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Last Updated: February 16, 2025

CLINICAL TRIALS PROFILE FOR EZETIMIBE; SIMVASTATIN


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All Clinical Trials for Ezetimibe; Simvastatin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00079638 ↗ Comparative Efficacy Evaluation of Lipids When Treated With Niaspan & Statin or Other Lipid-Modifying Therapies-COMPELL Completed Kos Pharmaceuticals Phase 4 2004-04-01 The purpose of this study is to evaluate the effectiveness of first-line treatment using Niaspan (an extended release version of niacin) and statins versus other drugs that lower lipid levels, in subjects with elevated fat levels in their blood (dyslipidemia). Statins are a class of medication that is often prescribed to patients who need to lower their cholesterol levels.
NCT00090298 ↗ Study to Evaluate the Cholesterol Lowering Effects of Two Marketed Drugs in Patients With Elevated Cholesterol Levels (0653A-058) Completed Merck Sharp & Dohme Corp. Phase 3 2004-04-01 A 10-week study to compare the reduction in cholesterol following treatment with two different marketed drugs in patients with hypercholesterolemia.
NCT00092599 ↗ Investigational Drug Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-801) Completed Merck Sharp & Dohme Corp. Phase 3 2003-02-01 This study will evaluate patients who have coronary heart disease to determine if an investigational drug will further lower cholesterol when taken in combination with an approved cholesterol lowering medication.
NCT00092612 ↗ Co-administration Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-802)(COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 3 2003-05-01 The purpose of this study is to investigate additional cholesterol lowering effects in patients with coronary heart disease by giving an investigational drug with a patient's current approved cholesterol lowering medication.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ezetimibe; Simvastatin

Condition Name

Condition Name for Ezetimibe; Simvastatin
Intervention Trials
Hypercholesterolemia 48
Atherosclerosis 14
Hyperlipidemia 7
Coronary Heart Disease 6
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Condition MeSH

Condition MeSH for Ezetimibe; Simvastatin
Intervention Trials
Hypercholesterolemia 55
Coronary Disease 17
Coronary Artery Disease 17
Atherosclerosis 16
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Clinical Trial Locations for Ezetimibe; Simvastatin

Trials by Country

Trials by Country for Ezetimibe; Simvastatin
Location Trials
United States 76
Brazil 10
Mexico 8
Spain 6
Germany 5
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Trials by US State

Trials by US State for Ezetimibe; Simvastatin
Location Trials
Texas 5
New York 5
California 4
Florida 3
Colorado 3
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Clinical Trial Progress for Ezetimibe; Simvastatin

Clinical Trial Phase

Clinical Trial Phase for Ezetimibe; Simvastatin
Clinical Trial Phase Trials
Phase 4 40
Phase 3 42
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Ezetimibe; Simvastatin
Clinical Trial Phase Trials
Completed 84
Unknown status 11
Terminated 6
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Clinical Trial Sponsors for Ezetimibe; Simvastatin

Sponsor Name

Sponsor Name for Ezetimibe; Simvastatin
Sponsor Trials
Merck Sharp & Dohme Corp. 64
Schering-Plough 6
University of Sao Paulo 3
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Sponsor Type

Sponsor Type for Ezetimibe; Simvastatin
Sponsor Trials
Industry 80
Other 68
NIH 2
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Ezetimibe and Simvastatin: Clinical Trials, Market Analysis, and Projections

Introduction to Ezetimibe and Simvastatin

Ezetimibe and simvastatin are two medications often combined in the drug VYTORIN, used to lower cholesterol levels and reduce the risk of cardiovascular events. Ezetimibe works by inhibiting the absorption of cholesterol in the small intestine, while simvastatin is a statin that reduces cholesterol production in the liver.

Clinical Trials: IMPROVE-IT Study

One of the most significant clinical trials involving ezetimibe and simvastatin is the IMPROVE-IT (IMProved Reduction of Outcomes: VYTORIN Efficacy International Trial) study. Here are the key findings:

  • Patient Population: The trial involved over 18,000 patients with acute coronary syndromes (ACS), including those with ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI), and unstable angina (UA)[3][4].
  • Treatment Groups: Patients were randomized to either ezetimibe 10 mg/simvastatin 40 mg or simvastatin 40 mg alone. The doses could be titrated to ezetimibe/simvastatin 10/80 mg or simvastatin 80 mg[3][4].
  • Outcomes: The study showed that patients taking the combination of ezetimibe and simvastatin experienced significantly fewer major cardiovascular events compared to those taking simvastatin alone. This included a reduction in cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, re-hospitalization for unstable angina, or coronary revascularization[3][4].
  • Risk Reduction: At seven years, 32.7% of patients taking VYTORIN experienced a first primary endpoint event, compared to 34.7% of patients taking simvastatin alone, resulting in a 6.4% relative risk reduction[3].

Additional Insights from IMPROVE-IT

  • Subgroup Analysis: Patients with diabetes, prior stroke, and prior coronary artery bypass grafting (CABG) showed a greater treatment effect than those without these conditions. The benefit was observed regardless of baseline LDL-C levels, including those with LDL-C <70 mg/dl at baseline[4].
  • Safety Profile: The study did not show an increase in the incidence of new-onset diabetes, which is sometimes observed with statin therapy. Adverse events such as myopathy, rhabdomyolysis, and liver enzyme elevations were similar between the two treatment groups[3].

