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ATHEROSCLEROSIS REGRESSION: FOR FIRST TIME, RECOGNIZED IN MEDICATION LABELING

 ATHEROSCLEROSIS REGRESSION:
 FOR FIRST TIME, RECOGNIZED IN MEDICATION LABELING
 KALAMAZOO, Mich., Dec. 19 /PRNewswire/ -- For the first time in U.S. history, the clinical pharmacology section of the package insert for a cholesterol-lowering medication, Colestid Granules (colestipol), will include a statement that intensive lipid-lowering combination therapy involving this medicine has caused atherosclerosis to regress. Uncontrolled atherosclerosis can lead to heart attack.
 Colestid is indicated as adjunctive therapy to diet for the reduction of elevated serum total and low-density lipoprotein (LDL) cholesterol in patients with primary hypercholesterolemia who do not respond adequately to diet.
 The clinical pharmacology section of the package insert for Colestid will state that, "When compared to conventional measures, intensive lipid-lowering combination therapy significantly reduced the frequency of progression and increased the frequency of regression of coronary atherosclerotic lesions in patients with or at risk for coronary artery disease." Colestid was used in combination with diet plus niacin and/or lovastatin in research that produced significant lowering of total cholesterol and LDL-cholesterol (the bad form of cholesterol).
 Colestid is one of the three medications recommended as first-line treatment after dietary modification for high cholesterol by the National Cholesterol Education Program of the National Heart, Lung, and Blood Institute. (The others are cholestyramine and niacin.) Colestid may be used alone or in combination with other drugs. Preliminary evidence suggests that the cholesterol-lowering effects of lovastatin and Colestid are additive.
 The American Heart Association and the National Heart, Lung, and Blood Institute reported last year that, "Numerous epidemiologic and laboratory studies have confirmed the continuous, positive correlation of elevated serum cholesterol levels to increased CHD (coronary heart disease) risk.
 "Clinical studies have shown that modification of serum cholesterol by diet or drugs can lower that risk. The benefits of modifying serum cholesterol levels extend to men and women, young and old, those with high-risk LDL serum cholesterol levels, and those with borderline high- risk levels. Furthermore, cholesterol interventions are cost- effective."
 The joint report issued by the American Heart Association and the National, Heart, Lung, and Blood Institute estimated that CHD cost the United States between $41.5 billion and $56 billion in 1990.
 This cost could be significantly reduced by aggressive treatment of high cholesterol, even figuring in the cost of doctor visits and medication to normalize cholesterol levels when diet alone is insufficient, the report said.
 According to the U.S. Public Health Service, one of every two adult Americans has a cholesterol level higher than "desirable," and one of four Americans over age 20 has a cholesterol level "high enough to need intensive medical attention." Yet, according to a recent industry report, more than four of five hypercholesterolemic people who need treatment are not receiving medication.
 The first step in controlling high cholesterol recommended by the National Cholesterol Education Program is diet, which should be tried for at least six months. If diet alone does not work, medication is indicated.
 Colestid works by traveling through the gastrointestinal system, attaching itself to certain cholesterol-containing molecules and carrying them out of the body; Colestid is not absorbed by the body(a). Because the medication can bind with other compounds, other drugs should be taken one hour before or four hours after Colestid.
 The most commonly reported side effect among Colestid patients has been constipation, which generally can be avoided or controlled by beginning with a small dose and increasing fluid and fiber intake. Colestid should not be taken dry, but mixed with fluids, such as fruit juices, and drunk directly from a glass or with a straw.
 Colestid, which is a product of The Upjohn Company's research efforts, has been available in the United States since 1977.
 Similar labeling changes also may be seen in the near future for other medications used in the clinical trials that demonstrated the regression of coronary atherosclerotic lesions.
 The Upjohn Company (NYSE: UPJ) is a worldwide, research-based provider of human health care products, animal health products, agronomic and vegetable seeds and specialty chemicals. Headquartered in Kalamazoo, the company has been dedicated to improving health and nutrition for more than a century.
 -0- 12/19/91
 /NOTE: (a) -- A more detailed explanation of how Colestid works follows: To help an individual liquify and digest fats, the body manufactures substances known as bile acids. Bile acids are produced in the liver and gallbladder and are made using cholesterol. Following normal digestion, more than 90 percent of these bile acids are recycled back through the liver for reuse. This can contribute to high cholesterol levels in the bloodstream. Colestid binds with bile acids in the intestine and removes them from the system. As they are removed, the liver draws more cholesterol from the bloodstream in order to manufacture new bile acids. This lowers the cholesterol level in the bloodstream.
 CONTACT: Jan R. AufderHeide of The Upjohn Company, 616-323-6546/
 (UPJ) CO: The Upjohn Company ST: Michigan IN: MTC SU:


KK -- DE015 -- 3914 12/19/91 12:47 EST
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Publication:PR Newswire
Date:Dec 19, 1991
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