A Multi-national, Non-interventional Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Routine Clinical Practice in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,120
- 试验地点
- 24
- 主要终点
- Incidence of adverse events
研究概览
简要总结
There is limited efficacy and safety data of bempedoic acid or its fixed dose combination (FDC) with ezetimibe in Asian and Latin American patients. This non-interventional study (NIS) will be conducted to characterize the risks and benefits of bempedoic acid or FDC with ezetimibe in a real-world clinical setting in adult patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia.
详细描述
The primary objective of this study is to describe patient characteristics and evaluate adverse drug reactions (ADRs) that occurred since initiation of bempedoic acid/FDC with ezetimibe and adverse events (AEs) collected after signed informed consent and initiation of bempedoic acid/FDC with ezetimibe in a regular clinical care setting in patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia during 1-year follow-up.
The secondary objectives are defined as the assessment of the cardiovascular risk, rate, level of LDL-C goal attainment, changes over time in LDL-C levels, inflammatory markers, and uric acid levels from prior to treatment with bempedoic acid/FDC, and adverse events (AEs)/adverse drug reactions (ADRs).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 can be enrolled, when they fulfil the following inclusion criteria:
- •Written informed consent to participate.
- •At least 18 years of age.
- •Patients suffering from documented primary hypercholesterolemia or mixed dyslipidaemia treated or intended to be treated with bempedoic acid/ FDC with ezetimibe at the discretion of the physician are appropriate for participation in the observation.
- •For patients who are treated with bempedoic acid/FDC with ezetimibe prior to signed informed consent, initiation of bempedoic acid/FDC with ezetimibe must be within a maximum of three months prior to inclusion.
- •No contraindications exist according to the SmPC of bempedoic acid/FDC with ezetimibe.
- •No concurrent participation in an interventional study (simultaneous participation in other non-interventional study is possible)
- •Life expectancy > 1 year.
- •No explicit
排除标准
- •exist to avoid selection bias and to allow for documentation of routine clinical practice.
研究组 & 干预措施
Bempedoic acid/FDC with ezetimibe
Adult participants who were diagnosed with primary hypercholesterolemia (heterozygous familial and nonfamilial) or mixed dyslipidemia and treated with bempedoic acid/fixed dose combination (FDC) with ezetimibe in a regular clinical care setting.
干预措施: Combination of bempedoic acid and ezetimibe (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy
Adverse events (AEs) will be collected after signed informed consent and initiation of bempedoic acid/FDC with ezetimibe.
次要结局
- Cardiovascular (CV) risk of patients treated with bempedoic acid/FDC with ezetimibe using 2019 ESC/EAS guidelines risk classification(From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy)
- Proportion of patients with level of LDL-C goal attainment(From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy)
- Change from baseline in LDL-C levels(From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy)
- Change from baseline in plasma levels of other potentially ASCVD-modifying cholesterol fragments(From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy)
- Change from baseline in the levels of inflammatory marker hsCRP(From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy)
- Change from baseline in uric acid levels(From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy)
- Incidence of relevant cardiovascular events(From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy)
- Adverse effects related to lipid-modifying treatments (LMTs) other than bempedoic acid/FDC with ezetimibe(From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy)
- Use of lipid modifying therapies prior or concomitantly to receiving bempedoic acid/FDC with ezetimibe(From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy)
- Treatment duration of bempedoic acid/FDC with ezetimibe(From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy)