CLINICAL TRIALS PROFILE FOR PITAVASTATIN CALCIUM

All Clinical Trials for PITAVASTATIN CALCIUM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02056847 ↗	to Evaluate the Safety and Efficacy of Pitavastatin in Patients With IFG and Hyperlipidemia	Completed	Ajou University School of Medicine	Phase 4	2013-09-01	Primary Objective : To evaluate that there is no different effect on HbA1c between routine lipid lowering therapy(Livalo 2mg) and intensive lipid lowering therapy(Livalo 4mg) in the hyperlipidemic patients with impaired fasting glucose (IFG). H0: µT-µC ≥ 0.4 vs H1: µT-µC < 0.4 µT = the change of HbA1c in the test drug (Pitavastatin 4 MG) µC = the change of HbA1c in the control drug (Pitavastatin 2 MG)
NCT02056847 ↗	to Evaluate the Safety and Efficacy of Pitavastatin in Patients With IFG and Hyperlipidemia	Completed	Asan Medical Center	Phase 4	2013-09-01	Primary Objective : To evaluate that there is no different effect on HbA1c between routine lipid lowering therapy(Livalo 2mg) and intensive lipid lowering therapy(Livalo 4mg) in the hyperlipidemic patients with impaired fasting glucose (IFG). H0: µT-µC ≥ 0.4 vs H1: µT-µC < 0.4 µT = the change of HbA1c in the test drug (Pitavastatin 4 MG) µC = the change of HbA1c in the control drug (Pitavastatin 2 MG)
NCT02056847 ↗	to Evaluate the Safety and Efficacy of Pitavastatin in Patients With IFG and Hyperlipidemia	Completed	Chonbuk National University Hospital	Phase 4	2013-09-01	Primary Objective : To evaluate that there is no different effect on HbA1c between routine lipid lowering therapy(Livalo 2mg) and intensive lipid lowering therapy(Livalo 4mg) in the hyperlipidemic patients with impaired fasting glucose (IFG). H0: µT-µC ≥ 0.4 vs H1: µT-µC < 0.4 µT = the change of HbA1c in the test drug (Pitavastatin 4 MG) µC = the change of HbA1c in the control drug (Pitavastatin 2 MG)
NCT02056847 ↗	to Evaluate the Safety and Efficacy of Pitavastatin in Patients With IFG and Hyperlipidemia	Completed	Chonnam National University Hospital	Phase 4	2013-09-01	Primary Objective : To evaluate that there is no different effect on HbA1c between routine lipid lowering therapy(Livalo 2mg) and intensive lipid lowering therapy(Livalo 4mg) in the hyperlipidemic patients with impaired fasting glucose (IFG). H0: µT-µC ≥ 0.4 vs H1: µT-µC < 0.4 µT = the change of HbA1c in the test drug (Pitavastatin 4 MG) µC = the change of HbA1c in the control drug (Pitavastatin 2 MG)
NCT02056847 ↗	to Evaluate the Safety and Efficacy of Pitavastatin in Patients With IFG and Hyperlipidemia	Completed	Chungnam National University Hospital	Phase 4	2013-09-01	Primary Objective : To evaluate that there is no different effect on HbA1c between routine lipid lowering therapy(Livalo 2mg) and intensive lipid lowering therapy(Livalo 4mg) in the hyperlipidemic patients with impaired fasting glucose (IFG). H0: µT-µC ≥ 0.4 vs H1: µT-µC < 0.4 µT = the change of HbA1c in the test drug (Pitavastatin 4 MG) µC = the change of HbA1c in the control drug (Pitavastatin 2 MG)
NCT02056847 ↗	to Evaluate the Safety and Efficacy of Pitavastatin in Patients With IFG and Hyperlipidemia	Completed	Dong-A University Hospital	Phase 4	2013-09-01	Primary Objective : To evaluate that there is no different effect on HbA1c between routine lipid lowering therapy(Livalo 2mg) and intensive lipid lowering therapy(Livalo 4mg) in the hyperlipidemic patients with impaired fasting glucose (IFG). H0: µT-µC ≥ 0.4 vs H1: µT-µC < 0.4 µT = the change of HbA1c in the test drug (Pitavastatin 4 MG) µC = the change of HbA1c in the control drug (Pitavastatin 2 MG)
NCT02056847 ↗	to Evaluate the Safety and Efficacy of Pitavastatin in Patients With IFG and Hyperlipidemia	Completed	Eulji University Hospital	Phase 4	2013-09-01	Primary Objective : To evaluate that there is no different effect on HbA1c between routine lipid lowering therapy(Livalo 2mg) and intensive lipid lowering therapy(Livalo 4mg) in the hyperlipidemic patients with impaired fasting glucose (IFG). H0: µT-µC ≥ 0.4 vs H1: µT-µC < 0.4 µT = the change of HbA1c in the test drug (Pitavastatin 4 MG) µC = the change of HbA1c in the control drug (Pitavastatin 2 MG)

