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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR LIVALO


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All Clinical Trials for Livalo

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00344370 ↗ Follow-On Study of Pitavastatin Versus Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia Completed Kowa Research Europe Phase 3 2006-08-01 This is a sixteen-week double-blind active-controlled follow-on and 28-week single-blind extension study for patients who participated in study NK-104-305.
NCT00846118 ↗ Differential Intervention Trial by Standard Therapy Versus Pitavastatin in Patients With Chronic Hemodialysis (DIALYSIS) Terminated Chieko Hamada N/A 2009-02-01 The purpose of this study is to verify whether pitavastatin prevents from cardiovascular events and improves the mortality in chronic hemodialysis patients with hypercholesteremia.
NCT00889226 ↗ Efficacy and Safety Study of Pitavastatin Compared to atoRvastatin in Type 2 dIabeTes Mellitus With Hypercholesterolemia Completed JW Pharmaceutical Phase 4 2008-04-01 A randomized, open label, dose titration study to evaluate the efficacy and safety of Pitavastatin compared to atorvastatin in Type 2 Diabetes Mellitus with hypercholesterolemia
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Livalo

Condition Name

Condition Name for Livalo
Intervention Trials
Hyperlipidemia 6
Dyslipidemia 6
Hypertension 3
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Condition MeSH

Condition MeSH for Livalo
Intervention Trials
Hyperlipidemias 9
Hyperlipoproteinemias 7
Dyslipidemias 7
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Clinical Trial Locations for Livalo

Trials by Country

Trials by Country for Livalo
Location Trials
United States 106
Korea, Republic of 6
Poland 1
Canada 1
Denmark 1
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Trials by US State

Trials by US State for Livalo
Location Trials
Texas 7
New York 5
Massachusetts 5
Kansas 4
Indiana 4
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Clinical Trial Progress for Livalo

Clinical Trial Phase

Clinical Trial Phase for Livalo
Clinical Trial Phase Trials
Phase 4 11
Phase 3 5
Phase 1 5
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Clinical Trial Status

Clinical Trial Status for Livalo
Clinical Trial Phase Trials
Completed 17
Withdrawn 2
Terminated 1
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Clinical Trial Sponsors for Livalo

Sponsor Name

Sponsor Name for Livalo
Sponsor Trials
JW Pharmaceutical 6
Kowa Research Institute, Inc. 6
Kowa Pharmaceuticals America, Inc. 3
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Sponsor Type

Sponsor Type for Livalo
Sponsor Trials
Other 38
Industry 22
NIH 1
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Livalo (Pitavastatin): Clinical Trials, Market Analysis, and Projections

Introduction to Livalo (Pitavastatin)

Livalo, known generically as pitavastatin, is a statin medication used to lower cholesterol levels and reduce the risk of cardiovascular events. Here, we will delve into recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

LIVES Study

The LIVALO Effectiveness and Safety (LIVES) Study, a long-term prospective post-marketing surveillance, has provided significant insights into the efficacy and safety of pitavastatin. This study, involving approximately 20,000 patients, showed that pitavastatin significantly reduced low-density lipoprotein-cholesterol (LDL-C) by 29.1% and increased high-density lipoprotein-cholesterol (HDL-C) by 19.9% over 104 weeks. It also demonstrated that pitavastatin was well tolerated, with only 10.4% of patients experiencing adverse events, most of which were mild[3].

REPRIEVE Study

The REPRIEVE study focused on the use of pitavastatin in people living with HIV. Participants were randomly assigned to receive pitavastatin or a placebo, and the results showed a 35% lower rate of major cardiovascular events in the pitavastatin arm compared to the placebo arm. LDL cholesterol levels decreased by 30% in the pitavastatin group, and the risk of cardiovascular events or death from any cause was 21% lower. The study highlighted the safety and efficacy of pitavastatin in this population[4].

Potential in Cancer Treatment

Recent findings published in Nature Communications suggest that pitavastatin may have therapeutic potential in cancers arising from chronic inflammation by inhibiting the production of IL-33, a factor that contributes to cancer development[1].

Market Analysis

Current Market Size and Growth

The pitavastatin market was valued at USD 537.1 million in 2023 and is projected to reach USD 890.2 million by 2031, growing at a compound annual growth rate (CAGR) of 6.7% during the forecast period from 2024 to 2031. This growth is driven by increasing awareness of preventive healthcare measures and the escalating incidence of cardiovascular diseases, particularly hyperlipidemia[2].

