AHCPR findings reaffirm medical consensus; Coumadin -- Warfarin Sodium -- therapy prevents thromboembolic strokes in AF; saves money.

WILMINGTON, Del.--(HealthWire)--Sept. 7, 1995--The results of the U.S. Department of Health and Human Services/Agency for Health Care Policy and Research's PORT (Patient Outcomes Research Team) study, which found that expanded access to Coumadin(R) (Warfarin Sodium) therapy could reduce by more than 50 percent the nearly 80,000 strokes each year due to atrial fibrillation (AF) and save nearly $600 million in medical costs annually, reaffirm a well-established medical consensus about the benefits of anticoagulant therapy in this patient population.

Atrial fibrillation (AF) is a common heart arrhythmia in which the atrial chamber contracts rapidly and irregularly. More than one million Americans have the condition.

In a 1994 pooled analysis of five large-scale international clinical trials published in the July 11 issue of the Archives of Internal Medicine, investigators reported that warfarin therapy reduces the risk of thromboembolic stroke by 68 percent with minimal increase in the frequency of major bleeding. Moreover, the study indicated that the efficacy of warfarin was even more pronounced in women, lowering the stroke risk by 84 percent.

That same month, the American College of Physicians (ACP) promulgated its ``Guidelines for Medical Treatment for Stroke Prevention.'' The ACP recommended that warfarin be used as first-line treatment in patients with AF who are candidates for anticoagulation. And in 1992, the American College of Chest Physicians (ACCP), in its Consensus Conference report on antithrombotic therapy, recommended that ``long-term oral warfarin therapy be used in patients with atrial fibrillation who are eligible for anticoagulation, except in patients less than 60 years of age who have no associated cardiovascular disease.''

``The PORT study provides further evidence of the tremendous social benefits to be obtained by expanding access to anticoagulation therapy in eligible patients with AF,'' said David Grandison, MD, senior director of medical affairs, DuPont Merck. ``Today, we know that patients with AF with the highest risk of stroke include those above age 65, those who have had a previous stroke or transient ischemic attack, those with a history of hypertension, and those with diabetes. Anticoagulation therapy should be considered for this large pool of patients, as the benefits may be significant.

``To this end, DuPont Merck is continuing its efforts with such public interest groups as the National Stroke Association, the Alliance for Aging Research, the Stroke Belt Consortium, and medical societies including the ACP and the ACCP to help educate and inform patients and physicians about stroke and what can be done to prevent it.''

The most common risk associated with Coumadin is bleeding. Coumadin should not be used in women who are or may become pregnant, patients with unsupervised dementia or certain other psychoses, and in other conditions in which the risk of trauma with bleeding exceeds the clinical benefit of anticoagulation.

In addition to the prevention and treatment of the thromboembolic complications associated with AF and cardiac valve replacement, Coumadin is indicated for the prophylaxis and treatment of venous thrombosis and its extension, and for pulmonary embolism. Coumadin also is indicated to reduce the risk of death, recurrent myocardial infarction (MI), and thromboembolic events, such as stroke or systemic embolization, after MI.

One of the most frequently prescribed cardiovascular medications, Coumadin (Warfarin Sodium) is a product of The DuPont Merck Pharmaceutical Company, marketed under the DuPont Pharma banner. DuPont Merck is a worldwide, research-based pharmaceutical company. Formed in 1991 as a partnership between DuPont and Merck and Co., DuPont Merck is focused on research, development and delivery of pharmaceuticals to treat unmet medical needs in the fight against cardiovascular, central nervous system and inflammatory diseases, cancer, and AIDS. The company also is a leader in radiopharmaceuticals.

CONTACT: DuPont Merck, Wilmington

Laura Mastrangelo, 302/892-8453

or

Bozell Worldwide, Chicago

Jay Branson, 312/988-2337