CLINICAL TRIALS PROFILE FOR FLUVASTATIN SODIUM

All Clinical Trials for FLUVASTATIN SODIUM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02017197 ↗	Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil	Completed	Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4	2014-08-01	The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
NCT01551173 ↗	Efficacy and Safety of Fluvastatin Sodium Extended Release Tablets 80 mg Once Daily in Chinese Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia	Completed	Novartis Pharmaceuticals	Phase 4	2012-01-01	This study is to demonstrate therapeutic comparability of Fluvastatin sodium Extended Release Tablets 80 mg QD and Fluvastatin sodium Immediate Release Capsules 40 mg BID in LDL-C lowering from baseline to week 12 (endpoint) in patients with primary hypercholesterolemia or mixed dyslipidemia at moderate or high CV risk who did not achieve their lipid goals when treated with Fluvastatin sodium Immediate Release Capsules 40 mg QD.
NCT00382161 ↗	Improvement of Erectile Dysfunction by Fluvastatin in Patients With Cardiovascular Risk Factors	Withdrawn	Novartis	Phase 3	2006-10-01	The purpose of the study is to determine the effect of fluvastatin on penile arterial blood flow and erectile function in patients with arteriogenic ED and cardiovascular risk factors.
NCT00382161 ↗	Improvement of Erectile Dysfunction by Fluvastatin in Patients With Cardiovascular Risk Factors	Withdrawn	University Hospital, Saarland	Phase 3	2006-10-01	The purpose of the study is to determine the effect of fluvastatin on penile arterial blood flow and erectile function in patients with arteriogenic ED and cardiovascular risk factors.
NCT00416403 ↗	Effect of Fluvastatin on Biomarkers in Women Who Are Undergoing Surgery for Ductal Carcinoma In Situ or Stage I Breast Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2006-07-01	RATIONALE: Collecting samples of blood and tissue from patients with cancer to study in the laboratory may help doctors learn how fluvastatin effects biomarkers related to breast cancer. PURPOSE: This randomized phase II trial is studying how fluvastatin effects biomarkers in women undergoing surgery for ductal carcinoma in situ or stage I breast cancer.
NCT00416403 ↗	Effect of Fluvastatin on Biomarkers in Women Who Are Undergoing Surgery for Ductal Carcinoma In Situ or Stage I Breast Cancer	Completed	University of California, San Francisco	Phase 2	2006-07-01	RATIONALE: Collecting samples of blood and tissue from patients with cancer to study in the laboratory may help doctors learn how fluvastatin effects biomarkers related to breast cancer. PURPOSE: This randomized phase II trial is studying how fluvastatin effects biomarkers in women undergoing surgery for ductal carcinoma in situ or stage I breast cancer.
NCT00199927 ↗	Statins in Proteinuric Nephropathies	Completed	Mario Negri Institute for Pharmacological Research	Phase 3	2003-03-01	End stage renal disease (ESRD) is rapidly growing worldwide. Patients with ESRD have increased morbidity and mortality mostly because of a dramatic excess of cardiovascular disease. Thus, preventing or limiting the progression of chronic nephropathies, in addition to limit the incidence of ESRD, may also postpone death. Drugs that inhibit the renin angiotensin system, such as Angiotensin-Converting-Enzyme inhibitors (ACEi) and Angiotensin II receptor antagonists (ATA), are reno- and cardio-protective in the long-term. There are data that statins,in addition to limit cardiovascular events may have specific reno-protective properties. Thus we designed a study aimed to evaluate whether statins associated to ACEi and ATA may have an additional reno-protective effect. ESPLANADE is a multicenter, prospective, randomized, parallel group study in which, after 2 months treatment with ACEi and ATA, two groups of 90 patients, with or without type 2 diabetes, are randomized to 6 months Fluvastatin (40 or 80 mg/day) treatment YES or NO.Twenty Italian Nephrology Units are involved in the trial. The study is fully coordinated by the Clinical Research Center for Rare Disease Aldo e Cele Daccò, Villa Camozzi, Ranica.

Clinical Trial Conditions for FLUVASTATIN SODIUM

Condition Name

Condition Name for FLUVASTATIN SODIUM
Intervention	Trials
Breast Cancer	1
Chronic Nephropathy	1
Hypertension	1
Impotence	1

Condition MeSH

Condition MeSH for FLUVASTATIN SODIUM
Intervention	Trials
Erectile Dysfunction	1
Dyslipidemias	1
Proteinuria	1
Carcinoma, Intraductal, Noninfiltrating	1

Clinical Trial Locations for FLUVASTATIN SODIUM

Trials by Country

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Trials by Country for FLUVASTATIN SODIUM
Location	Trials
Italy	7
United States	4
Germany	1
Brazil	1
China	1

Trials by US State

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−

Trials by US State for FLUVASTATIN SODIUM
Location	Trials
New York	1
Massachusetts	1
Illinois	1
California	1

Clinical Trial Progress for FLUVASTATIN SODIUM

Clinical Trial Phase

Clinical Trial Phase for FLUVASTATIN SODIUM
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for FLUVASTATIN SODIUM
Clinical Trial Phase	Trials
Completed	4
Withdrawn	1

Clinical Trial Sponsors for FLUVASTATIN SODIUM

Sponsor Name

Sponsor Name for FLUVASTATIN SODIUM
Sponsor	Trials
Federal University of São Paulo	1
Mario Negri Institute for Pharmacological Research	1
Novartis	1

Sponsor Type

Sponsor Type for FLUVASTATIN SODIUM
Sponsor	Trials
Other	5
Industry	2
NIH	1

Fluvastatin Sodium: Clinical Trials, Market Analysis, and Projections

Introduction to Fluvastatin Sodium

Fluvastatin sodium is a cholesterol-lowering agent that belongs to the statin class of drugs. It works by inhibiting the enzyme 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, which is crucial for cholesterol production in the liver. Here, we will delve into the clinical trials, market analysis, and projections for fluvastatin sodium.

