Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 27
- 主要终点
- Description of adherence of treatment with PCSK9 inhibitors in a real-life Italian population.
研究概览
简要总结
Evaluation of adherence, persistence and efficacy of treatment with PCSK9 inhibitors in a real-life Italian population.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients under PCSK9 inhibitor treatment.
排除标准
- •Age < 18 years o > 80 years;
- •Patients who refuse to participate and to sign informed consent.
研究组 & 干预措施
Group 1
Subjects with hyperlipidaemia under PCSK9 inhibitors treatment (Repatha/Praulent).
干预措施: Repatha (evolocumab); Praluent (alirocumab) (Drug)
结局指标
主要结局
Description of adherence of treatment with PCSK9 inhibitors in a real-life Italian population.
时间窗: 6 months
Adherence will be assessed in terms of Medical Possession Ratio (MPR) which is defined as the ratio between the treatment units dispensed during the treatment period and the duration of the treatment period itself. MPR will be calculated as overall MPR (mean and median value), MPR by type of prevention (primary and secondary), MPR by type of antiPCSK9 inhibitor (alirocumab vs. evolocumab), MPR by type of background therapy (statin yes, statin no) , MPR by demographic variables (age, sex, geographic origin, basal LDL levels), MPR by type of prescriber (hospital or territorial).
Description of persistence of treatment with PCSK9 inhibitors in a real-life Italian population.
时间窗: 6 months
Persistence will be assessed in terms of therapeutic continuity from the start of treatment to enrollment.
Description of efficacy of treatment with PCSK9 inhibitors in a real-life Italian population.
时间窗: 6 months
Efficacy of treatment will be evaluated as a change in the LDL (deltaLDL) value from the start of treatment (percentage and absolute value). The deltaLDL will be calculated as an overall (mean and median value), by type of prevention (primary and secondary), by type of antiPCSK9 inhibitor (alirocumab vs. evolocumab), by type of basic therapy (statin yes, statin no), by demographic variables (age, sex, geographic origin, basal LDL levels), by type of prescriber (hospital or territorial).
次要结局
- Description of adherence, efficacy and safety of treatment with PCSK9 inhibitors in a real-life Italian population general and divided into subgroups.(6 months)
研究者
Pasquale Perrone Filardi
Professor
Federico II University