NCT06507852已完成不适用
Retrospective Assessment of Inclisiran Adherence, Treatment Patterns, Patient Characteristics, and Effectiveness Among ASCVD Patients With Hypercholesterolemia, ASCVD-risk Equivalent Patients With Hypercholesterolemia and Familial Hypercholesterolemia Patients Prescribed LEQVIO® (Inclisiran) in a Real-world Setting
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Percentage of Patients who Received Inclisiran Dose 2 and 3 Within Specified Time Intervals
研究概览
简要总结
This was a descriptive, non-interventional, retrospective cohort study among patients with atherosclerotic cardiovascular disease (ASCVD) and hypercholesterolemia, ASCVD-risk equivalent (ASCVD-RE) or familial hypercholesterolemia (FH) administered inclisiran in a real-world setting in Austria.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who were 18 years or older.
- •Signed informed consent was obtained.
- •Patients who received at least one inclisiran injection in the identification period.
- •Patients with at least one diagnosis of ASCVD, ASCVD-RE or FH diagnosis prior to index date.
- •Patients with at least one low-density lipoprotein cholesterol (LDL-C) measurement of 70 milligrams per deciliter (mg/dL) or greater, within 6 months prior to index date.
- •ASCVD was defined as previous diagnosis of coronary artery disease (CAD), peripheral artery disease (PAD) or cerebrovascular disease (CVD).
- •ASCVD-RE was defined as: no previous diagnosis of ASCVD at any time on the patient chart and they met at least one of the following criteria:
- •Diagnosis of type II diabetes mellitus (T2DM).
- •Diagnosis of type I diabetes mellitus (T1DM) of long duration (greater than 20 years).
- •10-year risk of 20% or greater by Framingham risk score.
排除标准
- 未提供
结局指标
主要结局
Percentage of Patients who Received Inclisiran Dose 2 and 3 Within Specified Time Intervals
时间窗: Up to 26 months
Time intervals: * Time from Dose 1 to Dose 2: 5 months or less. * Time from Dose 2 to Dose 3: * Less than 6 months. * Between 6 months and 9 months. * Greater than 9 months.
次要结局
- Glycated hemoglobin(Baseline)
- Prescribing Physician Specialty(Baseline)
- Body Mass Index(Baseline)
- Lipoprotein(a)(Baseline)
- Creatinine(Baseline)
- Alanine Aminotransferase(Baseline)
- Aspartate Aminotransferase(Baseline)
- Alkaline phosphatase(Baseline)
- Physical Activity(Baseline)
- Percentage of Patients who Received Inclisiran Doses Within Specified Time Intervals(Up to 26 months)
- Age(Baseline)
- Percentage of Atherosclerotic Cardiovascular Disease (ASCVD) Patients Categorized by Qualifying Diagnosis(Baseline)
- Gender(Baseline)
- Race(Baseline)
- Smoking Status(Baseline)
- Height(Baseline)
- Blood Pressure(Baseline)
- Percentage of Female Patients by Age Group(Baseline)
- Percentage of Patients Categorized by Comorbidities(Baseline)
- Cholesterol(Baseline)
- Apolipoprotein B(Baseline)
- Percentage of ASCVD-risk Equivalent Patients Categorized by Qualifying Criteria(Baseline)
- Percentage of Patients Categorized by Lipid Lowering Therapies (LLTs) Prior to Index Date(Up to 6 months pre-index date)
- Percentage of Patients Taking Different Concomitant Lipid Lowering Therapy (LLT) at Index Date(Day 1 of Month 6)
- Weight(Baseline)
- Percentage of Male Patients by Age Group(Baseline)
- Triglycerides(Baseline)
- Percentage of Patients With Procedures(Baseline)
研究者
研究点 (1)
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