Zocor (Simvastatin) - Summary

ZOCOR SUMMARY

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.

See all indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Zocor (Simvastatin)

ezetimibe and simvastatin, Vytorin
Source: MedicineNet ezetimibe Specialty [2008.04.16]
Title: ezetimibe and simvastatin, Vytorin
Category: Medications
Created: 1/31/2005 10:17:00 PM
Last Editorial Review: 4/16/2008

Progression Of Parkinson's Disease May Be Prevented By Widely Used Cholesterol-Lowering Drug
Source: Statins News From Medical News Today [2009.10.31]
Simvastatin, a commonly used, cholesterol-lowering drug, may prevent Parkinson's disease from progressing further. Neurological researchers at Rush University Medical Center conducted a study examining the use of the FDA-approved medication in mice with Parkinson's disease and found that the drug successfully reverses the biochemical, cellular and anatomical changes caused by the disease.

Study Demonstrates LIVALO(R) Is An Efficacious Treatment For Achieving Lipid Goals
Source: Cholesterol News From Medical News Today [2009.10.23]
New Phase III data published in "Current Medical Research and Opinion" highlight that the recommended starting dose of 2 mg of LIVALO (pitavastatin), a novel synthetic statin, was statistically superior to simvastatin at a dose of 20 mg over 12 weeks in reducing low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C) and total cholesterol (TC) in patients with primary hypercholesterolemia and combined dyslipidemia.

LIVALO(R) Demonstrates Sustained, Long-Term Efficacy And Tolerability In Patients With Primary Hypercholesterolemia Or Mixed Dyslipidemia
Source: Cholesterol News From Medical News Today [2009.09.02]
New data presented showed that in patients treated with LIVALO (pitavastatin), high-density lipoprotein cholesterol (HDL-C) concentrations increased, and nearly three-fourths of patients attained low-density lipoprotein cholesterol (LDL-C) targets, with results sustained over 52 weeks. Additionally, LIVALO was found to have comparable efficacy to atorvastatin and simvastatin, as measured by reduction in LDL-C from baseline.

more news >>

Published Studies Related to Zocor (Simvastatin)

A randomized, controlled trial of simvastatin versus rosuvastatin in patients with acute myocardial infarction: the Secondary Prevention of Acute Coronary Events - Reduction of Cholesterol to Key European Targets Trial. [2009.09.09]
CONCLUSION: We observed no superiority of either treatment for the ESC-03 lipid targets. Rosuvastatin 10 mg lowered mean cholesterol more effectively than simvastatin and achieved better results for the latest, more stringent, ESC target.

Correlation of non-high-density lipoprotein cholesterol and low-density lipoprotein cholesterol with apolipoprotein B during simvastatin + fenofibrate therapy in patients with combined hyperlipidemia (a subanalysis of the SAFARI trial). [2009.08.15]
Guidelines have recommended non-high-density lipoprotein (non-HDL) cholesterol as a secondary target for therapy after the low-density lipoprotein (LDL) cholesterol goals have been met in patients with hypertriglyceridemia; non-HDL cholesterol is viewed as a surrogate for apolipoprotein (Apo)B, an alternate end point of treatment.

Comparison of usefulness of simvastatin 20 mg versus 80 mg in preventing contrast-induced nephropathy in patients with acute coronary syndrome undergoing percutaneous coronary intervention. [2009.08.15]
Contrast-induced nephropathy limits the outcomes of percutaneous coronary intervention (PCI)... This benefit was associated with the lowering of high-sensitive C-reactive protein, P-selectin, and intercellular adhesion molecule-1 levels.

Effect of simvastatin on plasma interleukin-6 in patients with unstable angina. [2009.08.01]
PURPOSE: The primary aim of the study was to investigate the effect of sinvastatin on plasma interleukin-6 (IL-6) in patients with unstable angina pectoris (UAP)... CONCLUSIONS: Short-term treatment with simvastatin reduces plasma IL-6. The anti-inflammatory effect of simvastatin may contribute to its beneficial effects on the ventricular function and angina control.

