Atorvastatin Versus Ezetimibe and Fenofibrate as a Lipid-Lowering Strategy
Information source: Queen's University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dyslipidemia; Vascular Disease
Intervention: Lipitor 20 mg (Drug); Combination Ezetrol 10 mg and Lipidil Supra 160 mg (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Queen's University Official(s) and/or principal investigator(s):
Stephen A LaHaye, MD, Principal Investigator, Affiliation: Vascular Disease Prevention and Research Centre
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.
Clinical Details
Official title: The Comparison of the Efficacy of Ezetimibe and Fenofibrate Versus Atorvastatin Alone in the Lowering of LDL Cholesterol
Study design: Case-Crossover, Prospective
Primary outcome: To examine the efficacy of a combination of ezetimibe and fenofibrate in comparison with that of atorvastatin in lowering LDL-C.
Secondary outcome: To examine the efficacy of a combination of ezetimibe and fenofibrate in comparison with that of atorvastatin in lowering triglyceride levels, raising HDL-C levels and lowering of hsCRP levels.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
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.
Locations and Contacts
Vascular Disease Prevention and Research Centre, Hotel Dieu Hospital, Kingston, Ontario K7L 5G2, Canada
Additional Information
Starting date: January 2005
Ending date: July 2006
Last updated: May 13, 2008
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