A Retrospective, Observational Database Study to Assess the Real-World Effectiveness of Inclisiran and PCSK9 mAbs in Chinese Hypercholesterolemia Adult Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11,991
- 试验地点
- 1
- 主要终点
- Percentage Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline
研究概览
简要总结
The purpose of this study was to describe the effectiveness of inclisiran and proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies (mAbs) in the real-world setting in China.
Data for this study was obtained from three regional electronic health record (rEHR) databases and included patients who met the enrollment requirements during the study identification period (October 1, 2023 to June 30, 2024) who had used either inclisiran or PCSK9 mAb for the first time. The retrospective data up to the date of ethics committee (EC) approval was extracted from multiple rEHR databases to generate study-specific datasets supporting this study on respective secure data analysis platforms. Due to the requirements of data security policies, the patient-level data from rEHR databases could not be transferred out of the secure platform. Thus, independent analysis based on data from each of the three databases was performed separately and meta-analysis was conducted to integrate one result of all independent data analyses.
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
- •First received inclisiran or any PCSK9 mAbs during the indexing period.
排除标准
- •Participated in any interventional or observational study of inclisiran or PCSK9 mAbs anytime during the study period.
- •In the inclisiran cohort, the first inclisiran injection was during the index period, and patients were treated with PCSK9 mAbs within 3 months prior to first inclisiran.
研究组 & 干预措施
Inclisiran Cohort
Adult patients who first received inclisiran between 01 October 2023 and 30 June 2024.
PCSK9 mAbs Cohort
Adult patients who first received PCSK9 mAbs between 01 October 2023 and 30 June 2024.
结局指标
主要结局
Percentage Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline
时间窗: From Baseline to 6 months
次要结局
- Percentage Change in LDL-C From Baseline(From Baseline to 3, 9, and 12 months)
- Absolute Change in LDL-C From Baseline(From Baseline to 3, 6, 9, and 12 months)
- Proportion of Days Covered (PDC)(12 months)
- Proportion of Patients who Remained (Persistence) on Medication(12 months)
- Number of Inclisiran Injections(12 months)
- Percentage Change in Other Lipids and Lipoproteins From Baseline(From Baseline to 3, 6, 9, and 12 months)
- Absolute Change in Other Lipids and Lipoproteins From Baseline(From Baseline to 3, 6, 9, and 12 months)
- Number of Patients by Demographic Category(Baseline)
- Number of Patients by Clinical Characteristic(Baseline)
- LDL-C Measures of Variability - Standard Deviation(Baseline, Month 6, Month 9, Month 12)
- LDL-C Measures of Variability - Correlation of Variation(Baseline, Month 6, Month 9, Month 12)