A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

Launched by DAIICHI SANKYO EUROPE, GMBH, A DAIICHI SANKYO COMPANY · Nov 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with high cholesterol levels, specifically those with primary hypercholesterolemia or mixed dyslipidemia. The researchers are examining how effective and safe the combination of bempedoic acid, ezetimibe, and either rosuvastatin or atorvastatin is in lowering bad cholesterol (LDL-C). This trial is important because it aims to gather real-world data on how this combination therapy works in practice, which is still limited.

To participate in this trial, you need to be at least 18 years old and have high cholesterol that puts you at high risk for heart-related issues. You should also be able to provide written consent to join. Eligible participants will have started treatment with these medications within the last four weeks and must have a recent cholesterol test showing untreated levels. Throughout the trial, participants will be monitored for how well this combination works and any side effects they might experience. It's a great opportunity for those looking for new ways to manage their cholesterol effectively.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Written informed consent to participate
• • 2. At least 18 years of age
• • 3. 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
• 4. 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
• • 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:
• • 1. Patients who have received PCSK9i monoclonal antibody treatment in the last 3 months before the start of the triple therapy exposure
• • 2. Patients who have ever received PCSK9i-siRNA treatment