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Last Updated: February 16, 2025

CLINICAL TRIALS PROFILE FOR EZETIMIBE AND SIMVASTATIN


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All Clinical Trials for Ezetimibe And 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.
NCT00092651 ↗ A Study of MK0653A (Ezetimibe (+) Simvastatin) in Patients With Hypercholesterolemia (0653A-038) Completed Merck Sharp & Dohme Corp. Phase 3 2002-09-01 The purpose of this study is to evaluate the lipid lowering effects of an investigational drug in patients with hypercholesterolemia (high cholesterol).
NCT00092664 ↗ An Extension Study of An Investigational Drug in Patients With Hypercholesterolemia (0653A-038)(COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 3 2003-01-01 The purpose of this study is to evaluate the lipid lowering effects of an investigational drug in patients with hypercholesterolemia (high cholesterol).
NCT00092677 ↗ An Investigational Drug on Clinical Outcomes in Patients With Aortic Stenosis (Narrowing of the Major Blood Vessel of the Heart)(MK-0653A-043 AM4)(COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 3 2001-01-01 The purpose of this study is to evaluate whether treatment with an investigational drug as compared to placebo will reduce the risk of major cardiovascular events in patients with aortic stenosis.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ezetimibe And Simvastatin

Condition Name

Condition Name for Ezetimibe And Simvastatin
Intervention Trials
Hypercholesterolemia 48
Atherosclerosis 14
Hyperlipidemia 7
Metabolic Syndrome 6
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Condition MeSH

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

Trials by Country

Trials by Country for Ezetimibe And 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 And Simvastatin
Location Trials
Texas 5
New York 5
California 4
Florida 3
Colorado 3
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Clinical Trial Progress for Ezetimibe And Simvastatin

Clinical Trial Phase

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

Sponsor Name

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

Introduction

Ezetimibe and simvastatin, combined in the medication known as Vytorin, have been extensively studied for their efficacy in reducing cardiovascular events and lowering cholesterol levels. This article delves into the key findings from clinical trials, market analysis, and future projections for this drug combination.

Clinical Trials: IMPROVE-IT Study

The IMPROVE-IT (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial) study is a landmark clinical trial that compared the efficacy of ezetimibe/simvastatin with simvastatin alone in high-risk patients post-acute coronary syndrome (ACS)[1][3].

Patient Demographics and Trial Design

  • The trial involved 18,144 patients randomized at 1,158 sites in 39 countries.
  • Patients were divided into two groups: 9,067 received ezetimibe/simvastatin, and 9,077 received simvastatin alone.
  • The study included patients with various presentations of ACS, such as ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI), and unstable angina (UA).

Key Findings

  • The ezetimibe/simvastatin combination was superior to simvastatin alone in reducing long-term cardiovascular events.
  • The primary endpoint, which included cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, re-hospitalization for unstable angina, or coronary revascularization, was significantly reduced in the ezetimibe/simvastatin group (29.8% vs. 32.4%, HR 0.92, 95% CI 0.87-0.98, p = 0.012)[1][3].

Safety Profile

  • The study did not show any significant differences in cancer incidence, myopathy, or transaminitis between the two treatment groups.
  • The incidence of new-onset diabetes was also not increased in the ezetimibe/simvastatin group compared to the simvastatin group[1][3].

Additional Clinical Insights

Efficacy in Specific Patient Groups

  • Patients with diabetes, prior stroke, and prior coronary artery bypass grafting (CABG) showed a greater treatment effect with ezetimibe/simvastatin compared to those without these conditions[1].

LDL-C Reduction

  • Ezetimibe alone reduces LDL-C by approximately 18%, and when combined with simvastatin, it enhances the LDL-C-lowering effect by an additional 20-25%[4].

Market Analysis

Global Market Size and Growth

  • As of 2017, the global ezetimibe and simvastatin market size was significant, and it is forecast to grow at a notable CAGR from 2018 to 2025[2].
  • The market is driven by the rising prevalence of hypercholesterolemia, increasing awareness of cardiovascular diseases, and expanding healthcare accessibility[5].

Key Market Drivers

  • The growing geriatric population and the adoption of sedentary lifestyles and unhealthy diets contribute to the demand for cholesterol-lowering medications like ezetimibe and simvastatin[5].

Market Restraints

  • The availability of generic substitutes and the emergence of alternative therapies are potential restraints to market growth[5].

Competitive Landscape

  • The market is highly competitive, with leading players such as Merck, Teva, and Zydus Pharmaceuticals vying for market share[5].

Market Projections

Forecasted Growth

  • The global ezetimibe market is projected to grow at a significant CAGR from 2025 to 2033, driven by increasing cholesterol levels and healthcare awareness[5].

Regional Analysis

  • The market is expected to grow in key regions, with a focus on countries where cardiovascular diseases are prevalent and healthcare infrastructure is expanding[2].

Consumer Preferences and Trends

Increasing Awareness

  • There is a growing awareness of cardiovascular diseases, which is driving the demand for effective cholesterol-lowering medications like ezetimibe and simvastatin[5].

Healthcare Accessibility

  • Expanding healthcare accessibility, especially in developing countries, is expected to boost the market for ezetimibe and simvastatin[5].

Conclusion

The combination of ezetimibe and simvastatin has been proven to be effective in reducing cardiovascular events in high-risk patients, as demonstrated by the IMPROVE-IT trial. The market for this drug combination is expected to grow significantly due to increasing demand driven by rising cholesterol levels and growing awareness of cardiovascular health.

Key Takeaways

  • Clinical Efficacy: Ezetimibe/simvastatin is superior to simvastatin alone in reducing cardiovascular events in high-risk ACS patients.
  • Safety Profile: The combination does not increase the risk of cancer, myopathy, or transaminitis.
  • Market Growth: The global market for ezetimibe and simvastatin is projected to grow at a significant CAGR from 2025 to 2033.
  • Key Drivers: Rising prevalence of hypercholesterolemia, increasing geriatric population, and expanding healthcare accessibility.
  • Market Restraints: Availability of generic substitutes and emergence of alternative therapies.

FAQs

Q: What was the primary finding of the IMPROVE-IT trial?

A: The IMPROVE-IT trial found that ezetimibe/simvastatin was superior to simvastatin alone in reducing long-term cardiovascular events in high-risk post-ACS patients[1][3].

Q: How does ezetimibe enhance the effect of simvastatin?

A: Ezetimibe enhances the LDL-C-lowering effect of simvastatin by an additional 20-25% when combined[4].

Q: What are the key drivers of the global ezetimibe and simvastatin market?

A: The key drivers include the rising prevalence of hypercholesterolemia, increasing geriatric population, and expanding healthcare accessibility[5].

Q: What are the potential restraints to market growth?

A: The availability of generic substitutes and the emergence of alternative therapies are potential restraints to market growth[5].

Q: Which companies are leading the market for ezetimibe and simvastatin?

A: Leading players include Merck, Teva, and Zydus Pharmaceuticals[5].

Sources

  1. IMProved Reduction of Outcomes: Vytorin Efficacy International Trial - American College of Cardiology.
  2. Global Ezetimibe Market Analysis Revealing Key Drivers & Growth Trends through 2025 - FeedsFloor.
  3. Results from Investigational IMPROVE-IT Study of VYTORIN - Merck.
  4. New Insights on Simvastatin and Ezetimibe in a Single Tablet - ECR Journal.
  5. Decoding Ezetimibe Consumer Preferences 2025-2033 - Data Insights Market.

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