CLINICAL TRIALS PROFILE FOR LESCOL XL

All Clinical Trials for LESCOL XL

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.
NCT00821574 ↗	Reducing the Overall Risk Level in Patients Suffering From Metabolic Syndrome	Completed	Novartis	Phase 4	2005-07-01	This study will evaluate the efficacy of a multi factorial preventive scheme of action (including fluvastatin and valsartan) to reduce the overall risk level in patients with metabolic syndrome.
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 XL

Condition Name

Condition Name for LESCOL XL
Intervention	Trials
Hypercholesterolemia	3
Drug-drug Interaction	1
Heart Transplantation	1
Hyperlipidemias	1

Condition MeSH

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

Clinical Trial Locations for LESCOL XL

Trials by Country

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−

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

Trials by US State

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−

Trials by US State for LESCOL XL
Location	Trials
California	2
Oklahoma	2
Massachusetts	2
District of Columbia	1
Colorado	1

Clinical Trial Progress for LESCOL XL

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for LESCOL XL

Sponsor Name

Sponsor Name for LESCOL XL
Sponsor	Trials
Novartis	2
Medical University of Graz	1
Peking University First Hospital	1

Sponsor Type

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

Lescol XL: Clinical Trials, Market Analysis, and Projections

Clinical Trials and Efficacy

Lescol XL, a formulation of fluvastatin sodium, has been extensively studied in various clinical trials to assess its efficacy and safety in managing cholesterol levels and preventing cardiovascular events.

Efficacy in Cholesterol Reduction

In clinical studies, Lescol XL has demonstrated significant reductions in total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG), while increasing high-density lipoprotein cholesterol (HDL-C)[1][4].

• Primary Hypercholesterolemia and Mixed Dyslipidemia: Lescol XL has shown efficacy in reducing LDL-C by up to 34% and increasing HDL-C by up to 16% in patients with primary mixed dyslipidemia[1].
• Coronary Atherosclerosis: The Lipoprotein and Coronary Atherosclerosis Study (LCAS) used quantitative coronary angiography to assess the effect of fluvastatin on coronary atherosclerosis, showing a beneficial impact on slowing the progression of coronary atherosclerosis[1].

Safety Profile

The safety profile of Lescol XL has been evaluated in several studies, highlighting its tolerability across different age groups, including those above 65 years.

• Liver Function: While Lescol XL is generally safe, there have been reports of persistent transaminase elevations in some patients. It is recommended to perform liver enzyme tests before and during treatment[4].
• Other Adverse Effects: The majority of adverse effects are mild and include gastrointestinal symptoms, muscle pain, and dizziness. Rare but serious side effects such as fatal and non-fatal hepatic failure have been reported post-marketing[4].

Market Analysis

Market Segmentation

The cholesterol-lowering drugs market is segmented into several submarkets, with statins and fixed-dose combinations being a significant segment.

• Statins and Fixed-Dose Combinations: Lescol XL falls under this category, which includes other prominent statins like Crestor, Lipitor, and Zocor. This segment is expected to remain a major player in the market due to the widespread use of statins in managing hypercholesterolemia[2][5].

Revenue Forecasts

The market for cholesterol-lowering drugs, including Lescol XL, is projected to grow over the next few years.

• Global Market: Revenue forecasts indicate that the cholesterol-lowering drugs market will continue to grow, driven by increasing awareness of cardiovascular health and the introduction of new treatments. The global market is expected to see significant revenue growth through 2025[2][5].
• Regional Markets: The US, Japan, EU5, and BRIC countries are key regional markets. These regions are expected to contribute substantially to the overall revenue growth of the cholesterol-lowering drugs market, including the segment for statins like Lescol XL[5].

Competitive Landscape

The cholesterol-lowering drugs market is highly competitive, with several established and emerging players.

• Established Players: Novartis, the manufacturer of Lescol XL, competes with other major pharmaceutical companies such as Pfizer (Lipitor), AstraZeneca (Crestor), and Merck (Zocor)[2][5].
• Emerging Treatments: The market is also seeing the emergence of new treatments such as PCSK9 inhibitors (e.g., Praluent and Repatha) and novel cholesterol-lowering drugs, which could potentially impact the market share of traditional statins like Lescol XL[2][5].

Market Projections

Growth Drivers

Several factors are driving the growth of the cholesterol-lowering drugs market, including:

• Increasing Prevalence of Hypercholesterolemia: The rising incidence of high cholesterol and associated cardiovascular diseases is a significant driver[5].
• Advancements in Treatment Options: The introduction of new and more effective treatments, such as PCSK9 inhibitors, is expected to expand the market[2][5].

Challenges and Restraints

Despite the growth potential, there are challenges that could impact the market.

• Generic Competition: The expiration of patents for several statins has led to increased generic competition, which could reduce the market share of branded drugs like Lescol XL[5].
• Safety Concerns: Although rare, serious side effects such as liver damage can affect market perception and usage[4].

Key Takeaways

• Efficacy and Safety: Lescol XL has demonstrated significant efficacy in reducing cholesterol levels and is generally well-tolerated, although it requires monitoring for liver function.
• Market Position: Lescol XL is part of the statins and fixed-dose combinations segment, which is a major player in the cholesterol-lowering drugs market.
• Revenue Forecasts: The market for cholesterol-lowering drugs, including Lescol XL, is projected to grow through 2025, driven by increasing demand and new treatment options.
• Competitive Landscape: The market is highly competitive, with both established and emerging treatments vying for market share.

FAQs

What is Lescol XL used for?

Lescol XL is used to reduce elevated total cholesterol, LDL-C, Apo B, and triglycerides, and to increase HDL-C in adult patients with primary hypercholesterolemia and mixed dyslipidemia. It is also indicated for the secondary prevention of major adverse cardiac events in adults with coronary heart disease[1][4].

How effective is Lescol XL in reducing cholesterol?

Lescol XL has been shown to reduce LDL-C by up to 34% and increase HDL-C by up to 16% in clinical studies[1].

What are the common side effects of Lescol XL?

Common side effects include gastrointestinal symptoms, muscle pain, and dizziness. Rare but serious side effects such as liver damage have been reported[4].

How does Lescol XL compare to other statins in the market?

Lescol XL competes with other statins like Crestor, Lipitor, and Zocor. While it has a strong efficacy profile, the market share is influenced by the presence of generic alternatives and new treatment options like PCSK9 inhibitors[2][5].

What is the projected market growth for Lescol XL and similar drugs?

The cholesterol-lowering drugs market, including statins like Lescol XL, is expected to grow through 2025, driven by increasing demand and new treatment options[2][5].

Sources

1. Novartis: Lescol - Novartis.
2. PR Newswire: Cholesterol-Lowering Drugs Market Forecast 2015-2025.
3. HUGIN Online: PR 03 06 03 Lescol ALERT Study_E.
4. FDA: Fluvastatin Sodium Sponsor.
5. PR Newswire: Cholesterol-lowering Drugs Market Forecast 2015-2025.