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

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00203476
• Other study ID #: TREAC Cholesterol Study
• Secondary ID: TREAC Cholestero
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: August 8, 2014
• Start date: May 2005
• Est. completion date: January 2008

Study information

• Verified date: August 2014
• Source: Tuscaloosa Research & Education Advancement Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hyperlipidemia
• Hyperlipidemias

Intervention

Drug:
• Niacin

• Colestipol

• Ezetimibe

Locations

Country	Name	City	State
United States	Tuscaloosa Research & Education Advancement Corporation	Tuscaloosa	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
Tuscaloosa Research & Education Advancement Corporation	American Society of Health-System Pharmacists Research and Education Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL Goal Attainment	Each participant had his LDL goal calculated based on the NCEP ATPIII guidelines.	12 weeks	No
Secondary	LFT Elevation		12 weeks	No
Secondary	Incidents of Rhabdomyolysis		12 weeks	No
Secondary	Change in HDL From Baseline to 12 Weeks.		baseline and 12 weeks	Yes