CLINICAL TRIALS PROFILE FOR LESCOL

All Clinical Trials for LESCOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00532311 ↗	Efficacy of Lapaquistat Acetate Co-Administered With Statins in Subjects With Hypercholesterolemia	Terminated	Takeda	Phase 3	2007-07-01	The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily (QD), taken with statins on cholesterol levels in subjects with hypercholesterolemia
NCT00487318 ↗	Fluvastatin, Rosuvastatin Added to Pegylated Interferon and Ribavirin	Completed	US Department of Veterans Affairs	Phase 2	2007-06-01	Hypothesis: addition of fluvastatin will increase the cure rate of standard anti-HCV therapy. Summary: This trial is limited to veterans in Oklahoma who qualify for care with the Veterans Administration. It is a randomized control format including genotypes 1 and 3. There will also be pilot arms for HCV carriers who present for screening already on a statin, who will be allowed to stay on their current statin or switched to another statin. In all ways, standard therapy as noted on pegylated interferon and ribavirin will be given per FDA package insert.
NCT00487318 ↗	Fluvastatin, Rosuvastatin Added to Pegylated Interferon and Ribavirin	Completed	VA Office of Research and Development	Phase 2	2007-06-01	Hypothesis: addition of fluvastatin will increase the cure rate of standard anti-HCV therapy. Summary: This trial is limited to veterans in Oklahoma who qualify for care with the Veterans Administration. It is a randomized control format including genotypes 1 and 3. There will also be pilot arms for HCV carriers who present for screening already on a statin, who will be allowed to stay on their current statin or switched to another statin. In all ways, standard therapy as noted on pegylated interferon and ribavirin will be given per FDA package insert.
NCT00487318 ↗	Fluvastatin, Rosuvastatin Added to Pegylated Interferon and Ribavirin	Completed	Bader, Ted, M.D.	Phase 2	2007-06-01	Hypothesis: addition of fluvastatin will increase the cure rate of standard anti-HCV therapy. Summary: This trial is limited to veterans in Oklahoma who qualify for care with the Veterans Administration. It is a randomized control format including genotypes 1 and 3. There will also be pilot arms for HCV carriers who present for screening already on a statin, who will be allowed to stay on their current statin or switched to another statin. In all ways, standard therapy as noted on pegylated interferon and ribavirin will be given per FDA package insert.
NCT00814723 ↗	Fluvastatin 80 mg Ret. vs Combination With Ezetimibe 10 mg in Patients With High Cardiovascular Risk	Completed	Medical University of Graz	Phase 4	2005-09-01	Patients with coronary heart disease (CHD) or CHD equivalent (e. g. diabetes mellitus) often have abnormalities in lipids (hypercholesterolemia). Besides, hypercholesterolemia is an evident risk factor for atherosclerosis. Hitherto, there are only few studies of patients with primary hypercholesterolemia where the combination therapy with statins (HMG-Co-reductase inhibitors) and ezetimib was investigated. This combination therapy should be more effective in reducing low density lipoprotein cholesterol (LDL-C) and total cholesterol levels compared to monotherapy.
NCT00421005 ↗	Fluvastatin After Heart Transplantation	Unknown status	University of Bologna	Phase 4	2004-11-01	Statin therapy is a treatment with a proven positive impact on survival after heart transplantation. However, it is unclear whether the beneficial effect of this class of drugs depends solely on their LDL-lowering properties or on anti-inflammatory and immuno-modulatory properties. Thus, this study was designed to compare safety and efficacy of two different strategies: 1. high fixed statin dose vs. 2. low starting dose with LDL-driven doses adjustments.

Clinical Trial Conditions for LESCOL

Condition Name

Condition Name for LESCOL
Intervention	Trials
Hypercholesterolemia	3
Adipose Tissue, Brown	1
Non-ST Segment Elevation Myocardial Infarction	1
Atherosclerosis	1

Condition MeSH

Condition MeSH for LESCOL
Intervention	Trials
Hypercholesterolemia	3
Coronary Disease	2
Coronary Artery Disease	2
Myocardial Ischemia	2

Clinical Trial Locations for LESCOL

Trials by Country

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−

Trials by Country for LESCOL
Location	Trials
United States	37
Switzerland	2
China	2
Austria	1
Canada	1

Trials by US State

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−

Trials by US State for LESCOL
Location	Trials
Massachusetts	2
California	2
Oklahoma	2
North Carolina	1
New Jersey	1

Clinical Trial Progress for LESCOL

Clinical Trial Phase

Clinical Trial Phase for LESCOL
Clinical Trial Phase	Trials
Phase 4	8
Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for LESCOL
Clinical Trial Phase	Trials
Completed	7
Unknown status	2
Recruiting	1

Clinical Trial Sponsors for LESCOL

Sponsor Name

Sponsor Name for LESCOL
Sponsor	Trials
Novartis	2
Peking University First Hospital	1
Beijing Anzhen Hospital	1

Sponsor Type

Sponsor Type for LESCOL
Sponsor	Trials
Other	10
Industry	4
U.S. Fed	2

Lescol: Clinical Trials, Market Analysis, and Projections

Introduction

Lescol, also known as fluvastatin, is a statin medication used to lower cholesterol and prevent cardiovascular disease. Here, we will delve into the current state of clinical trials, market analysis, and future projections for Lescol.

