Ezetimib Krka (Ezetimibe)

Cholesterol absorption inhibitor for lowering LDL cholesterol

Rx - Prescription Only Cholesterol Absorption Inhibitor
Active Ingredient
Ezetimibe
Dosage Form
Tablet
Available Strength
10 mg
Manufacturer
KRKA, d.d., Novo mesto
Medically reviewed | Last reviewed: | Evidence level: 1A
Ezetimib Krka contains ezetimibe, a cholesterol absorption inhibitor that lowers blood cholesterol by reducing cholesterol uptake in the small intestine. It is used alone or in combination with statins to treat high cholesterol (hypercholesterolemia) and reduce cardiovascular risk. Available as a 10 mg tablet taken once daily, ezetimibe is especially useful for patients who cannot achieve target cholesterol levels with statins alone or who are unable to tolerate statins.
Published:
Reviewed:
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Written and reviewed by iMedic Medical Editorial Team | Specialists in cardiology and clinical pharmacology

Quick Facts About Ezetimib Krka

Active Ingredient
Ezetimibe
Cholesterol absorption inhibitor
Drug Class
Lipid-Lowering
Cholesterol absorption inhibitor
Standard Dose
10 mg
Once daily, oral
Common Uses
High Cholesterol
Hypercholesterolemia
Available Forms
Tablet
10 mg strength
Prescription Status
Rx Only
Prescription required

Key Takeaways About Ezetimib Krka

  • Unique mechanism: Ezetimibe works by blocking cholesterol absorption in the intestine, complementing statins which reduce cholesterol production in the liver
  • Proven cardiovascular benefit: The landmark IMPROVE-IT trial showed that adding ezetimibe to statin therapy reduces heart attacks, strokes, and cardiovascular events
  • Well tolerated: Ezetimibe has a favorable safety profile with few common side effects, making it suitable for long-term use
  • Flexible use: Can be taken alone (monotherapy) or combined with a statin for enhanced cholesterol reduction of up to 25% additional LDL lowering
  • Simple dosing: One 10 mg tablet once daily at any time of day, with or without food, requiring no dose adjustments for most patients

What Is Ezetimib Krka and What Is It Used For?

Ezetimib Krka is a cholesterol-lowering medication containing ezetimibe that works by selectively inhibiting the absorption of cholesterol in the small intestine. It reduces total cholesterol, LDL ("bad") cholesterol, and triglycerides while increasing HDL ("good") cholesterol. It is used alone or with statins to treat high cholesterol and reduce cardiovascular risk.

Ezetimib Krka belongs to a class of medications known as cholesterol absorption inhibitors. Unlike statins, which reduce cholesterol synthesis in the liver, ezetimibe targets the Niemann-Pick C1-Like 1 (NPC1L1) protein located at the brush border of the small intestine. This protein is responsible for the uptake of dietary and biliary cholesterol from the intestinal lumen into enterocytes. By blocking NPC1L1, ezetimibe reduces the amount of cholesterol delivered to the liver, which in turn leads to an upregulation of LDL receptors on hepatocytes and increased clearance of LDL cholesterol from the bloodstream.

When used as monotherapy, ezetimibe typically reduces LDL cholesterol by approximately 15-20%. However, its true clinical value lies in combination therapy with statins, where the complementary mechanisms of action provide an additional 20-25% reduction in LDL cholesterol beyond what the statin achieves alone. This combination approach is supported by major international guidelines, including those from the European Society of Cardiology (ESC) and the American Heart Association (AHA).

The efficacy of ezetimibe in reducing cardiovascular events was definitively established by the IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) study, published in the New England Journal of Medicine in 2015. This landmark randomized controlled trial of over 18,000 patients who had experienced acute coronary syndromes demonstrated that adding ezetimibe to simvastatin significantly reduced the composite endpoint of cardiovascular death, major coronary events, and stroke compared to simvastatin alone over a median follow-up of six years.

Approved Indications

Ezetimib Krka is prescribed for several clinical conditions related to elevated blood lipids:

  • Primary hypercholesterolemia (heterozygous familial and non-familial): Used together with a statin when statin therapy alone does not adequately control cholesterol levels, or used alone when statin treatment is considered inappropriate or not tolerated
  • Homozygous familial hypercholesterolemia: A rare inherited condition causing extremely high cholesterol levels, where ezetimibe is used alongside a statin and potentially other lipid-lowering therapies
  • Homozygous sitosterolemia (phytosterolemia): A rare inherited condition that increases blood levels of plant sterols, where ezetimibe helps reduce their absorption
  • Cardiovascular risk reduction: In patients with established heart disease, ezetimibe combined with a statin reduces the risk of heart attack, stroke, coronary revascularization procedures, and hospitalization for unstable angina
Important to know:

Ezetimibe does not help with weight loss. Before starting treatment, you should already be following a cholesterol-lowering diet, and this diet should be continued throughout treatment. Lifestyle modifications including regular physical activity, maintaining a healthy weight, and not smoking are essential components of cardiovascular risk management alongside medication.

Other Brand Names

Ezetimibe is available under several brand names internationally. In addition to Ezetimib Krka, the same active substance is marketed as Ezetrol (the original brand by MSD/Organon), Ezetimib Medical Valley, Ezetimib Sandoz, Ezetimib STADA, Ezetimibe Accord, Ezetimibe Viatris, and Ezetimibe Zentiva. All contain the same 10 mg dose of ezetimibe and are therapeutically equivalent.

What Should You Know Before Taking Ezetimib Krka?

Before taking Ezetimib Krka, inform your doctor about all medical conditions, especially liver disease, allergies, and all medications you are currently taking. Do not take ezetimibe with a statin if you are pregnant, breastfeeding, or have active liver problems. Liver function tests are recommended before starting combination therapy.

Contraindications

There are specific situations where Ezetimib Krka should not be used. Understanding these contraindications is essential for safe treatment:

  • Allergy to ezetimibe: Do not take Ezetimib Krka if you are allergic to ezetimibe or any of the other ingredients in the tablet (sodium lauryl sulfate, povidone K30, mannitol, croscarmellose sodium, microcrystalline cellulose, or sodium stearyl fumarate)
  • Active liver disease with a statin: If you are taking ezetimibe together with a statin, the combination must not be used if you have active liver disease or unexplained persistent elevations of liver transaminases
  • Pregnancy with a statin: The combination of ezetimibe and a statin is contraindicated during pregnancy due to the potential harm statins can cause to the developing fetus
  • Breastfeeding with a statin: Do not take ezetimibe together with a statin while breastfeeding, as it is unknown whether these medications pass into breast milk

Warnings and Precautions

Several warnings and precautions should be considered before and during treatment with Ezetimib Krka:

Your doctor should perform a blood test to assess your liver function before starting Ezetimib Krka in combination with a statin. Periodic monitoring of liver function may also be necessary during treatment. If liver transaminase levels become significantly elevated (more than three times the upper limit of normal), your doctor may recommend discontinuing one or both medications.

Ezetimib Krka is not recommended for patients with moderate to severe hepatic impairment, as the exposure to ezetimibe is increased in these patients, and the clinical significance of this increased exposure has not been fully established.

Although rare, cases of myopathy and rhabdomyolysis (serious muscle breakdown) have been reported with ezetimibe, particularly when used in combination with a statin. Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or malaise. The risk of muscle-related adverse effects may be increased in patients taking higher doses of statins, elderly patients, patients with renal impairment, or patients with untreated hypothyroidism.

The safety and efficacy of ezetimibe used concurrently with fibrates have not been established. If your doctor considers prescribing ezetimibe with a fibrate, careful monitoring is recommended, as both drug classes can increase the risk of cholelithiasis (gallstones).

