VYTORIN SUMMARY
VYTORIN contains ezetimibe, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and simvastatin, a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor.
VYTORIN is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non- familial) hypercholesterolemia or mixed hyperlipidemia.
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.
Therapy with lipid-altering agents should be a component of multiple risk-factor intervention in individuals at increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lipid- altering agents should be used in addition to an appropriate diet (including restriction of saturated fat and cholesterol) and when the response to diet and other non-pharmacological measures has been inadequate.
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NEWS HIGHLIGHTSMedia Articles Related to Vytorin (Ezetimibe / Simvastatin)
FDA Backs Cholesterol Drug Vytorin
Source: MedicineNet ezetimibe Specialty [2009.01.09]
Title: FDA Backs Cholesterol Drug Vytorin
Category: Health News
Created: 1/9/2009 2:00:00 AM
Last Editorial Review: 1/9/2009
Is Vytorin Cancer Risk Real?
Source: MedicineNet ezetimibe Specialty [2008.08.25]
Title: Is Vytorin Cancer Risk Real?
Category: Health News
Created: 8/25/2008
Last Editorial Review: 8/25/2008
FDA to Explore Possible Vytorin-Cancer Link
Source: MedicineNet ezetimibe Specialty [2008.08.22]
Title: FDA to Explore Possible Vytorin-Cancer Link
Category: Health News
Created: 8/22/2008
Last Editorial Review: 8/22/2008
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
Published Studies Related to Vytorin (Ezetimibe / Simvastatin)
The VYtorin on Carotid intima-media thickness and overall arterial rigidity (VYCTOR) study. [2009.07]
This study assessed the effect of 3 lipid-lowering therapies on the reduction of the carotid intima-media thickness (IMT) in high-risk coronary Mexican patients. The study was a randomized, comparative, and open clinical trial...
Lipid-altering efficacy and safety of ezetimibe/simvastatin versus atorvastatin in patients with hypercholesterolemia and the metabolic syndrome (from the VYMET study). [2009.06.15]
Patients with the metabolic syndrome are at an increased risk of cardiovascular disease and might require intensive lipid therapy... In conclusion, ezetimibe/simvastatin was more likely to result in lipid treatment end points than atorvastatin and was generally well tolerated at the doses compared in our patients.
Lipid-altering efficacy of ezetimibe/simvastatin 10/20 mg compared with rosuvastatin 10 mg in high-risk hypercholesterolaemic patients inadequately controlled with prior statin monotherapy - The IN-CROSS study. [2009.04]
AIMS: To evaluate the efficacy of switching from a previous statin monotherapy to ezetimibe/simvastatin (EZE/SIMVA) 10/20 mg vs. rosuvastatin (ROSUVA) 10 mg... CONCLUSION: EZE/SIMVA 10/20 mg produced greater improvements in LDL-C, total cholesterol, non-HDL-C and apoB with a similar safety profile as for ROSUVA 10 mg.
Efficacy of ezetimibe/simvastatin 10/40 mg compared to doubling the dose of low-, medium- and high-potency statin monotherapy in patients with a recent coronary event. [2009]
OBJECTIVE: The aim of the study was to compare the efficacy/safety of doubling the dose of low-, medium- and high-potency statins on lipids/lipoproteins versus ezetimibe/simvastatin (EZE/SIMVA) 10/40 mg in patients with a recent coronary event... CONCLUSIONS: EZE/SIMVA 10/40 mg produced greater improvements in lipids with a similar safety profile compared to doubling the dose of low-, medium- and high-potency statins. Copyright 2008 S. Karger AG, Basel.
Effect of ezetimibe coadministration with simvastatin in a Middle Eastern population: a prospective, multicentre, randomized, double-blind, placebo-controlled trial. [2008.07]
OBJECTIVES: To assess the efficacy and safety of ezetimibe coadministered with simvastatin in patients with primary hypercholesterolaemia and coronary artery disease (CAD)... CONCLUSION: When coadministered with simvastatin therapy, ezetimibe resulted in significant additional reduction in LDL-C and enabled more patients to achieve NCEP ATP III LDL-C target levels. This was achieved safely and with excellent tolerability.
Clinical Trials Related to Vytorin (Ezetimibe / Simvastatin)
Assessment of Interaction Between Vytorin and Niaspan in Healthy Subjects (P04955AM2)(COMPLETED) [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
Vytorin As Strategy To Reduce Dislipidemia In Adults [Completed]
This study is intended to allow physicians to check the superior clinical efficacy of Vytorin
compared to atorvastatin, as the most adequate therapy using the ATP-III goals achievement
and cardiovascular risk reduction in adult patients with dislipidemia.Â
IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (Study P04103AM3) [Recruiting]
This is a randomized, active-control, double-blind study of subjects with stabilized
high-risk acute coronary syndrome (ACS). The primary objective is to evaluate the clinical
benefit of Ezetimibe/Simvastatin Combination 10/40 (single tablet, under the brand VYTORIN
in the United States) compared with Simvastatin 40 mg. If LDL-C response is inadequate, the
dose of simvastatin in the VYTORIN arm or simvastatin arm, as appropriate, may be increased
to 80 mg. Clinical benefit will be defined as the reduction in the risk of the occurrence
of the composite endpoint of CV death, major coronary events, and stroke.
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.
Clinical Trial of Zocor and Vytorin in Adolescents With Type 1 Diabetes [Recruiting]
The purpose of the study is to establish the safety of Zocor and Vytorin in adolescents
with Type 1 Diabetes and to determine the amount of decrease in LDL-cholesterol. The study
hypothesizes that Zocor and Vytorin will be safe in adolescents with Type 1 Diabetes and
will lower LDL-cholesterol at 6 months.
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PATIENT REVIEWS / RATINGS / COMMENTSBased 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 |
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| | 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 food—the 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.
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| 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 food—the 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. |
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| | 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. |
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Page last updated: 2009-10-20
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