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

Primary Hypercholesterolemia Clinical Trial

— MILOS-Spain  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05798390
• Other study ID #: DSE-BMP-01-22-EU
• Status: Withdrawn
• Start date: September 1, 2023
• Est. completion date: April 1, 2026

Study information

• Verified date: November 2023
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemias
• Hypercholesterolemia
• Mixed Dyslipidemia
• Primary Hypercholesterolemia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Mean Change From Baseline in Low-density Lipoprotein Cholesterol Levels		Baseline up to 12 months
Secondary	Mean Change From Baseline in Atherosclerotic Cardiovascular Disease-Modifying Cholesterol Fragments Levels		Baseline up to 12 months
Secondary	Mean Change From Baseline in Inflammatory Marker hsCRP Levels		Baseline up to 12 months
Secondary	Mean Change From Baseline In Uric Acid Levels		Baseline up to 12 months
Secondary	Number of Participants With Relevant Cardiovascular (CV) Events		Baseline up to 12 months
Secondary	Number of Participants With Adverse Effects and Adverse Drug Reactions Associated With Bempedoic Acid/FDC Ezetimibe		Baseline up to 12 months
Secondary	Types of Practitioners Caring for Patients Treated With Bempedoic acid/ FDC with Ezetimibe		Baseline up to 12 months
Secondary	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
Secondary	Mean Treatment Duration, By Therapy		Baseline up to 12 months
Secondary	Mean Dosage of Bempedoic Acid/FDC Treatment		Baseline up to 12 months
Secondary	Mean Length of Prescription Intervals of Bempedoic Acid/FDC Treatment		Baseline up to 12 months
Secondary	Number of Participants Who Permanently Discontinued or Switched From Bempedoic Acid/FDC Treatment		Baseline up to 12 months
Secondary	Healthcare Resource Use In Participants Who Were Treated With Bempedoic Acid/FDC With Ezetimibe Treatment		Baseline up to 12 months
Secondary	Mean Change From Baseline In EuroQol (EQ-5D-5L) and PAM-13		Baseline up to 12 months