CLINICAL TRIALS PROFILE FOR PRAVACHOL

All Clinical Trials for Pravachol

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00166036 ↗	Effect of Statins on Oxidative Stress and Endothelial Progenitor Cells	Completed	Emory University	Phase 2	2004-09-01	Thirty-six subjects with hyperlipidemia and metabolic syndrome and/or diabetes were randomized in a double-blind manner to either pravastatin 80 mg or atorvastatin 10 mg daily. Oxidative stress (dROMs assay that measures lipid hydroperoxides, plasma thiobarbituric acid reactive substances [TBARS], and aminothiol levels) and brachial artery flow-mediated dilation (FMD) were measured at baseline and after 12 weeks of statin therapy.
NCT00360217 ↗	The Triglyceride Lowering Effect of an Omega-3 Fat (DHA) in Addition to Statin Therapy for Patients With CAD or Diabetes	Completed	Maine Center for Lipids and Cardiovascular Health	N/A	2006-01-01	This study will explore the ability of an algae (ocean plant) omega-3 fat supplement (DHA) to reduce triglyceride levels in patients currently being treated with statin therapy (Zocor or simvastatin, Lipitor or atorvastatin, Pravachol or pravastatin, Crestor or rosuvastatin, etc.) for coronary artery disease(CAD)or risk equivalents (any of the following: heart attack, post angioplasty or stent, post coronary bypass surgery, angina, vascular disease, stroke or diabetes). The rationale for the study is based around the finding that patients with CAD have an approximately 20 % reduction in the risk of sudden death when treated with fish oil (DHA is one of the ingredients in fish oil). In studies of statin-based therapies, it has been observed that statins reduce the risk of coronary events 20-45%. There has not yet been research trials exploring the combination of the two ingredients (i.e., DHA plus statin) in patient treatment either to reduce recurrent cardiac events or to address another reported finding of fish oils to lower triglyceride levels (triglyceride is a form of "blood fat"). This research project will be a pilot project to assess the safety and effectiveness of DHA "add-on" therapy in patients currently being treated with statins for CAD. The study hypothesis is to test the effectiveness of DHA as compared to placebo to lower triglyceride levels in the blood. This is a double-blinded randomized clinical trial.
NCT00459745 ↗	A Study to Evaluate Daily Pravastatin, Fenofibrate or Pravafen in the Treatment of Combined Hyperlipidemia	Completed	Integrium	Phase 3	2007-04-01	This is a multi-center, double blind, prospective, longitudinal, randomized, 12-week study with a 52-week open-label follow-up to evaluate the safety and efficacy of daily administration of Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen (the combination of both Pravastatin and Fenofibrate 40/160 mg) in the treatment of combined hyperlipidemia. There will be an open-label, 8-week, Selection Phase prior to randomization in which all patients will be stabilized on Pravastatin 40 mg/day. Following the Selection Phase, and if the patients meet all inclusion/exclusion criteria, they will be randomized to a three arm, double blind, 12-week Efficacy Phase during which they would receive either Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen (the combination of Pravastatin and Fenofibrate 40/160 mg). The 12-week Efficacy Phase will be followed by an open-label, 52-week, Safety Phase in which all patients will receive Pravafen. After the 8-week Selection Phase, patients that still meet the inclusion/exclusion criteria will be randomized on a 1:1:2 ratio to Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen (the combination of both Pravastatin and Fenofibrate 40/160 mg) for 12 weeks. After the completion of the 12-week double-blind phase of the study, all patients that haven't had changes in their well being, will be allowed to roll-over into the 52-week, open-label, follow-up portion of the study. During the 52 week, open label, Safety Phase of the study, all patients will receive Pravafen (the combination of Pravastatin and Fenofibrate 40/160 mg). Patients will be evaluated at baseline and every three weeks thereafter throughout the initial 12-week Efficacy Phase of the study. Patients that roll-over into the 52-week, open-label, follow-up Safety Phase will be evaluated at 12, 24, 36 and 52 weeks. Participation in the study can be up to 72 weeks.
NCT00459745 ↗	A Study to Evaluate Daily Pravastatin, Fenofibrate or Pravafen in the Treatment of Combined Hyperlipidemia	Completed	Shionogi	Phase 3	2007-04-01	This is a multi-center, double blind, prospective, longitudinal, randomized, 12-week study with a 52-week open-label follow-up to evaluate the safety and efficacy of daily administration of Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen (the combination of both Pravastatin and Fenofibrate 40/160 mg) in the treatment of combined hyperlipidemia. There will be an open-label, 8-week, Selection Phase prior to randomization in which all patients will be stabilized on Pravastatin 40 mg/day. Following the Selection Phase, and if the patients meet all inclusion/exclusion criteria, they will be randomized to a three arm, double blind, 12-week Efficacy Phase during which they would receive either Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen (the combination of Pravastatin and Fenofibrate 40/160 mg). The 12-week Efficacy Phase will be followed by an open-label, 52-week, Safety Phase in which all patients will receive Pravafen. After the 8-week Selection Phase, patients that still meet the inclusion/exclusion criteria will be randomized on a 1:1:2 ratio to Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen (the combination of both Pravastatin and Fenofibrate 40/160 mg) for 12 weeks. After the completion of the 12-week double-blind phase of the study, all patients that haven't had changes in their well being, will be allowed to roll-over into the 52-week, open-label, follow-up portion of the study. During the 52 week, open label, Safety Phase of the study, all patients will receive Pravafen (the combination of Pravastatin and Fenofibrate 40/160 mg). Patients will be evaluated at baseline and every three weeks thereafter throughout the initial 12-week Efficacy Phase of the study. Patients that roll-over into the 52-week, open-label, follow-up Safety Phase will be evaluated at 12, 24, 36 and 52 weeks. Participation in the study can be up to 72 weeks.

