At a glance
ClinicalIndex Comparison Record- ✓Veterans eligible for treatment at Tuscaloosa VA Medical Center
- ✓Age ≥50 years
- ✓Hyperlipidemia despite maximum tolerated dose of statin for >6 weeks
- ✓Currently not meeting NCEP ATP III LDL cholesterol treatment goals
- ✕Known hypersensitivity or intolerance to ezetimibe, niacin, or colestipol
- ✕Previous failed adequate trial of adjunctive ezetimibe, niacin, or colestipol
- ✕Consumes more than 8 oz grapefruit juice daily
- ✕Significant medical conditions affecting safety (elevated LFTs, hepatitis, severe dermatitis, uncontrolled diabetes, severe GI disease, fibromyalgia, renal failure, recent CVA or MI, pancreatitis)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction
In Brief
A Phase 4 clinical trial evaluating Niacin, Colestipol, and 1 other intervention for Hyperlipidemia and Hypercholesterolemia. Completed, enrolled 30 participants across 1 site.
Detailed 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.