Extended-Release Niacin/Lovastatin Versus Usual Care for Treatment of Dyslipidemia in a Primary Care Setting (EXTEND Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- In His Image
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Lipid parameter change at 3 and 6 months
研究概览
简要总结
The purpose of this study is to investigate the benefits of combination niacin ER/lovastatin in patients receiving standard care who are not at LDL goal per ATP III guidelines.
详细描述
Both LDL and HDL are important contributors in the pathophysiology of atherosclerosis and coronary artery disease (CAD); however, HDL is often ignored in primary care. The combination of niacin extended-release (ER)/lovastatin in a single tablet formulation (Advicor®) may be the most effective therapeutic option for simultaneously correcting both of these lipoprotein abnormalities to reduce CAD risk. The purpose of this study is to investigate the benefits of combination niacin ER/lovastatin in patients receiving standard care who are not at LDL goal per ATP III guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years old with CAD or risk factors for CAD
- •under standard care at Family Medical Care of Tulsa
- •not at LDL goal per ATP III guidelines
排除标准
- •pregnancy/lactating
- •liver disease
- •allergies to statin or niacin
- •active peptic ulcer disease
- •previous treatment with combination therapy for dyslipidemia
结局指标
主要结局
Lipid parameter change at 3 and 6 months
Percent of patients achieving ATP III LDL goals at 3 and 6 months
次要结局
未报告次要终点