A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
- Conditions
- Primary HypercholesterolaemiaMixed Dyslipidemia
- Interventions
- Drug: Combination of bempedoic acid and ezetimibe
- Registration Number
- NCT07206472
- Lead Sponsor
- Daiichi Sankyo
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 2560
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Bempedoic acid/FDC with ezetimibe Combination of bempedoic acid and 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.
- Primary Outcome Measures
Name Time Method Incidence of adverse events 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.
- Secondary Outcome Measures
Name Time Method 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 Cardiovascular (CV) risk of patients treated with bempedoic acid/FDC with ezetimibe will be assessed using 2019 ESC/EAS guidelines risk classification.
Proportion of patients with level of LDL-C goal attainment From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy The proportion of patients with level of LDL-C goal attainment at any subsequent data collection time point will be assessed.
Change from baseline in LDL-C levels From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy Changes over time in LDL-C levels from prior to treatment with bempedoic acid/FDC to any subsequent data collection points will be assessed.
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 Changes over time in plasma levels of other potentially atherosclerotic cardiovascular disease (ASCVD)-modifying cholesterol fragments, namely, TC, apoB, HDL-C, non-HDL-C, TGs and Lp(a) from prior to treatment with bempedoic acid/FDC with ezetimibe to any subsequent data collection point will be assessed.
Change from baseline in the levels of inflammatory marker hsCRP From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy Changes over time in the levels of inflammatory marker Hs C-reactive Protein (hsCRP) from prior to treatment with bempedoic acid/FDC with ezetimibe to any subsequent data collection point will be assessed.
Change from baseline in uric acid levels From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy Changes over time in uric acid levels from prior to treatment with bempedoic acid/FDC with ezetimibe to any subsequent data collection point will be assessed.
Incidence of relevant cardiovascular events From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy The incidence of relevant CV events, including myocardial infarction (MI), unstable angina requiring hospitalization, CABG, PCI, stroke (ischemic and haemorrhagic), TIA , acute peripheral arterial occlusion, other arterial revascularization procedures, all-cause death, and CV-death will be assessed.
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 Adverse effects related to lipid-modifying treatment (LMT) other than bempedoic acid/FDC with ezetimibe, including insufficient lipid lowering efficacy, laboratory abnormalities, muscle-associated symptoms, new onset and/or worsening of existing diabetes mellitus, reduced kidney function, drug-drug interaction assessed by the physician, and non-compliance assessed by the physician will be assessed.
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 The use of LMTs prior or concomitantly to receiving bempedoic acid/FDC with ezetimibe (including combination treatments) will be assessed.
Treatment duration of bempedoic acid/FDC with ezetimibe From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy Bempedoic acid/FDC with ezetimibe treatment parameters such as treatment duration by therapy, dosage, prescription intervals, permanent discontinuations, switches and reasons for these will be assessed.