A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bempedoic acid, Ezetimibe, Rosuvastatin, Atorvastatin.
- Who it may be relevant to
- Registry conditions: Primary Hypercholesterolemiia, Mixed Dyslipidemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria, Belgium, Germany, Italy, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
- Drug Bempedoic acid
No drug was administered in this observational study. - Drug Ezetimibe
No drug was administered in this observational study. - Drug Rosuvastatin
No drug was administered in this observational study. - Drug Atorvastatin
No drug was administered in this observational study.
Primary outcome measures
- Relative LDL-C change between untreated and 8 week after triple therapy start [Time frame: Baseline to 8 weeks after initiation of triple therapy]
Secondary outcome measures (8)
- Proportion of patients at ESC/EAS 2019 dyslipidemia guideline goal at 8 weeks and 1 year [Time frame: Baseline to 1 year after initiation of triple therapy]
- Relative LDL-C change between untreated and 1 year after triple therapy start [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 [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 [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 [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 [Time frame: Baseline to 1 year after initiation of triple therapy]
- Incidence of adverse events under triple therapy exposure [Time frame: Baseline to 1 year after initiation of triple therapy]
- Proportion of patients with MACE-3 and MACE-4 events [Time frame: Baseline to 1 year after initiation of triple therapy]
Eligibility criteria
Inclusion criteria
- 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
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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 43 centers
Center list to be confirmed — check the primary protocol.
Germany · 38 centers
- Praxis für Kardiologie Aachen — Aachen
- Klinikum Ahaus — Ahaus
- Praxis W. Almohamed — Alsfed
- Zentrum für klinische Studien Bad Homburg — Bad Homburg
- Dialysezentrum Hellersdorf Mitte — Berlin
- Lipidambulanz Charite Campus Virchow — Berlin
- MEDICLIN Reha-Zentrum Spreewald — Burg
- Kardiologische Gemeinschaftspraxis Flemmingstr. — Chemnitz
- … and 30 more centers
Spain · 36 centers
Center list to be confirmed — check the primary protocol.
Austria · 24 centers
- Innere Medizin — Braunau am Inn
- Innere Medizin 1 — Feldkirch
- Uniklinik Graz, Endokrinologie und Diabetes — Graz
- Uniklinik Graz, Kardiologie — Graz
- Innere Medizin 3 - Kardiologie — Innsbruck
- Klinikum Wels-Grieskirchen GmbH+B18 — Kepler Universitätsklinikum Gmb+
- Innere Medizin — Klagenfurt
- Innere Medizin — Linz
- … and 16 more centers
Belgium · 22 centers
- Azorg — Aalst
- UZA (Antwerp University Hospital) — Antwerp
- Epicure Hornu — Boussu
- A.Z. KLINA Brasschaat — Brasschaat
- Algemeen Ziekenhuis Sint-Jan Oostende — Bruges
- CHU Brugman — Brussels
- UZ Brussel — Brussels
- CHU Charleroi Hopital civil Marie-Curie — Charleroi
- … and 14 more centers
Identifiers
NCT: NCT06686615 · DSE-BMP-01-24-EU