work includes: -- ISIS-2, published in the British medical journal The Lancet in 1988, involved more than 17,000 people in 417 hospitals. It showed that aspirin can play a significant role in increasing the chances of survival during and after heart attack. -- ANTIPLATELET TRIALISTS' COLLABORATION, published on Jan. 6, 1994, in the British Medical Journal, which, after analyzing the results of 145 randomized trials, determined that among a much a wider range of patients at high risk for blockage to the blood vessels than is currently treated, an aspirin regimen 75-325mg/day and taken for some years routinely offers worthwhile protection against heart attack, stroke and death. -- RISC Group study, appearing in The Lancet on Oct. 6, 1990, linked regular use of low-dose aspirin to a reduction in the risk of heart attack between 57 and 69 percent in men with unstable coronary artery disease. -- DUTCH TIA study, published in the Oct. 31, 1991, New England Journal of Medicine, demonstrated that low-dose aspirin had fewer side effects yet the same effectiveness as higher doses in preventing recurrent nonfatal stroke and nonfatal heart attack.
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