A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- LDL Goal Attainment
研究概览
简要总结
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.
详细描述
: 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Statin with Niacin
Niacin dose range of 500-1500mg (average 888mg)
干预措施: Niacin (Drug)
Statin with Colestipol
Colestipol dose range 5-15gm (average 9.5gm)
干预措施: Colestipol (Drug)
Statin with Ezitimibe
Ezitimibe 10mg (average 10mg)
干预措施: Ezetimibe (Drug)
结局指标
主要结局
LDL Goal Attainment
时间窗: 12 weeks
Each participant had his LDL goal calculated based on the NCEP ATPIII guidelines.
次要结局
- Incidents of Rhabdomyolysis(12 weeks)
- LFT Elevation(12 weeks)
- Change in HDL From Baseline to 12 Weeks.(baseline and 12 weeks)
研究者
Raela Williford, PharmD
Clinical Pharmacist/PI
Tuscaloosa Research & Education Advancement Corporation