An observational study in Primary Hypercholesterolemiia and Mixed Dyslipidemia, sponsored by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company. Active, not recruiting at 163 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company · Observational
Data on the real-world use and effectiveness and safety of bempedoic acid combined with both a statin and ezetimibe in clinical practice is limited. There is an increased focus on using combination therapy to lower LDL-C.
The aim of the current study is to evaluate the effectiveness and safety of bempedoic acid combined with ezetimibe and either atorvastatin or rosuvastatin (hereafter defined as triple therapy) in a real-world clinical setting. No drug will be administered during this observational study.
The primary objective of the study is to evaluate the effectiveness of the triple therapy in terms of LDL-C reduction at 8 weeks.
The secondary objectives will include the following:
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company is the lead sponsor of 17 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Prospective data from routine clinical practice will be collected over the course of 1 year involving approximately 2000 patients across approximately 200 sites in Europe (Germany, Italy, Spain, Austria, and Belgium) treated by both specialized and non-specialized physicians in hospital and office-based settings.
Key Inclusion Criteria:
Patients treated with:
6) Initiation of triple therapy within a maximum of four weeks prior to inclusion 7) An untreated LDL-C value must be available within 5 years prior to the start of the triple therapy. Untreated means that the LDL-C value is not influenced by any lipid lowering therapy at the time of blood collection. Time window for not being treated as specified in the protocol.
8) No contraindications exist according to the SmPC of bempedoic acid, the respective statin and ezetimibe as per physicians' assessment 9) No concurrent participation in an interventional study (simultaneous participation in other non-interventional studies is possible) 10) Life expectancy > 1 -year
Key Exclusion Criteria:
Adult patients who have been diagnosed with primary hypercholesterolaemia (heterozygous familial and nonfamilial) or mixed dyslipidaemia treated with bempedoic acid in combination with ezetimibe and either rosuvastatin or atorvastatin (ie, triple therapy) and will be followed for up to 1 year after initiation of triple therapy. A direct comparison between rosuvastatin and atorvastatin is not planned, only an assessment of triple therapy on LDL-C change in patients with primary hypercholesterolaemia.
Drug: Bempedoic acid · Drug: Ezetimibe · Drug: Rosuvastatin · Drug: Atorvastatin
No drug was administered in this observational study.
No drug was administered in this observational study.
No drug was administered in this observational study.
No drug was administered in this observational study.
Relative LDL-C change between untreated and 8 week after triple therapy start
LDL-C will be assessed using a standard lipid panel blood test,
Time frame: Baseline to 8 weeks after initiation of triple therapy
Proportion of patients at ESC/EAS 2019 dyslipidemia guideline goal at 8 weeks and 1 year
The 2019 EAS/ESC guidelines recommend treatment targets of at least a 50% reduction from baseline LDL-C levels and an LDL-C concentration below 1.8 mmol/L for patients at high and 1.4 mmol/l for patients at very high cardiovascular risk.
Time frame: Baseline to 1 year after initiation of triple therapy
Relative LDL-C change between untreated and 1 year after triple therapy start
LDL-C will be assessed using a standard lipid panel blood test,
Time frame: From any prior LMT exposure to 1 year after initiation of triple therapy
Relative LDL-C change between pre-bempedoic acid/pre-FDC initiation and 8 weeks after triple therapy start
LDL-C will be assessed using a standard lipid panel blood test,
Time frame: From pre-bempedoic acid/pre-FDC initiation to 8 weeks after initiation of triple therapy
Relative LDL-C change between pre-bempedoic acid/pre-FDC initiation and 1 year after triple therapy start
LDL-C will be assessed using a standard lipid panel blood test,
Time frame: From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of triple therapy
Relative change in laboratory values between triple therapy start and 8 weeks and 1 year thereafter
Labs will be assessed using a standard panel blood test,
Time frame: Baseline to 1 year after initiation of triple therapy
Patient and physician reported adherence at 8 weeks and 1 year after triple therapy start
Adherence will be judged by the physician/patient.
Time frame: Baseline to 1 year after initiation of triple therapy
Incidence of adverse events under triple therapy exposure
Adverse events are defined as any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time frame: Baseline to 1 year after initiation of triple therapy
Proportion of patients with MACE-3 and MACE-4 events
MACE-3 and MACE-4 events will consist of non-fatal MI, non-fatal stroke, CV-death, and coronary revascularization (for MACE-4 only).
Time frame: Baseline to 1 year after initiation of triple therapy
Showing the first 100 of 163 sites across 5 countries.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company