Lescol XL (fluvastatin sodium) tablet, extended release
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
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)