Clinical Trial Conditions for PITAVASTATIN CALCIUM

Condition Name

Condition Name for PITAVASTATIN CALCIUM
Intervention	Trials
Dyslipidemias	1
HbA1c Level Associated With Lipid Compositions	1
Hypertension	1
Prediabetic State	1

Condition MeSH

Condition MeSH for PITAVASTATIN CALCIUM
Intervention	Trials
Hyperlipoproteinemias	1
Hyperlipidemias	1
Prediabetic State	1
Hypertension	1

Clinical Trial Locations for PITAVASTATIN CALCIUM

Trials by Country

+

−

Trials by Country for PITAVASTATIN CALCIUM
Location	Trials
China	7
Korea, Republic of	1

Clinical Trial Progress for PITAVASTATIN CALCIUM

Clinical Trial Phase

Clinical Trial Phase for PITAVASTATIN CALCIUM
Clinical Trial Phase	Trials
Phase 4	2

Clinical Trial Status

Clinical Trial Status for PITAVASTATIN CALCIUM
Clinical Trial Phase	Trials
Completed	1
Unknown status	1

Clinical Trial Sponsors for PITAVASTATIN CALCIUM

Sponsor Name

Sponsor Name for PITAVASTATIN CALCIUM
Sponsor	Trials
The Catholic University of Korea Uijeongbu St.Marys Hostpial	1
Hanllym University Medical Center	1
The Catholic University of Korea Yeouido St.Marys Hostpial	1

Sponsor Type

Sponsor Type for PITAVASTATIN CALCIUM
Sponsor	Trials
Other	26
Industry	1

Pitavastatin Calcium: Clinical Trials, Market Analysis, and Projections

Introduction to Pitavastatin Calcium

Pitavastatin calcium is a potent statin used to manage hyperlipidemia and reduce the risk of cardiovascular diseases. It works by inhibiting HMG-CoA reductase, an enzyme crucial for cholesterol production, thereby significantly reducing low-density lipoprotein (LDL) cholesterol levels.

Clinical Trials Update

The REPRIEVE Trial

One of the most significant clinical trials involving pitavastatin calcium is the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) trial. This global trial assessed the efficacy of pitavastatin calcium in preventing major adverse cardiovascular events (MACE) among participants with HIV infection who were at low-to-moderate predicted cardiovascular risk.

• Key Findings: The trial was stopped early for efficacy after an interim analysis showed a 35% reduction in MACE in the pitavastatin group compared to the placebo group, without any unanticipated safety effects. The trial involved 7,769 participants and was conducted over a median follow-up period of 5.1 years[1][4].

• Outcomes: The primary outcomes included cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, transient ischemic attack, peripheral arterial ischemia, revascularization, or death from an undetermined cause. The final data confirmed the efficacy and safety of pitavastatin in reducing these cardiovascular events[1].

Effects on Coronary Artery Disease

A substudy of the REPRIEVE trial investigated the effects of pitavastatin on noncalcified coronary artery plaque using coronary computed tomography angiography (CTA). This study found that pitavastatin reduced noncalcified plaque volume and progression, as well as markers of lipid oxidation and arterial inflammation, over a 24-month period[4].

• Mechanistic Insights: The reduction in noncalcified plaque volume and inflammatory biomarkers suggests that pitavastatin’s benefits extend beyond just LDL cholesterol reduction, contributing to the observed reduction in MACE[4].

Market Analysis

Market Size and Growth

The pitavastatin calcium market is experiencing significant growth driven by several key factors:

• Increasing Demand: The growing prevalence of cardiovascular diseases and hyperlipidemia, fueled by lifestyle factors and aging populations, is driving the demand for effective cholesterol-lowering medications like pitavastatin[3][5].

• Economic Value: Pitavastatin’s competitive pricing and cost-effective long-term management of cholesterol-related conditions make it an attractive option in the pharmaceutical market. This economic value is substantial, given that cardiovascular diseases remain a leading cause of mortality globally[3].

• Regulatory Developments: Recent approvals and updates in treatment guidelines are expanding the indications for pitavastatin, allowing it to be used in a broader range of clinical scenarios. These regulatory changes are driving market growth and demand[3].

Market Trends and Innovations

• Strategic Partnerships: Collaborations between pharmaceutical companies and research institutions are focusing on expanding research into new therapeutic uses, improving drug formulations, and increasing market reach. These partnerships have led to the development of novel pitavastatin-based products and innovative treatment solutions[3].

