Comparison Of Cardiovascular Event Rates In Elderly Patients With Newly Initiated Atorvastatin Or Simvastatin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31,603
- 主要终点
- Hazard Ratio for First Cardiovascular (CV) Event
研究概览
简要总结
The purpose of this study is to compare rates and risk of primary cardiovascular events among elderly patients newly initiating therapy with atorvastatin or simvastatin. The specific objectives for this project are to: 1) examine the demographic and clinical characteristics of the elderly patients in whom atorvastatin or simvastatin was newly initiated; and 2) compare cardiovascular event rates in elderly patients in whom atorvastatin or simvastatin was newly initiated.
详细描述
All subjects meeting sample definition, all inclusion criteria, and none of the exclusion criteria.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 1 fill for atorvastatin or simvastatin (not including combination therapy) between 01 July 2006 and 30 November 2008
- •Age ≥ 65 years as of the year of index date
- •Continuous enrollment with medical and pharmacy benefits during the analytic period
排除标准
- •1 or more fills for a statin or other dyslipidemia medication in the 12-month pre-index period
- •A pharmacy fill for clopidogrel or nitrates (except concomitant hydralazine) in the 12-month pre-index period
- •Patients with evidence of a cardiovascular event in the 12-month pre-index period.
- •Patients who received both atorvastatin and simvastatin on the index date
- •Patients with unknown gender or region
- •Patients who received dyslipidemia medications other than the index drug within 1 months (30 days) following the index date
结局指标
主要结局
Hazard Ratio for First Cardiovascular (CV) Event
时间窗: At least 3 months from the post-index date (baseline) or end of study (28 February 2009)
Hazard ratio of atorvastatin versus simvastatin for first CV event. Hazard ratio of atorvastatin versus simvastatin was obtained from a Cox proportional hazards model.
Number of Participants With Post-index Cardiovascular (CV) Events
时间窗: At least 3 months from the post-index date (baseline) or end of study (28 February 2009)
CV events were defined as an inpatient or emergency department admission for heart failure (HF), myocardial infarction (MI), ischemic heart disease (IHD), cerebrovascular disease, peripheral vascular disease (PVD), aortic aneurysm, and/or revascularization. CV events were identified using medical claims.
次要结局
- Low-density Lipoprotein Cholesterol (LDL-C)(At least 3 months from the post-index date (baseline) or end of study (28 February 2009))
- Mean Dose(At least 3 months from the post-index date (baseline) or end of study (28 February 2009))
- Percentage of Participants Who Adhered to Index Therapy(At least 3 months from the post-index date (baseline) or end of study (28 February 2009))
- Number of Participants Per Dose(At least 3 months from the post-index date (baseline) or end of study (28 February 2009))
- Length of Post-index Period(Index date (baseline) up to end of study (28 February 2009))