The following information is obtained from various newswires,
published medical journal articles, and medical conference presentations.
Company: Andrx
Approval Status: Approved June 2002
Treatment for: Hypercholesterolemia
General Information
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.
Clinical Results
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 placebo.
Side Effects
Adverse events associated with the use of Altocor (lovastatin) may include (but are not limited to) the following:
- Nausea
- Abdominal pain
- Insomnia
- Dyspepsia
- Headache
- Asthenia
- Myalgia
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.
Additional Information
For additional information on Altocor, please visit Andrx Corporation.
