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| |  Statement Regarding The Results of LCAS Issued EAST HANOVER, N.J., Nov. 13, 1996 -- Sandoz Pharmaceuticals Corporation congratulates The Lipoprotein and Coronary Atherosclerosis Study investigators. LCAS demonstrated that LESCOL(R) (fluvastatin sodium) significantly slowed the progression of atherosclerosis and produced improvement in myocardial perfusion and clinical event rates among patients with mild to moderately elevated low-density lipoprotein cholesterol levels (as low as 115 mg/d1) and coronary heart disease (CHD). The majority of patients with CHD have mild to moderate elevations in LDL-C, such as the range studied in LCAS. Prior to LCAS, benefits of cholesterol-lowering treatment have been controversial in patients with mildly elevated LDL-C. As a result, appropriate treatment may not be commonly prescribed for the estimated 6 million patients with CHD and relatively lower LDL-C levels (between 100 mg/dl and 130 mg/dl) and higher elevations (between 130 mg/dl and 190 mg/d1) despite the fact that the National Cholesterol Education Program (NCEP) recommends treating patients to an LDL-C goal of 100 mg/dl. "The data from LCAS confirm that LESCOL provides benefits consistent with those shown in trials of similar drugs. The study also demonstrates the extent to which patients with mild to average elevations in LDL cholesterol can benefit from intervention with lipid-regulating therapy," said Helen Torley, M.D., medical spokesperson for Sandoz. "Information provided by LCAS, along with data from previous research, should help shed light on the appropriate course of treatment for patients with established coronary heart disease." LCAS was a randomized, double-blind, placebo-controlled trial designed to assess the effects of LESCOL on atherosclerotic lesions in patients with coronary heart disease and mildly to moderately elevated low-density lipoprotein cholesterol (LDL-C) levels. Conducted at the Baylor College of Medicine in Houston, Texas, LCAS is the first large-scale trial of LESCOL to use coronary angiography -- a technique used to visualize the heart's blood vessels -- to determine clinical benefits. Fluvastatin patients exhibited significantly less atherosclerotic progression than placebo patients: minimum lumen diameter decreased only 0.028 mm with fluvastatin versus 0.100 mm with placebo. LCAS demonstrated similar treatment benefit among both men and women treated with fluvastatin. The number of patients with new lesions was reduced by 40.5 percent with fluvastatin. New lesions occurred in 22 fluvastatin patients and 37 placebo patients. In addition, regression of atherosclerosis occurred in nearly twice as many patients receiving LESCOL than placebo (14.6 versus 8.3 percent) and progression occurred less frequently (28.7 versus 39.1 percent of patients). Although the study was not designed to detect clinical events, LCAS demonstrated a clear trend consistent with changes seen in trials of other statins. Compared to placebo, combined all-cause mortality and total cardiac events decreased by 32.8 percent in patients with baseline LDL-C < 160 mg/dl and, in this population, the number of patients requiring coronary revascularization procedures decreased 33.6 percent, while a 35.8 percent reduction was seen in the number of patients requiring any revascularization procedure (coronary, peripheral or cartoid). Functional benefits, as detected by positron-emission tomography (PET) performed in a subset of patients (79 analyzed), showed improvement in myocardial perfusion. PET scanning is a diagnostic technique based on the detection of positively charged particles (positrons) that are emitted by labeled substances (radioisotopes) introduced into the body. PET scanning produces three dimensional images that allow physicians to examine metabolic changes in the body. "The data from LCAS served as a foundation for the submission of a supplemental NDA on October 23, 1996 for an indication to slow the progression of coronary atherosclerosis in patients with coronary heart disease," said Dr. Torley. About LESCOL LESCOL is the newest member of a class of drugs known as HMG-CoA reductase inhibitors, or "statins," which are considered by many experts to be the most effective and well-tolerated drugs in lowering LDL-C levels. Priced 30 to 60 percent less than the most commonly prescribed doses of competitive products, LESCOL is the most affordably priced of the statins and provides value that could make a critical difference in long-term compliance.* In the two years since its launch into the competitive cholesterol-lowering market, LESCOL has surpassed expectations to become one of the most successful product introductions in Sandoz' history. To date, LESCOL has been prescribed to more than 1,000,000 patients and has provided consumers with health care savings of more than $160 million. In addition, more than a dozen studies confirm that LESCOL delivers the efficacy that millions of patients need to meet cholesterol-lowering goals set by the National Cholesterol Education Program (NCEP) to reduce coronary risk. LESCOL is indicated as an adjunct to diet in the treatment of elevated total cholesterol and LDL-C levels in patients with primary hypercholesterolemia whose response to dietary restriction and other non-pharmacological measures has not been adequate. In clinical trials, adverse reactions to LESCOL were mild and similar to placebo. Common adverse effects were fatigue, nausea, diarrhea, dyspepsia, abdominal pain and rash. Although rare, instances of rhabdomyolysis (inflammation of the muscles) and myopathy have been reported with fluvastatin and with other drugs in this class. Sandoz Pharmaceuticals Corporation Sandoz Pharmaceuticals Corporation is a leader in the discovery, development, manufacturing and marketing of innovative pharmaceuticals and high-quality consumer health products. Particular emphasis and expertise are focused on finding new breakthrough treatments or cures in the areas of transplantation, dermatology, disorders of the central nervous system and oncology. Sandoz Pharmaceuticals Corporation, headquartered in East Hanover, NJ, is an affiliate of Sandoz, LTD of Basel, Switzerland, a leading worldwide pharmaceutical and nutrition company. * Note: Retail pricing may vary from community to community and may affect cost savings to the patient. Price comparisons are on the most commonly prescribed doses and are not intended to imply similar levels of effectiveness of these products.
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