Mixed Dyslipidemia, Primary Hypercholesterolemia
Conditions
Keywords
Primary Hypercholesterolemia, Mixed Dyslipidemia, Bempedoic acid and/or its fixed-dose combination with ezetimibe
Brief summary
Cardiovascular disease (CVD), especially its management and associated costs, remains a major concern globally. There is a direct correlation between circulating levels of low-density lipoprotein cholesterol (LDL-C) and the incidence of CVD. This study will assess bempedoic acid/FDC in a real-world clinical setting in adult patients in Spain with hypercholesterolaemia or mixed dyslipidemia.
Detailed description
This non-interventional study will be conducted in order to further understand the potential risks and benefits of bempedoic acid/fixed dose combination (FDC) with ezetimibe in a real-world clinical setting in adult patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia and to gain insight into the effectiveness (managing plasma levels of LDL-C) as well as safety (clinical events associated with the treatment modalities). No study medication will be provided as part of this protocol to the patients. Medications will be as prescribed by the treating physician in line with clinical practice.
Interventions
DRUGBempedoic acid and/or its fixed dose combination with ezetimibe
This is a non-interventional study. No study medication will be provided as part of this protocol to the patients. Medications will be as prescribed by the treating physician in line with clinical practice.
Sponsors
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent to participate * At least 18 years of age * Participants suffering from documented primary hypercholesterolemia or mixed dyslipidemia * Part 1: For participants treated to a maximum of 6 months or intended to be treated with bempedoic acid/FDC under usual clinical practice conditions and as long as the decision of the physician to start treatment is prior to the inclusion of the participant in the study at the discretion of the physician under no reimbursement conditions at enrollment * Part 2: For participants treated or intended to be treated with bempedoic acid/FDC under usual clinical practice conditions and as long as the decision of the physician to start treatment is prior to the inclusion of the patient in the study under reimbursed conditions at enrollment * No contraindications exist according to the SmPC of bempedoic acid/ FDC * No concurrent participation in an interventional study (Simultaneous participation in other non-interventional studies is possible) * Life expectancy \> 1 -year
Exclusion criteria
* As this is a non-interventional study, no explicit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Summary of Patient Characteristics in Participants With Primary Hypercholesterolaemia or Mixed Dyslipidaemia Following Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe | Baseline up to 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Mean Change From Baseline in Second Manifestations of Arterial Disease (SMART) Score Following Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe | Baseline up to 12 months |
| Mean Change From Baseline in Framingham Risk Score Following Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe | Baseline up to 12 months |
| Mean Change From Baseline in Low-density Lipoprotein Cholesterol Levels | Baseline up to 12 months |
| Mean Change From Baseline in Atherosclerotic Cardiovascular Disease-Modifying Cholesterol Fragments Levels | Baseline up to 12 months |
| Mean Change From Baseline in Inflammatory Marker hsCRP Levels | Baseline up to 12 months |
| Mean Change From Baseline In Uric Acid Levels | Baseline up to 12 months |
| Number of Participants With Relevant Cardiovascular (CV) Events | Baseline up to 12 months |
| Number of Participants With Adverse Effects and Adverse Drug Reactions Associated With Bempedoic Acid/FDC Ezetimibe | Baseline up to 12 months |
| Mean Change From Baseline in Systematic Coronary Risk Estimation (SCORE) System Following Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe | Baseline up to 12 months |
| Number of Participants Who Reported Use of Lipid-modifying Treatments Prior To Or Concomitantly To Receiving Bempedoic Acid/FDC With Ezetimibe | Baseline up to 12 months |
| Mean Treatment Duration, By Therapy | Baseline up to 12 months |
| Mean Dosage of Bempedoic Acid/FDC Treatment | Baseline up to 12 months |
| Mean Length of Prescription Intervals of Bempedoic Acid/FDC Treatment | Baseline up to 12 months |
| Number of Participants Who Permanently Discontinued or Switched From Bempedoic Acid/FDC Treatment | Baseline up to 12 months |
| Healthcare Resource Use In Participants Who Were Treated With Bempedoic Acid/FDC With Ezetimibe Treatment | Baseline up to 12 months |
| Mean Change From Baseline In EuroQol (EQ-5D-5L) and PAM-13 | Baseline up to 12 months |
| Types of Practitioners Caring for Patients Treated With Bempedoic acid/ FDC with Ezetimibe | Baseline up to 12 months |
Outcome results
None listed