Clinical Trial Conditions for Pravachol

Condition Name

Condition Name for Pravachol
Intervention	Trials
Healthy	6
Hypercholesterolemia	3
Hyperlipidemia	3
Adult Acute Megakaryoblastic Leukemia (M7)	2

Condition MeSH

Condition MeSH for Pravachol
Intervention	Trials
Hyperlipidemias	5
Hyperlipoproteinemias	4
Syndrome	4
Hypercholesterolemia	3

Clinical Trial Locations for Pravachol

Trials by Country

Trials by Country for Pravachol
Location	Trials
United States	74
Canada	5
China	1
Sweden	1

Trials by US State

Trials by US State for Pravachol
Location	Trials
Massachusetts	6
Washington	4
Florida	3
Maine	3
Georgia	3

Clinical Trial Progress for Pravachol

Clinical Trial Phase

Clinical Trial Phase for Pravachol
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	2
Phase 2	4

Clinical Trial Status

Clinical Trial Status for Pravachol
Clinical Trial Phase	Trials
Completed	22
Terminated	4
Recruiting	2

Clinical Trial Sponsors for Pravachol

Sponsor Name

Sponsor Name for Pravachol
Sponsor	Trials
Teva Pharmaceuticals USA	4
Brigham and Women's Hospital	3
Genpharm ULC	2

Sponsor Type

Sponsor Type for Pravachol
Sponsor	Trials
Other	21
Industry	19
NIH	4

Pravachol: Clinical Trials, Market Analysis, and Projections

Introduction

Pravachol, known generically as pravastatin sodium, is an HMG-CoA reductase inhibitor (statin) widely used to manage cholesterol levels and reduce the risk of cardiovascular events. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Primary Indications

Pravachol is indicated as an adjunctive therapy to diet for several conditions, including reducing the risk of myocardial infarction (MI), revascularization, and cardiovascular mortality in hypercholesterolemic patients with and without clinically evident coronary heart disease (CHD)[3].

Clinical Trial Outcomes

Numerous clinical trials have demonstrated the efficacy of pravastatin. For instance, the West of Scotland Coronary Prevention Study (WOS), the Cholesterol and Recurrent Events study (CARE), and the Long-term Intervention with Pravastatin in Ischemic Disease study (LIPID) have shown that pravastatin significantly reduces the risk of total mortality, coronary death, MI, revascularization, stroke/TIA, and the progression of coronary atherosclerosis[3].

Safety Profile

Clinical trials have also evaluated the safety profile of pravastatin. In long-term placebo-controlled trials involving 19,592 subjects, the incidence of marked liver function test abnormalities was similar between the pravastatin and placebo groups, indicating that liver function test abnormalities observed during pravastatin therapy were usually asymptomatic and not associated with cholestasis[1].