Children and Adolescents

The use of Ezetimib Krka in children and adolescents aged 6 to 17 years should only be initiated and supervised by a specialist, as clinical data in this population are limited. Ezetimibe should not be given to children under 6 years of age, as no safety or efficacy data are available for this age group. In adolescents with heterozygous familial hypercholesterolemia, ezetimibe may be prescribed alongside dietary management and, if necessary, statin therapy under specialist supervision.

Pregnancy and Breastfeeding

The safety of ezetimibe during pregnancy has not been established through adequate clinical studies. If you are taking Ezetimib Krka together with a statin and become pregnant, you should discontinue both medications immediately and inform your doctor, as statins are known to be harmful to the developing fetus (FDA Pregnancy Category X when combined with a statin).

If you are taking Ezetimib Krka alone (without a statin) and are pregnant or planning to become pregnant, consult your doctor before continuing treatment. The decision to use ezetimibe monotherapy during pregnancy should be based on a careful assessment of the potential benefit versus the potential risk to the fetus.

Ezetimib Krka should not be used during breastfeeding when taken together with a statin, as it is unknown whether ezetimibe or its metabolites are excreted in human breast milk. Ezetimibe alone should also not be used during breastfeeding unless the potential benefit justifies the potential risk to the nursing infant.

Driving and Operating Machinery

Ezetimib Krka is not expected to affect your ability to drive or operate machinery. However, some patients have reported dizziness as a side effect. If you experience dizziness while taking ezetimibe, you should exercise caution when driving or operating machinery until you know how the medication affects you.

How Does Ezetimib Krka Interact with Other Drugs?

Ezetimib Krka can interact with several medications including cyclosporine, anticoagulants (warfarin), cholestyramine, and fibrates. Always inform your doctor about all medications you are taking, including over-the-counter drugs and supplements, to avoid potentially harmful interactions.

Drug interactions are an important consideration when taking any medication. Ezetimibe has a relatively favorable interaction profile compared to many other lipid-lowering agents, but certain combinations require caution or dose adjustments. The following table summarizes the most clinically significant interactions:

Known Drug Interactions with Ezetimib Krka
Interacting Drug Severity Effect Recommendation
Cyclosporine Major Cyclosporine significantly increases ezetimibe levels (up to 12-fold increase in AUC). Ezetimibe may also increase cyclosporine levels. Use with caution. Monitor cyclosporine levels closely. Your doctor should weigh the benefits against the risks.
Warfarin / Anticoagulants Moderate Ezetimibe may enhance the anticoagulant effect of warfarin, phenprocoumon, acenocoumarol, or fluindione, increasing the risk of bleeding. Monitor INR (International Normalized Ratio) more frequently when starting or stopping ezetimibe. Dose adjustments of the anticoagulant may be needed.
Cholestyramine Moderate Cholestyramine decreases the absorption of ezetimibe by approximately 55%, significantly reducing its cholesterol-lowering effect. Take ezetimibe at least 2 hours before or 4 hours after cholestyramine or any other bile acid sequestrant.
Fibrates (e.g., fenofibrate, gemfibrozil) Moderate Fibrates may increase cholesterol excretion into bile and increase the risk of gallstones. The safety of this combination has not been established in clinical trials. This combination is generally not recommended unless the potential benefit outweighs the risks. If used, monitor for signs of gallbladder disease.
Statins Low No clinically significant pharmacokinetic interaction. The combination is intentional and provides additive cholesterol-lowering effects. Safe to combine. This is the most common therapeutic use. Both can be taken at the same time of day.

Major Interactions

The most clinically significant interaction is with cyclosporine, an immunosuppressant commonly used in organ transplant recipients. Co-administration of cyclosporine with ezetimibe results in a dramatic increase in ezetimibe exposure (up to 12-fold increase in area under the curve), which raises the risk of adverse effects. Additionally, ezetimibe may increase cyclosporine blood levels, potentially leading to cyclosporine toxicity including nephrotoxicity. If this combination is deemed necessary, close therapeutic drug monitoring of cyclosporine levels is essential.