Regional Market Performance

The North America region is expected to hold the highest market share, with a noticeable shift towards combination therapies involving pitavastatin. The Asia Pacific region is also projected to grow rapidly, driven by the integration of digital health solutions such as telehealth services and mobile apps to improve patient accessibility and adherence[2].

End-User Segments

The hospital segment has witnessed significant growth, reflecting the widespread use of pitavastatin in managing hyperlipidemia. Healthcare providers are increasingly recommending pitavastatin as part of holistic treatment strategies to target various cardiovascular risk factors[2].

Market Projections

Future Growth Drivers

The market for pitavastatin is expected to be driven by several factors, including:

  • Increasing Prevalence of Hyperlipidemia: The rising incidence of high lipid levels in the blood is a significant risk factor for cardiovascular diseases, driving the demand for effective lipid-lowering medications like pitavastatin.
  • Advancements in Formulations: Ongoing research and development have led to improvements in pitavastatin formulations, enhancing efficacy and patient adherence.
  • Digital Health Solutions: The integration of digital technologies in healthcare is expected to improve patient accessibility, adherence, and monitoring of pitavastatin prescriptions, particularly in the Asia Pacific region[2].

Challenges and Opportunities

Despite the positive outlook, the market faces several challenges:

  • Regulatory Standards: Evolving regulatory standards and challenges in obtaining approvals for new formulations or indications could delay market entry or expansion.
  • Generic Alternatives: The emergence of generic alternatives poses a risk to branded pitavastatin, potentially leading to price erosion and a reduction in market share.
  • Healthcare Policies: Changes in healthcare policies and reimbursement structures can impact the affordability and accessibility of pitavastatin, influencing patient access and market demand[2].

Competitive Landscape

Key Players

The cholesterol-lowering drugs market, including statins like pitavastatin, is dominated by several key players:

  • Kowa Pharmaceuticals: The manufacturer of Livalo, which is one of the leading statins in the market.
  • Other Major Companies: AstraZeneca, Merck, Pfizer, Daiichi Sankyo, Abbvie, Novartis, Sanofi, and Amgen are also significant players in the broader cholesterol-lowering drugs market[5].

Conclusion

Pitavastatin, marketed as Livalo, has demonstrated strong efficacy and safety in clinical trials, particularly in reducing LDL-C and increasing HDL-C levels. The market for pitavastatin is poised for growth driven by increasing awareness of preventive healthcare and the rising incidence of cardiovascular diseases. However, the market must navigate challenges such as regulatory hurdles, generic competition, and changes in healthcare policies.

Key Takeaways

  • Clinical Efficacy: Pitavastatin has shown significant reductions in LDL-C and increases in HDL-C in clinical trials.
  • Market Growth: The pitavastatin market is projected to grow at a CAGR of 6.7% from 2024 to 2031.
  • Regional Performance: North America and Asia Pacific are key regions driving market growth.
  • Challenges: Regulatory standards, generic alternatives, and healthcare policies are potential challenges.
  • Future Prospects: Advancements in formulations and digital health solutions are expected to drive future growth.

FAQs

Q: What is the primary use of pitavastatin?

A: Pitavastatin is primarily used to lower cholesterol levels and reduce the risk of cardiovascular events.

Q: What were the key findings of the LIVES Study?

A: The LIVES Study showed that pitavastatin significantly reduced LDL-C and increased HDL-C levels, and it was well tolerated with minimal adverse events.

Q: How does pitavastatin perform in patients with HIV?

A: The REPRIEVE study found that pitavastatin reduced the risk of major cardiovascular events by 35% in people living with HIV.

Q: What are the projected market growth drivers for pitavastatin?

A: The market growth is driven by the increasing prevalence of hyperlipidemia, advancements in formulations, and the integration of digital health solutions.

Q: What challenges does the pitavastatin market face?

A: The market faces challenges such as evolving regulatory standards, the emergence of generic alternatives, and changes in healthcare policies.

Sources

  1. Onclive: Pitavastatin Offers Therapeutic Potential in Cancers Arising From Chronic Inflammation.
  2. InsightAce Analytic: Pitavastatin Market Current Scenario Analysis Report 2024-2031.
  3. PubMed: Pitavastatin: clinical effects from the LIVES Study.
  4. Aidsmap: Pitavastatin lowers risk of cardiovascular events in people living with HIV.
  5. PR Newswire: Cholesterol-lowering Drugs Market Forecast 2015-2025.

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