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.
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
Study Type
OBSERVATIONAL
Enrollment
2,000
No drug was administered in this observational study.
No drug was administered in this observational study.
No drug was administered in this observational study.
Relative LDL-C change between untreated and 8 week after triple therapy start
LDL-C will be assessed using a standard lipid panel blood test,
Time frame: Baseline to 8 weeks after initiation of triple therapy
Proportion of patients at ESC/EAS 2019 dyslipidemia guideline goal at 8 weeks and 1 year
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.
Time frame: Baseline to 1 year after initiation of triple therapy
Relative LDL-C change between untreated and 1 year after triple therapy start
LDL-C will be assessed using a standard lipid panel blood test,
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
LDL-C will be assessed using a standard lipid panel blood test,
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
LDL-C will be assessed using a standard lipid panel blood test,
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
Labs will be assessed using a standard panel blood test,
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
No drug was administered in this observational study.
Innere Medizin
Braunau am Inn, Austria
RECRUITINGInnere Medizin 1
Feldkirch, Austria
ACTIVE_NOT_RECRUITINGUniklinik Graz, Endokrinologie und Diabetes
Graz, Austria
RECRUITINGUniklinik Graz, Kardiologie
Graz, Austria
RECRUITINGInnere Medizin 3 - Kardiologie
Innsbruck, Austria
RECRUITINGKlinikum Wels-Grieskirchen GmbH+B18
Kepler Universitätsklinikum Gmb+, Austria
ACTIVE_NOT_RECRUITINGInnere Medizin
Klagenfurt, Austria
RECRUITINGInnere Medizin
Linz, Austria
RECRUITINGKepler Universitätsklinikum GmbH Klinik für Innere Medizin 1 - Kardiologie und Internistische Intensivmedizin
Linz, Austria
RECRUITINGKardiologie-Urfahr Dr. Hönig & Dr. Gammer & Dr. Buchmayr
Linz, Austria
RECRUITING...and 153 more locations
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
Adherence will be judged by the physician/patient.
Time frame: Baseline to 1 year after initiation of triple therapy
Incidence of adverse events under triple therapy exposure
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.
Time frame: Baseline to 1 year after initiation of triple therapy
Proportion of patients with MACE-3 and MACE-4 events
MACE-3 and MACE-4 events will consist of non-fatal MI, non-fatal stroke, CV-death, and coronary revascularization (for MACE-4 only).
Time frame: Baseline to 1 year after initiation of triple therapy