Real World Adherence of PCSK9 Targeted Therapy: A Retrospective Analysis of Japan Databases
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3,600
- 主要终点
- Medication adherence at 12 months : proportion of days covered (PDC) within a period that the patient is persistent
研究概览
简要总结
Retrospective observational cohort study to compare medication adherence at 12 months between patients in Japan with dyslipidemia and/or hypercholesterolemia (familial and non-familial hypercholesterolemia) who newly initiate inclisiran versus those who newly initiate evolocumab.
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
- •The patients are included if they meet all the following criteria:
- •At least one prescription of inclisiran or evolocumab (140 mg Pens) during the identification period.
- •At least one diagnosis of dyslipidemia and/or hypercholesterolemia (familial and non-familial hypercholesterolemia) without suspicion flag during the look back period.
- •At least 18 years on the index date.
- •At least one claim record within the 210 days prior to the index date (excluding the index date).
排除标准
- •Those with any of the following criteria will be excluded.
- •Both prescription records of inclisiran and evolocumab 140 mg Pens on the index date.
- •At least one claim data for inclisiran or evolocumab 140 mg Pens within the 210 days prior to the index date (excluding the index date).
- •At least one claim data for evolocumab 420 mg Auto mini-dosers during the observation period.
- •Incomplete data for the one year (365 days) follow-up period due to loss to follow-up (the end of the observation period) or death. (only for adherence cohort).
研究组 & 干预措施
exposure group
patients who initiated inclisiran as their first treatment
control group
patients who initiated evolocumab as their first treatment
结局指标
主要结局
Medication adherence at 12 months : proportion of days covered (PDC) within a period that the patient is persistent
时间窗: 12 months
Adherence is defined using proportion of days covered (PDC) within a period that the patient is persistent: calculated as the number of days covered by the target drug (inclisiran in the exposure group, evolocumab in the control group) during the 12 months follow-up period, divided by 365 days.
次要结局
- Proportion of patients with good adherence(12 months)
- Number of patients by demographic category(Baseline)
- Time to discontinuation(12 months)
- Proportion of patients receiving LLTs(12 months)