Anti-inflammatory Effects of Simvastatin

NCT ID: NCT04638400

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2021-11-01

Brief Summary

The purpose of this research study is to determine which of the two ingredients of Vytorin (Simvastatin or Ezetimibe) is responsible for the anti-inflammatory effects of Vytorin

Detailed Description

Cardiovascular disease is currently the leading cause of death in the developed countries. Atherosclerosis is the most important cause of cardiovascular disease. Statins are known to exert a powerful anti-atherogenic action which is reflected in a marked beneficial effect on the prevention of cardiovascular effects and cardiovascular mortality. They induce a reduction in the progression and an increase in the regression of atherosclerotic lesions. Statins exert powerful effect on lowering LDLc and are also anti-inflammatory due to their ability to lower CRP concentrations. But little is known about their anti-inflammatory effects at a cellular and molecular levels in humans, in vivo.

Vytorin, a preparation containing simvastatin and ezetimibe, has a powerful effect on lowering LDLc concentration through a combination of effects on the absorption of cholesterol from the gut and hepatic cholesterol biosynthesis. In our previous study we have shown that Vytorin exerts a potent anti-inflammatory effect in the obese in the fasting state and following acute inflammatory changes induced by the intake of cream. The IMPROVE-IT trial, which examined the benefits of adding ezetimibe to simvastatin, showed a small additional benefit of ezetimibe (a 6% reduction in cardiovascular events) compared to simvastatin alone. This is marginal when compared to the established cardiovascular benefits of statins.

We, therefore, explore further into the anti-inflammatory actions of the two components of Vytorin by comparing the effects of simvastatin versus ezetimibe on intracellular lipid and inflammation in obese patients to determine which of the two ingredients of Vytorin is responsible for the specific combination of these effects.

Conditions

Inflammation; Atherosclerosis; Hypercholesterolemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Simvastatin

Obese subjects with elevated cholesterol

Group Type: ACTIVE_COMPARATOR

Simvastatin 40mg

Intervention Type: DRUG

Simvastatin administered daily for 6 weeks

Ezetimibe

Obese subjects with elevated cholesterol

Group Type: ACTIVE_COMPARATOR

Ezetimibe 10mg

Intervention Type: DRUG

Ezetimibe administered daily for 6 weeks

Interventions

Simvastatin 40mg

Simvastatin administered daily for 6 weeks

Intervention Type: DRUG

Ezetimibe 10mg

Ezetimibe administered daily for 6 weeks

Intervention Type: DRUG

Other Intervention Names

Simvastatin; Zetia

Eligibility Criteria

Inclusion Criteria

1. Age: 18 to 75 years of age.

2. Obese (BMI ≥30 kg/m2)

3. LDL cholesterol of ≥100 mg/dl

4. Not taking any vitamins or antioxidants

Exclusion Criteria

1. Currently using anti-hyperlipidemic therapies

2. Triglycerides >500 mg/dl.

3. Myocardial infarction, angioplasty/stent placement or coronary artery bypass surgery in the past 6 months.

4. Patient on chronic use of non-steroidal anti-inflammatory drugs or steroids

5. Hepatic disease

6. Renal impairment.

7. History of drug or alcohol abuse

8. Participation in any other concurrent clinical trial

9. Use of an investigational agent or therapeutic regimen within 30 days of study.

10. Smoker

11. Pregnancy

12. Premenopausal women who are not on birth control pills and have not had a hysterectomy or tubal ligation

13. Anemia with hemoglobin <12 g/dl

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

paresh Dandona

OTHER

Sponsor Role: lead

Responsible Party

paresh Dandona

Distinguished Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Paresh Dandona, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Distinguished Professor of Medicine

Locations

Diabetes and Endocrinology Research Center of WNY

Buffalo, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY00001035

Identifier Type: -

Identifier Source: org_study_id