Clinical trial NCT00203476: A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction
Official title: A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperlipidemia
Hypercholesterolemia
Keywords: ezetimibe
niacin
colestipol
hyperlipidemia
adjunct therapy
zetia
Lead sponsor: Tuscaloosa Research & Education Advancement Corporation
Sponsor class: OTHER
Collaborators: name: American Society of Health-System Pharmacists Research and Education Foundation
First posted: 2005-09-20
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: LDL Goal Attainment
timeFrame: 12 weeks
Secondary outcomes:
measure: LFT Elevation
timeFrame: 12 weeks
measure: Incidents of Rhabdomyolysis
timeFrame: 12 weeks
measure: Change in HDL From Baseline to 12 Weeks.
timeFrame: baseline and 12 weeks
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Tuscaloosa Research & Education Advancement Corporation
state: Alabama
Study officials:
affiliation: Tuscaloosa Veterans Affairs Medical Center
name: Raela B Williford, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ansell BJ. Rationale for combination therapy with statin drugs in the treatment of dyslipidemia. Curr Atheroscler Rep. 2005 Feb;7(1):29-33. doi: 10.1007/s11883-005-0072-7.