Pleiotropism of Statin Therapy in High Dose Versus Low Dose Combined With Ezetimibe

Federal University of Bahia

Status: Unknown

Conditions: Endothelial Function

Treatments: Drug: simvastatin, combined with simvastatin ezetimibe, placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01241097

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Details and patient eligibility

About

• To test the hypothesis that therapy with high dose statin provides endothelial superior benefit to the same cholesterol lowering with low-dose statin combined with ezetimibe.
• To test the hypothesis that therapy with high dose statin provides anti-inflammatory effect than the same reduction of cholesterol with low dose of statin plus ezetimibe

Full description

Randomized, double-blind, placebo-controlled study. Inclusion Criteria: Obese women with body mass index (BMI)> 25 kg / m², aged 18 years and LDL-C> 100 mg / dl For treatment with simvastatin 80 mg, the participant will receive two identical vials, each containing a simvastatin 40 mg. For treatment with the combination simvastatin 10 mg and ezetimibe 10 mg, the participant will receive two identical bottles, one bottle with simvastatin 10 mg, and another bottle with ezetimibe 10mg. In the control group, each participant will receive two identical bottles, each bottle containing inert tablets. Each group with 20 participants.

Dependent Variable (Final Primary Outcome): Percentage change vasodilation of brachial artery flow-mediated, after treatment for eight weeks.

Covariates: clinical, biochemical markers and ultrasound.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women with body mass index (BMI)> 25 kg / m²
• Aged > 18 years
• LDL-C> 100 mg / dl

Exclusion criteria

• Previous use of statins, fibrates or ezetimibe
• Triglycerides> 400 mg / dl
• Serum creatinine greater than 2.0 md / dl
• Elevated liver enzymes, more than one and half times the upper limit of normal
• Creatine kinase (CK) levels more than three times the upper limit of normal
• Pregnant
• Breast-feeding
• Heart failure
• Psychiatric disorders
• Hormone replacement therapy.
• The occurrence of recent onset within the last four weeks of treatment with beta-blockers, converting enzyme inhibitor or calcium channel blocker, the intervention should be undertaken after a period of at least four weeks of continuous use.
• Acute inflammatory processes in the last month, assessed by clinical history and physical examination (ear, throat, skin lesions or other inflammatory manifestations) as well as reports of chronic diseases such as collagen, or the occurrence of active tuberculosis in the last three months will be excluded from work.

Trial design

60 participants in 1 patient group

high-dose simvastatin, combined, placebo

Experimental group

Description:

simvastatin 80 mg per days or simvastatin 10 mg and ezetimibe 10 mg, over a period of eight weeks, treatment consisted of tablets identical, or placebo

Treatment:

Drug: simvastatin, combined with simvastatin ezetimibe, placebo