Effects of Ezetimibe Add-On to Statin Therapy on Adipokine Production in Obese and Metabolic Syndrome Patients With Atherosclerosis

NCT00485121 | Completed

• 1 other identifier: P05080
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effects of adding ezetimibe to statin therapy on levels of inflammatory markers and adipokines in patients with atherosclerosis disease and features of the metabolic syndrome,whose LDL-c remains above target (\> 2.0 mmol/L) despite statin monotherapy. We hypothesize that the addition of Ezetimibe (10mg per day for 12 weeks) to ongoing statin therapy in patients with atherosclerosis and features of the metabolic syndrome will favourably modify levels of inflammatory biomarkers and adipokines.

Conditions

Metabolic Syndrome; Obesity; Coronary Artery Disease

Keywords

Ezetimibe; Statin; Low- density lipoprotein cholesterol; Adipokine; Adiponectin; C-reactive protein; Coronary artery disease; Metabolic Syndrome; Obesity

Outcome Measures

Primary Outcomes (1)

• Change in adiponectin levels

  12 weeks

Secondary Outcomes (1)

• Change in CRP, PAI-1, Il-6, TNF-α, resistin, leptin levels and serum lipids (total cholesterol, HDL-cholesterol, LDL-cholesterol, Triglycerides).

  12 weeks

Interventions

Ezetimibe DRUG

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients on statin therapy (no dose change within past 4 weeks) with LDL-c \> 2mmol/l
• Presence of atherosclerosis (CHD\* and/or cerebrovascular disease\*\* and/ or peripheral arterial disease (PAD)\*\*\*) plus at least one of the following:
• Metabolic Syndrome (according to modified NCEP ATP III criteria, using waist circumference cut-offs of 80 cm for women and 90 cm for men in all subjects of Asian origin and cut-offs of 88 cm for women and 102 cm for men in all Caucasian subjects)
• Obesity (BMI \> 30 Kg/m2 or waist circumference of \> 102 for men and \> 88 for women. For subjects of Asian origin the cutoff values should be 25, 90 and 80 respectively)
• CHD defined as (any one of the following): previous myocardial infarction; coronary angiography demonstrating at least 50% diameter stenosis in an epicardial coronary artery or its major branch; previous percutaneous transluminal coronary angioplasty (PTCA) with or without stent implantation (atherectomy included) or previous coronary artery bypass grafting (CABG)
• Cerebrovascular disease defined as (any one of the following): prior ischemic stroke, documented TIA, or flow-limiting stenosis in extracranial artery documented by Doppler or angiography.
• PAD defined as (any one of the following): prior peripheral arterial revascularization (PTA or surgery), amputation, or documented intermittent claudication with ABI \< 0.9

You may not qualify if:

• Women who are pregnant, breast feeding, or not using a reliable method of contraception
• Clinical signs of congestive heart failure or measured left ventricular ejection fraction \<40%
• Hemodynamically significant valvular heart disease or hypertrophic obstructive cardiomyopathy
• Renal dysfunction (creatinine \> 1.8 x ULN)
• Hepatic disease (liver function test \>1.5 x ULN \[upper limit normal\])
• Other significant laboratory abnormalities that the investigator feels may compromise the patient's safety by participation in the study
• History of systemic inflammatory disease (rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematous), myositis/myopathic process, or cancer)
• HIV
• Use of steroids or chemotherapy drugs within the past year or chronic use of nonsteroidal anti-inflammatory drugs besides aspirin (use for \> 2 weeks within the past year);
• Known hypersensitivity to Ezetimibe
• Participation in another clinical study concurrently or within the 30-day phase prior to screening for entry into the present study
• Unwilling to provide written informed consent for study participant and/or
• Unreliability as a study participant as based on the investigator's prior knowledge of the patient, such as the inability or willingness to participate in or complete the study or the presence of concurrent physical or psychological disorders that may make it impractical for the patient to participate in or complete the study.

Sponsors & Collaborators

• Canadian Collaborative Research Network: lead
• Schering-Plough: collaborator

Study Sites (1)

Partners Research

Brampton, Ontario, L6V 1B4, Canada

Location

MeSH Terms

Conditions

Metabolic Syndrome; Obesity; Coronary Artery Disease

Interventions

Ezetimibe

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Milan K Gupta, MD

  Partners Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 8, 2007
• First Posted: June 12, 2007
• Study Start: April 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: April 1, 2009
• Last Updated: November 25, 2010

Record last verified: 2008-05

Locations

CA (1)