Market Analysis

Global Market Size and Growth

The global market for ezetimibe and simvastatin tablets is significant and growing. Here are some key market insights:

  • Current Market Size: As of 2025, the global market size for ezetimibe is valued at millions of dollars, with a projected Compound Annual Growth Rate (CAGR) of several percent during the forecast period of 2025-2033[2].
  • Market Drivers: The growth is driven by the rising prevalence of hypercholesterolemia, increasing awareness of cardiovascular diseases, and expanding healthcare accessibility. The growing geriatric population and adoption of sedentary lifestyles and unhealthy diets also contribute to the demand for cholesterol-lowering medications like ezetimibe[2].

Competitive Landscape

The market for ezetimibe and simvastatin is highly competitive, with several key players:

  • Leading Players: Companies such as Merck, Teva, and Zydus Pharmaceuticals are major players in the market. Merck, in particular, has been at the forefront with its product VYTORIN[2][5].
  • Generic Substitutes: The availability of generic substitutes is a potential restraint to market growth. However, the branded version of VYTORIN continues to hold a significant market share due to its established efficacy and safety profile[2].

Regional Market Insights

The market for ezetimibe and simvastatin tablets varies by region:

  • North America and Europe: These regions have a well-established market with a high demand for cholesterol-lowering medications. The market size and growth rate in these regions are detailed in various reports, highlighting the segmentation by type and application[5].
  • Asia and Other Regions: The market in Asia, Middle East, Africa, and Latin America is also growing, driven by increasing healthcare spending and awareness of cardiovascular diseases. These regions offer significant growth opportunities for pharmaceutical companies[5].

Projections and Future Outlook

Market Forecast

The global ezetimibe and simvastatin tablets market is expected to continue growing over the next several years:

  • Forecast Period: The market is projected to grow at a CAGR of several percent from 2025 to 2033. This growth will be driven by increasing demand for effective cholesterol-lowering treatments and expanding healthcare infrastructure[2][5].
  • Regional Growth: North America, Europe, and Asia are expected to be key regions driving this growth, with emerging markets also contributing significantly to the overall market size[5].

Challenges and Opportunities

While the market for ezetimibe and simvastatin is promising, there are challenges and opportunities to consider:

  • Generic Competition: The availability of generic substitutes could impact the market share of branded products like VYTORIN. However, the established brand loyalty and the ongoing need for effective cholesterol management will continue to support the market[2].
  • Emerging Therapies: The emergence of alternative therapies could pose a challenge, but the proven efficacy and safety of ezetimibe and simvastatin combination therapy make it a strong contender in the market[2].

Key Takeaways

  • Clinical Efficacy: The IMPROVE-IT study has demonstrated the superiority of the ezetimibe and simvastatin combination in reducing major cardiovascular events in high-risk patients.
  • Market Growth: The global market for ezetimibe and simvastatin tablets is growing, driven by increasing demand for cholesterol-lowering medications and expanding healthcare accessibility.
  • Competitive Landscape: The market is highly competitive, with Merck and other major pharmaceutical companies vying for market share.
  • Future Outlook: The market is expected to continue growing, with significant opportunities in both established and emerging markets.

FAQs

What is the primary finding of the IMPROVE-IT study?

The primary finding of the IMPROVE-IT study is that the combination of ezetimibe and simvastatin is superior to simvastatin alone in reducing major cardiovascular events in high-risk patients with acute coronary syndromes[3][4].

What are the key drivers of the global ezetimibe market?

The key drivers include the rising prevalence of hypercholesterolemia, increasing awareness of cardiovascular diseases, and expanding healthcare accessibility. Additionally, the growing geriatric population and adoption of sedentary lifestyles and unhealthy diets contribute to the demand[2].

Who are the leading players in the ezetimibe and simvastatin market?

The leading players include Merck, Teva, and Zydus Pharmaceuticals. Merck, in particular, is a major player with its product VYTORIN[2][5].

What are the potential restraints to market growth for ezetimibe and simvastatin?

The availability of generic substitutes and the emergence of alternative therapies are potential restraints to market growth[2].

What is the projected growth rate for the global ezetimibe and simvastatin tablets market?

The market is projected to grow at a CAGR of several percent from 2025 to 2033, driven by increasing demand and expanding healthcare infrastructure[2][5].

Sources

  1. Merck News: New Analyses from the IMPROVE-IT Outcomes Study of VYTORIN® (ezetimibe and simvastatin) and the TECOS Cardiovascular Safety Trial of JANUVIA® (sitagliptin) Will Be Presented at the European Society of Cardiology Congress[1].
  2. Data Insights Market: Decoding Ezetimibe Consumer Preferences 2025-2033[2].
  3. Merck News: Results from Investigational IMPROVE-IT Study of VYTORIN® (ezetimibe and simvastatin) Published in the New England Journal of Medicine[3].
  4. American College of Cardiology: IMProved Reduction of Outcomes: Vytorin Efficacy International Trial - IMPROVE-IT[4].
  5. QYResearch: Global Ezetimibe/Simvastatin Tablets Market Insights, Forecast to 2030[5].

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