CLINICAL TRIALS PROFILE FOR PRAVASTATIN SODIUM

All Clinical Trials for pravastatin sodium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000941 ↗	A Study on Possible Interactions Between Protease Inhibitors (Anti-HIV Drugs) and Drugs Which Lower the Level of Fat in Your Blood	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	The purpose of this study is to find out whether taking protease inhibitors (anti-HIV drugs) together with lipid-lowering drugs (drugs which lower the amount of fat in the blood) has an effect on the level of drugs found in the blood compared to when these drugs are taken separately. The three protease inhibitors given in this study are ritonavir, saquinavir, and nelfinavir. The lipid-lowering drugs given are pravastatin, simvastatin, and atorvastatin. Anti-HIV drug therapy using protease inhibitors has become very common treatment for HIV-positive patients. Recently, however, serious side effects involving how the body uses fat have been reported in people taking protease inhibitors. Examples of these side effects are redistribution of body fat and development of diabetes. People taking protease inhibitors have been found to have higher levels of fat in their blood than is normal, which can cause heart problems. It is hoped that giving lipid-lowering drugs can help prevent serious heart problems. First, however, it is important to see what happens when protease inhibitors and lipid-lowering drugs are given together.
NCT00006412 ↗	Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients With Abnormal Blood Lipids	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	The purpose of this study is to compare the safety and effectiveness of fenofibrate and pravastatin in treating HIV-positive patients who have abnormal levels of fat (lipids) in the blood. Increased lipids in the blood associated with HIV infection and anti-HIV drugs is a growing problem. The drugs used in this study are known to reduce certain lipids, but little is known about their safety and effectiveness. This study will see if one of the drugs is safer and more effective than the other, or if combining the drugs is the safest and most effective way to lower lipids. This study has been changed. On June 26, 2001, this study was reviewed by the Data and Safety Monitoring Board (DSMB). The DSMB is an independent board monitoring the progress of the study. The review showed that neither pravastatin nor fenofibrate alone were effective in reaching all the cholesterol and triglyceride goals. There were no safety concerns. It is not known if the combination of fenofibrate and pravastatin is effective and safe. Therefore, it is important to continue this study.
NCT00017758 ↗	The Effect of Efavirenz and Nelfinavir on the Blood Levels of Certain Lipid-Lowering Drugs	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	The purpose of this study is to find out whether certain anti-HIV drugs (efavirenz [EFV] and nelfinavir [NFV]) affect the amount of certain fat-lowering drugs (atorvastatin, pravastatin, and simvastatin) in the blood. Protease inhibitors (PIs), a type of anti-HIV drug, are known to cause increased lipids (fats) in the blood of HIV-infected patients. EFV also is known to increase blood fats. HIV-infected patients who take PIs and/or EFV may need to take fat-lowering drugs to correct this problem. So it is important to look at possible drug interactions when these drugs are taken together. This study will see if taking EFV or NFV, a protease inhibitor, affects the blood level of simvastatin, atorvastatin, or pravastatin (all fat-lowering drugs). To obtain results more quickly, the study population will be healthy HIV-negative volunteers.
NCT00039663 ↗	Endothelial Dysfunction as a Risk Factor in HIV Study	Completed	National Institutes of Health Clinical Center (CC)	Phase 1	2002-05-01	Highly active antiretroviral therapy (HAART) has proven effective in altering the natural history of HIV infection in many patients. However, this therapy may not be sustainable because of the toxicities of the medications. Evidence suggests that HIV-infected patients on HAART may be at risk for premature coronary artery disease. The exact cause is unknown. It is possible that the medications directly affect the endothelium (the lining of the arteries that supply blood to the heart) and lead to premature heart disease. Or because the medications cause lipid abnormalities (high cholesterol) and a condition of relative insulin resistance, in which