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

Not Applicable

• Conditions: Endothelial Function
• Interventions: Drug: simvastatin, combined with simvastatin ezetimibe, placebo

• Registration Number: NCT01241097
• Lead Sponsor: Federal University of Bahia

Brief Summary

* 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

Detailed 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.

Study Timeline

• Study Start: 2010-03
• Status Verified: 2010-06
• Study First Submitted: 2010-11-15
• Study First Submitted QC: 2010-11-15
• Last Update Submitted: 2010-11-15
• Study First Posted: 2010-11-16
• Last Update Posted: 2010-11-16
• Primary Completion: 2010-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high-dose simvastatin, combined, placebo	simvastatin, combined with simvastatin ezetimibe, placebo	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

Primary Outcome Measures

Name	Time	Method
Percent change vasodilation of brachial artery flow-mediated, after eight weeks of treatment.	8 weeks

Secondary Outcome Measures

Name	Time	Method
biochemical markers	8 weeks

Trial Locations

Locations (1)

Escola Bahiana de Medicina e Saúde Púiblica; 🇧🇷 Salvador, Bahia, Brazil