A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
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).
official title
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