Vytorin (Ezetimibe / Simvastatin) - Summary

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 HIGHLIGHTS

Published Studies Related to Vytorin (Ezetimibe / Simvastatin)

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.

Lipid-altering efficacy of switching to ezetimibe/simvastatin 10/20 mg versus rosuvastatin 10 mg in high-risk patients with and without metabolic syndrome. [2011]
Metabolic syndrome (MetS) is a clustering of atherosclerotic coronary heart disease risk factors. This post-hoc analysis compared the effects of switching to ezetimibe/simvastatin 10/20 mg or rosuvastatin 10 mg in a cohort of 618 high-risk hypercholesterolaemic patients with (n=368) and without (n=217) MetS who had previously been on statin monotherapy...

Achievement of recommended lipid and lipoprotein levels with combined ezetimibe/statin therapy versus statin alone in patients with and without diabetes. [2011]
Treatment guidelines identify low-density lipoprotein cholesterol (LDL-C) as the primary target of therapy with secondary targets of non-high-density lipoprotein cholesterol (non-HDL-C) and apolipoprotein B (apoB). Data were pooled from 27 randomised, double-blind, active or placebo-controlled trials in 21,794 adult hypercholesterolaemic patients (LDL-C 1.81-6.48 mmol/L) receiving ezetimibe/statin or statin for 4-24 weeks...

Ezetimibe/simvastatin 10/20 mg versus rosuvastatin 10 mg in high-risk hypercholesterolemic patients stratified by prior statin treatment potency. [2010.11.04]
OBJECTIVE: This post-hoc analysis compared the lipid-altering efficacy of Ezetimibe/Simvastatin 10/20 mg (EZ/Simva) versus Rosuvastatin 10 mg (Rosuva) in patients stratified by statin potency/dose prior to randomization... CONCLUSIONS: Compared with Rosuva, switching to EZ/Simva provided greater reductions in LDL-C, total cholesterol, non-HDL-C and apolipoprotein B and higher target attainment in patients on prior statin treatment, regardless of potency, although patients treated with higher potency statins prior to randomization experienced greater between treatment differences in favor of EZ/Simva. TRIAL REGISTRATION: Registered at ClinicalTrials.gov: NCT00479713.

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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 in the Treatment of Alopecia Areata [Recruiting]
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.

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 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. 

Vascular and Metabolic Effects of Vytorin [Recruiting]

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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

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 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.
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.

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.