Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia — MILOS  

Hypercholesterolemia Clinical Trial

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 (MILOS)

Status Recruiting

Clinical Trial Summary

The primary objective is to describe in the real-world setting patient characteristics and outcomes of patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia using bempedoic acid and/or its fixed-dose combination with ezetimibe in managing plasma levels of low-density lipoprotein cholesterol (LDL-C).

Secondary objectives are to document and evaluate as applicable:

• Assessment of the cardiovascular risk of patients treated with bempedoic acid and/or its fixed-dose combination with ezetimibe using different risk scores (e.g. Systematic Coronary Risk Estimation (SCORE) system, SMART score for Very High Risk patients and Framingham risk score for High Risk patients. The scores will be re-calculated during the analysis and used as an analytical tool only).

• Changes in low-density lipoprotein cholesterol (LDL-C) levels prior to treatment with bempedoic acid and/or its fixed-dose combination with ezetimibe compared to 1 year follow-up and subsequent data collection points, if applicable.

• Characterize plasma levels of other potentially ASCVD-modifying cholesterol fragments, namely, LDL-C, total cholesterol (TC), apolipoprotein B (apoB), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, triglycerides (TGs) and lipoprotein A (Lp[a]) compared to 1 year follow-up and subsequent data collection points, if applicable.

• Changes in the levels of inflammatory marker hsCRP compared to 1 year follow-up and subsequent data collection points, if applicable.

• Adverse Drug Reactions associated to bempedoic acid and/or its fixed-dose combination with ezetimibe.

• Changes in uric acid levels compared to 1 year follow-up and subsequent data collection points, if applicable.

• Relevant CV events:

• Myocardial infarction

• Unstable angina

• Coronary artery bypass graft surgery (CABG)

• Percutaneous transluminal coronary angioplasty (PTCA)

• Stroke

• Transient ischemic attack (TIA)

• Acute peripheral arterial occlusion

• All-cause death

• Cardiovascular (CV)-death

• Adverse effects associated with lipid-modifying treatment (LMT)

• Laboratory abnormalities

• Muscle-associated symptoms

• New onset and/or worsening diabetes

• Changes in the patients´ glycemic status over time

• Site characteristics (sites and practitioners) caring for patients treated with bempedoic acid and/or its fixed-dose combination with ezetimibe.

• Use of LMTs prior or concomitantly to receiving bempedoic acid and/or its fixed-dose combination with ezetimibe (therapies including combination treatments).

• Bempedoic acid and/or its fixed-dose combination with ezetimibe treatment parameters such as treatment duration by therapy, dosage, prescription intervals, permanent discontinuations, switches and reasons for these, (concomitant medication, additional therapy/interventions).

• Healthcare resource use especially consultation visits with specialist, nurse time and hospitalizations as well as patient-reported outcome using EQ-5D-5L and PAM-13.

Clinical Trial Description

This non-interventional study will be conducted to characterize the risks and benefits of bempedoic acid and/or its fixed-dose combination with ezetimibe in a real-world clinical setting in adult patients with primary hypercholesterolaemia or mixed dyslipidaemia and to gain insight into the effectiveness (managing plasma levels of low-density lipoprotein cholesterol) as well as safety (clinical events associated with the treatment modalities). Real world evidence will be collected in 5000 participants, treated by specialized as well as non-specialized physicians in hospitals and office based centers. ;

Related Conditions & MeSH terms

• Dyslipidemias
• Hypercholesterolemia
• Mixed Dyslipidemia

• NCT number: NCT04579367
• Study type: Observational
• Source: Daiichi Sankyo, Inc.
• Contact: Daiichi Sankyo Contact for Clinical Trial Information
• Phone: 908-992-6400
• Email: CTRinfo@dsi.com
• Status: Recruiting
• Start date: January 15, 2021
• Completion date: September 2025