A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction

Study Description

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Brief Summary:

To compare LDL reduction compared to baseline in patients using maximum tolerated HMG CoA Reductase inhibitor (statin) therapy with adjunctive therapy with ezetimibe, colestipol, or niacin. The patient's cardiovascular risks are assessed to determine if National Cholesterol Education Program's Adult Treatment Panel III (NCEP ATP III) guidelines for low density lipoprotein (LDL) reduction were achieved between the three groups. Secondary measures examine the safety issues with liver function test (LFT) monitoring and rhabdomyolysis. High-density lipoproteins (HDL) elevations are monitored between the three groups to determine efficacy as a secondary outcome.

Condition or disease	Intervention/treatment	Phase
Hyperlipidemia; Hypercholesterolemia	Drug: Niacin; Drug: Colestipol; Drug: Ezetimibe	Phase 4

Detailed Description:

: Patients with hyperlipidemia who sign consent and who are currently at maximum tolerated dose of a statin and are not meeting NCEP ATPIII treatment goals for LDL cholesterol are enrolled in 12-week open label, prospective trial. Patients are randomized into one of three groups to receive ezetimibe, niacin, or colestipol in addition to current statin therapy. Patients are titrated as tolerated to therapeutic doses of study medications (ezetimibe 10mg/day, niacin 1500mg/day, and colestipol 20gm/day). At baseline, informed consent; a laboratory admission profile (Chem20); weight; height; blood pressure; concomitant medications; cholesterol medication history; and grapefruit juice consumption data are gathered. At weeks 6 and 12, patients have their cholesterol panels and liver function tests assessed. Patients are also interviewed regarding side effects (including rhabdomyolysis), tolerance, changes in concomitant medications, and grapefruit juice consumption, along with weight and blood pressure measurements.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	30 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction
Study Start Date :	May 2005
Actual Primary Completion Date :	January 2008
Actual Study Completion Date :	January 2008

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Statin with Niacin; Niacin dose range of 500-1500mg (average 888mg)	Drug: Niacin
Active Comparator: Statin with Colestipol; Colestipol dose range 5-15gm (average 9.5gm)	Drug: Colestipol
Active Comparator: Statin with Ezitimibe; Ezitimibe 10mg (average 10mg)	Drug: Ezetimibe; Other Name: Zetia

Outcome Measures

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Primary Outcome Measures :

1. LDL Goal Attainment [ Time Frame: 12 weeks ]
   Each participant had his LDL goal calculated based on the NCEP ATPIII guidelines.

Secondary Outcome Measures :

1. LFT Elevation [ Time Frame: 12 weeks ]
2. Incidents of Rhabdomyolysis [ Time Frame: 12 weeks ]
3. Change in HDL From Baseline to 12 Weeks. [ Time Frame: baseline and 12 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	50 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Veterans eligible for treatment at the Tuscaloosa VA Medical Center
• 50 years of age
• Male or female
• Any race or ethnic group
• Signed informed consent
• Hyperlipidemia despite current maximum tolerated dose of an HMG CoA Reductase inhibitor (statin) for > 6 weeks
• Currently not meeting NCEP ATPIII treatment goals for LDL cholesterol

Exclusion Criteria:

• Known hypersensitivity or intolerance to ezetimibe, niacin, or colestipol
• Previous failed adequate trial of adjunctive ezetimibe, niacin, or colestipol
• Consumes more than 8oz. grapefruit juice daily
• Significant medical condition that would impact safety evaluations (i.e. significantly elevated LFT, hepatitis, severe dermatitis, uncontrolled diabetes, severe GI disease, fibromyalgia, renal failure, recent CVA or MI, pancreatitis, etc.)
• Receiving medications that would be contraindicated to use in combination with ezetimibe, niacin, or colestipol

Contacts and Locations

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Locations

United States, Alabama
Tuscaloosa Research & Education Advancement Corporation
Tuscaloosa, Alabama, United States, 35404

Sponsors and Collaborators

Tuscaloosa Research & Education Advancement Corporation

American Society of Health-System Pharmacists Research and Education Foundation

Investigators

Principal Investigator:	Raela B Williford, PharmD	Tuscaloosa VA Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Ansell BJ. Rationale for combination therapy with statin drugs in the treatment of dyslipidemia. Curr Atheroscler Rep. 2005 Feb;7(1):29-33. Review.

Responsible Party:	Raela Williford, PharmD, Clinical Pharmacist/PI, Tuscaloosa Research & Education Advancement Corporation
ClinicalTrials.gov Identifier:	NCT00203476 History of Changes
Other Study ID Numbers:	TREAC Cholesterol Study
First Posted:	September 20, 2005
Results First Posted:	August 12, 2014
Last Update Posted:	August 12, 2014
Last Verified:	August 2014

Keywords provided by Raela Williford, PharmD, Tuscaloosa Research & Education Advancement Corporation:

ezetimibe; niacin; colestipol	hyperlipidemia; adjunct therapy; zetia

Additional relevant MeSH terms:

Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Ezetimibe; Niacin; Colestipol; Niacinamide; Nicotinic Acids; Anticholesteremic Agents	Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Vasodilator Agents; Vitamin B Complex; Vitamins; Micronutrients; Growth Substances; Physiological Effects of Drugs; Sequestering Agents