Clinical Trials Overview

Patient Demographics and Trial Design

In clinical trials involving fluvastatin capsules, a total of 2326 patients were treated, with an age range of 18 to 75 years. The demographic breakdown included 44% women, 94% White, 4% Black or African American, and 2% from other ethnicities. The median treatment duration was 24 weeks[1].

Adverse Reactions and Safety Profile

The most common adverse reactions that led to treatment discontinuation in these trials included increased transaminase levels, upper abdominal pain, dyspepsia, fatigue, and diarrhea. Approximately 1.1% of patients developed dose-related, persistent elevations of serum transaminase levels to more than three times the upper limit of normal (ULN), with 0.6% of these patients being discontinued from therapy[1].

Efficacy in Clinical Trials

The LESCOL Intervention Prevention Study (LIPS) was a significant trial that assessed the effect of fluvastatin capsules on the risk of recurrent cardiac events in patients with coronary heart disease who had undergone a percutaneous coronary intervention. This multicenter, randomized, double-blind, placebo-controlled trial involved 1677 patients treated with either fluvastatin capsules 40 mg twice daily or placebo for a median of 3.9 years. The results showed a reduction in the risk of recurrent cardiac events, highlighting the efficacy of fluvastatin in secondary prevention of cardiovascular events[1].

Market Analysis

Current Market Size and Growth

The global market for pharmaceutical-grade fluvastatin sodium was valued at USD 0.85 billion in 2022 and is projected to reach USD 1.25 billion by 2030, growing at a CAGR of 4.7% from 2024 to 2030[2].

Market Segments and Regional Analysis

The market is segmented by type (capsules and tablets) and by application (children and adults). Regionally, the market spans North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa. Each region presents unique opportunities and challenges, influenced by economic conditions, regulatory frameworks, and consumer preferences[2].

Key Drivers and Restraints

• Drivers: The rising prevalence of hypercholesterolemia and cardiovascular diseases, increasing healthcare awareness, and advancements in drug delivery technologies are driving the market[3].
• Restraints: Increased competition from newer cholesterol-lowering agents such as PCSK9 inhibitors and the dominance of generic fluvastatin sodium in low-cost markets are expected to limit market growth[2].

Market Projections

Short-Term Outlook (2023-2025)

The market is expected to experience moderate growth in the short term, driven by the continued reliance on generic versions of fluvastatin sodium. This period will see a steady, albeit slow, growth trajectory[2].

Mid-Term Outlook (2025-2030)

Beyond 2025, the market may face challenges due to the increasing adoption of novel cholesterol-lowering therapies, such as biologics and more effective treatments. This could potentially reduce the market share of fluvastatin sodium in developed regions[2].

Long-Term Outlook (2030-2033)

In the long term, the rise in global health initiatives focusing on cardiovascular disease prevention may offer some recovery for fluvastatin sodium, particularly in emerging markets. However, the overall market growth is expected to be moderate due to the increasing competition from newer therapies[2].

Competitive Landscape

The market for fluvastatin sodium is competitive, with key players including Novartis, Mylan, and Teva Pharmaceuticals. The increasing availability of generic versions of fluvastatin sodium is a significant factor in the competitive landscape, particularly in low-cost markets like India and China[5].

Regional Market Dynamics

• North America: This region is expected to see moderate growth, influenced by regulatory changes and consumer preferences.
• Europe: Similar to North America, Europe will experience moderate growth, with a focus on innovative delivery systems.
• Asia-Pacific: This region is anticipated to drive significant growth due to an aging population and increasing healthcare awareness[2].

Key Takeaways

• Clinical Efficacy: Fluvastatin sodium has been shown to be effective in reducing the risk of recurrent cardiac events in patients with coronary heart disease.
• Market Growth: The market is projected to grow at a CAGR of 4.7% from 2024 to 2030, driven by the rising prevalence of cardiovascular diseases.
• Competition: The market faces competition from newer cholesterol-lowering agents and generic versions, which may impact its growth trajectory.
• Regional Dynamics: The Asia-Pacific region is expected to be a key driver of growth due to demographic and healthcare trends.

FAQs

What is the projected market size of fluvastatin sodium by 2030?

The global market for fluvastatin sodium is projected to reach USD 1.25 billion by 2030[2].

What are the key drivers of the fluvastatin sodium market?

The key drivers include the rising prevalence of hypercholesterolemia and cardiovascular diseases, increasing healthcare awareness, and advancements in drug delivery technologies[3].

How does the competition from newer cholesterol-lowering agents affect the market?

The competition from newer agents like PCSK9 inhibitors is expected to erode the market share of fluvastatin sodium, particularly in developed regions[2].

What is the impact of generic versions on the fluvastatin sodium market?

The increasing availability of generic fluvastatin sodium will continue to reduce pricing pressures, especially in low-cost markets like India and China[2].

Which regions are expected to drive the growth of the fluvastatin sodium market?

The Asia-Pacific region is anticipated to drive significant growth due to an aging population and increasing healthcare awareness[2].

Sources

1. RxList: Lescol XL (Fluvastatin Sodium Extended-release Tablets) - RxList.
2. GitHub: Pharmaceutical Grade Fluvastatin Sodium Market Insights and Growth Outlook 2024.
3. Business Research Insights: Fluvastatin Sodium Drug Market Size 2032.
4. FDA: 214012Orig1s000 CLINICAL REVIEW(S).
5. Valuates Reports: Fluvastatin Sodium Drug - Market Size.