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

Comparison of the Effect on Endothelial Function of Statin Therapy in High Dose Versus Low Dose Combined With Ezetimibe

• 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

Study Overview

• Status: Unknown
• Conditions: Endothelial Function
• Intervention / Treatment: Drug: simvastatin, combined with simvastatin ezetimibe, placebo

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maristela M Garcia, MD; Phone Number: 55-71-99739981; Email: marismacardiol@gmail.com
• Study Contact Backup: Name: Luis Claudio L Correia, Phd; Phone Number: 55-71-99711032; Email: lccorreia@terra.com.br

Study Locations

• Brazil
  • Bahia
    • Salvador, Bahia, Brazil, 40000
      • Recruiting
      • Escola Bahiana de Medicina e Saúde Púiblica
      • Contact: Marilia G Rodrigues, MD; Phone Number: 55-71-3359485; Email: mgaleffi@cardiol.br
      • Contact: Paulo Roberto P Lima, student; Phone Number: 55-71-99184765; Email: prpassoslima@hotmail.com
      • Sub-Investigator: Carolina Garcez, student

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: high-dose simvastatin, combined, 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	Drug: 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; Other Names: zocor, vytorin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent change vasodilation of brachial artery flow-mediated, after eight weeks of treatment.	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
biochemical markers	8 weeks

Collaborators and Investigators

• Sponsor: Federal University of Bahia
• Collaborators: Escola Bahiana de Medicina e Saude Publica
• Investigators: Principal Investigator: Maristela M Garcia, MD, Escola bahiana de Medicina e Saúde Pública

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (ANTICIPATED): December 1, 2010
• Study Completion (ANTICIPATED): December 1, 2011

Study Registration Dates

• First Submitted: November 15, 2010
• First Submitted That Met QC Criteria: November 15, 2010
• First Posted (ESTIMATE): November 16, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): November 16, 2010
• Last Update Submitted That Met QC Criteria: November 15, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: endothelial function; statins; ezetimibe; pleiotropism
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Simvastatin; Ezetimibe
• Other Study ID Numbers: sxse