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.

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.

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.

The study population will include participants with primary hypercholesterolemia or mixed dyslipidemia who are being treated with bempedoic acid and/or its fixed dose combination with ezetimibe.

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.

Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.