Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination of bempedoic acid and ezetimibe | Drug | No drug was administered in this observational study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Adverse events (AEs) will be collected after signed informed consent and initiation of bempedoic acid/FDC with ezetimibe. | From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular (CV) risk of patients treated with bempedoic acid/FDC with ezetimibe using 2019 ESC/EAS guidelines risk classification | Cardiovascular (CV) risk of patients treated with bempedoic acid/FDC with ezetimibe will be assessed using 2019 ESC/EAS guidelines risk classification. | From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy |
Not provided
Patients can be enrolled, when they fulfil the following inclusion criteria:
No explicit exclusion criteria exist to avoid selection bias and to allow for documentation of routine clinical practice.
Not provided
Not provided
Not provided
The study population includes adult patients diagnosed with primary hypercholesterolemia or mixed dyslipidemia treated by specialized as well as non-specialized physicians in hospitals and office-based centers from six countries (Brazil, Hong Kong, South Korea, Taiwan, Thailand, and Vietnam).
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Global Team Lead | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto do Coração do Hospital das ClÃnicas da Faculdade de Medicina da Universidade de São Paulo - InCor HCFMUSP | São Paulo | 05403-000 | Brazil |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Proportion of patients with level of LDL-C goal attainment | The proportion of patients with level of LDL-C goal attainment at any subsequent data collection time point will be assessed. | From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy |
| Change from baseline in LDL-C levels | Changes over time in LDL-C levels from prior to treatment with bempedoic acid/FDC to any subsequent data collection points will be assessed. | 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 | 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. | From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy |
| Change from baseline in the levels of inflammatory marker hsCRP | 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. | From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy |
| Change from baseline in uric acid levels | 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. | From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy |
| Incidence of relevant cardiovascular events | 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. | 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 | 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. | 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 | The use of LMTs prior or concomitantly to receiving bempedoic acid/FDC with ezetimibe (including combination treatments) will be assessed. | From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy |
| Treatment duration of bempedoic acid/FDC with ezetimibe | 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. | From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy |
| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided