High-Density Lipoprotein (HDL) Treatment Study - Full Text View

Purpose

A low level of plasma high-density lipoprotein (HDL) cholesterol, "the good cholesterol", is the most common lipid abnormality observed in patients with a premature atherosclerotic cardiovascular disease. HDL carry excess cholesterol from peripheral tissues to the liver to be metabolized or excreted, a process known as reverse cholesterol transport.

Epidemiological studies have shown an inverse correlation between plasma levels of HDL cholesterol and the risk of cardiovascular disease. An increase in plasma HDL cholesterol levels by 1 mg/dL may reduce the risk of cardiovascular disease by 2 to 3%. The standard care of treatment for a low level of HDL cholesterol is: 1) lifestyle modifications including exercise, smoking cessation, weight control, moderate alcohol intake and decreased dietary fat intake - all patients are encouraged to follow these lifestyle modifications; 2) medications which can raise HDL cholesterol.

Currently used medications to treat lipid disorders can increase, in some extent, HDL cholesterol. These include niacin (vitamin B3), fibric acid derivatives (fibrates) and statins. However there is no data on the effect of these medications on severe cases of HDL deficiency. This project aims to determine whether currently available medications, used in standard medical practice for the treatment of lipoprotein disorders, can substantially increase HDL cholesterol in severe cases of HDL deficiencies.

Condition	Intervention
Coronary Arteriosclerosis Hypoalphalipoproteinemias Genetic Diseases, Inborn	Drug: Atorvastatin; Fenofibrate; Niacin

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Treatment Study for Severe High-Density Lipoprotein Deficiency

Resource links provided by NLM:

Genetics Home Reference related topics: Chanarin-Dorfman syndrome cholesteryl ester storage disease familial HDL deficiency Farber lipogranulomatosis Tangier disease

MedlinePlus related topics: Cholesterol Coronary Artery Disease Statins

Drug Information available for: Niacin Niacinamide Fenofibrate Atorvastatin calcium

U.S. FDA Resources

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:

HDL cholesterol [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

apo AI [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment:	19
Study Start Date:	November 2006
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Atorvastatin 20 mg; Fenofibrate 200 mg; Niacin 2g used sequentially for 8 weeks, after 4 weeks washout.

Other Name: Lipotor; Tricor; Niaspan

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

- HDL deficiency (HDL-cholesterol < 5th percentile, age and gender-matched)

Exclusion Criteria:

Triglycerides ≥ 5 mmol/L
Diabetes
Severe obesity (BMI ≥ 30)
Alcohol intake > 21 drinks/week
Untreated disease (thyroid, hepatic or renal)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00458055

Locations

Canada, Quebec
MUHC-Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1

Sponsors and Collaborators

McGill University Health Center

Investigators

Principal Investigator:

Jacques Genest, MD

McGill University Health Center

More Information

Additional Information:

Treatment of high cholesterol This link exits the ClinicalTrials.gov site

Publications:

McPherson R, Frohlich J, Fodor G, Genest J, Canadian Cardiovascular Society. Canadian Cardiovascular Society position statement--recommendations for the diagnosis and treatment of dyslipidemia and prevention of cardiovascular disease. Can J Cardiol. 2006 Sep;22(11):913-27. Erratum in: Can J Cardiol. 2006 Oct;22(12):1077.

Brewer HB Jr. High-density lipoproteins: a new potential therapeutic target for the prevention of cardiovascular disease. Arterioscler Thromb Vasc Biol. 2004 Mar;24(3):387-91. No abstract available.

Rubins HB, Robins SJ, Collins D, Fye CL, Anderson JW, Elam MB, Faas FH, Linares E, Schaefer EJ, Schectman G, Wilt TJ, Wittes J. Gemfibrozil for the secondary prevention of coronary heart disease in men with low levels of high-density lipoprotein cholesterol. Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial Study Group. N Engl J Med. 1999 Aug 5;341(6):410-8.

Schaefer JR, Schweer H, Ikewaki K, Stracke H, Seyberth HJ, Kaffarnik H, Maisch B, Steinmetz A. Metabolic basis of high density lipoproteins and apolipoprotein A-I increase by HMG-CoA reductase inhibition in healthy subjects and a patient with coronary artery disease. Atherosclerosis. 1999 May;144(1):177-84.

Ashen MD, Blumenthal RS. Clinical practice. Low HDL cholesterol levels. N Engl J Med. 2005 Sep 22;353(12):1252-60. Review. No abstract available. Erratum in: N Engl J Med. 2006 Jan 12;354(2):215.

Schaefer EJ, Asztalos BF. The effects of statins on high-density lipoproteins. Curr Atheroscler Rep. 2006 Jan;8(1):41-9. Review.

Responsible Party:	Jacques Genest MD, McGill University Hospital Center
ClinicalTrials.gov Identifier:	NCT00458055 History of Changes
Other Study ID Numbers:	MUHC-RI 0906
Study First Received:	April 5, 2007
Last Updated:	June 2, 2008
Health Authority:	Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:

Lipid lowering agents
Drug treatment
Statin

Fibrate
Niacin
Cellular cholesterol efflux

Additional relevant MeSH terms:

Genetic Diseases, Inborn
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Hypolipoproteinemias
Hypoalphalipoproteinemias
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Dyslipidemias
Lipid Metabolism Disorders

Metabolic Diseases
Niacin
Fenofibrate
Atorvastatin
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vitamin B Complex
Vitamins
Micronutrients

ClinicalTrials.gov processed this record on May 23, 2013