A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia (Musashi)

Daiichi Sankyo

Status: Not yet enrolling

Conditions: Mixed Dyslipidemia; Primary Hypercholesterolaemia

Treatments: Drug: Combination of bempedoic acid and ezetimibe

Study type: Observational

Funder types: Industry

Identifiers

NCT07206472

DS-ASCAHQ-BMP-HC001

Details and patient eligibility

About

There is limited efficacy and safety data of bempedoic acid or its fixed dose combination (FDC) with ezetimibe in Asian and Latin American patients. This non-interventional study (NIS) will be conducted to characterize the risks and benefits of bempedoic acid or FDC with ezetimibe in a real-world clinical setting in adult patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia.

Full description

The primary objective of this study is to describe patient characteristics and evaluate adverse drug reactions (ADRs) that occurred since initiation of bempedoic acid/FDC with ezetimibe and adverse events (AEs) collected after signed informed consent and initiation of bempedoic acid/FDC with ezetimibe in a regular clinical care setting in patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia during 1-year follow-up.

The secondary objectives are defined as the assessment of the cardiovascular risk, rate, level of LDL-C goal attainment, changes over time in LDL-C levels, inflammatory markers, and uric acid levels from prior to treatment with bempedoic acid/FDC, and adverse events (AEs)/adverse drug reactions (ADRs).

Enrollment: 2,560 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patients can be enrolled, when they fulfil the following inclusion criteria:

• Written informed consent to participate.
• At least 18 years of age.
• Patients suffering from documented primary hypercholesterolemia or mixed dyslipidaemia treated or intended to be treated with bempedoic acid/ FDC with ezetimibe at the discretion of the physician are appropriate for participation in the observation.
• For patients who are treated with bempedoic acid/FDC with ezetimibe prior to signed informed consent, initiation of bempedoic acid/FDC with ezetimibe must be within a maximum of three months prior to inclusion.
• No contraindications exist according to the SmPC of bempedoic acid/FDC with ezetimibe.
• No concurrent participation in an interventional study (simultaneous participation in other non-interventional study is possible)
• Life expectancy > 1 year.

No explicit exclusion criteria exist to avoid selection bias and to allow for documentation of routine clinical practice.

Trial design

2,560 participants in 1 patient group

Bempedoic acid/FDC with ezetimibe

Description:

Adult participants who were diagnosed with primary hypercholesterolemia (heterozygous familial and nonfamilial) or mixed dyslipidemia and treated with bempedoic acid/fixed dose combination (FDC) with ezetimibe in a regular clinical care setting.

Treatment:

Drug: Combination of bempedoic acid and ezetimibe