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

Phase 4

Completed

• Conditions: Hypercholesterolemia; Hyperlipidemia
• Interventions: Drug: Niacin; Drug: Colestipol; Drug: Ezetimibe

• Registration Number: NCT00203476
• Lead Sponsor: Tuscaloosa Research & Education Advancement Corporation

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.

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 Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Results First Submitted: 2013-12-05
• Status Verified: 2014-08
• Results First Submitted QC: 2014-08-08
• Last Update Submitted: 2014-08-08
• Results First Posted: 2014-08-12
• Last Update Posted: 2014-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Statin with Niacin	Niacin	Niacin dose range of 500-1500mg (average 888mg)
Statin with Colestipol	Colestipol	Colestipol dose range 5-15gm (average 9.5gm)
Statin with Ezitimibe	Ezetimibe	Ezitimibe 10mg (average 10mg)

Primary Outcome Measures

Name	Time	Method
LDL Goal Attainment	12 weeks	Each participant had his LDL goal calculated based on the NCEP ATPIII guidelines.

Secondary Outcome Measures

Name	Time	Method
Incidents of Rhabdomyolysis	12 weeks
LFT Elevation	12 weeks
Change in HDL From Baseline to 12 Weeks.	baseline and 12 weeks

Trial Locations

Locations (1)

Tuscaloosa Research & Education Advancement Corporation; 🇺🇸 Tuscaloosa, Alabama, United States