A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
- Conditions
- Primary HypercholesterolemiiaMixed Dyslipidemia
- Interventions
- Registration Number
- NCT06686615
- Lead Sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
- Brief 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.
- Detailed Description
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:
* Goal attainment at 8 weeks and 1 year after start of triple therapy
* Effectiveness of triple therapy in terms of LDL-C reduction at 1 year
* Effectiveness of adding bempedoic acid to statin and ezetimbe at 8 weeks and 1 year
* Effectiveness of adding bempedoic acid/ezetimibe FDC to statin in terms of LDL-C reduction at 8 weeks and 1 year
* Changes in laboratory values at 8 weeks and 1 year after start of triple therapy
* Adherence to triple therapy treatment
* Collection and recording of all adverse events occurred since initiation of triple therapy
* MACE-3 and MACE-4 (consisting of non-fatal MI, non-fatal stroke, CV-death, and coronary revascularization (for MACE-4 only)) during the year of follow-up
* Treatment changes at LMT initiation and at triple therapy initiation
* Treatment pathway from triple therapy initiation to 1-year after start of triple therapy
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2000
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Written informed consent to participate
-
At least 18 years of age
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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
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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
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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.
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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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Triple therapy Bempedoic acid 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. Triple therapy Atorvastatin 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. Triple therapy Rosuvastatin 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. Triple therapy Ezetimibe 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.
- Primary Outcome Measures
Name Time Method Relative LDL-C change between untreated and 8 week after triple therapy start Baseline to 8 weeks after initiation of triple therapy LDL-C will be assessed using a standard lipid panel blood test,
- Secondary Outcome Measures
Name Time Method Relative LDL-C change between pre-bempedoic acid/pre-FDC initiation and 1 year after triple therapy start From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of triple therapy LDL-C will be assessed using a standard lipid panel blood test,
Relative change in laboratory values between triple therapy start and 8 weeks and 1 year thereafter Baseline to 1 year after initiation of triple therapy Labs will be assessed using a standard panel blood test,
Patient and physician reported adherence at 8 weeks and 1 year after triple therapy start Baseline to 1 year after initiation of triple therapy Adherence will be judged by the physician/patient.
Proportion of patients at ESC/EAS 2019 dyslipidemia guideline goal at 8 weeks and 1 year Baseline to 1 year after initiation of triple therapy 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.
Relative LDL-C change between untreated and 1 year after triple therapy start From any prior LMT exposure to 1 year after initiation of triple therapy LDL-C will be assessed using a standard lipid panel blood test,
Relative LDL-C change between pre-bempedoic acid/pre-FDC initiation and 8 weeks after triple therapy start From pre-bempedoic acid/pre-FDC initiation to 8 weeks after initiation of triple therapy LDL-C will be assessed using a standard lipid panel blood test,
Incidence of adverse events under triple therapy exposure Baseline to 1 year after initiation of triple therapy 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.
Proportion of patients with MACE-3 and MACE-4 events Baseline to 1 year after initiation of triple therapy MACE-3 and MACE-4 events will consist of non-fatal MI, non-fatal stroke, CV-death, and coronary revascularization (for MACE-4 only).
Trial Locations
- Locations (1)
Kardiologische Gemeinschaftspraxis am Park Sanssouci
🇩🇪Potsdam, Germany