Vytorin

Ezetimibe/simvastatin

For High Cholesterol

Track record

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Long (approved in 2004)

Bottom line

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High Cholesterol

What is High Cholesterol?

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Other treatments for High Cholesterol

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Non-drug

Over-the-counter

Prescription

TABLE OF CONTENTS

Overview

FDA-approved use

To lower LDL "bad" cholesterol and to raise HDL "good" cholesterol

Vytorin is a combination pill of a statin (simvastatin) and ezetimibe (Zetia). FDA officially approved Vytorin to lower LDL "bad" cholesterol, raise HDL "good" cholesterol, and lower triglycerides in adults with abnormal cholesterol levels from a genetic condition. The FDA-approved package insert currently says "Vytorin has not been shown to reduce heart attacks or strokes more than simvastatin alone (Zocor)". FDA is holding an Advisory Committee Meeting December 2015 to help decide whether to approve Vytorin for reducing heart attacks based on evidence from a new trial (IMPROVE-IT).

Who might consider taking it?

Adults with high "bad" (LDL) cholesterol

Genetic conditions include primary hypercholesterolemia (heterozygous familial and nonfamilial), mixed hyperlipidemia and homozygous familial hypercholesterolemia (HoFH)

What is not known

Not tested in people with Fredrickson Type I, III, IV, and V dyslipidemias

Not tested in children younger than age 10 or in girls who have not started their period

Track record

LONG TRACK RECORD

Long track record means that new‚ unexpected side effects are unlikely. Vytorin was approved by FDA in 2004. Since Vytorin has now been used by large numbers of people over a long time‚ the emergence of important side effects is less likely than with new drugs.

Open questions

No FDA-required studies at approval

Do not take if you...

Take medicines in the family called "strong CYP3A4 inhibitors"

Certain anti-fungal medicines (such as itraconazole, ketoconazole, posaconazole, or voriconazole), HIV protease inhibitors (such as indinavir, nelfinavir, ritonavir, saquinavir, tipranavir, or atazanavir), certain hepatitis C virus protease inhibitors (such as boceprevir or telaprevir), certain antibiotics (such as erythromycin, clarithromycin, or telithromycin), nefazodone, and medicines containing cobicistat

Take cyclosporine, gemfibrozil, or danazol

Are allergic to Vytorin (simvastatin or ezetimibe) or its ingredients

Have liver disease

Including people who have unexplained high liver inflammation blood tests

Are pregnant or may become pregnant

Vytorin may harm your unborn baby. If you become pregnant, stop taking Vytorin

Are breastfeeding

Safe if pregnant or breastfeeding?

Pregnant

Do not take: Controlled human studies show Vytorin harms baby and potential benefits do not outweigh potential harms (FDA Category X)

Breastfeeding

Do not breastfeed while taking Vytorin - either stop breastfeeding or stop Vytorin

NEXT: TRIALS

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