A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction
Information source: Tuscaloosa Research & Education Advancement Corporation
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperlipidemia; Hypercholesterolemia
Intervention: ezetimibe (Drug); niacin (Drug); colestipol (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Tuscaloosa Research & Education Advancement Corporation Official(s) and/or principal investigator(s):
Raela B Williford, PharmD, Principal Investigator, Affiliation: Tuscaloosa VA Medical Center
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.
Clinical Details
Official title: A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction
Study design: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: 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 i
Secondary outcome: . 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.
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Tuscaloosa Research & Education Advancement Corporation, Tuscaloosa, Alabama 35404, United States; Recruiting
Raela B Williford, PharmD, Phone: 205-554-2000, Ext: 2733, Email: Raela.Williford@va.gov
Raela B Williford, PharmD, Principal Investigator
Additional Information
Related 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.
Starting date: May 2005
Ending date: May 2008
Last updated: March 16, 2007
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