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)

Daiichi Sankyo

Status: Withdrawn

Conditions: Mixed Dyslipidemia; Primary Hypercholesterolemia

Treatments: Drug: Bempedoic acid and/or its fixed dose combination with ezetimibe

Study type: Observational

Funder types: Industry

Identifiers

NCT05798390

DSE-BMP-01-22-EU

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

0 participants in 1 patient group

Bempedoic acid and/or fixed-dose combination with ezetimibe

Description:

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

Treatment:

Drug: Bempedoic acid and/or its fixed dose combination with ezetimibe