FDA approves Lescol and Lescol XL for secondary prevention of coronary events in heart disease patients
BASEL, SWITZERLAND, May 28, 2003 -- Novartis announced that the 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."
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. (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. JAMA 2002;287:3215-3222.)
Lescol and Lescol XL are statin drugs used in the treatment of atherosclerosis and vascular disease.
Source: Novartis www.novartis.com
Posted: May 2003
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