Minor Interactions

Ezetimibe does not appear to inhibit or induce cytochrome P450 enzymes (CYP1A2, CYP2C8, CYP2C9, CYP2D6, or CYP3A4), which means it has minimal potential for interactions mediated through these metabolic pathways. This favorable pharmacokinetic profile is one reason why ezetimibe is considered a relatively safe add-on therapy. No clinically meaningful interactions have been observed with commonly used medications including oral contraceptives, digoxin, antacids, or cimetidine.

Food interactions:

Ezetimib Krka can be taken with or without food. Food does not significantly affect the bioavailability of ezetimibe, so there is no need to time your dose around meals. This flexibility makes it easy to incorporate into your daily routine.

What Is the Correct Dosage of Ezetimib Krka?

The standard dose of Ezetimib Krka is one 10 mg tablet once daily by mouth, taken at any time of day with or without food. This dose applies to adults, elderly patients, and adolescents aged 10 years and older. No dose adjustment is required for patients with mild hepatic impairment or renal impairment.

Ezetimibe dosing is straightforward compared to many other medications. There is only one available strength (10 mg), and the dose does not need to be titrated. Before starting treatment, patients should already be following a cholesterol-lowering diet, and this dietary approach should be maintained throughout the course of therapy.

Adults

The recommended dose is 10 mg once daily. Ezetimibe can be taken at any time of day, with or without food. If prescribed alongside a statin, both medications may be taken at the same time. The cholesterol-lowering effect is typically apparent within 2 weeks of starting treatment, with maximum effect seen after approximately 4 weeks.

Children and Adolescents (6-17 years)

For children and adolescents aged 6 to 17 years with heterozygous familial hypercholesterolemia, the dose is 10 mg once daily under specialist supervision. Ezetimibe should not be given to children under 6 years of age. Treatment in pediatric patients should be initiated by a physician experienced in managing lipid disorders in children.

Elderly Patients

No dose adjustment is necessary for elderly patients. The same 10 mg once daily dose applies. However, elderly patients may be at increased risk for statin-related muscle side effects when ezetimibe is combined with a statin, and this should be considered during clinical monitoring.

Patients with Hepatic or Renal Impairment

No dose adjustment is required for patients with mild hepatic impairment (Child-Pugh score 5-6) or any degree of renal impairment. However, ezetimibe is not recommended for patients with moderate to severe hepatic impairment (Child-Pugh score 7 or above) due to the significantly increased exposure to ezetimibe in these patients.

Missed Dose

If you forget to take a dose of Ezetimib Krka, do not take a double dose to make up for the missed one. Simply take your next dose at the usual time the following day. Consistency is important for optimal cholesterol control, so try to take your medication at the same time each day to help establish a routine. Setting a daily alarm or keeping the medication with other daily items (such as by your toothbrush) can help you remember.

Overdose

If you take more Ezetimib Krka than prescribed, or if a child accidentally swallows the medication, contact your doctor or local poison control center immediately for assessment and advice. In clinical studies, ezetimibe at doses up to 50 mg/day was generally well tolerated, but there is limited experience with doses above the recommended 10 mg. Treatment of overdose is supportive, as there is no specific antidote for ezetimibe. Standard measures to remove any unabsorbed drug should be considered.

Stopping Treatment

Do not stop taking Ezetimib Krka without consulting your doctor. If you discontinue treatment, your cholesterol levels are likely to increase again. Your doctor will determine the appropriate duration of treatment based on your individual cardiovascular risk profile and cholesterol response. In most cases, treatment with cholesterol-lowering medications is lifelong, as the benefits in terms of cardiovascular risk reduction are maintained only with continued therapy.

Ezetimib Krka Dosage by Patient Group
Patient Group Dose Frequency Special Notes
Adults 10 mg Once daily Can be taken with or without food, at any time of day
Children 6-17 years 10 mg Once daily Under specialist supervision only
Elderly 10 mg Once daily No dose adjustment required
Mild hepatic impairment 10 mg Once daily No dose adjustment required
Moderate/severe hepatic impairment Not recommended N/A Increased drug exposure; not recommended
Renal impairment 10 mg Once daily No dose adjustment needed at any severity level

What Are the Side Effects of Ezetimib Krka?

