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| |  Preliminary Findings with Lescol in Coronary Heart Disease HOUSTON, Nov. 14, 1995 -- In a presentation made on Nov. 9 at the Drugs Affecting Lipid Metabolism (DALM) meeting here, Antonio M. Gotto, Jr., M.D., Ph.D., Chairman of the Department of Medicine at Baylor College of Medicine, presented preliminary findings with Lescol(R) (fluvastatin sodium) in patients with coronary heart disease. Lescol is the most recently introduced HMG-CoA reductase inhibitor, a class of drugs (also called statins) which is indicated for the control of high blood cholesterol. In a pilot study performed in patients with documented coronary artery disease, 12 weeks of treatment with Lescol demonstrated a significant increase of 30 percent in blood flow to affected vessels. Dr. Gotto stated that these findings from a German study will be definitively assessed in a large clinical trial nearing completion here at the Baylor College of Medicine. This study, the Lipoprotein and Coronary Atherosclerosis Study (LCAS) will examine the benefit of Lescol treatment over two and one-half years in patients with proven coronary disease. In addition to studying the effect of treatment through classic heart catheterization findings, LCAS will also provide data in a group of patients examined by position emission topography (PET) scanning. This advanced technology is perhaps the most accurate method of assessing changes in blood flow to the heart, without requiring a major invasive procedure. LCAS will conclude treatment early in 1996, with reporting of the data planned later next year. "The emerging data with statins in the treatment of coronary heart disease and the reduction of coronary events is the most exciting thing I have witnessed in this field in the last 20 years,"said Dr. Gotto. Dr. Gotto also acknowledged a retrospective analysis of safety data from earlier clinical trials conducted with Lescol. This pooled database indicated that serious cardiac adverse events were less commonly seen with fluvastatin than with corresponding placebo. Although these data are consistent with other studies of statin drugs, they will require confirmation through studies such as LCAS. Lescol, which has now been introduced in over 30 countries around the world, is marketed by Sandoz LTD., Basel, Switzerland. Lescol is distributed in the United States by Sandoz Pharmaceuticals Corp.. CONTACT: Peter Foley of Porter/Novelli, 212-872-8091; or William J. O'Donnel of Sandoz Pharmaceuticals, 201-503-7070
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