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

This study has been completed.
Sponsor:
Collaborator:
American Society of Health-System Pharmacists Research and Education Foundation
Information provided by (Responsible Party):
Raela Williford, PharmD, Tuscaloosa Research & Education Advancement Corporation
ClinicalTrials.gov Identifier:
NCT00203476
First received: September 12, 2005
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Hyperlipidemia
Hypercholesterolemia
Drug: Niacin
Drug: Colestipol
Drug: Ezetimibe
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction

Resource links provided by NLM:


Further study details as provided by Tuscaloosa Research & Education Advancement Corporation:

Primary Outcome Measures:
  • LDL Goal Attainment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Each participant had his LDL goal calculated based on the NCEP ATPIII guidelines.


Secondary Outcome Measures:
  • LFT Elevation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Incidents of Rhabdomyolysis [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in HDL From Baseline to 12 Weeks. [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: May 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Statin with Niacin
Niacin dose range of 500-1500mg (average 888mg)
Drug: Niacin
Active Comparator: Statin with Colestipol
Colestipol dose range 5-15gm (average 9.5gm)
Drug: Colestipol
Active Comparator: Statin with Ezitimibe
Ezitimibe 10mg (average 10mg)
Drug: Ezetimibe
Other Name: Zetia

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00203476

Locations
United States, Alabama
Tuscaloosa Research & Education Advancement Corporation
Tuscaloosa, Alabama, United States, 35404
Sponsors and Collaborators
Tuscaloosa Research & Education Advancement Corporation
American Society of Health-System Pharmacists Research and Education Foundation
Investigators
Principal Investigator: Raela B Williford, PharmD Tuscaloosa VA Medical Center
  More Information

Publications:
Responsible Party: Raela Williford, PharmD, Clinical Pharmacist/PI, Tuscaloosa Research & Education Advancement Corporation
ClinicalTrials.gov Identifier: NCT00203476     History of Changes
Other Study ID Numbers: TREAC Cholesterol Study, TREAC Cholesterol Study
Study First Received: September 12, 2005
Results First Received: December 5, 2013
Last Updated: August 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Tuscaloosa Research & Education Advancement Corporation:
ezetimibe
niacin
colestipol
hyperlipidemia
adjunct therapy
zetia

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Colestipol
Niacin
Ezetimibe
Nicotinic Acids
Niacinamide
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Sequestering Agents
Vasodilator Agents
Cardiovascular Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Anticholesteremic Agents

ClinicalTrials.gov processed this record on August 20, 2014