Like all medications, Ezetimib Krka can cause side effects, although not everyone experiences them. Common side effects include abdominal pain, diarrhea, flatulence, and fatigue when used alone. When combined with a statin, headache and muscle pain may also occur. Seek immediate medical attention for unexplained muscle pain, swelling of the face or throat, or signs of liver problems.

The side effect profile of ezetimibe varies depending on whether it is used alone (monotherapy) or in combination with a statin. In general, ezetimibe is well tolerated, with most side effects being mild and transient. The following frequency classifications are based on clinical trial data and post-marketing surveillance:

Side Effects When Ezetimibe Is Used Alone

Common

May affect up to 1 in 10 people
  • Abdominal pain
  • Diarrhea
  • Flatulence (gas)
  • Fatigue

Uncommon

May affect up to 1 in 100 people
  • Elevated liver enzymes (transaminases)
  • Elevated creatine kinase (CK)
  • Cough
  • Indigestion (dyspepsia) and heartburn
  • Nausea
  • Joint pain (arthralgia)
  • Muscle cramps
  • Neck pain
  • Decreased appetite
  • Pain and chest pain
  • Hot flush
  • High blood pressure (hypertension)

Additional Side Effects When Used with a Statin

Common

May affect up to 1 in 10 people
  • Elevated liver enzymes (transaminases)
  • Headache
  • Muscle pain, tenderness, or weakness (myalgia)

Uncommon

May affect up to 1 in 100 people
  • Tingling or numbness (paraesthesia)
  • Dry mouth
  • Itching (pruritus)
  • Skin rash
  • Hives (urticaria)
  • Back pain
  • Muscle weakness
  • Pain in arms and legs
  • Unusual tiredness or weakness
  • Swelling, particularly in hands and feet (edema)

Side Effects When Used with Fenofibrate

Common

May affect up to 1 in 10 people
  • Abdominal pain

Post-Marketing Reports (Frequency Unknown)

Reported During General Use

Frequency cannot be estimated from available data
  • Dizziness
  • Muscle pain (myalgia)
  • Liver problems (hepatitis)
  • Allergic reactions including skin rash and hives
  • Erythema multiforme (raised red, target-like skin rash)
  • Rhabdomyolysis (serious muscle breakdown with kidney damage)
  • Gallstones or gallbladder inflammation (cholecystitis)
  • Pancreatitis (inflammation of the pancreas with severe abdominal pain)
  • Constipation
  • Decreased platelet count (thrombocytopenia), causing bruising or bleeding
  • Tingling sensation (paraesthesia)
  • Depression
  • Unusual tiredness or weakness
  • Shortness of breath (dyspnoea)
When to seek immediate medical attention:

Contact your doctor or go to the nearest emergency department immediately if you experience: unexplained muscle pain, tenderness, or weakness (especially if accompanied by fever or a general feeling of being unwell); swelling of the face, lips, tongue, or throat causing difficulty breathing or swallowing (signs of a severe allergic reaction); yellowing of the skin or whites of the eyes, dark urine, or persistent nausea (signs of liver problems); or severe abdominal pain (possible pancreatitis).

It is important to note that in clinical trials, the overall incidence of side effects with ezetimibe was comparable to placebo. The majority of side effects reported are mild and resolve on their own without the need to discontinue treatment. If you experience persistent or bothersome side effects, discuss them with your doctor, as adjusting your treatment regimen may be possible.

How Should You Store Ezetimib Krka?

Store Ezetimib Krka in its original packaging to protect from moisture, at room temperature, out of the sight and reach of children. Do not use after the expiry date printed on the carton. Do not dispose of medications via household waste or down the drain.

Proper storage of medication is essential to ensure its effectiveness and safety throughout the treatment period. Ezetimib Krka tablets should be stored in their original blister packaging to protect them from moisture, as the formulation is moisture-sensitive. Keep the medication at room temperature, away from direct sunlight and heat sources.

