Home » Drug Information » FDA Approved Drugs » 2002
Medical Areas: Cardiology/Vascular Diseases
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Altocor (lovastatin) Extended-Release Tablets
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved June 2002
Treatment Area: Hypercholesterolemia
Altocor extended-release tablets have been approved by the FDA
as a once-daily adjunct to diet for the reduction of elevated
total-cholesterol, LDL cholesterol, Apolipoprotein B, triglycerides
and to increase HDL cholesterol in those with primary
hyper-cholesterolemia. Additionally, Altocor is indicated to slow
the progression of coronary atherosclerosis in patients with
coronary artery disease, as part of a cholesterol lowering
treatment strategy. Altocor should be used in addtion to a diet
restricted in saturated fat and cholesterol.
From 25 to 30 percent of American adults have been told at one
time they have high cholesterol levels.
The approval of Altocor is supported by results from a
multi-center placebo-controlled trial including 365 subjects.
Altocor was shown to reduce total and LDL cholesterol levels and
triglycerides and increase HDL cholesterol in subjects with
hypercholesterolemia. Response was observed after four weeks of
treatment and was maintained with continuation of therapy for up to
six months. Altocor performed significantly superior to
Adverse events associated with the use of Altocor (lovastatin)
may include (but are not limited to) the following:
- Abdominal pain
Mechanism of Action
Altocor (lovastatin) is a HMG-CoA reductase inhibitor product
that utilizes Andrx's proprietary SCOT technology to achieve
sustained blood levels of the active drug.