Observational Study of Superstat® (Rosuvastatin) in Hypercholesterolemia Patients in Lebanon
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 317
- 主要终点
- Percent change in mean low-density lipoproteins (LDL-C)
研究概览
简要总结
This study assessed the safety and efficacy of generic Rosuvastatin in reducing plasma low density lipoprotein (LDL) cholesterol in Lebanese adult patients (18 years or older) with dyslipidemia for both primary and secondary prevention based on their total cardiovascular risk. No visits or interventions, additional to the routine clinical practice, were requested or performed.
详细描述
An observational, multicenter, prospective study of Lebanese adult (18 years or older) hypercholesterolemic patients administered generic Rosuvastatin (Superstat®).
Eligible newly diagnosed hypercholesterolemic patients took generic Rosuvastatin as prescribed by their treating physician. Assigning patients to generic Rosuvastatin was decided within the current practice and medical indication and was independent from the recruitment into the study.
Patients were followed-up at the clinic as per the standard practice of care. Each patient was followed-up for a period of 2 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Males and females ≥ 18 years of age
- •Patients with dyslipidemia requiring statin therapy according to CV risk factors as per the ESC/EAS 2011 guidelines for primary or secondary prevention
- •Patients provided written informed consent
排除标准
- •Age <18 years
- •Statin use in the past 3 months
- •Any contraindication to HMG-CoA reductase inhibitors
- •Co-administration of non-statin lipid lowering agent (ezitimibe, fibrates, niacin, omega 3)
- •Conditions which may cause secondary dyslipidemia
- •Any of the following abnormal laboratory tests:
- •TG level of > 400 mg/dL, Abnormal liver enzymes (AST or ALT) ≥ 3 ULN, Abnormal serum creatine kinase (CK) > 5 ULN
结局指标
主要结局
Percent change in mean low-density lipoproteins (LDL-C)
时间窗: 2 months
次要结局
- Percent change in mean total cholesterol, triglycerides, high density lipoprotein (HDL-C)(2 months)
- Proportion of patients who meet their target (LDL-C)(2 months)
- Incidence rate of adverse events (AEs) in association with generic rosuvastatin(2 months)