Retrospective Study to Evaluate the Safety of the Fixed-dose Combination Rosuvastatin / Ezetimibe as a Treatment for Patients With Dyslipidaemia in Usual Medical Practice.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Adverse events presented
研究概览
简要总结
Retrospective, analytical, longitudinal, multicenter study to evaluate the safety of the fixed-dose combination of rosuvastatin / ezetimibe as treatment for patients with dyslipidemia in routine medical practice.
详细描述
To assess the safety of the fixed-dose combination of rosuvastatin / ezetimibe in subjects older than 18 years of age (gender indistinct) with dyslipidemia who at the discretion have been candidates for treatment with the combination. For the safety analysis, all the research subjects who have taken rosuvastatin / ezetimibe will be considered. The information recorded by the treating physicians in the file will be reviewed and within the case report format (CRF) of all adverse events that occur in the study. The terms originally used in the case report format by the investigators to identify adverse events (AE) will be coded in the analysis stage of Results using the current MEdDRA dictionary. The incidence of AE will be synthesized such as the frequency count and percentage of research subjects with events adverse by organ / system.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age> 18 years of age.
- •Diagnosis of dyslipidemia.
- •That treatment with the fixed-dose combination of rosuvastatin / ezetimibe is documented.
- •Have security questioning on at least two occasions.
排除标准
- •Subjects who has taken any other statins, fibrates, bile acid sequestrants, niacin (> 500 mg) or inhibitors of PCSK9 concomitantly during treatment with rosuvastatin / ezetimibe.
研究组 & 干预措施
Group A: Rosuvastatin /Ezetimibe fixed dose (TREZETE®)
Rosuvastatin /Ezetimibe fixed dose (TREZETE®) Pharmaceutical Form: Tablets Dosage: 10 mg / 10 mg or 20 mg / 10 mg Administration way: Oral
干预措施: Rosuvastatin 10 or 20mg /Ezetimibe 10 mg Fixed Dose (Drug)
结局指标
主要结局
Adverse events presented
时间窗: 2 months
Describe the frequency and intensity of adverse events presented.
Average difference in lipid profile values
时间窗: Baseline, 2 months
Evaluate the average difference in lipid profile values between at least 2 measurements.
次要结局
- Adherence to treatment(2 months)
- Significant reduction in LDL cholesterol(2 months)
- Percentage of patients who met established goals according to cardiovascular risk(2 months)