Effects of simvastatin and carnitine versus simvastatin on lipoprotein(a) and apoprotein(a) in type 2 diabetes mellitus. [2009.08]
AIM: The aim of the present study was to compare the effects of simvastatin and L-carnitine coadministration versus simvastatin monotherapy on lipid profile, lipoprotein(a) (Lp(a)) and apoprotein(a) (Apo(a)) levels in type II diabetic patients... CONCLUSIONS: The coadministration of carnitine and simvastatin resulted in a significant reduction in Lp(a) and apo(a) and may represent a new therapeutic option in reducing plasma Lp(a) levels, LDL cholesterol and Apo B100.

more studies >>

Clinical Trials Related to Zocor (Simvastatin)

Ezetimibe Plus Simvastatin Versus Simvastatin in Untreated Subjects With High Cholesterol (P03435)(COMPLETED) [Completed]
This study will assess whether co-administration of ezetimibe 10 mg with simvastatin 20 mg will be more effective than treatment with simvastatin 20 mg alone in reducing LDL-C concentrations when administered for 6 weeks.

Zolip 0501: Comparison of the Combination of Fenofibrate and 20 mg Simvastatin Versus 40 mg Simvastatin Monotherapy [Active, not recruiting]
Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall objective of the study is to evaluate the efficacy and safety of combining fenofibrate and simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

Zolip 0502: Comparison of the Combination of Fenofibrate and 40 mg Simvastatin Versus 40 mg Simvastatin Monotherapy [Active, not recruiting]
Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall objective of the study is to evaluate the efficacy and safety of combining fenofibrate and simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

The Effects of Ezetimibe/Simvastatin 10/20 mg Versus Simvastatin 40 mg in High Cholesterol and Coronary Heart Disease (Study P04039AM2)(COMPLETED) [Completed]
This study is being conducted to compare the efficacy, safety, and tolerability of ezetimibe/simvastatin 10/20 mg when administered daily versus doubling the dose of simvastatin to 40 mg in patients with hypercholesterolemia and coronary heart disease.

Ezetimibe Plus Simvastatin Versus Simvastatin Alone in African-American Subjects With Primary Hypercholesterolemia (P03377) [Completed]
The purpose of this study is to evaluate whether coadministration of ezetimibe 10 mg/day with simvastatin 20 mg/day for 12 weeks will result in greater reduction of LDL-C, total cholesterol (TC), triglycerides (TG), non HDL-C, and apolipoprotein B (ApoB), and greater increase in HDL-C, compared with simvastatin 20 mg/day as monotherapy for 12 weeks in African-American subjects with primary hypercholesterolemia. This study is being performed to better define the efficacy of ezetimibe coadministered with simvastatin in this population.

more trials >>

PATIENT REVIEWS / RATINGS / COMMENTS

Zocor review by 61 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		high cholestoral
Dosage & duration:		20mg taken once per day for the period of 3 yrs
Other conditions:		none
Other drugs taken:		anti depressants
		Reported Results
Benefits:		Brought down my overall cholestorol reading from 218 to 150, LDL from 135 to 90 and triglycerides from 180 to 140 within 3 months time.
Side effects:		I had soreness of muscles for the first several weeks which finally went away.
Comments:		I started on the medication 3yrs ago and still take it today with continued good results and no side effects.

Zocor review by 63 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		high cholesterol
Dosage & duration:		40mg taken 1 per day for the period of 2 weeks
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		I was originally prescribed 20 mg, but the rating was creeping up again, so the dosage was doubled. As I only took it for 2 weeks, cannot be sure of effectiveness
Side effects:		About 2 days after starting the course I began to get muscle pains. I had had these pains before (months ago) but the drug seemed to amplify them. The sites were a) in the groin area b) in the heel area, probably the achilles tendon
Comments:		I told the doctor of the problems, and he immediately changed me over to atorvastatin, 20mg, and the pains have disappeared.

Zocor review by 51 year old male patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		High cholesterol
Dosage & duration:		20 mg taken 1 per day for the period of 3 months
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		lowering high cholesterol
Side effects:		impotence
Comments:		I have a family history of high cholesterol. And I have high cholesterol as well. In order to reduce the high cholesterol readings down to normal levels for cholesterol, my health care physician prescribed cholesterol reducing drug. We tried Zocor for a while. However, when taking Zocor at 10 mg per day, I experience significant problems with impotence. I reported this to the doctor and the doctor had not receive any feedback like this before. My prescription for high cholesterol was changed to Lipitor.