Mixed Dyslipidemia, Primary Hypercholesterolaemia
Conditions
Keywords
Primary hypercholesterolemia, Mixed dyslipidemia
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).
Interventions
DRUGCombination of bempedoic acid and ezetimibe
No drug was administered in this observational study.
Sponsors
Daiichi Sankyo
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
exist to avoid selection bias and to allow for documentation of routine clinical practice.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Brazil, Hong Kong
Contacts
CONTACTDaiichi Sankyo Contact for Clinical Trial Information
STUDY_DIRECTORGlobal Team Lead
Daiichi Sankyo
Outcome results
None listed