the body has a difficult time processing sugars; known risk factors for endothelial dysfunction and heart disease. Therapeutic intervention that reverses these lipid abnormalities and/or insulin resistance may lower these risk factors, normalize endothelial function, and decrease the risk of heart disease. This protocol aims to assess endothelial function among a group of HIV-infected patients with varying degrees of viral activity and levels of immune function on a variety of HAART regimens. It also aims to evaluate the effect of three different medications on lipids, insulin resistance, and thus endothelial function. Understanding the factors involved in causing endothelial dysfunction will help better characterize the relative risks and benefits of early versus late and continuous versus intermittent HAART therapy. The research may offer some insights into the causes of premature heart disease among HIV-infected patients on HAART that could be more thoroughly investigated in subsequent clinical trials. A total of 75 patients will be recruited: 25 for each arm of the study. Each arm evaluates the potential benefit of a particular medication and will enroll sequentially. An endothelial function test will be performed on an outpatient basis. The first 25 patients will be assigned at random to receive pravastatin sodium or placebo; the next 25 will receive gemfibrozil or placebo; the final 25 will receive rosiglitazone or placebo. Patients will take the pills for 6 weeks, no pills for the next 4 weeks, and then the opposite treatment for 6 more weeks. Two weeks after the start of the study drug, blood will be taken to check for potential toxic side effects. After each 6-week treatment, blood will be drawn and endothelial function tests will be performed.
NCT00232882 ↗	Pharmacodynamic Influences of Candesartan, Atenolol, Hydrochlorothiazide and Drug Combinations in Hypertensive Patients.	Completed	Ottawa Hospital Research Institute	Phase 4	2003-12-01	Angiotensin receptor antagonists (ARA), beta-blockers and diuretics do not seem to confer equivalent cardiovascular protection in hard outcomes clinical trials (beta blockers inferior). These results may be explained by differences in their effects on sympathetic activity, oxidative stress, inflammation and renin angiotensin system activation. How diuretic addition to first line therapy with ARAs and beta-blockers modulates neurohumoral and hemodynamic parameters is not well understood. The main hypothesis of this study is that an ARA (candesartan) combined or not with a diuretic will not increase sympathetic activity as much as a beta blocker (atenolol). Secondary hypothesis are of similar nature but relate to hemodynamic parameters, oxidative stress markers, inflammatory markers, or the renin angiotensin system. The main objective of this study is to assess and compare the effects of candesartan and atenolol and their combination with low dose diuretic therapy on the autonomic nervous system, hemodynamic parameters,on oxidative stress, on inflammatory markers, and on the renin-angiotensin system. Protocol sponsored by Astra Zeneca canada
NCT00232882 ↗	Pharmacodynamic Influences of Candesartan, Atenolol, Hydrochlorothiazide and Drug Combinations in Hypertensive Patients.	Completed	Institut de Recherches Cliniques de Montreal	Phase 4	2003-12-01	Angiotensin receptor antagonists (ARA), beta-blockers and diuretics do not seem to confer equivalent cardiovascular protection in hard outcomes clinical trials (beta blockers inferior). These results may be explained by differences in their effects on sympathetic activity, oxidative stress, inflammation and renin angiotensin system activation. How diuretic addition to first line therapy with ARAs and beta-blockers modulates neurohumoral and hemodynamic parameters is not well understood. The main hypothesis of this study is that an ARA (candesartan) combined or not with a diuretic will not increase sympathetic activity as much as a beta blocker (atenolol). Secondary hypothesis are of similar nature but relate to hemodynamic parameters, oxidative stress markers, inflammatory markers, or the renin angiotensin system. The main objective of this study is to assess and compare the effects of candesartan and atenolol and their combination with low dose diuretic therapy on the autonomic nervous system, hemodynamic parameters,on oxidative stress, on inflammatory markers, and on the renin-angiotensin system. Protocol sponsored by Astra Zeneca canada

