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.
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.
None
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, and Thailand).
Cohort
Prospective
Combination of bempedoic acid and ezetimibe
DrugNo drug was administered in this observational study.
Incidence of adverse events
Adverse events (AEs) will be collected after signed informed consent and initiation of bempedoic acid/FDC with ezetimibe.
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.
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.
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.
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.
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