Patterns of Inclisiran Use in the Real World: A Retrospective Analysis of US Databases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37,688
- 试验地点
- 1
- 主要终点
- Number of Patients per Demographic Category
研究概览
简要总结
This was a retrospective observational cohort study of patients who initiated inclisiran, alirocumab, or evolocumab in a real-world setting in the United States. The study used data extracted from three databases: (1) open and closed claims from Komodo's Healthcare map and electronic medical records (EMRs) from outpatient clinics affiliated with (2) Healix and (3) Metro Infusion Centers.
The study period spanned from 01 January 2021 to the latest date of the available data for each database. Index date was defined as the date of the first claim for inclisiran, alirocumab, or evolocumab within the patient identification period. The 12-month period prior to the index date (including the index date) was the baseline period. Follow-up spanned from the index date up to patient disenrollment, death, or the end of the study period, whichever came first.
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 with a first claim for inclisiran within the identification period.
- •Patients without a claim for inclisiran and with a first alirocumab claim or first evolocumab claim within the identification period.
- •Patients with 12 months of continuous enrollment (CE) before index, inclusive of index date.
- •Additional inclusion criteria for secondary outcome measures:
- •Patients with at least 6-month or 12-month CE period post-index.
- •Patients with continuous use of the index medications.
- •Patients with available low-density lipoprotein cholesterol (LDL-C) measurements at baseline and after treatment initiation.
- •Exclusion criteria:
- •Patients with ≥1 prescription claims for the index medications in the 12-month prior-index period (exclusive of index date).
排除标准
- 未提供
结局指标
主要结局
Number of Patients per Demographic Category
时间窗: Baseline
Demographics included: * Age group * Gender * Insurance type * Race/ethnicity
Number of Patients per Clinical Characteristic Category
时间窗: Baseline
Clinical characteristics included: * Body mass index * Atherosclerotic Cardiovascular Disease (ASCVD) diagnosis * Familial Hypercholesterolemia (FH) diagnosis * Comorbidities * Type of lipid lowering therapy (LLT)
次要结局
- Change From Baseline in LDL-C Levels(From Baseline up to 1 year)
- Number of Patients who Achieved a Reduction of 50% or more in LDL-C Levels After Initiating Treatment(Up to 1 year)
- Number of Patients who Achieved LDL-C Levels Below 70 Milligrams per Deciliter (mg/dL) and 55 mg/dL After Initiating Treatment(Up to 1 year)
- Medication Adherence(Up to 1 year)