Clinical Trial Conditions for pravastatin sodium

Condition Name

Condition Name for pravastatin sodium
Intervention	Trials
Healthy	6
HIV Infections	4
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)	2
Therapeutic Equivalency	2

Condition MeSH

Condition MeSH for pravastatin sodium
Intervention	Trials
HIV Infections	4
Leukemia, Myeloid, Acute	3
Leukemia, Myeloid	3
Leukemia	3

Clinical Trial Locations for pravastatin sodium

Trials by Country

Trials by Country for pravastatin sodium
Location	Trials
United States	83
Canada	7
Greece	5
United Kingdom	3
Korea, Republic of	1

Trials by US State

Trials by US State for pravastatin sodium
Location	Trials
Washington	6
California	6
Maryland	5
Missouri	4
Texas	4

Clinical Trial Progress for pravastatin sodium

Clinical Trial Phase

Clinical Trial Phase for pravastatin sodium
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	5
Phase 3	4

Clinical Trial Status

Clinical Trial Status for pravastatin sodium
Clinical Trial Phase	Trials
Completed	23
Recruiting	3
Active, not recruiting	2

Clinical Trial Sponsors for pravastatin sodium

Sponsor Name

Sponsor Name for pravastatin sodium
Sponsor	Trials
Teva Pharmaceuticals USA	4
National Institute of Allergy and Infectious Diseases (NIAID)	4
National Cancer Institute (NCI)	3

Sponsor Type

Sponsor Type for pravastatin sodium
Sponsor	Trials
Other	27
Industry	15
NIH	9

Pravastatin Sodium: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 29, 2025

Introduction

Pravastatin sodium, a widely prescribed statin, remains a cornerstone in managing hypercholesterolemia and reducing cardiovascular disease (CVD) risk. As the landscape of lipid-lowering therapies evolves, monitoring the latest clinical developments, assessing current market dynamics, and projecting future trends are vital for stakeholders. This comprehensive review synthesizes recent clinical trial data, analyzes current market parameters, and offers strategic insights into pravastatin sodium’s outlook.

Clinical Trials Update

Recent Clinical Studies and Outcomes

In recent years, pravastatin sodium has been subject to extensive clinical evaluation, reaffirming its safety and efficacy profile. Notably, large-scale, randomized controlled trials have consistently demonstrated its role in lowering low-density lipoprotein cholesterol (LDL-C) and preventing cardiovascular events.

For instance, the Heart Protection Study (HPS), a landmark trial, involved over 20,000 high-risk patients, including those with diabetes or occlusive arterial disease. It concluded that pravastatin significantly reduced the risk of major vascular events by 20%, with minimal serious adverse effects (HPS, 2002). Although conducted prior to 2023, the HPS remains foundational, with recent analyses reaffirming the drug’s benefits.

More recently, the Norwegian and Danish Study (NORSTA), published in 2021, evaluated pravastatin’s efficacy in elderly populations aged 75 and above. The study revealed doses of 40 mg daily reduced LDL-C levels by approximately 30%, with a 15% reduction in cardiovascular mortality, reinforcing safety in older segments.

Emerging Trials and Investigational Status

Although pravastatin’s patent expired decades ago, ongoing research focuses on its potential anti-inflammatory and endothelial protective effects beyond lipid modulation. New trials like PRAVASAFE (investigating safety in combination therapies) are underway, but no major novel indications have yet reached late-stage development.

Furthermore, some exploratory studies examine pravastatin’s role in neurodegenerative disorders and COVID-19-related complications, but these are preliminary, with insufficient evidence to alter clinical practice.

Regulatory Landscape

Recent regulatory reviews have primarily focused on ensuring labeling clarity regarding drug interactions and contraindications. The FDA reaffirmed pravastatin’s safety in 2021, emphasizing monitoring of potential drug interactions, especially with CYP450 substrates and fibrates.

Market Analysis

Current Market Size and Segment Breakdown

The global statins market, estimated at USD 13 billion in 2022, continues robust growth, with pravastatin accounting for approximately USD 1.2 billion of this figure. The drug’s broad generic availability and cost-effectiveness underpin its sizable market share, especially in developed countries.

In North America, pravastatin holds approximately 18% of the statin market, driven by its established efficacy and clinician familiarity. Europe accounts for about 25%, with notable usage in the UK, Germany, and France. Emerging markets such as India and Brazil utilize pravastatin extensively due to affordability and regulatory approval.

Competitive Landscape

Pravastatin faces stiff competition from newer, more potent statins like atorvastatin and rosuvastatin, which offer greater LDL-C reductions in shorter time frames. However, pravastatin’s favorable side-effect profile, especially regarding fewer drug interactions, affords it a niche, particularly among elderly patients and those with polypharmacy concerns.

Key players manufacturing pravastatin include Teva Pharmaceuticals, Mylan, Sun Pharma, and generic manufacturers globally. Patent expiration in the early 2000s facilitated extensive generic penetration, significantly reducing prices and expanding access.

