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Zocor (Simvastatin) - Summary

 

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ZOCOR SUMMARY

ZOCOR®
(SIMVASTATIN)
TABLETS

ZOCOR1 (simvastatin) is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding (beta)-hydroxyacid form. This is an 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.

Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol.

In patients with CHD or at high risk of CHD, ZOCOR can be started simultaneously with diet.

Reductions in Risk of CHD Mortality and Cardiovascular Events

In patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, ZOCOR is indicated to:

  • Reduce the risk of total mortality by reducing CHD deaths.
  • Reduce the risk of non-fatal myocardial infarction and stroke.
  • Reduce the need for coronary and non-coronary revascularization procedures.

Patients with Hypercholesterolemia Requiring Modifications of Lipid Profiles

ZOCOR is indicated to:

  • Reduce elevated total-C, LDL-C, Apo B, and TG, and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson types IIa and IIb4).
  • Treat patients with hypertriglyceridemia (Fredrickson type IV hyperlipidemia).
  • Treat patients with primary dysbetalipoproteinemia (Fredrickson type III hyperlipidemia).
  • Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.

Adolescent Patients with Heterozygous Familial Hypercholesterolemia (HeFH)

ZOCOR is indicated as an adjunct to diet to reduce total-C, LDL-C, and Apo B levels in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heterozygous familial hypercholesterolemia, if after an adequate trial of diet therapy the following findings are present:

  1. LDL cholesterol remains >/=190 mg/dL; or
  2. LDL cholesterol remains >/=160 mg/dL and

  • There is a positive family history of premature cardiovascular disease (CVD) or
  • Two or more other CVD risk factors are present in the adolescent patient

The minimum goal of treatment in pediatric and adolescent patients is to achieve a mean LDL-C <130 mg/dL. The optimal age at which to initiate lipid-lowering therapy to decrease the risk of symptomatic adulthood CAD has not been determined.

ZOCOR NEWS HIGHLIGHTS

Media Articles Related to Zocor (Simvastatin)

FDA Issues Alert on Rhabdomyolysis Risk When Combining Simvastatin with Amiodarone
Source: MedPage Today Product Alert [2008.08.08]

Congress Requests Ezetimibe/Simvastatin (Vytorin) Cancer Data from FDA
Source: MedPage Today Hematology/Oncology [2008.08.01]

Results From The SEAS (Simvastatin And Ezetimibe In Aortic Stenosis) Study
Source: Cholesterol News From Medical News Today [2008.07.22]

Patients More Likely To Stay On Lipitor Than Simvastatin, A Large Observational Study Shows
Source: Cholesterol News From Medical News Today [2008.07.09]

ezetimibe and simvastatin, Vytorin
Source: MedicineNet Peripheral Vascular Disease Specialty [2008.04.16]

more>>

Published Studies Related to Zocor (Simvastatin)

Effect of ezetimibe coadministration with simvastatin in a Middle Eastern population: a prospective, multicentre, randomized, double-blind, placebo-controlled trial. [2008.07]

Effects of ezetimibe and/or simvastatin on LDL receptor protein expression and on LDL receptor and HMG-CoA reductase gene expression: a randomized trial in healthy men. [2008.05]

Lipid-altering efficacy and safety of ezetimibe/simvastatin coadministered with extended-release niacin in patients with type IIa or type IIb hyperlipidemia. [2008.04.22]

Simvastatin and rosuvastatin mobilize Endothelial Progenitor Cells but do not prevent their acute decrease during systemic inflammation. [2008.04.21]

Simvastatin with or without ezetimibe in familial hypercholesterolemia. [2008.04.03]

more>>

Clinical Trials Related to Zocor (Simvastatin)

Ezetimibe Plus Simvastatin Versus Simvastatin in Untreated Subjects With High Cholesterol (P03435)(COMPLETED) [Completed]

Zolip 0501: Comparison of the Combination of Fenofibrate and 20 mg Simvastatin Versus 40 mg Simvastatin Monotherapy [Active, not recruiting]

Zolip 0502: Comparison of the Combination of Fenofibrate and 40 mg Simvastatin Versus 40 mg Simvastatin Monotherapy [Active, not recruiting]

The Effects of Ezetimibe/Simvastatin 10/20 mg Versus Simvastatin 40 mg in High Cholesterol and Coronary Heart Disease (Study P04039AM2)(COMPLETED) [Completed]

Ezetimibe Plus Simvastatin Versus Simvastatin Alone in African-American Subjects With Primary Hypercholesterolemia (P03377) [Completed]

more>>

Page last updated: 2008-08-08

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