A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
Effectiveness and Safety of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia: an Observational Study
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
2,000 participants
Feb 12, 2025
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria10
- Written informed consent to participate
- At least 18 years of age
- High and very high risk patients as assessed by the physician suffering from documented primary hypercholesterolemia or mixed dyslipidemia at start of bempedoic acid treatment
- Patients treated with:
- bempedoic acid added to ezetimibe and rosuvastatin or atorvastatin,
- bempedoic acid plus ezetimibe added to rosuvastatin or atorvastatin,
- bempedoic acid plus atorvastatin or rosuvastatin added to ezetimibe
- initiation of bempedoic acid, ezetimibe, and atorvastatin or rosuvastatin simultaneously
- \) 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.
- \) 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
Exclusion Criteria2
- Patients who have received PCSK9i monoclonal antibody treatment in the last 3 months before the start of the triple therapy exposure
- Patients who have ever received PCSK9i-siRNA treatment
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Interventions
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.
Locations(159)
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NCT06686615