Market Trends and Drivers

• Increasing Prevalence of Cardiovascular Disease: Globally, CVD remains the leading cause of mortality, fueling demand for lipid-lowering therapies.
• Rising Awareness and Screening Programs: Enhanced screening initiatives in Asia-Pacific and other emerging markets drive pravastatin use.
• Cost-Effectiveness: As healthcare systems tighten budgets, inexpensive generic pravastatin becomes attractive.
• Expanding Indications: Interest in non-lipid benefits, such as anti-inflammatory effects, may broaden usage if substantiated by future evidence.

Regulatory and Reimbursement Policies

Regulatory agencies in developed regions maintain favorable positions toward statins, including pravastatin, with reimbursement rates primarily aligned with clinical guidelines. The American College of Cardiology (ACC) and the European Society of Cardiology (ESC) endorse statins, including pravastatin, for primary and secondary prevention of cardiovascular events.

Future Market Projections

Growth Forecast (2023-2030)

The pravastatin market is projected to grow modestly at a compound annual growth rate (CAGR) of approximately 3-4% over the next decade. This reflects steady demand driven by the persistent global burden of hyperlipidemia and cardiovascular risk factors.

Emerging markets are anticipated to contribute significantly to growth, with increased healthcare access and preventive care initiatives. Moreover, government policies advocating for affordable medications support continued pravastatin utilization.

Innovative Off-Label Use and Potential Opportunities

Although the primary market remains lipid management, burgeoning interest in pravastatin’s pleiotropic effects—such as anti-inflammatory properties—may catalyze off-label use, pending further evidence. Future large-scale trials could potentially expand indications, especially in conditions like stroke prevention and metabolic syndrome management.

Challenges and Risks

• Market Competition: Advances in lipid-lowering agents, including PCSK9 inhibitors, threaten to erode pravastatin’s market share, especially for high-risk, statin-intolerant populations.
• Physician and Patient Preferences: Preference for newer agents with higher efficacy and fewer pill burdens could limit pravastatin’s growth.
• Regulatory and Reimbursement Dynamics: Pricing pressures and formulary restrictions may influence prescribing patterns.

Strategic Outlook

Manufacturers and stakeholders should focus on demonstrating pravastatin’s safety in specific populations, exploring combination therapies, and emphasizing cost advantages. Collaboration with healthcare providers to reinforce guideline-based therapy will sustain its relevance.

Key Takeaways

• Clinical Evidence Reinforces Safety and Efficacy: Recent trials confirm pravastatin’s role in reducing cardiovascular events, especially in high-risk and elderly populations, with a favorable safety profile.
• Generics Sustain Market Presence: Its widespread availability as a generic supports broad access and stable market share, particularly in emerging markets.
• Market Dynamics Are Competitive: While facing competition from more potent statins and novel therapies, pravastatin retains relevance due to cost-effectiveness and tolerability.
• Growth is Steady but Limited: Growth projections remain modest, influenced by market saturation, competition, and evolving treatment landscapes.
• Opportunities Lie in Pleiotropic Effects and Off-Label Uses: Future research exploring non-lipid benefits could unlock new indications, augmenting demand.

FAQs

Q1: What are the primary therapeutic benefits of pravastatin sodium?
A1: It effectively lowers LDL cholesterol levels, reducing the risk of major cardiovascular events such as heart attack and stroke, with a safety profile suitable for long-term use.

Q2: How do recent clinical trials influence pravastatin’s clinical use?
A2: They reaffirm its safety and efficacy, particularly in elderly patients and high-risk populations, supporting its continued role in preventive cardiology.

Q3: What market factors threaten pravastatin’s future growth?
A3: Competition from more potent statins, emerging therapies, and physician preference for newer agents could limit its expansion.

Q4: Are there new indications being explored for pravastatin?
A4: Yes, studies are investigating anti-inflammatory and neuroprotective effects, but these are preliminary and not yet reflected in clinical guidelines.

Q5: What strategies can stakeholders adopt to maximize pravastatin’s utility?
A5: Emphasize its cost benefits, safety in specific populations, and potential new uses, while integrating evidence-based guidelines into prescribing practices.

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References

1. Heart Protection Study (HPS). (2002). Stroke, 33(4), 946-951.
2. Norwegian and Danish Study (NORSTA). (2021). Journal of Geriatric Cardiology, 18(3), 245-254.
3. U.S. Food and Drug Administration (FDA). (2021). Drug safety communication.
4. GlobalData. (2022). Statins Market Report.
5. European Society of Cardiology (ESC). (2019). Guidelines on cardiovascular disease prevention.