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Home » Drug Information » FDA Approved Drugs » 2000
Medical Areas: Cardiology/Vascular Diseases | Endocrinology | Family Medicine

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Lescol XL (fluvastatin sodium) tablet, extended release

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Novartis
Approval Status: Approved October 2000
Treatment Area: For the use as an adjunct to diet to reduce elevated total cholesterol

General Information

Lescol is water soluble and acts through the inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. It is available by prescription only for the reduction of cholesterol levels. Specifically, Lescol is indicated for the use as an adjunct to diet to reduce elevated total cholesterol (total-C), LDL-C, TG, and Apo B levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia (Frederickson Type IIa and IIb) whose response to dietary restriction of saturated fat and cholesterol and other nonpharmacological measures has not been adequate and to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total and LDL cholesterol to target levels (From FDA Label).

Clinical Results

Twelve placebo-controlled studies were conducted involving subjects with Type IIa or IIb hyperlipoproteinemia. Lescol was administered daily to 1621 subjects for at least 6 weeks. After 24 weeks, treatment resulted in average LDL-C reductions of 22% for the 20mg dose, 25% for the 40mg dose and 36% for the 80mg dose. Treatment with Lescol reduced Apo B and triglycerides while increasing HDL-C.

Five studies testing Lescol XL Extended-Release Tablets have been conducted in subjects with Type IIa and IIb hyperlipoproteinemia. Over 900 subjects received treatment with the treatment period ranging from 4 to 26 weeks. The three largest of these studies administered 80mg of Lescol XL in one single daily dose. Results showed that Lescol XL significantly reduced Total-C, LDL-C, TG and Apo B.

For more complete clinical trial results please see the FDA label at: Lescol XL

Side Effects

Lescol XL has been shown to cause birth defects and fetal mortality in test animals. The drug is present in the milk of nursing mothers in a 2:1 ratio (milk to drug). All women of child-bearing age should consult their doctor as to the risks associated with taking Lescol XL.

Common side effects of Lescol XL include, but are not limited to:

  • Upper respiratory tract infection
  • Coughing
  • Bronchitis
  • Sinusitis
  • Dyspepsia
  • Diarrhea
  • Abdominal Pain
  • Nausea
  • Dizziness
  • Headache
  • Back Pain
  • Insomnia
  • Fatigue
  • Urinary Tract Infections

36 of 912 patients treated with Lescol XL during clinical trials discontinued use due to adverse events. Lescol XL also has negative interactions with multiple drugs. For a more complete listing of adverse events see the company web site at: Lescol XL

Mechanism of Action

Lescol is a competitive inhibitor of HMG-CoA reductase, which is responsible for the conversion of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) to mevalonate, a precursor of sterols, including cholesterol. The inhibition of cholesterol biosynthesis reduces the cholesterol in hepatic cells, which stimulates the synthesis of LDL receptors and thereby increases the uptake of LDL particles. The end result of these biochemical processes is a reduction of the plasma cholesterol concentration. (From FDA Label)