Always check the expiry date printed on the carton before taking a dose. The expiry date refers to the last day of the stated month. Do not use Ezetimib Krka after this date, as the chemical stability and efficacy of the medication can no longer be guaranteed.

Keep this medication out of the sight and reach of children. Child-resistant packaging provides an additional layer of safety, but it should not be relied upon as the sole measure to prevent accidental ingestion by children.

When you no longer need the medication or it has expired, do not throw it in household waste or flush it down the toilet. Ask your pharmacist about proper medication disposal programs in your area. These measures help protect the environment from pharmaceutical contaminants.

What Does Ezetimib Krka Contain?

Each Ezetimib Krka tablet contains 10 mg of the active substance ezetimibe. The inactive ingredients include sodium lauryl sulfate, povidone K30, mannitol (E421), croscarmellose sodium (E468), microcrystalline cellulose (E460), and sodium stearyl fumarate. The tablets are white to off-white, capsule-shaped with beveled edges.

Active Ingredient

The active pharmaceutical ingredient in Ezetimib Krka is ezetimibe at a dose of 10 mg per tablet. Ezetimibe is a selective cholesterol absorption inhibitor that was first approved by the FDA in 2002 and subsequently by the European Medicines Agency (EMA). It is one of the most widely prescribed lipid-lowering agents worldwide.

Inactive Ingredients (Excipients)

The inactive ingredients serve various pharmaceutical functions in the tablet formulation:

  • Sodium lauryl sulfate: Acts as a surfactant to improve drug dissolution and absorption
  • Povidone K30: Functions as a binder to maintain tablet integrity
  • Mannitol (E421): Serves as a filler and provides a pleasant taste
  • Croscarmellose sodium (E468): Acts as a disintegrant to help the tablet break down in the digestive tract
  • Microcrystalline cellulose (E460): Functions as a filler and binder
  • Sodium stearyl fumarate: Serves as a lubricant during the manufacturing process
Sodium content:

Ezetimib Krka contains sodium as part of its excipients. Patients on a controlled sodium diet should be aware of this, although the amount of sodium per tablet is minimal and unlikely to have a clinically significant effect. Consult your doctor or pharmacist if you have concerns about sodium intake.

Tablet Appearance and Packaging

Ezetimib Krka tablets are white to off-white, capsule-shaped tablets with beveled edges, measuring 8 x 4 mm. They are packaged in OPA/Aluminium/PVC/Aluminium blisters. Available pack sizes include 14, 28, 30, 50, 56, 60, 90, 98, and 100 tablets in standard blisters, as well as unit-dose perforated blisters in the same quantities. Not all pack sizes may be marketed in every country.

Frequently Asked Questions About Ezetimib Krka

Ezetimibe and statins lower cholesterol through completely different mechanisms. Statins (such as atorvastatin, rosuvastatin, or simvastatin) work by inhibiting HMG-CoA reductase, an enzyme in the liver responsible for producing cholesterol. Ezetimibe, on the other hand, works in the small intestine by blocking the NPC1L1 protein that is responsible for absorbing cholesterol from food and bile. Because they target different pathways, combining ezetimibe with a statin provides a complementary and additive cholesterol-lowering effect that is greater than either drug alone.

Yes, Ezetimib Krka can be used as monotherapy (without a statin). This approach is specifically indicated for patients who cannot tolerate statins due to side effects (most commonly muscle pain or elevated liver enzymes), or for patients in whom statin therapy is considered inappropriate. As monotherapy, ezetimibe typically reduces LDL cholesterol by 15-20%, which may be sufficient for some patients, particularly those who are close to their cholesterol targets.

Ezetimibe begins working immediately to reduce cholesterol absorption, but measurable changes in blood cholesterol levels typically become apparent within 2 weeks of starting treatment. The maximum cholesterol-lowering effect is usually achieved within 4 weeks. Your doctor will likely order a blood test after 4-6 weeks of treatment to assess your response and determine whether any adjustments to your therapy are needed.

