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

Recruiting

• Conditions: Hypercholesterolemia; Mixed Dyslipidemia
• Interventions: Drug: Bempedoic acid and/or its fixed-dose combination with ezetimibe

• Registration Number: NCT04579367
• Lead Sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-10-01
• Study First Submitted QC: 2020-10-01
• Study First Posted: 2020-10-08
• Study Start: 2021-01-15
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-08
• Last Update Posted: 2025-07-09
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• Written informed consent to participate
• At least 18 years of age
• Participants suffering from documented primary hypercholesterolemia or mixed dyslipidemia treated or intended to be treated with bempedoic acid and/or its fixed dose combination with ezetimibe at the discretion of the physician are appropriate for participation in the observation.
• No contraindications exist according to the SmPC of bempedoic acid and/or its fixed-dose combination with ezetimibe
• No concurrent participation in an interventional study (simultaneous participation in other non-interventional study is possible)
• Life expectancy > 1 year

Exclusion Criteria

• As this is a non-interventional study, no explicit exclusion criteria are defined. The prescribing behavior will not be influenced. Only patients will be included where the decision has been made by the treating physician to treat the patients either with bempedoic acid and/or its fixed-dose combination with ezetimibe.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Summary of patient characteristics in patients with primary hypercholesterolemia or mixed dyslipidemia following treatment with bempedoic acid and/or its fixed-dose combination with ezetimibe	Baseline (date of signed informed consent) up to 1 year minimum or 2 year maximum follow up (depending on the availability of bempedoic acid in countries)

Secondary Outcome Measures

Name	Time	Method
Overview of the cardiovascular risk of patients with primary hypercholesterolemia or mixed dyslipidemia following treatment with bempedoic acid/ and/or its fixed-dose combination with ezetimibe	Baseline (date of signed informed consent) up to 1 year minimum or 2 year maximum follow up (depending on the availability of bempedoic acid in countries)	Cardiovascular risk scores will be assessed using the Systematic Coronary Risk Estimation (SCORE) system, Second manifestations of arterial disease (SMART) and Framingham risk scores. The SMART risk score will estimate 10-year risk for very high-risk participants based on clinical patient characteristics. The gender-specific Framingham risk score will be used to estimate 10-year cardiovascular risk for high-risk participants.
Summary of changes in plasma low-density lipoprotein cholesterol levels following treatment with bempedoic acid and/or its fixed-dose combination with ezetimibe in patients with primary hypercholesterolemia or mixed dyslipidemia	Baseline (date of signed informed consent) up to 1 year minimum or 2 year maximum follow up (depending on the availability of bempedoic acid in countries)
Summary in changes in plasma levels of atherosclerotic cardiovascular disease-modifying cholesterol fragments following treatment with bempedoic acid and/or its fixed-dose combination with ezetimibe	Baseline (date of signed informed consent) up to 1 year minimum or 2 year maximum follow up (depending on the availability of bempedoic acid in countries)	Plasma levels of total cholesterol (TC), apolipoprotein B (apoB), high-density lipoprotein cholesterol (HDL-C), triglycerides (TGs) and lipoprotein a (Lp\[a\]) will be assessed.
Summary of changes in plasma inflammatory marker hsCRP levels following treatment with bempedoic acid and/or its fixed-dose combination with ezetimibe in patients with primary hypercholesterolemia or mixed dyslipidemia	Baseline (date of signed informed consent) up to 1 year minimum or 2 year maximum follow up (depending on the availability of bempedoic acid in countries)	Inflammatory status was assessed using high-sensitive C-reactive protein.

Trial Locations

Locations (476)

Dr. Armin Öhlinger Kardiologe & innere Medizin; 🇦🇹 Dornbirn, Austria

Landeskrankenhaus Feldkirch; 🇦🇹 Feldkirch, Austria

Institut für Herz- und Gefäßerkrankungen GmbH; 🇦🇹 Graz, Austria

LKH-Univ. Klinikum Graz; 🇦🇹 Graz, Austria

Medizinische Universität Graz; 🇦🇹 Graz, Austria

Internist Dr. med. univ. Stefan Moser; 🇦🇹 Horsching, Austria

Medizinische Universität Innsbruck; 🇦🇹 Innsbruck, Austria

KABEG Klinikum Klagenfurt am Wörthersee; 🇦🇹 Klagenfurt am Worthersee, Austria

Konventhospital der Barmherzigen Brüder Linz; 🇦🇹 Linz, Austria

Ordination Dr. Johannes Föchterle; 🇦🇹 Linz, Austria

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