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FDA Approves Lescol (Fluvastatin) And Lescol XL For Secondary Prevention Of Coronary Events In Patients With Coronary Heart Disease BASEL, SWITZERLAND -- May 28, 2003 -- Novartis announced today that the US Food and Drug Administration (FDA) has approved Lescol® (fluvastatin sodium) and Lescol® XL (fluvastatin sodium) 80 mg extended-release tablets to reduce the risk of undergoing coronary revascularization procedures in patients with coronary heart disease. The FDA approval is based on the positive findings of the landmark Lescol Intervention Prevention Study (LIPS) which was the first prospective statin trial in post-angioplasty patients. Lescol and Lescol XL 80 mg extended-release tablets have been approved for secondary prevention in several countries, including the United Kingdom, Germany and Mexico. Regulatory reviews are also ongoing in other key markets. "The fact that nearly 2 million people world-wide require an angioplasty procedure each year underscores the importance of this new indication," said Thomas Ebeling, chief executive officer of Novartis Pharma AG. "The approval of Lescol to reduce the risk of revascularization procedures significantly broadens its scope in treating patients with coronary heart disease." About the LIPS Trial LIPS was designed to investigate whether cholesterol lowering with Lescol, initiated shortly after successful completion of a first PCI, with or without stent, would prolong cardiac disease-free survival. LIPS was the first prospective, randomized, placebo-controlled trial to examine a statin in this patient population and involved 1,677 patients in 57 centers in 10 countries. The data demonstrated that treatment with Lescol 80 mg (40 mg twice daily), routinely initiated within days after a first PCI procedure, significantly reduced the risk of major cardiac events (cardiac death, nonfatal MI, coronary revascularization) by 22 percent (p=0.013) versus placebo, even in patients with normal cholesterol levels with or without a history of myocardial infarction.[i] The LIPS data further underscored the excellent safety profile of Lescol. In the study, there were no significant elevations of creatine phosphokinase (CPK) above 10 times the upper limits of normal (ULN) over the three to four years of follow up. Elevated CPK is an indication of muscle breakdown and is a potential side effect of statin therapies. These safety data match those from recent analyses finding that the rate of clinically relevant CPK elevations in patients receiving Lescol or Lescol XL as monotherapy or in combination with a fibrate was not significantly different from the rate seen in patients receiving placebo.[ii],[iii] About Lescol Lescol and Lescol XL are statin drugs used in the treatment of atherosclerosis and vascular disease. Novartis introduced Lescol extended-release, once-daily 80 mg formulation in 2000 (Lescol XL), which has been shown in trials to provide effective lipid management, with reductions of 38% in LDL-cholesterol, up to 31% in triglycerides and increases of up to 21% in HDL-cholesterol.[i] References: [i] Ballantyne et al. Efficacy and tolerability of fluvastatin extended-release deliver system: a pooled analysis. Clin Ther 2001;23:177-192. [i] Serruys PWJC, de Feyter P, Macaya C, et al. Fluvastatin for prevention of cardiac events following successful first percutaneous coronary intervention; a randomized controlled trial. J Am Med Assoc 2002;287:3215-3222. [ii] Benghozi R, Bortolini M, Jia Y, Isaacsohn JL, Troendle AJ, Gonasun L. Frequency of creatine kinase elevation during treatment with fluvastatin. Am J Cardiol 2002;89:231-233. [iii] Farnier M, Bortolini M, Salko T, et al. Frequency of creatine kinase elevation during treatment with fluvastatin in combination with fibrates (bezafibrate, fenofibrate, or gemfibrozil. Am J Cardiol 2003;91:238-240. SOURCE: Novartis E-mail this page to a friend or colleague! To print, use this version