Adverse Events

The most common adverse reactions leading to treatment discontinuation were increased liver function tests, nausea, anxiety/depression, and dizziness. However, these events were generally mild and transient, with only a small percentage of patients discontinuing treatment due to adverse events[3].

Market Analysis

Global Market Size and Growth

The global pravastatin market is anticipated to grow at a significant rate. As of 2023, the market was valued at a substantial amount and is expected to increase further by 2030, with a compound annual growth rate (CAGR) during the forecast period of 2024-2030[2].

Regional Market Trends

Geographically, the market is segmented into North America, Europe, Asia-Pacific, and the Rest of the World. Europe holds a considerable share in the global pravastatin market, driven by the rising prevalence of cardiovascular disorders. For instance, cardiovascular diseases account for 45% and 37% of total fatalities in Europe and EU partner nations, respectively[5].

Market Segmentation

The market is segmented by dosage type (10 mg, 20 mg, 40 mg, and 80 mg tablets) and by end-user (children and adults). The rising pharmaceutical research activities, particularly in regions like Europe, are generating development opportunities for the market[5].

Market Projections

Forecast Period

The global pravastatin market is projected to grow at a CAGR of 5.4% during the forecast period of 2022-2028. This growth is driven by increasing demand due to the rising burden of cardiovascular diseases and ongoing pharmaceutical research activities[5].

Key Drivers

• Rising Prevalence of Cardiovascular Diseases: The high incidence of cardiovascular diseases, especially in regions like Europe, is a significant driver for the market.
• Pharmaceutical Research: Ongoing research and development in the pharmaceutical sector are expected to enhance the market growth.
• Regional Market Expansion: The Asia-Pacific region is also expected to contribute significantly to the market growth due to increasing healthcare expenditure and awareness about cardiovascular health[2][5].

Technological Trends and New Product Developments

Innovations in Statin Therapy

The statin market, including pravastatin, is witnessing technological advancements and new product developments. These innovations focus on improving the efficacy and safety profiles of statins, as well as developing new formulations and delivery systems to enhance patient compliance and outcomes[2].

Competitive Landscape

The market is competitive, with several key players. The report provides profiles of the competitive landscape, key competitors, and their respective market ranks, helping manufacturers, new entrants, and industry-related companies understand the market dynamics[2].

Key Takeaways

• Clinical Efficacy: Pravachol has been proven effective in reducing cardiovascular events and managing cholesterol levels through extensive clinical trials.
• Safety Profile: The drug has a generally favorable safety profile, although liver function tests and other adverse events need to be monitored.
• Market Growth: The global pravastatin market is expected to grow significantly, driven by the rising prevalence of cardiovascular diseases and ongoing pharmaceutical research.
• Regional Trends: Europe and the Asia-Pacific region are key markets, with Europe driven by high cardiovascular disease prevalence and the Asia-Pacific region by increasing healthcare expenditure.

FAQs

What are the primary indications for Pravachol?

Pravachol is indicated for reducing the risk of MI, revascularization, and cardiovascular mortality in hypercholesterolemic patients with and without clinically evident CHD, as well as managing various forms of dyslipidemia[3].

What are the common adverse reactions associated with Pravachol?

Common adverse reactions include increased liver function tests, nausea, anxiety/depression, and dizziness. These events are generally mild and transient[3].

How is the global pravastatin market expected to grow?

The global pravastatin market is anticipated to grow at a CAGR of 5.4% during the forecast period of 2022-2028, driven by the rising prevalence of cardiovascular diseases and ongoing pharmaceutical research[5].

Which regions are key markets for Pravachol?

Europe and the Asia-Pacific region are significant markets for Pravachol, with Europe driven by high cardiovascular disease prevalence and the Asia-Pacific region by increasing healthcare expenditure[2][5].

What are the technological trends in the statin market?

The statin market is witnessing advancements in formulations, delivery systems, and new product developments aimed at improving efficacy and safety profiles[2].

Sources

1. FDA Label: Pravachol Label - accessdata.fda.gov
2. OpenPR: Pravastatin Sodium Market Analysis (2024-2030): Key Trends, Growth Drivers, and Forecast
3. FDA Approval Package: PRAVACHOL Sponsor - accessdata.fda.gov
4. JAMA Internal Medicine: Clinical Outcomes in Statin Treatment Trials: A Meta-analysis
5. GII Research: Pravastatin Market 2022-2028 - GII Research