Altoprev (Lovastatin) - Summary

ALTOPREV SUMMARY

ALTOPREV™ (Lovastatin) Extended-Release Tablets contain a cholesterol-lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding (beta)-hydroxyacid form. This is a principal metabolite and inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol.

Therapy with ALTOPREV™ (Lovastatin) Extended-Release Tablets should be a component of multiple risk factor intervention in those individuals with dyslipidemia who are at risk for atherosclerotic vascular disease. ALTOPREV™ should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower Total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk.

ALTOPREV™ is indicated for the following:

Primary Prevention of Coronary Heart Disease

In individuals without symptomatic cardiovascular disease, average to moderately elevated Total-C and LDL-C, and below average HDL-C, ALTOPREV™ is indicated to reduce the risk of:

• Myocardial infarction
• Unstable angina
• Coronary revascularization procedures

(See CLINICAL PHARMACOLOGY, Clinical Studies.)

Coronary Heart Disease

ALTOPREV™ is indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower Total-C and LDL-C to target levels.

Hyperlipidemia

Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for artherosclerotic vascular disease due to hypercholesterolemia

ALTOPREV™ is indicated as an adjunct to diet for the reduction of elevated Total-C, LDL-C, Apo B, and TG, and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and non-familial) and mixed dyslipidemia (Fredrickson types IIa and IIb, see Table VI) when the response to diet restricted in saturated fat and cholesterol and to other non-pharmacological measures alone has been inadequate.

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NEWS HIGHLIGHTS

Published Studies Related to Altoprev (Lovastatin)

Lovastatin for the adjunctive treatment of schizophrenia: a preliminary randomized double-blind placebo-controlled trial. [2014]
While statins target many of the pathways to neuroprogression in schizophrenia, the safety and efficacy of statins for treating schizophrenia has never been examined. This is an 8-week randomized double blind controlled clinical trial examining the efficacy and safety of adjunctive lovastatin (20 mg/day) treatment or placebo for people with schizophrenia...

A randomized, double-blind, placebo-controlled phase II clinical trial of lovastatin for various endpoints of melanoma pathobiology. [2014]
On the basis of large cardiovascular clinical trials of lipid-lowering agents that showed a considerable decrease in the incidence of primary melanomas in the active agent arm, we have carried out a randomized, double-blind clinical trial examining the impact of lovastatin on various biomarkers of melanoma pathogenesis...

Augmentation of fluoxetine with lovastatin for treating major depressive disorder, a randomized double-blind placebo controlled-clinical trial. [2013]
BACKGROUNDS: There are contradictory evidence about the effect of statins on depression. This 6-week-randomized placebo-controlled clinical trial assessed the efficacy and safety of lovastatin as an adjuvant agent for treating major depressive disorder (MDD)... DISCUSSION: These results suggest that lovastatin as an adjuvant treatment may be effective for treating patients with MDD.

Thalidomide, dexamethasone and lovastatin with autologous stem cell transplantation as a salvage immunomodulatory therapy in patients with relapsed and refractory multiple myeloma. [2011.10]
The treatment of patients with multiple myeloma usually includes many drugs including thalidomide, lenalidomide and bortezomib.Our results suggest that the addition of lovastatin to the TD regimen may improve the response rate in patients with relapsed or refractory myeloma.

Influence of one-year treatment with lovastatin on myocardial remodeling and ischemia in patients with coronary artery disease. [2011.02]
OBJECTIVE: Emerging evidence assumes that statins have a benefit to influence the myocardial remodeling and ischemia in patients with coronary artery disease (CAD). Our aim was to investigate the possible and direct favorable effects of lovastatin on left ventricular (LV) systolic, diastolic function and myocardial ischemia in patients with CAD... CONCLUSION: Lipid-lowering therapy with lovastatin improved the LV systolic function and decreased myocardial ischemia.

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Clinical Trials Related to Altoprev (Lovastatin)

Phase II Trial - Breast Cancer Chemoprevention by Lovastatin [Terminated]
The purpose of the study is to determine whether oral lovastatin, used for 6 months, results in a decrease of abnormal breast duct cytology in women at high inherited breast cancer risk.

Evaluation of Interferon-Lovastatin Therapy for Malignant Melanoma [Withdrawn]
The purpose of this study is to determine whether an outpatient combination of lovastatin and low-to-moderate dose interferon is effective in the treatment of patients with malignant melanoma.

Lovastatin for the Treatment of Mildly Active Rheumatoid Arthritis [Completed]

A Phase II Study of Interaction of Lovastatin and Paclitaxel For Patients With Refractory or Relapsed Ovarian Cancer [Recruiting]

Lovastatin in Treating Patients At High Risk of Melanoma [Completed]
The use of lovastatin may slow disease progression in patients at high risk of melanoma. It is not yet known whether lovastatin is more effective than a placebo in treating patients at high risk of melanoma. This randomized phase II trial studies how well giving lovastatin or placebo works in treating patients at high risk of melanoma.

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