A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 5/5/2014 |
| Start Date: | May 2005 |
| End Date: | May 2008 |
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.
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.
: 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.
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.
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
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