KCT0009248进行中（未招募）Unknown
A retrospective cohort study to evaluate the efficacy and safety of pravastatin in hyperlipidemia patients in Korea using a common data model of multi-institutional electronic medical records
Daiichi-Sankyo Korea0 个研究点目标入组 8,464 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 8,464
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1) Patients prescribed pravastatin 40 mg or atorvastatin 10 mg within the common data model data utilization period (we define the date of first prescription as the index date)
- •2) Patients with documented healthcare utilization for at least one year before the index date
- •3) Patients with a documented diagnosis of dyslipidemia before the index date
- •4) Patients with no other statin prescriptions for at least one year before the index date
- •5) Patients who have been prescribed a statin for more than 180 consecutive days as of the index date
排除标准
- •Exclusion criteria
- •1) Patients with unverified age and gender at the index date
- •2) Patients whose age is less than 19 years at the index date
- •3) Patients with a prescription record for a statin with a different component or different dose other than study drugs statin before the time at risk start date.
- •(e.g., if a patient is prescribed pravastatin 40 mg on the index date, they will be excluded from the study if they have a prescription record for a statin with a different component other than pravastatin or a different dose of pravastatin other than pravastatin 40mg during the entire before to the time at risk start date).
- •4) Patients prescribed a fixed-dose combination containing pravastatin 40 mg or atorvastatin 10 mg before the time at risk start date.
- •5) Patients with any of the following medical conditions (based on diagnosis codes) before the time at risk start date
- •? Human immunodeficiency virus
- •? Solid organ transplant
- •Define exclusion criteria differently for primary and secondary outcome variables to build cohorts by outcome variable.
- •Cohort for evaluation of primary prevention effect on major adverse cardiac events
- •1) Patients with a history of the following before the time at risk start date
- •? Acute myocardial infarction
- •? Ischemic stroke
- •? Heart failure for hospitalization
- •? Coronary revascularization
- •Relevant cohorts for evaluation of secondary prevention of major adverse cardiac events
- •*Build a cohort that includes patients with a history of major cardiovascular events before the time at risk start date.
- •Cohort for safety assessment of type II diabetes mellitus development
- •1) Patients with a medical history of diabetes mellitus before the time at risk start date
- •Cohort for safety assessment of dementia development
- •1) Patients with a medical history of dementia before the time at risk start date
- •Cohort for safety assessment of myalgia or rhabdomyolysis
- •1) Patients with a medical history of myalgia or rhabdomyolysis before the the time at risk start date
- •Cohort for safety assessment of liver toxicity
- •1) Patients with a medical history of liver-relatemyalgia or rhabdomyolysis before the the time at risk start date
研究者
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