Atorvastatin Versus Ezetimibe and Fenofibrate as a Lipid-lowering Strategy

NCT ID: NCT00299884

Last Updated: 2016-03-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2006-07-31

Brief Summary

The primary aim of this study is to evaluate the efficacy and non-inferiority of a lipid-lowering medication regimen comprised of the medications ezetimibe and fenofibrate taken daily, versus atorvastatin daily in lowering levels of low-density lipoprotein (LDL-C) cholesterol. Additionally, other aims would include effects on other types of blood cholesterol and examining the safety of the ezetimibe and fenofibrate regimen, as compared to atorvastatin.

Detailed Description

It has been demonstrated in several previous primary and secondary studies that lowering low-density lipoprotein cholesterol (LDL-C) with the use of medications such as 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors improves mortality and morbidity related to cardiovascular events in patients with hypercholesterolemia. Such inhibitors, which are known as 'statins', act to block the synthesis of cholesterol in the liver. These medications are generally well tolerated by the vast majority of patients, but a small number experience side effects, most seriously those of myopathies, rhabdomyolysis and elevated liver enzymes - recognition of this fact, that statins are not universally without problems, highlights the need for viable alternatives.

Ezetimibe is a relatively new medication in Canada, approved for use in patients with cholesterol problems. It is an intestinal cholesterol binder that is known to be well-tolerated, with side effects similar to placebo. Alone, it has a modest effect in the lowering of LDL-C. Fenofibrate is a medication that also works through the liver and has long been used to adjust blood lipid levels in patients with mixed lipid problems. Alone it also has a modest effect in the lowering of LDL-C. Recent study, however, has shown that the effect of ezetimibe and fenofibrate together in the lowering of LDL-C is greater than that of either drug alone. This combination, if as effective in this regard as atorvastatin, would prove a valid alternative to the use of the atorvastatin in the lowering of LDL-C, and a benefit for patients who have had problems tolerating statin therapy but still require medication for elevated cholesterol.

Conditions

Dyslipidemia; Vascular Disease

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Lipitor 20 mg

Lipitor 20 mg

Intervention Type: DRUG

A/A for 6 weeks

2

Lipidil Supra 160 mg and Ezetrol 10 mg

Combination Ezetrol 10 mg and Lipidil Supra 160 mg

Intervention Type: DRUG

a/a for 6 weeks

Interventions

Lipitor 20 mg

A/A for 6 weeks

Intervention Type: DRUG

Combination Ezetrol 10 mg and Lipidil Supra 160 mg

a/a for 6 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

-Study is confined to subjects with elevated LDL-C levels 3.0 mmol/L and greater.

Exclusion Criteria

• Abnormal liver enzymes (ie, AST, ALT greater than three times the upper limit of normal);
• Creatine kinase levels more than two times the upper limit of normal;
• Uncontrolled ethanol use (this may affect compliance);
• Pregnant or breastfeeding women or women not using adequate contraceptive methods;
• Previous history of intolerance or adverse effects with statins;
• Previous history of intolerance or adverse effects with fibric acid derivatives;
• Previous history of intolerance or adverse effects with ezetimibe;
• Uncontrolled diabetes (HbA1c > 10%);
• Recent myocardial infarction (within 6 weeks);
• Concurrent enrollment in another study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Stephen LaHaye

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen A LaHaye, MD

Role: PRINCIPAL_INVESTIGATOR

Vascular Disease Prevention and Research Centre

Locations

Vascular Disease Prevention and Research Centre, Hotel Dieu Hospital

Kingston, Ontario, Canada

Countries

Canada

Other Identifiers

DMED-816-04

Identifier Type: -

Identifier Source: org_study_id