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Zocor (Simvastatin) - Summary

 
 



ZOCOR SUMMARY

ZOCOR (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 β-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.

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. Drug therapy is indicated 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. In patients with coronary heart disease (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.
Hyperlipidemia

ZOCOR is indicated to:

  • Reduce elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hyperlipidemia (Fredrickson type IIa, heterozygous familial and nonfamilial) or mixed dyslipidemia (Fredrickson type IIb).
  • Reduce elevated TG in patients with hypertriglyceridemia (Fredrickson type lV hyperlipidemia).
  • Reduce elevated TG and VLDL-C in 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 HeFH, if after an adequate trial of diet therapy the following findings are present:

  • LDL cholesterol remains ≥190 mg/dL; or
  • 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.

Limitations of Use

ZOCOR has not been studied in conditions where the major abnormality is elevation of chylomicrons (i.e., hyperlipidemia Fredrickson types I and V).


See all Zocor indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Zocor (Simvastatin)

High Cholesterol (Hyperlipidemia) Quiz: Test Your Medical IQ
Source: MedicineNet Heart Attack and Atherosclerosis Prevention Specialty [2017.09.19]
Title: High Cholesterol (Hyperlipidemia) Quiz: Test Your Medical IQ
Category: MedicineNet Quiz
Created: 11/11/2011 6:30:00 PM
Last Editorial Review: 9/19/2017 7:03:33 PM

more news >>

Published Studies Related to Zocor (Simvastatin)

Simvastatin as an adjuvant therapy to fluoxetine in patients with moderate to severe major depression: A double-blind placebo-controlled trial. [2015]
Statins have been shown to decrease depressive symptoms in certain groups of patients, an effect that is mostly attributed to their anti-inflammatory and neurotransmitter modulatory potentials. We aimed to investigate the antidepressant effects of simvastatin as an adjuvant therapy in patients with moderate to severe depression...

Cardiovascular and inflammatory effects of simvastatin therapy in patients with COPD: a randomized controlled trial. [2015]
obstructive pulmonary disease... CONCLUSION: There was a nonsignificant improvement in aortic PWV in those taking

High-dose simvastatin for aneurysmal subarachnoid hemorrhage: multicenter randomized controlled double-blinded clinical trial. [2015]
clinical outcomes... CONCLUSIONS: High-dose simvastatin treatment should not be prescribed routinely

Simvastatin in the acute respiratory distress syndrome. [2014]
would improve clinical outcomes in patients with ARDS... CONCLUSIONS: Simvastatin therapy, although safe and associated with minimal

Simvastatin in aneurysmal subarachnoid haemorrhage (STASH): a multicentre randomised phase 3 trial. [2014]
improve the long-term outcome in patients with this disorder... INTERPRETATION: The STASH trial did not detect any benefit in the use of

more studies >>

Clinical Trials Related to Zocor (Simvastatin)

Clinical Trial of Zocor (Simvastatin) and Vytorin (Ezetimibe/Simvastatin) in Adolescents With Type 1 Diabetes [Completed]
The purpose of the study is to establish the safety of ezetimibe/simvastatin and simvastatin in adolescents with Type 1 Diabetes and to determine the amount of decrease in LDL-cholesterol. The study hypothesizes that simvastatin and ezetimibe/simvastatin will be safe in adolescents with Type 1 Diabetes and will lower LDL-cholesterol at 6 months.

A Study of the Efficacy and Safety of MK-0431D (a Fixed-dose Combination of Sitagliptin and Simvastatin) for the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Metformin Monotherapy (MK-0431D-266) [Terminated]
The purpose of this study is to assess the efficacy and safety of sitagliptin/simvastatin fixed-dose combination (FDC) in participants with T2DM who have inadequate glycemic control while on metformin monotherapy. The primary hypothesis of this study is that after 16 weeks of therapy, the mean change from baseline in hemoglobin A1C (A1C) in participants treated with sitagliptin/simvastatin FDC is non-inferior compared to sitagliptin alone.

Study of Metformin With Simvastatin for Men With Prostate Carcinoma [Withdrawn]
The purpose of this study is to find out whether the two drugs used in the study, metformin and simvastatin, can slow down the speed of rise of prostate specific antigen (PSA) or stop its rise or even bring the level down. Recently, scientists noticed that men who take metformin to treat their high blood sugar or simvastatin to treat their high cholesterol are less likely to develop prostate cancer. Also, scientists found that, when these drugs are used in preclinical studies, they can slow down the growth of the prostate cancer cells. This study will try to find out whether these drugs can actually slow down the growth of prostate cancer in men.

Ezetimibe/Simvastatin (MK-0653A) Versus Rosuvastatin Versus Doubling Statin Dose in Participants With Cardiovascular Disease and Diabetes Mellitus (MK-0653A-133)(COMPLETED) [Completed]
The purpose of this study is to determine the efficacy of switching to a combination tablet ezetimibe/simvastatin (10mg/20mg) versus rosuvastatin (10 mg) versus 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.

Bioequivalence Study of Simvastatin Tablets, 80 mg of Dr. Reddy's Under Fed Conditions [Completed]
The purpose of this study is to

- compare the single dose bioavailability of Simvastatin 80 mg tablets with Zocor® 80 mg

tablets of MercK & Co. Inc, USA in healthy subjects under fed conditions

- monitor adverse events and to ensure the safety of subjects.

more trials >>

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

Based on a total of 18 ratings/reviews, Zocor has an overall score of 5.06. The effectiveness score is 6.78 and the side effect score is 6.44. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

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.

See all Zocor reviews / ratings >>

Page last updated: 2017-09-19

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