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

Tuscaloosa Research & Education Advancement Corporation

Status and phase: Completed; Phase 4

Conditions: Hyperlipidemia; Hypercholesterolemia

Treatments: Drug: Niacin; Drug: Colestipol; Drug: Ezetimibe

Study type: Interventional

Funder types: Other

Identifiers

NCT00203476

TREAC Cholesterol Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Statin with Niacin

Active Comparator group

Description:

Niacin dose range of 500-1500mg (average 888mg)

Treatment:

Drug: Niacin

Statin with Colestipol

Active Comparator group

Description:

Colestipol dose range 5-15gm (average 9.5gm)

Treatment:

Drug: Colestipol

Statin with Ezitimibe

Active Comparator group

Description:

Ezitimibe 10mg (average 10mg)

Treatment:

Drug: Ezetimibe