CLINICAL TRIALS PROFILE FOR LOVASTATIN

505(b)(2) Clinical Trials for Lovastatin

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT00092846 ↗	A 6-Month Consumer Behavior Study of a Self-Management System (0803-084)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2002-12-04	The purpose of this study is to evaluate the ability of patients with intermediate risk of heart disease to appropriately use a Self-Management System.

All Clinical Trials for Lovastatin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000463 ↗	Post Coronary Artery Bypass Graft (CABG) Study	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1987-04-01	To determine the relative effectiveness of moderate versus more aggressive lipid lowering, and of low dose anticoagulation versus placebo, in delaying saphenous vein coronary bypass graft atherosclerosis and preventing occlusion of saphenous grafts of patients with saphenous vein coronary bypass grafts placed 1 to 11 years previously.
NCT00000469 ↗	Asymptomatic Carotid Artery Plaque Study (ACAPS)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	1988-05-01	To determine whether warfarin or lovastatin alone or in combination retarded the progression of atherosclerotic plaques in the carotid arteries of high risk individuals with asymptomatic carotid stenosis. Also, to determine if a full scale trial was feasible.
NCT00000477 ↗	Cholesterol Reduction in Seniors Program (CRISP)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	1990-07-01	To conduct a pilot study to determine whether lowering elevated serum cholesterol levels with 3-hydroxy-3-methyl-glutaryl coenzyme A (HMG CoA) reductase inhibitors reduced mortality due to the sequelae of atherosclerotic cardiovascular disease in older men and women.
NCT00000512 ↗	Familial Atherosclerosis Treatment Study	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1984-01-01	To compare the effects of two intensive lipid-lowering regimens with conventional therapy on coronary atherosclerosis as assessed by arteriography.
NCT00000512 ↗	Familial Atherosclerosis Treatment Study	Completed	University of Washington	Phase 3	1984-01-01	To compare the effects of two intensive lipid-lowering regimens with conventional therapy on coronary atherosclerosis as assessed by arteriography.
NCT00004346 ↗	Phase II Study of Cholesterol- and Cholestanol-Free Diet, Lovastatin, and Chenodeoxycholic Acid for Cerebrotendinous Xanthomatosis	Unknown status	Oregon Health and Science University	Phase 2	1996-01-01	OBJECTIVES: I. Assess the biosynthesis of cholesterol and cholestanol, and measure the turnover of individual sterols and bile acids in patients with cerebrotendinous xanthomatosis before and after a cholesterol- and cholestanol-free diet. II. Assess the biosynthesis of cholesterol and cholestanol, and measure the turnover of individual sterols and bile acids in these patients before and after lovastatin and chenodeoxycholic acid.
NCT00004346 ↗	Phase II Study of Cholesterol- and Cholestanol-Free Diet, Lovastatin, and Chenodeoxycholic Acid for Cerebrotendinous Xanthomatosis	Unknown status	National Center for Research Resources (NCRR)	Phase 2	1996-01-01	OBJECTIVES: I. Assess the biosynthesis of cholesterol and cholestanol, and measure the turnover of individual sterols and bile acids in patients with cerebrotendinous xanthomatosis before and after a cholesterol- and cholestanol-free diet. II. Assess the biosynthesis of cholesterol and cholestanol, and measure the turnover of individual sterols and bile acids in these patients before and after lovastatin and chenodeoxycholic acid.

Clinical Trial Conditions for Lovastatin

Condition Name

Condition Name for Lovastatin
Intervention	Trials
Hypercholesterolemia	7
Cardiovascular Diseases	5
Heart Diseases	4
Fragile X Syndrome	3

Condition MeSH

Condition MeSH for Lovastatin
Intervention	Trials
Hypercholesterolemia	9
Cardiovascular Diseases	7
Dyslipidemias	5
Syndrome	5

Clinical Trial Locations for Lovastatin

Trials by Country

Trials by Country for Lovastatin
Location	Trials
United States	140
Canada	15
Taiwan	7
Netherlands	4
Korea, Republic of	3

Trials by US State

Trials by US State for Lovastatin
Location	Trials
California	17
North Carolina	8
New York	7
Florida	6
Ohio	6

Clinical Trial Progress for Lovastatin

Clinical Trial Phase

Clinical Trial Phase for Lovastatin
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	10
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Lovastatin
Clinical Trial Phase	Trials
Completed	48
Terminated	10
Not yet recruiting	4

Clinical Trial Sponsors for Lovastatin

Sponsor Name

Sponsor Name for Lovastatin
Sponsor	Trials
National Heart, Lung, and Blood Institute (NHLBI)	5
National Taiwan University Hospital	4
National Science Council, Taiwan	3

Sponsor Type

Sponsor Type for Lovastatin
Sponsor	Trials
Other	88
Industry	27
NIH	15

Lovastatin: Clinical Trials, Market Analysis, and Projections

Introduction to Lovastatin

Lovastatin, a member of the statin class of drugs, is widely used to lower cholesterol levels and prevent cardiovascular diseases. It works by inhibiting the enzyme HMG-CoA reductase, which is crucial for cholesterol production in the liver.

Clinical Trials Update

The Expanded Clinical Evaluation of Lovastatin (EXCEL) study is one of the most significant clinical trials conducted on lovastatin. This randomized, double-blind, placebo- and diet-controlled multicenter trial involved 8,245 patients with moderately severe hypercholesterolemia over a period of 48 weeks.

