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

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tuscaloosa Research & Education Advancement Corporation
• Collaborator: American Society of Health-System Pharmacists Research and Education Foundation
• Treatments: Colestipol; Ezetimibe; Niacin; Niacinamide; Nicotinic Acids

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