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

Federal University of Bahia60 enrolled

Overview

* 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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

TRIPLE

Enrollment

Conditions

Endothelial Function

Interventions

simvastatin, combined with simvastatin ezetimibe, placeboDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Escola Bahiana de Medicina e Saúde Púiblica

Salvador, Estado de Bahia, Brazil

RECRUITING

Outcomes

Primary Outcomes

Percent change vasodilation of brachial artery flow-mediated, after eight weeks of treatment.

Time frame: 8 weeks

Secondary Outcomes

biochemical markers

Time frame: 8 weeks

Central Contacts

Maristela M Garcia, MD

CONTACT

55-71-99739981 marismacardiol@gmail.com

Luis Claudio L Correia, Phd

CONTACT

55-71-99711032 lccorreia@terra.com.br

Data from ClinicalTrials.gov

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