Mixed Dyslipidemia, Primary Hypercholesterolemiia
Conditions
Keywords
Primary hypercholesterolemia, Mixed dyslipidemia
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
Interventions
DRUGBempedoic acid
No drug was administered in this observational study.
DRUGEzetimibe
No drug was administered in this observational study.
DRUGRosuvastatin
No drug was administered in this observational study.
DRUGAtorvastatin
No drug was administered in this observational study.
Sponsors
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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, |
| 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. |
| 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). |
Countries
Austria, Belgium, Germany, Italy, Spain
Contacts
CONTACTDaiichi Sankyo Contact for Clinical Trial Information
Outcome results
None listed