Effects of Simvastatin and Ezetimibe on Cardiovascular Risk Markers in Patients With Dyslipidemia

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-12-31

Brief Summary

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Coadministration of drugs is common in the pharmacologic treatment of dyslipidemia, with statins and ezetimibe generally constituting the medication of choice. By acting at different levels, the combination of these drugs allows the therapeutic objective to be achieved. However, it is not known how these drugs qualitatively affect the composition of lipoprotein subfractions, which differ in size and atherogenic potential. The investigators set out to evaluate this effect as well as their effects on inflammatory, oxidative stress and endothelial function parameters.

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Detailed Description

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The study consisted of a randomised parallel trial and took place during a period of 2 months. A total of 42 hyperlipidemic patients were randomly assigned to one of 2 groups: one received simvastatin (40 mg/day) and the other received ezetimibe (10 mg/day) for 4 weeks, after which both groups were administered combined therapy for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.

Conditions

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Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Simvastatin

Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.

Group Type EXPERIMENTAL

Simvastatin

Intervention Type DRUG

simvastatin (40 mg/day) for 4 weeks

Simvastatin + Ezetimibe

Intervention Type DRUG

combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period

Ezetimibe

Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.

Group Type EXPERIMENTAL

Ezetimibe

Intervention Type DRUG

ezetimibe (10 mg/day) for 4 weeks

Simvastatin + Ezetimibe

Intervention Type DRUG

combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period

Interventions

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Simvastatin

simvastatin (40 mg/day) for 4 weeks

Intervention Type DRUG

Ezetimibe

ezetimibe (10 mg/day) for 4 weeks

Intervention Type DRUG

Simvastatin + Ezetimibe

combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* LDL cholesterol concentration of between 160-190 mg/dl in patients with less than 2 cardiovascular risk factors
* LDL concentration of between 130-160 mg/dl in patients that presented 2 or more cardiovascular risk factors.

Cardiovascular risk factors were defined as: age (≥ 45 years in men and ≥55 years in women), a smoking habit, hypertension (≥140/90 mmHg), diabetes mellitus, a high-density lipoprotein (HDL) cholesterol concentration of ≤ 40mg/dl, and a family history of cardiovascular disease.