80 mg, an extended-release tablet formulation of fluvastatin. The drug provides effective management of all major lipid parameters for patients with a variety of lipid disorders that place them at risk for heart disease. Phase III data demonstrate that this new formulation has the potential to bring the majority of patients who require statin therapy to their treatment goals. The National Heart, Lung, and Blood Institute created the NCEP to contribute to reducing illness and death from coronary heart disease in the United States by reducing the percent of Americans with high blood cholesterol.
Statins block the enzymatic pathway for cholesterol synthesis in the liver.
The reformulated extended-release Lescol XL 80 mg tablet provides patients with a higher dose of medication, while maintaining safety. With this slow release delivery form of the drug, availability of the statin to the liver is increased while minimizing the risk of systemic exposure to high drug doses throughout the body. In addition, fluvastatin is not predominantly metabolized by the cytochrome P450 3A4 pathway, thus minimizing the potential for interactions with drugs that patients commonly take on a daily basis that are metabolized through this pathway. Lescol XL 80 mg also has been approved by health authorities in Austria, Brazil, Portugal, Switzerland, Thailand, and the United Kingdom. The FDA approved Lescol XL 80mg based on their review of data from five controlled clinical trials that were four to 24 weeks in duration in more than 900 patients with Type IIa or IIb hyperlipoproteinemia.