• Efficacy: The study showed that lovastatin significantly reduced LDL cholesterol levels by 24% to 40% and triglyceride levels by 10% to 19%, while increasing HDL cholesterol levels by 6.6% to 9.5%[1].
• Long-term Follow-up: In the second year of the study, the efficacy of lovastatin in lowering LDL cholesterol was maintained, and the increases in HDL cholesterol were moderately greater than in the first year. The study also highlighted that lovastatin is generally well tolerated with a favorable safety profile, including rare instances of myopathy and transaminase elevations[1].

Market Analysis

Global Statin Market Overview

The global statin market, which includes lovastatin, is experiencing significant growth driven by the increasing prevalence of cardiovascular diseases and lifestyle-related disorders.

• Market Size: The statin market was valued at USD 16.10 billion in 2023 and is anticipated to reach USD 23.25 billion by 2031, growing at a CAGR of 4.70%[3].
• Regional Growth: North America is expected to lead the global statin market due to its robust healthcare infrastructure and high medication utilization rates. The Asia Pacific region is also witnessing significant growth due to a rapidly expanding patient population and evolving lifestyle patterns[3].

Lovastatin Market Share and Ranking

Lovastatin is one of the key products in the statin market, although it faces competition from other statins like atorvastatin, rosuvastatin, and simvastatin.

• Market Forecast: The global lovastatin market is forecast to grow as part of the broader statin market, driven by increasing demand for effective cholesterol management. The market is expected to be influenced by advancements in drug formulations and delivery systems, as well as the development of combination therapies[2][5].

Market Drivers and Trends

Increasing Prevalence of Cardiovascular Diseases

The rising prevalence of cardiovascular diseases, obesity, diabetes, and other lifestyle-related conditions is a major driver of the statin market, including lovastatin.

• Global Health Trends: According to the WHO, Europe and North America have the highest elevated total cholesterol levels worldwide. In North America, over 70% of American adults suffer from LDL cholesterol, driving the demand for effective treatments like lovastatin[5].

Advancements in Formulations and Delivery Systems

Ongoing research and development in statin formulations aim to enhance patient compliance and minimize side effects.

• Innovative Formulations: Pharmaceutical companies are exploring innovative statin formulations that improve bioavailability and reduce side effects, making these medications more tolerable for patients[3].

Combination Therapies

The development of combination therapies, where statins are paired with other lipid-lowering agents or cardiovascular medications, offers a more comprehensive approach to managing cholesterol levels and reducing cardiovascular risk.

• Personalized Treatment: This personalized treatment strategy improves patient adherence and optimizes therapeutic outcomes, contributing to the increasing uptake of statins in clinical practice[3].

Regional Market Analysis

North America

North America is poised to lead the global statin market due to its robust healthcare infrastructure and high medication utilization rates.

• High Demand: The region's growing focus on research and development initiatives enhances the market's potential for innovation and growth. The prevalence of chronic conditions such as high cholesterol, obesity, diabetes, and heart disease further fuels demand for statins[3].

Asia Pacific

The Asia Pacific region is witnessing significant growth in the statin market due to a rapidly expanding patient population affected by cardiovascular diseases and evolving lifestyle patterns.

• Emerging Markets: Countries such as China and India are major contributors to this market expansion, supported by advancements in healthcare infrastructure, increasing healthcare spending, and heightened awareness of cholesterol management[3].

Impact of COVID-19 and Other Global Events

The COVID-19 pandemic and the Russia-Ukraine War have had indirect impacts on the statin market, including disruptions in supply chains and changes in healthcare priorities.

• Market Recovery: Despite these challenges, the statin market is expected to recover and continue growing, driven by the increasing demand for cholesterol management and the ongoing innovations in drug development[5].

Key Takeaways

• Clinical Efficacy: Lovastatin has been shown to be highly effective in lowering LDL cholesterol and triglyceride levels while increasing HDL cholesterol levels.
• Market Growth: The global statin market, including lovastatin, is expected to grow significantly due to the rising prevalence of cardiovascular diseases and lifestyle-related disorders.
• Regional Trends: North America and the Asia Pacific region are key markets for statins, driven by robust healthcare infrastructure and growing patient populations.
• Innovations: Advancements in formulations and the development of combination therapies are expected to drive market expansion.

FAQs

What is Lovastatin used for?

Lovastatin is used to lower cholesterol levels and prevent cardiovascular diseases by inhibiting the enzyme HMG-CoA reductase.

What were the key findings of the EXCEL study on Lovastatin?

The EXCEL study showed that lovastatin significantly reduced LDL cholesterol and triglyceride levels while increasing HDL cholesterol levels, and it was generally well tolerated with a favorable safety profile[1].

How is the global statin market expected to grow?

The global statin market is anticipated to grow from USD 16.10 billion in 2023 to USD 23.25 billion by 2031, at a CAGR of 4.70%[3].

What are the main drivers of the statin market?

The main drivers include the increasing prevalence of cardiovascular diseases, obesity, diabetes, and other lifestyle-related conditions, as well as advancements in drug formulations and delivery systems[3][5].

How has the COVID-19 pandemic impacted the statin market?

The COVID-19 pandemic has had indirect impacts, including disruptions in supply chains, but the market is expected to recover and continue growing driven by increasing demand for cholesterol management[5].

Cited Sources

1. Expanded Clinical Evaluation of Lovastatin (EXCEL) study results - PubMed.
2. Lovastatin - Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030 - Market Research Reports.
3. Statin Market Size, Share, Growth, Report & Industry Trends By 2031 - Data Bridge Market Research.
4. NIA-Funded Active Alzheimer's and Related Dementias Clinical Trials - National Institute on Aging (not relevant to the topic).
5. Statin Market Present and Future Growth 2032| 103 Pages Report - News Channel Nebraska.