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 Zocor indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Zocor (Simvastatin)

FDA Warns of Zocor Risk to Muscles
Source: MedicineNet amiodarone Specialty [2010.03.22]
Title: FDA Warns of Zocor Risk to Muscles
Category: eMedicine Health News
Created: 3/22/2010 10:45:00 AM
Last Editorial Review: 3/22/2010 10:45:21 AM

Statins May Reduce Exercise Benefits For Obese Adults
Source: Health News from Medical News Today [2013.05.18]
Statins, the most widely prescribed drugs worldwide, are often suggested to lower cholesterol and prevent heart disease in individuals with obesity, diabetes and metabolic syndrome, which is a combination of medical disorders including excess body fat and/or high levels of blood pressure, blood sugar and/or cholesterol. However, University of Missouri researchers found that simvastatin, a generic type of statin previously sold under the brand name "Zocor," hindered the positive effects of exercise for obese and overweight adults...

Diabetic Wound Healing Accelerated By Topical Simvastatin
Source: Statins News From Medical News Today [2012.11.29]
Delayed wound healing is a major complication of diabetes because the physiological changes in tissues and cells impair the wound healing process. This can result in additional disease outcomes such as diabetic foot ulcer, a significant cause of morbidity in the growing population of diabetic patients...

High Cholesterol (Hyperlipidemia) Quiz: Test Your Medical IQ
Source: MedicineNet cerivastatin Specialty [2011.11.14]
Title: High Cholesterol (Hyperlipidemia) Quiz: Test Your Medical IQ
Category: MedicineNet Quiz
Created: 11/11/2011 6:30:00 PM
Last Editorial Review: 11/14/2011 2:45:07 PM

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Published Studies Related to Zocor (Simvastatin)

Randomised clinical trial: simvastatin as adjuvant therapy improves significantly the Helicobacter pylori eradication rate--a placebo-controlled study. [2012]
patients with H. pylori infection will improve the eradication rate... CONCLUSION: In this randomised clinical trial simvastatin as adjuvant to standard

The effect of ezetimibe and simvastatin on hemostasis in patients with isolated hypercholesterolemia. [2012]
The aim of this study was to assess the strength of hemostatic effects of ezetimibe, administered alone or in combination with simvastatin, in patients with isolated hypercholesterolemia. One hundred and four patients with isolated primary hypercholesterolemia were randomized to one of four treatment groups, simultaneously treated for 90 days with ezetimibe (10 mg daily), simvastatin (40 mg daily), ezetimibe (10 mg daily) plus simvastatin (40 mg daily), or placebo.

Can simvastatin improve erectile function and health-related quality of life in men aged >40 years with erectile dysfunction? Rationale and design of the Erectile Dysfunction and Statins (EDS) Trial [ISRCTN66772971](1). [2011.12]
What's known on the subject? and What will the study add? Erectile dysfunction is often associated with endothelial dysfunction. It is also recognized as a marker for underlying vascular disease. This study tests the hypothesis that statin therapy may improve erectile function and also reduce the risk of future cardiovascular events via a reduction in serum cholesterol and by improving endothelial function. The study will also determine whether the treatment improves quality of life related to sexual function. OBJECTIVE: * To describe the rationale and design of the Erectile Dysfunction and Statins (EDS) Trial which aims to evaluate the effectiveness of simvastatin on erectile function and health-related quality of life in men aged >/=40 years with erectile dysfunction... CONCLUSION: * If simvastatin improves erectile function it would provide an inexpensive treatment for ED suitable for most men, and reduce the risk of future CVD. (c) 2011 UNIVERSITY OF HERTFORDSHIRE. BJU INTERNATIONAL (c) 2011 BJU INTERNATIONAL.

The effect of simvastatin in penile erection: a randomized, double-blind, placebo-controlled clinical trial (Simvastatin treatment for erectile dysfunction-STED TRIAL). [2011.11]
The aim of the study is to evaluate the effect of simvastatin in erectile dysfunction (ED) secondary to endothelial dysfunction. This study is a double-blind, randomized, placebo-controlled, clinical trial in patients with ED and endothelial dysfunction...

Comparative efficacy of pitavastatin and simvastatin in high-risk patients: a randomized controlled trial. [2011.09]
INTRODUCTION: Despite the proven efficacy of 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) in lowering total and low-density lipoprotein cholesterol (LDL-C), many patients do not reach recommended lipid targets. This study compared pitavastatin, a new and highly effective statin, and simvastatin in patients at high risk of coronary heart disease (CHD). The primary objective was to demonstrate noninferiority of pitavastatin to simvastatin... CONCLUSION: Pitavastatin 4 mg is as effective as simvastatin 40 mg in lowering LDL-C in dyslipidemic patients at high risk of CHD, with additional effects on HDL-C and triglycerides. Therefore, pitavastatin may be appropriate for the management of dyslipidemic patients at high cardiovascular risk.

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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/Simvastatin (MK0653A) vs Rosuvastatin vs Doubling Statin Dose in Patients With Cardiovascular Disease and Diabetes Mellitus (0653A-133) [Recruiting]
The purpose of this study is to determine the efficacy of switching to a combination tablet ezetimibe/simvastatin (10mg/20mg) vs rosuvastatin (10 mg) vs doubling the statin dose in those patients who have cardiovascular disease and diabetes mellitus not adequately controlled on simvastatin 20 mg or atorvastatin 10 mg.

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Reports of Suspected Zocor (Simvastatin) Side Effects

Rhabdomyolysis (162),  Myalgia (136),  Muscular Weakness (75),  Pain (74),  Arthralgia (68),  Renal Failure Acute (66),  Muscle Spasms (65),  Pain in Extremity (65),  Drug Interaction (63),  Asthenia (61), more >>

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 53 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		colestrol
Dosage & duration:		40mg taken once nightly for the period of 2 years
Other conditions:		high blood pressure
Other drugs taken:		plavix 75 mg
		Reported Results
Benefits:		Reduced blood pressure and stopped cholestrol from forming in my arteries.
Side effects:		My hip joints hurt so bad I can no longer go on long walks.
Comments:		I am looking for a more natural remedy for high blood pressure and control for cholestrol. I do not like taking drugs but do not feel I have a choice at the this time? Any suggestions would be greatly appreciated.

Zocor review by 50 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		high colesterol
Dosage & duration:		40mg taken 1 per day for the period of 2 weeks
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		the treatment was to help lower my colesterol levels, i only took it for two weeks so i did not benefit from taken this treatment,
Side effects:		muscle pain, loss of mobility, depresion, headaches i was admitted to hospital with chest pains, thought to be heart problems, it was caused by the tightening of my chest muscles.
Comments:		1 to be taken daily, i only took this medication for two weeks after which i stopped taking it, the side effects that i had been suffering then stopped.