Efficacy and Safety of Atorvastatin 40mg Versus Rosuvastatin 20mg in Type II Diabetic Patients With Previous Acute Coronary Syndrome : Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Mean Change from baseline in Low Density Lipoprotein Cholesterol (LDL-C)
研究概览
简要总结
The purpose of this study was to compare the efficacy and safety of high dose atorvastatin (40 mg) versus high dose rosuvastatin (20 mg) in Egyptian type II diabetic patients with previous acute coronary syndrome history. This open-labeled prospective, randomized clinical trial compared once daily atorvastatin 40mg (Ator®) versus once daily rosuvastatin 20mg (Crestor®). The primary outcome was the 50% reduction in low-density lipoprotein cholesterol levels at 12 weeks. The secondary outcome was the achievement of low-density lipoprotein cholesterol level < 55 mg/dl.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis with type 2 diabetes.
- •Previous history of acute coronary syndrome.
- •Abnormal baseline lipid profile.
排除标准
- •Patients taking concurrent lipid lowering agents such as bile acid sequestrants (cholestyramine, colesevelam), niacin, ezetimibe, fenofibrate and/or omega
- •Patients taking concurrent interacting medications such as ciclosporin, gemfibrozil, clarithromycin and/or itraconazole.
- •Patients with active liver disease, bile duct problems, or ALT > 3 × upper limit of normal (ULN).
- •Patients with serum creatinine > 2 mg/dl.
- •Patients have incidence or history of hypersensitivity reaction to any of the statin used.
- •Women who were pregnant, breast-feeding or of child-bearing potential and not using a reliable form of contraception at the time of recruitment
研究组 & 干预措施
Atorvastatin
Atorvastatin tablets Dosage and frequency: 40mg orally once daily
干预措施: Atorvastatin 40 Mg Oral Tablet (Drug)
Rosuvastatin
Rosuvastatin tablets Dosage and frequency: 20mg orally once daily
干预措施: Rosuvastatin 20 Mg Oral Tablet (Drug)
结局指标
主要结局
Mean Change from baseline in Low Density Lipoprotein Cholesterol (LDL-C)
时间窗: Post intervention at week 12
A measure of participants with response
次要结局
未报告次要终点
研究者
Yassmin Genina
Teaching assistant at pharmacy practice department Faculty of pharmacy Helwan University
Helwan University