No, unlike some statins (particularly simvastatin and atorvastatin), ezetimibe does not interact with grapefruit or grapefruit juice. Ezetimibe is not significantly metabolized by the CYP3A4 enzyme, which is the pathway through which grapefruit exerts its drug interaction effects. Therefore, you can consume grapefruit freely while taking ezetimibe alone. However, if you are also taking a statin that does interact with grapefruit, you should follow the grapefruit guidance for that specific statin.

Ezetimib Krka and Ezetrol both contain the same active ingredient (ezetimibe 10 mg) and are therapeutically equivalent. Ezetrol is the original brand-name product developed by MSD/Organon, while Ezetimib Krka is a generic version manufactured by KRKA, d.d., Novo mesto (Slovenia). Generic medications must demonstrate bioequivalence to the original product, meaning they deliver the same amount of active ingredient to the bloodstream at the same rate. The inactive ingredients (excipients) may differ slightly between brands, but this does not affect clinical efficacy.

There is no specific interaction between ezetimibe and alcohol. However, excessive alcohol consumption can increase triglyceride levels and worsen liver function, both of which can counteract the benefits of cholesterol-lowering treatment. If you are taking ezetimibe in combination with a statin, alcohol should be consumed in moderation, as both statins and excessive alcohol can affect the liver. Discuss your alcohol intake with your doctor to determine what level of consumption is safe for you.

All information on this page is based on internationally recognized medical guidelines and peer-reviewed research, including: the ESC/EAS 2019 Guidelines for the Management of Dyslipidaemias (European Heart Journal), the AHA/ACC 2018 Cholesterol Guidelines, the IMPROVE-IT trial published in the New England Journal of Medicine (2015), the European Medicines Agency (EMA) Summary of Product Characteristics for ezetimibe, NICE Clinical Guidelines (UK), and the WHO Model List of Essential Medicines. All medical claims follow the GRADE evidence framework with Level 1A evidence from systematic reviews and randomized controlled trials.

References

  1. Mach F, Baigent C, Catapano AL, et al. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. European Heart Journal. 2020;41(1):111-188. doi:10.1093/eurheartj/ehz455
  2. Cannon CP, Blazing MA, Giugliano RP, et al. Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes (IMPROVE-IT). New England Journal of Medicine. 2015;372(25):2387-2397. doi:10.1056/NEJMoa1410489
  3. Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol. Journal of the American College of Cardiology. 2019;73(24):e285-e350. doi:10.1016/j.jacc.2018.11.003
  4. European Medicines Agency (EMA). Ezetimibe - Summary of Product Characteristics. Accessed January 2026.
  5. National Institute for Health and Care Excellence (NICE). Cardiovascular disease: risk assessment and reduction, including lipid modification. Clinical guideline [CG181]. Updated 2023.
  6. World Health Organization (WHO). Model List of Essential Medicines, 23rd List. 2023.
  7. Sudhop T, Lutjohann D, Kodal A, et al. Inhibition of intestinal cholesterol absorption by ezetimibe in humans. Circulation. 2002;106(15):1943-1948.
  8. Baigent C, Landray MJ, Reith C, et al. The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial. Lancet. 2011;377(9784):2181-2192.

Medical Editorial Team

This article has been written and reviewed by the iMedic Medical Editorial Team, a group of licensed specialist physicians with expertise in cardiology, clinical pharmacology, and internal medicine. Our editorial process follows international medical standards and guidelines.

Medical Review

All content reviewed by board-certified physicians specializing in cardiology and clinical pharmacology, following ESC/EAS and AHA/ACC guidelines.

Evidence Standard

Level 1A evidence based on systematic reviews and meta-analyses of randomized controlled trials. GRADE framework applied to all recommendations.

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Updates

Content is regularly reviewed and updated to reflect current medical evidence and guideline changes. Last review: January 2026.