Clinical Trials Update

Ongoing Studies

As of the latest updates, there are 64 active clinical studies exploring the potential of Lescol for various conditions. These include:

• Hardening of the Arteries: 23 trials are actively recruiting patients, spanning across different phases such as Phase 1, Phase 2, Phase 3, and Phase 4[1].
• Coronary Heart Disease: Eight trials are actively recruiting, with some in early Phase 1[1].
• Primary Hypercholesterolemia: Twelve trials are ongoing, primarily in Phase 2 and Phase 3[1].
• Hypercholesterolemia and Dyslipidemias: Additional trials are focused on these conditions, with some in Phase 1 and Phase 2[1].

Specific Indications

Lescol is indicated for several specific conditions:

• Heterozygous Familial Hypercholesterolemia: In boys and post-menarchal girls aged 10 to 16 years who have failed an adequate trial of diet therapy[3][4].
• Coronary Heart Disease (CHD): To reduce the risk of undergoing revascularization procedures and to slow the progression of atherosclerosis in patients with clinically evident CHD[3][4].

Adverse Reactions and Safety

Clinical trials have highlighted several adverse reactions associated with Lescol, including:

• Liver Enzyme Elevations: Approximately 1.1% of patients developed dose-related, persistent elevations of serum transaminase levels. Most of these cases occurred within 12 weeks of therapy[3][4][5].
• Common Adverse Reactions: These include abdominal pain, diarrhea, nausea, dyspepsia, and chest pain, which led to treatment discontinuation in some cases[4][5].

Market Analysis

Global Dyslipidemia Drugs Market

The global market for dyslipidemia drugs, which includes Lescol, is projected to reach $26.7 billion by 2031, growing at a CAGR of 9.6% over the forecast period. This growth is driven by an increasing number of patients and the sales of newer and effective add-on therapies worldwide[2].

Market Drivers

Key drivers of the market include:

• Increasing Patient Population: The rising prevalence of dyslipidemia and associated cardiovascular diseases is driving the demand for effective treatments.
• Newer Therapies: The introduction of PCSK9 inhibitors and other late-phase pipeline molecules like bempedoic acid and inclisiran is expected to provide additional options for lowering LDL-C levels, further bolstering the market[2].

Market Challenges

Despite the growth, the market faces challenges such as:

• High Cost of New Therapies: The high cost of PCSK9 inhibitors, although contributing to revenue growth, can be a barrier to access for some patients.
• Patent Expirations: The expiration of patents for existing drugs can lead to increased competition from generics, potentially affecting the market share of branded drugs like Lescol[2].

Market Projections

Future Growth

The dyslipidemia drugs market is expected to continue growing, driven by the increasing need for effective cholesterol-lowering therapies. Lescol, with its established presence and ongoing clinical trials, is likely to remain a significant player in this market.

Emerging Therapies

The introduction of new therapies and the expansion of existing ones into new indications will further shape the market. For example, late-phase pipeline molecules are expected to offer additional treatment options, which could impact the market share of existing drugs like Lescol[2].

Key Takeaways

• Ongoing Clinical Trials: Lescol is being explored in numerous clinical trials for various conditions, including hardening of the arteries, coronary heart disease, and primary hypercholesterolemia.
• Market Growth: The global dyslipidemia drugs market is projected to reach $26.7 billion by 2031, driven by an increasing patient population and the introduction of new therapies.
• Adverse Reactions: Lescol is associated with liver enzyme elevations and other adverse reactions, highlighting the need for careful monitoring.
• Market Drivers and Challenges: The market is driven by the need for effective treatments but faces challenges such as high costs and patent expirations.

FAQs

What are the primary indications for Lescol?

Lescol is primarily indicated for heterozygous familial hypercholesterolemia in children and to reduce the risk of revascularization procedures and slow the progression of atherosclerosis in patients with coronary heart disease[3][4].

What are the common adverse reactions associated with Lescol?

Common adverse reactions include abdominal pain, diarrhea, nausea, dyspepsia, and chest pain. Liver enzyme elevations are also a significant concern[3][4][5].

How is the global dyslipidemia drugs market expected to grow?

The global dyslipidemia drugs market is projected to reach $26.7 billion by 2031, growing at a CAGR of 9.6% over the forecast period[2].

What new therapies are expected to impact the market?

Newer therapies such as PCSK9 inhibitors, bempedoic acid, and inclisiran are expected to provide additional treatment options and drive market growth[2].

Are there any specific patient populations being targeted in Lescol clinical trials?

Yes, clinical trials are targeting adolescents 1 year post-menarche with secondary hyperlipidemia and patients with primary hypercholesterolemia, among others[1].

Sources

1. Withpower.com: Lescol: Everything you need to know | Power - Clinical Trials
2. IHealthcareAnalyst.com: Global Dyslipidemia Drugs Market $26.7 Billion by 2031
3. Novartis.com: Lescol® XL (fluvastatin) extended-release tablets, for oral use
4. Accessdata.fda.gov: Lescol Label
5. Accessdata.fda.gov: Lescol® XL (fluvastatin) extended-release tablets, for oral use (2023 update)