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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Mixed Dyslipidemia; Primary Hypercholesterolemia
• Intervention / Treatment: 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 Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of 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 no reimbursement conditions (Part 1) or under reimbursed conditions (Part 2) at enrollment and who are unable to reach their LDL-C goals with the maximum tolerated dose of statins or patients who are determined by their treating physician to be statin intolerant.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
• Investigators: Study Director: Global Clinical Leader, Daiichi Sankyo, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: March 10, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Primary Hypercholesterolemia; Mixed Dyslipidemia; Bempedoic acid and/or its fixed-dose combination with ezetimibe
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Ezetimibe; 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
• Other Study ID Numbers: DSE-BMP-01-22-EU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No