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Last Updated: February 11, 2025

CLINICAL TRIALS PROFILE FOR MEVACOR


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All Clinical Trials for Mevacor

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000512 ↗ Familial Atherosclerosis Treatment Study Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1984-01-01 To compare the effects of two intensive lipid-lowering regimens with conventional therapy on coronary atherosclerosis as assessed by arteriography.
NCT00000512 ↗ Familial Atherosclerosis Treatment Study Completed University of Washington Phase 3 1984-01-01 To compare the effects of two intensive lipid-lowering regimens with conventional therapy on coronary atherosclerosis as assessed by arteriography.
NCT00062556 ↗ Effect of Niacin ER/Lovastatin on Peak Walking Time & Claudication Onset Time in Patients With Intermittent Claudication Completed Kos Pharmaceuticals Phase 3 2003-01-01 The purpose of this study is to evaluate if Niacin ER/Lovastatin, at two different doses, compared to diet control (this group will receive a tablet containing 50 mg. of immediate-release niacin) is a safe and effective medicine in subjects with leg pain caused by a narrowing of their leg arteries, a condition called intermittent claudication. At least 366 subjects with leg pain caused by a narrowing of their leg arteries will participate in this study. Niacin ER/Lovastatin is a combination of two FDA (United States Food and Drug Administration) approved cholesterol modifying medications: Niaspan® (extended-release niacin) and lovastatin, a statin (the same medicine found in Mevacor®). Niacin ER/Lovastatin was approved by the FDA under the name of Advicor® for use in the treatment of elevated cholesterol. The use of Niacin ER/Lovastatin in the treatment of peripheral arterial disease and symptomatic relief of intermittent claudication is considered investigational. An investigational use is one that is not approved by the FDA.
NCT00071266 ↗ The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients With Intermittent Claudication - TROPIC Completed Kos Pharmaceuticals Phase 3 2003-10-01 The purpose of this study is to compare the dose response and safety of Niacin ER/Lovastatin, Niaspan® and Lovastatin with each other, in subjects with leg pain caused by a narrowing of their leg arteries. At least 870 subjects, with leg pain caused by a narrowing of their leg arteries will take part in this study. Both Niaspan and lovastatin (Mevacor®) are approved by the United States Food and Drug Administration (FDA) to treat high cholesterol. Niacin ER/Lovastatin (Advicor®), a combination of these two drugs, is also approved by the FDA to treat high cholesterol. The use of Niacin ER/Lovastatin to treat narrowing of leg arteries and relieve "intermittent claudication" (leg pain caused by narrowing of the arteries in the leg) is considered investigational. An investigational use is one that is not approved by the FDA.
NCT00243880 ↗ Neuroprotection With Statin Therapy for Acute Recovery Trial (Neu-START) Completed Columbia University Phase 1 2005-09-01 The purpose of this dose escalation study is to evaluate the use of lovastatin for the treatment of acute ischemic stroke.
NCT00285857 ↗ Phase 2 Study of Lovastatin as Breast Cancer Chemoprevention Terminated Stanford University Phase 2 2005-11-01 The study evaluates if a 6-month course of oral lovastatin at 80 mg/day would decrease abnormal breast duct cytology in women with a high inherited breast cancer risk.
NCT00302952 ↗ Lovastatin for the Treatment of Mildly Active Rheumatoid Arthritis Terminated Autoimmunity Centers of Excellence Phase 2 2007-11-06 Rheumatoid arthritis (RA) is the most common inflammatory arthritis and a major health problem. The purpose of this study is to determine the safety and effectiveness of lovastatin for controlling inflammation in mildly active RA.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Mevacor

Condition Name

Condition Name for Mevacor
Intervention Trials
Fragile X Syndrome 2
Healthy 2
Breast Cancer 2
Stroke 2
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Condition MeSH

Condition MeSH for Mevacor
Intervention Trials
Syndrome 3
Intermittent Claudication 2
Fragile X Syndrome 2
Breast Neoplasms 2
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Clinical Trial Locations for Mevacor

Trials by Country

Trials by Country for Mevacor
Location Trials
United States 86
Canada 3
Taiwan 2
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Trials by US State

Trials by US State for Mevacor
Location Trials
California 9
North Carolina 4
Florida 4
Iowa 4
New York 4
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Clinical Trial Progress for Mevacor

Clinical Trial Phase

Clinical Trial Phase for Mevacor
Clinical Trial Phase Trials
Phase 4 5
Phase 3 4
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Mevacor
Clinical Trial Phase Trials
Completed 17
Terminated 6
Withdrawn 2
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Clinical Trial Sponsors for Mevacor

Sponsor Name

Sponsor Name for Mevacor
Sponsor Trials
University of Iowa 3
Kos Pharmaceuticals 2
Mutual Pharmaceutical Company, Inc. 2
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Sponsor Type

Sponsor Type for Mevacor
Sponsor Trials
Other 26
Industry 8
NIH 5
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MEVACOR (Lovastatin): Clinical Trials, Market Analysis, and Projections

Introduction

MEVACOR, known generically as lovastatin, is a cholesterol-lowering medication that belongs to the class of drugs called statins. Introduced by Merck in 1987, it was the first statin to be approved for use in the United States. Here, we will delve into the clinical trials, market analysis, and future projections for MEVACOR.

