Lescol XL 80 mg (fluvastatin sodium), from Novartis, was approved by the FDA. Lescol XL is an extended-release and higher dose formulation of Lescol, an HMG-CoA reductase inhibitor used to treat dyslipidemia.
According to Novartis, Phase III clinical trials demonstrated that Lescol XL 80 mg produced up to 38 percent median decrease in low-density lipoprotein cholesterol in patients with dyslipidemia, and a 25 percent median decrease in triglycerides and a 13 percent mean increase in high-density lipoprotein cholesterol in patients with primary mixed dyslipidemia, as compared with Lescol 40 mg therapy.
Lescol 80 mg is indicated as an adjunct to diet to reduce elevated total cholesterol and apolipoprotein B levels, and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia and to slow the progression of atherosclerosis in patients with coronary heart disease.
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