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| | | ![]() Lescol/LescolXL (Fluvastatin) Maintains Favorable Efficacy/Safety Profile in Lipid Management BASEL, SWITZERLAND -- January 18, 2002 -- Lescol®/Lescol® XL (fluvastatin), the cholesterol-lowering drug from Novartis, offers a particularly favourable efficacy/safety profile, according to a large-scale analysis of creatine phosphokinase (CPK) safety data published in this month’s American Journal of Cardiology (1). Based on an analysis of all the Lescol studies conducted by Novartis from 1987 to 2001 and involving nearly 9000 patients, the report confirms that Lescol/Lescol XL as monotherapy is highly effective in lowering blood lipids, and has a CPK safety profile similar to that of placebo (inactive treatment). "This is a key finding", said co-author Dr Jonathon Isaacsohn, Cincinnati, Ohio. "Statins have proved generally well tolerated and have a favourable safety profile, but there may be significant differences between them. Our analysis of CPK elevations in these clinical trials shows that Lescol/Lescol XL has a very favourable safety profile, similar to that of placebo. No cases of rhabdomyolysis were observed." Importantly, a previous pooled analysis of three phase-3 studies demonstrated that Lescol/Lescol XL was effective in managing lipid levels, achieving reductions of up to 38 percent in harmful low-density lipoprotein (LDL)-cholesterol, and up to 31 percent in triglycerides, while raising levels of beneficial high-density lipoprotein (HDL)-cholesterol by up to 21 percent (2). This underscores the drug's favourable efficacy/safety profile in patients who need comprehensive lipid management. References: (1) Benghozi et al. Am J Cardiol 2002;89:231-3. (2) Ballantyne et al: Efficacy and Tolerability of Fluvastatin Extended-Relases Delivery System: A Pooled Analysis. Clinical Therapeutics 2001, No 2, Vol 23, p177-192.
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