Clinical Trials and Efficacy

Primary Hypercholesterolemia and Mixed Hyperlipidemia

Clinical trials have demonstrated that MEVACOR is highly effective in reducing total cholesterol (total-C) and low-density lipoprotein cholesterol (LDL-C) in patients with heterozygous familial and non-familial forms of primary hypercholesterolemia and mixed hyperlipidemia. A significant response was observed within 2 weeks, with the maximum therapeutic effect achieved within 4-6 weeks of treatment[1].

Dose Response and Administration

Studies have shown that single daily doses of MEVACOR given in the evening are more effective than the same dose given in the morning, likely due to the nocturnal synthesis of cholesterol. Doses ranging from 10 mg to 40 mg per day were compared to placebo, with MEVACOR significantly decreasing LDL-C, total-C, and the total-C/HDL-C and LDL-C/HDL-C ratios. Additionally, MEVACOR increased high-density lipoprotein cholesterol (HDL-C) and modestly decreased very low-density lipoprotein cholesterol (VLDL-C) and triglycerides (TG)[1].

Cardiovascular Outcomes

The AFCAPS/TexCAPS trial, which involved 6,605 participants, demonstrated that MEVACOR reduced the risk of acute major coronary events, including myocardial infarction, unstable angina, and sudden cardiac death, by 37% compared to placebo. This trial also showed reductions in the risk of unstable angina, myocardial infarction, and the need for coronary revascularization procedures[1].

Market Analysis

Historical Market Presence

MEVACOR was a pioneering drug in the statin class and held a significant market share upon its introduction. However, its U.S. patent expired in 2001, allowing generic versions to enter the market. Despite this, MEVACOR remains a recognized brand in the cholesterol-lowering segment[3].

Over-the-Counter (OTC) Approval

In 2007, GlaxoSmithKline (GSK) obtained exclusive U.S. OTC marketing rights for MEVACOR from Merck. The FDA reviewed an application for OTC MEVACOR 20 mg, proposed for use in adults with moderately elevated cholesterol and one or more heart disease risk factors. This move aimed to expand the drug's reach into the consumer market[3].

Current Market Dynamics

The statin market has evolved significantly since MEVACOR's introduction. While MEVACOR is no longer a dominant player in the prescription statin market due to the presence of newer statins and generic alternatives, it still maintains a niche presence. The OTC segment, however, offers a different landscape where MEVACOR could potentially regain some market share by targeting consumers directly.

Market Projections

Statin Market Trends

The statin market, while mature, continues to be significant. However, the growth rate has slowed down with the introduction of newer cholesterol-lowering agents like PCSK9 inhibitors (e.g., Leqvio) and other lipid-lowering therapies. These newer agents are expected to capture a larger share of the market, potentially impacting the sales of traditional statins like MEVACOR[4].

Competitive Landscape

The competitive landscape for cholesterol-lowering drugs is intense, with multiple statins and non-statin options available. MEVACOR faces competition not only from other statins but also from newer classes of drugs that offer alternative mechanisms of action. This competition is likely to continue, making it challenging for MEVACOR to regain significant market share in the prescription segment.

Future Outlook

Given the maturity of the statin market and the emergence of new therapies, the future growth prospects for MEVACOR are limited. However, its established brand and potential in the OTC market could help it maintain a stable, albeit smaller, market presence. The focus for MEVACOR may shift towards maintaining its position in the OTC segment and potentially targeting specific patient populations where it remains a preferred option.

Key Takeaways

  • Clinical Efficacy: MEVACOR has been proven effective in reducing LDL-C and total-C, with significant reductions in cardiovascular events.
  • Market Dynamics: The drug's market presence has diminished since its patent expiration but remains relevant in the OTC segment.
  • Future Projections: Limited growth is expected due to market maturity and competition from newer therapies.
  • OTC Potential: MEVACOR's OTC approval offers a potential avenue for maintaining market relevance.

FAQs

Q: What is MEVACOR used for?

A: MEVACOR (lovastatin) is used to lower cholesterol levels and reduce the risk of heart attacks, unstable angina, and coronary revascularization procedures in patients with elevated cholesterol.

Q: How does MEVACOR work?

A: MEVACOR works by inhibiting the enzyme HMG-CoA reductase, which is involved in the biosynthesis of cholesterol, thereby reducing the production of LDL-C.

Q: What are the common side effects of MEVACOR?

A: Common side effects include muscle pain or weakness, liver enzyme elevations, and potential interactions with other medications.

Q: Is MEVACOR available over-the-counter?

A: Yes, MEVACOR 20 mg has been proposed for OTC use in adults with moderately elevated cholesterol and one or more heart disease risk factors.

Q: How does MEVACOR compare to newer cholesterol-lowering drugs?

A: MEVACOR is less potent than some newer statins and PCSK9 inhibitors but remains effective for many patients, especially in the OTC segment.

Sources

  1. MEVACOR Label - FDA.
  2. In the Eye of the Storm: PD-(L)1 Inhibitors Weathering Turbulence - IQVIA.
  3. GlaxoSmithKline Obtains Exclusive U.S. OTC Marketing Rights to MEVACOR - Biospace.
  4. New Novartis data show early addition of twice-yearly Leqvio (inclisiran) - Novartis.

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