Real-World Long-Term Adherence and Persistence to Inclisiran, Evolocumab, and Alirocumab in Italy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,995
- 试验地点
- 1
- 主要终点
- Proportion of Days Covered (PDC) With Inclisiran
研究概览
简要总结
This study aims to evaluate the long-term adherence and persistence to inclisiran and anti-proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies (mAbs) in real-world clinical practice.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A first ever prescription of injection of inclisiran, evolocumab, or alirocumab during the identification period.
- •Age ≥18 years at index date.
- •With at least 12 months data availability prior to index date.
排除标准
- •Patients who received either evolocumab or alirocumab as their index study drug and who were dispensed the other anti-PCSK9-mAb (alirocumab and evolocumab respectively) before the identification period.
研究组 & 干预措施
Inclisiran Cohort
Patients receiving inclisiran injection(s).
Evolocumab Cohort
Patients receiving evolocumab injection(s).
Alirocumab Cohort
Patients receiving alirocumab injection(s).
Pooled Anti-PCSK9-mAb Cohort
Patients receiving anti-PCSK9-mAbs either evolocumab or alirocumab.
结局指标
主要结局
Proportion of Days Covered (PDC) With Inclisiran
时间窗: 6 months after index date and every 3 months thereafter until the end of follow-up, assessed up to 48 months
PDC is defined as the number of days with medication supply (covered days) within a period of interest divided by the number of days in the period of interest. Index date is the date of first use of the treatment.
Annual PDC With Inclisiran
时间窗: 0-12 months, 12-24 months, 24-48 months
PDC is defined as the number of days with medication supply (covered days) within a period of interest divided by the number of days in the period of interest.
Persistence With Inclisiran Treatment
时间窗: 6 months after index date and every 3 months thereafter until the end of follow-up, assessed up to 48 months
Persistence is defined as time to discontinuation by exceeding a pre-specified allowable gap beyond the scheduled time for the next dose/prescription. Index date is the date of first use of the treatment.
次要结局
- PDC With Anti-PCSK9-mAbs(6 months after index date and every 3 months thereafter until the end of follow-up, assessed up to 48 months)
- Annual PDC With Anti-PCSK9-mAbs(0-12 months, 12-24 months, 24-48 months)
- Persistence With Anti-PCSK9-mAb Treatment(6 months after index date and every 3 months thereafter until the end of follow-up, assessed up to 48 months)
- Baseline Demographics(Baseline)
- Baseline Clinical Characteristics: Number of Patients by Diagnosis(Baseline)
- Baseline Clinical Characteristics: Number of Patients by Comorbidity(Baseline)
- Baseline Clinical Characteristics: Charlson Comorbidity Index (CCI) Score(Baseline)
- PDC With Lipid Lowering Therapies (LLTs) at Baseline(Baseline)
- Number of Patients by LLTs Received(Every 3 months from baseline through index date until the end of follow-up, assessed up to 48 months)
- Number and Percentage of Patients Receiving Each of the Inclisiran Doses(From index date until the end of follow-up, assessed up to 48 months)
- Time Between Inclisiran Doses(From index date until the end of follow-up, assessed up to 48 months)
- Number of Anti-PCSK9-mAb Prescriptions(From index date until the end of follow-up, assessed up to 48 months)
- Time Between Anti-PCSK9-mAb Prescriptions(From index date until the end of follow-up, assessed up to 48 months)
- Association Between Treatment Adherence and Baseline Characteristics per Cohort(Baseline, up to 48 months)
- Association Between Treatment Persistence and Baseline Characteristics per Cohort(Baseline, up to 48 months)