Clinical trial NCT06686615: A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Hypercholesterolemiia
Mixed Dyslipidemia
Keywords: Primary hypercholesterolemia
Mixed dyslipidemia
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2024-11-13
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective data from routine clinical practice will be collected over the course of 1 year involving approximately 2000 patients across approximately 200 sites in Europe (Germany, Italy, Spain, Austria, and Belgium) treated by both specialized and non-specialized physicians in hospital and office-based settings.

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

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

Primary outcomes:
measure: Relative LDL-C change between untreated and 8 week after triple therapy start
timeFrame: Baseline to 8 weeks after initiation of triple therapy
Secondary outcomes:
measure: Proportion of patients at ESC/EAS 2019 dyslipidemia guideline goal at 8 weeks and 1 year
timeFrame: Baseline to 1 year after initiation of triple therapy
measure: Relative LDL-C change between untreated and 1 year after triple therapy start
timeFrame: From any prior LMT exposure to 1 year after initiation of triple therapy
measure: Relative LDL-C change between pre-bempedoic acid/pre-FDC initiation and 8 weeks after triple therapy start
timeFrame: From pre-bempedoic acid/pre-FDC initiation to 8 weeks after initiation of triple therapy
measure: Relative LDL-C change between pre-bempedoic acid/pre-FDC initiation and 1 year after triple therapy start
timeFrame: From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of triple therapy
measure: Relative change in laboratory values between triple therapy start and 8 weeks and 1 year thereafter
timeFrame: Baseline to 1 year after initiation of triple therapy
measure: Patient and physician reported adherence at 8 weeks and 1 year after triple therapy start
timeFrame: Baseline to 1 year after initiation of triple therapy
measure: Incidence of adverse events under triple therapy exposure
timeFrame: Baseline to 1 year after initiation of triple therapy
measure: Proportion of patients with MACE-3 and MACE-4 events
timeFrame: Baseline to 1 year after initiation of triple therapy
Other outcomes:
Locations:
city: Potsdam
country: Germany
facility: Kardiologische Gemeinschaftspraxis am Park Sanssouci
Study officials:
References: