Effects of Ezetimibe on Postprandial Hyperlipidemia and Endothelial Function

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

In the present study the investigators are researching the effects of the cholesterol absorption inhibitor ezetimibe on postprandial lipemia and postprandial endothelial function in patients with the metabolic syndrome. The lipid-lowering effect of high-dose statin monotherapy on fasting lipids is equal to the combination therapy of low-dose statin and ezetimibe.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UMC Utrecht
• Treatments: Ezetimibe; Ezetimibe, Simvastatin Drug Combination; Simvastatin

Criteria

Inclusion Criteria:

1. Male and female (postmenopausal) patients, 18-70 years of age

2. Diagnosis of the metabolic syndrome according to ATP III criteria(4), including 3 or more of the following metabolic abnormalities:

• abdominal obesity (waist circumference > 102 cm in men and > 88 cm in women)

• elevated blood pressure (³ 130 mmHg systolic or ³ 85 mmHg diastolic)

• hypertriglyceridemia (serum triglycerides ³ 1.70 mmol/L

• low high-density lipoprotein (HDL) cholesterol (serum HDL-cholesterol <1.04 mmol/L in men and < 1.29 mmol/L in women)

• high fasting glucose (fasting serum glucose ³ 6.1 mmol/L)

3. Written informed consent

Exclusion Criteria:

1. Smoking

2. Thyroid disease (TSH > 5 mU/L with clinical symptoms of hypothyroidism)

3. Hepatic disease (ASAT or ALAT > 2 times the upper limit of normal)

4. Renal disease (serum creatinine > 1.7 times the upper limit of normal).

5. A history of coronary heart disease, cerebrovascular disease or peripheral arterial disease.

6. Use of lipid lowering therapy

7. Systolic blood pressure ≥ 180 mmHg and /or diastolic blood pressure ≥ 110 mmHg

8. BMI > 35

9. HbA1c > 6.5%

10. Triglycerides > 8.0 mmol/L