MILOS-Spain: Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe in Routine Clinical Practice in Patients With Primary Hypercholesterolemia Or Mixed Dyslipidemia

Sponsor

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05798390

Collaborator

(none)

1,100

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Hypercholesterolemia Mixed Dyslipidemia	Drug: Bempedoic acid and/or its fixed dose combination with ezetimibe

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Non-Interventional Study On The Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe in Routine Clinical Practice in Patients With Primary Hypercholesterolemia Or Mixed Dyslipidemia

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2026

Anticipated Study Completion Date :

Apr 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Bempedoic acid and/or fixed-dose combination with ezetimibe Participants with primary hypercholesterolemia or mixed dyslipidemia who received bempedoic acid and/or its fixed-dose combination with ezetimibe.	Drug: Bempedoic 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.

Arm

Intervention/Treatment

Bempedoic acid and/or fixed-dose combination with ezetimibe

Participants with primary hypercholesterolemia or mixed dyslipidemia who received bempedoic acid and/or its fixed-dose combination with ezetimibe.

Drug: Bempedoic 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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]
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]
Types of Practitioners Caring for Patients Treated With Bempedoic acid/ FDC 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 exclusion criteria exist in order to avoid selection bias and to allow for documentation of routine clinical practice.