"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]
[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.
This release contains certain "forward-looking statements," relating to the business of Novartis, which can be identified by express or implied statements regarding the potential for additional sales of Lescol as a result of this new FDA approval. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantees that the new FDA approval will result in any additional sales of Lescol. Any such results can be affected by, amongst other things, uncertainties relating to clinical trial results and product development, regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection and competition in general, as well as factors discussed in the Company's Form 20-F filed with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2002, the Group's businesses achieved sales of USD 20.9 billion and a net income of USD 4.7 billion. The Group invested approximately USD 2.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 77 200 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
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