• Advancements in Clinical Research: Ongoing research into new indications, combination therapies, and improved formulations is expanding the use of pitavastatin and enhancing its therapeutic benefits. This includes studies on its effects on noncalcified coronary plaque and inflammatory biomarkers[3][4].

• Growing Awareness and Preventive Care: Increasing awareness and demand for preventive care are fueling the market growth of pitavastatin. As individuals become more proactive about managing their health and preventing cardiovascular diseases, the demand for effective preventive treatments like pitavastatin is rising[3].

Regional Market Insights

The global pitavastatin calcium market is segmented by region, with significant growth expected in various parts of the world:

• Global Revenue: The market is projected to grow substantially, with revenue forecasts indicating a strong CAGR from 2025 to 2030. Regions such as North America, Europe, Asia, and Latin America are expected to contribute significantly to this growth[2][5].

• Sales and Revenue Share: The market share by region and by application (e.g., hospitals, clinics, retail pharmacies) is also expected to shift, reflecting changes in healthcare policies, patient accessibility, and market dynamics[2][5].

Market Projections

Forecast to 2030

• Market Size: The pitavastatin calcium market is expected to expand significantly by 2030, driven by the increasing demand for effective cholesterol-lowering treatments and the growing prevalence of cardiovascular diseases[2][3][5].

• CAGR and Revenue: The market is projected to grow at a notable Compound Annual Growth Rate (CAGR), with revenue forecasts indicating substantial growth in the coming years. This growth will be supported by ongoing research, regulatory approvals, and strategic partnerships[2][3].

• Regional Growth: Different regions will experience varying growth rates, with Asia and Latin America expected to show significant expansion due to increasing healthcare spending and growing awareness of cardiovascular health[2][5].

Challenges and Opportunities

Challenges

• Generic Competition: The expiration of patents for pitavastatin calcium could lead to increased generic competition, which may impact market dynamics and pricing strategies[5].

• Side Effects and Drug Interactions: Potential side effects or drug interactions could limit broader adoption, although current clinical trials have shown a favorable safety profile[1][4].

Opportunities

• Investment in R&D: Increased investment in pharmaceutical research and development is expected to drive innovation and expand the therapeutic uses of pitavastatin, contributing to market growth[3].

• Expanding Indications: Regulatory approvals and updates in treatment guidelines are expected to expand the indications for pitavastatin, allowing it to be used in a broader range of clinical scenarios[3].

Key Takeaways

• Clinical Efficacy: Pitavastatin calcium has demonstrated significant efficacy in reducing MACE and managing hyperlipidemia, as shown in the REPRIEVE trial and other studies.
• Market Growth: The market is expected to grow substantially due to increasing demand, regulatory developments, and ongoing research.
• Regional Insights: Different regions will experience varying growth rates, with significant expansion expected in Asia and Latin America.
• Challenges and Opportunities: While generic competition and potential side effects are challenges, investment in R&D and expanding indications present significant opportunities.

FAQs

What is the primary use of pitavastatin calcium?

Pitavastatin calcium is primarily used to manage hyperlipidemia and reduce the risk of cardiovascular diseases by lowering LDL cholesterol levels.

What were the key findings of the REPRIEVE trial?

The REPRIEVE trial found a 35% reduction in MACE in the pitavastatin group compared to the placebo group, without any unanticipated safety effects.

How does pitavastatin affect coronary artery disease?

Pitavastatin reduces noncalcified coronary plaque volume and progression, as well as markers of lipid oxidation and arterial inflammation, contributing to the observed reduction in MACE.

What are the key drivers of the pitavastatin calcium market?

The market is driven by increasing demand for effective cholesterol-lowering treatments, regulatory developments, strategic partnerships, and growing awareness of cardiovascular health.

What challenges might the pitavastatin calcium market face?

The market may face challenges such as generic competition, potential side effects, and high treatment costs, but these are balanced by opportunities in R&D and expanding indications.

Sources

1. Trial Update of Pitavastatin to Prevent Cardiovascular Events in HIV Infection. N Engl J Med, Published May 1, 2024.
2. Global Pitavastatin Calcium Tablets Market Insights, Forecast to 2030. GI Research, September 4, 2024.
3. Pitavastatin Calcium Market Size And Projection. Market Research Intellect, August 31, 2024.
4. Effects of Pitavastatin on Coronary Artery Disease and Inflammatory Biomarkers. JAMA Cardiology, February 21, 2024.
5. Pitavastatin Calcium Tablets Market Size & Share 2025-2030. 360 Research Reports.