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Vytorin (Ezetimibe / Simvastatin) - Summary

 
 



VYTORIN SUMMARY

VYTORIN contains ezetimibe, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and simvastatin, an HMG-CoA reductase inhibitor.

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.

Primary Hyperlipidemia

VYTORIN® is indicated for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia.

Homozygous Familial Hypercholesterolemia (HoFH)

VYTORIN is indicated for the reduction of elevated 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.

Limitations of Use

No incremental benefit of VYTORIN on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin has been established.

VYTORIN has not been studied in Fredrickson type I, III, IV, and V dyslipidemias.


See all Vytorin indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Vytorin (Ezetimibe / Simvastatin)

Changes in lipoprotein particle number with ezetimibe/simvastatin coadministered with extended-release niacin in hyperlipidemic patients. [2013]
CONCLUSIONS: These results suggest that E/S+N improves lipoprotein particle

The effects of ezetimibe/simvastatin versus simvastatin monotherapy on platelet and inflammatory biomarkers in patients with metabolic syndrome. [2013]
In a randomized, double-blind, crossover study of 15 aspirin-naive patients (mean age 48.8 ± 10.2 years) with the metabolic syndrome, statin monotherapy (simvastatin 40 mg daily) was compared to combination therapy (simvastatin 40 mg and ezetimibe 10 mg daily) on biomarkers of inflammation and platelet activity...

A comparison of efficacy and safety of an ezetimibe/simvastatin combination compared with other intensified lipid-lowering treatment strategies in diabetic patients with symptomatic cardiovascular disease. [2013]
The low-density lipoprotein cholesterol (LDL-C) lowering efficacy of switching to ezetimibe/simvastatin (EZ/S) 10/20 mg versus doubling the run-in statin dose (to simvastatin 40 mg or atorvastatin 20 mg) or switching to rosuvastatin 10 mg in subjects with cardiovascular disease (CVD) and diabetes was assessed...

Switching from statin monotherapy to ezetimibe/simvastatin or rosuvastatin modifies the relationships between apolipoprotein B, LDL cholesterol, and non-HDL cholesterol in patients at high risk of coronary disease. [2011.06]
OBJECTIVE: To evaluate relationships between apolipoprotein B (Apo B), LDL cholesterol (LDL-C), and non-HDL-C in high-risk patients treated with lipid-lowering therapy... CONCLUSION: The use of Apo B for monitoring the efficacy of lipid-altering therapy would likely lead to more stringent criteria for lipid lowering. Copyright (c) 2011 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Assessment of potential pharmacokinetic interactions of ezetimibe/simvastatin and extended-release niacin tablets in healthy subjects. [2011.05]
BACKGROUND: Efforts to lower plasma lipid levels sometimes require multiple agents with different mechanisms of action to achieve results specified by national treatment guidelines... CONCLUSION: There is a small pharmacokinetic drug interaction between ER niacin and ezetimibe/simvastatin and although this is not considered to be clinically significant, the concomitant use of these drugs should be appropriately monitored, especially during the niacin titration period.

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Clinical Trials Related to Vytorin (Ezetimibe / Simvastatin)

Vytorin in the Treatment of Alopecia Areata [Completed]
Subjects, non pregnant/lactating and over 18years old, with 40% alopecia areata will take vytorin (statin/ezetimibe) for 24 or 52 weeks and be monitored for hair regrowth. The investigators hypothesize that Vytorin medication may have an effect on the inflammatory process of alopecia areata. Inactivating the inflammatory process may help in permitting hair regrowth in those subjects.

Assessment of Interaction Between Vytorin and Niaspan in Healthy Subjects (P04955AM2) [Completed]
This is a single-center, randomized, open-label, 3-period, 3-treatment multiple-dose crossover study designed to assess the interaction between VYTORIN (Ezetimibe and Simvastatin) and NIASPAN (Niacin Extended-Release Tablets) in healthy subjects. Treatment spans 7 days

Effects of Ezetimibe, Simvastatin, and Vytorin on Reducing L5 a Subfraction of LDL in Patients With Metabolic Syndrome. [Not yet recruiting]
The purpose of this study is:

- To identify the common factor for L5 prevalence in patients with Metabolic Syndrome.

- To determine whether Ezetimibe, Simvastatin, and Vytorin can correct the L5- promoting

factor and reduce L5 in Metabolic Syndrome patients.

Vytorin Reexamination Study (0653A-174) [Completed]
This survey is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of VYTORIN through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.

Comparison of the Effect of Vytorin 10/80 Tablet Split Into 4 and Simvastatin 20 Milligrams on Low-density Lipoprotein (LDL) Cholesterol [Completed]
The purpose of this study is to compare the efficacy of a Vytorin 10/80 tablet, an approved agent for the treatment of elevated LDL cholesterol which combines the cholesterol absorption inhibitor Ezetimibe 10 mg and simvastatin 80 mg, when split into 4 using a tablet splitter, versus a whole simvastatin 20 milligram tablet.

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Reports of Suspected Vytorin (Ezetimibe / Simvastatin) Side Effects

Rhabdomyolysis (18)Myalgia (14)Fall (13)Pain in Extremity (12)Cerebrovascular Accident (11)Fatigue (9)Nausea (9)Diarrhoea (9)Muscle Spasms (8)Arthralgia (8)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 5 ratings/reviews, Vytorin has an overall score of 4.60. The effectiveness score is 6 and the side effect score is 7.20. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Vytorin review by 51 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   cholesterol
Dosage & duration:   10/20 (dosage frequency: once a day) for the period of 2 years
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   significant reduction in cholesterol levels
Side effects:   none
Comments:   1 pill once a day

 

Vytorin review by 37 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   high cholesterol
Dosage & duration:   5 mg taken 1 a day for the period of 3 months
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   i did not observe cholesterol lowering although Your doctor may decide that, along with diet and exercise, VYTORIN is right for you. If so, remember to take 1 pill a day in the evening, as your doctor prescribes. Take VYTORIN with or without foodthe choice is yours. VYTORIN is a tablet containing two medicines: Zetia (ezetimibe) and Zocor (simvastatin). VYTORIN was clinically proven to lower bad cholesterol more than Lipitor or Zocor alone.
Side effects:   Unexplained muscle pain or weakness could be a sign of a rare but serious side effect and should be reported to your doctor right away. VYTORIN may interact with other medicines or certain foods, increasing your risk of getting this serious side effect. So, tell your doctor about any other medications you are taking. Your doctor may do simple blood tests before and during treatment with VYTORIN to check for liver problems.
Comments:   i did not observe cholesterol lowering although Your doctor may decide that, along with diet and exercise, VYTORIN is right for you. If so, remember to take 1 pill a day in the evening, as your doctor prescribes. Take VYTORIN with or without foodthe choice is yours. VYTORIN is a tablet containing two medicines: Zetia (ezetimibe) and Zocor (simvastatin). VYTORIN was clinically proven to lower bad cholesterol more than Lipitor or Zocor alone.Unexplained muscle pain or weakness could be a sign of a rare but serious side effect and should be reported to your doctor right away. VYTORIN may interact with other medicines or certain foods, increasing your risk of getting this serious side effect. So, tell your doctor about any other medications you are taking. Your doctor may do simple blood tests before and during treatment with VYTORIN to check for liver problems.

 

Vytorin review by 57 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   high cholesterol
Dosage & duration:   10/20 (dosage frequency: 1 day) for the period of 5 months
Other conditions:   Possible TIA 6 months before
Other drugs taken:   Dexedrine 20 mg
  
Reported Results
Benefits:   None. My LDL level did not drop.
Side effects:   My ck levels jumped to 480, bruising without trauma, loss of memory, lapses of time up to 4 hours, significant pain in legs which kept me awake at night, made my legs jump. My left leg contorted during a spasm, my foot turned out which couldn't be straigntened without help and masssge of the calf and foot.
Comments:   Cholesterol levels are high with genetic factors. LDL >170, HDL 80, total 276. The cardiologist used Vytorin as first and only treatment. My diet contained <20% fat intake, almost no saturated fat. I had pain in my legs within weeks, informed the doctor who checked my ck levels. Lab showed "within normal range" and I was told to resume the vytorin. Within 3 weeks the pain was unmanagable, so I called the doctor again. The nurse said I had to put up with a little discomfort but I insisted on another lab. Lab resulted in ck levels of 480, I was told to stop the vytorin and drink a lot of water. I changed cardiologist at that time.

See all Vytorin reviews / ratings >>

Page last updated: 2014-11-30

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