Advicor (Lovastatin) - Summary

ADVICOR SUMMARY

ADVICOR contains niacin extended-release and lovastatin in combination. Niacin, a B-complex vitamin, and lovastatin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, are both lipid-altering agents.

ADVICOR is a fixed-dose combination product and is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). Therapy with lipid-altering agents should be only one component of multiple risk-factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Initial medical therapy is indicated with a single agent as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate (see also Table 7 and the NCEP treatment guidelines¹).

ADVICOR is indicated for the treatment of primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Frederickson Types IIa and IIb; Table 6) in:

• Patients treated with lovastatin who require further TG-lowering or HDL-raising who may benefit from having niacin added to their regimen
• Patients treated with niacin who require further LDL-lowering who may benefit from having lovastatin added to their regimen

NEWS HIGHLIGHTS

Published Studies Related to Advicor (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 Advicor (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.

The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients With Intermittent Claudication - TROPIC [Completed]
The purpose of this study is to compare the dose response and safety of Niacin ER/Lovastatin, Niaspan� and Lovastatin with each other, in subjects with leg pain caused by a narrowing of their leg arteries. At least 870 subjects, with leg pain caused by a narrowing of their leg arteries will take part in this study. Both Niaspan and lovastatin (Mevacor�) are approved by the United States Food and Drug Administration (FDA) to treat high cholesterol. Niacin ER/Lovastatin (Advicor�), a combination of these two drugs, is also approved by the FDA to treat high cholesterol. The use of Niacin ER/Lovastatin to treat narrowing of leg arteries and relieve “intermittent claudication” (leg pain caused by narrowing of the arteries in the leg) is considered investigational. An investigational use is one that is not approved by the FDA.

Effect of Niacin ER/Lovastatin on Peak Walking Time & Claudication Onset Time in Patients With Intermittent Claudication [Completed]
The purpose of this study is to evaluate if Niacin ER/Lovastatin, at two different doses, compared to diet control (this group will receive a tablet containing 50 mg. of immediate-release niacin) is a safe and effective medicine in subjects with leg pain caused by a narrowing of their leg arteries, a condition called intermittent claudication. At least 366 subjects with leg pain caused by a narrowing of their leg arteries will participate in this study. Niacin ER/Lovastatin is a combination of two FDA (United States Food and Drug Administration) approved cholesterol modifying medications: Niaspan� (extended-release niacin) and lovastatin, a statin (the same medicine found in Mevacor®). Niacin ER/Lovastatin was approved by the FDA under the name of Advicor® for use in the treatment of elevated cholesterol. The use of Niacin ER/Lovastatin in the treatment of peripheral arterial disease and symptomatic relief of intermittent claudication is considered investigational. An investigational use is one that is not approved by the FDA.

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Reports of Suspected Advicor (Lovastatin) Side Effects

Flushing (5),  Blood Cholesterol Abnormal (1),  Liver Injury (1),  Blood Creatine Phosphokinase Increased (1),  Product Contamination Microbial (1),  Rhabdomyolysis (1),  Pain (1),  Stent Placement (1),  Headache (1),  Erythema (1), more >>