Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Hypercholesterolemia or Mixed Dyslipidemia
The primary objective is to describe in the real-world setting patient characteristics and outcomes of patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia using bempedoic acid and/or its fixed-dose combination with ezetimibe in managing plasma levels of low-density lipoprotein cholesterol (LDL-C). Secondary objectives are to document and evaluate as applicable: Assessment of the cardiovascular risk of patients treated with bempedoic acid and/or its fixed-dose combination with ezetimibe using different risk scores (e.g. SMART score for Very High Risk patients and Framingham risk score for High Risk patients. The scores will be re-calculated during the analysis and used as an analytical tool only). Changes in low-density lipoprotein cholesterol (LDL-C) levels prior to treatment with bempedoic acid and/or its fixed-dose combination with ezetimibe compared to 1 year follow-up and subsequent data collection points, if applicable. Characterize plasma levels of other potentially ASCVD-modifying cholesterol fragments, namely, LDL-C, total cholesterol (TC), apolipoprotein B (apoB), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, triglycerides (TGs) and lipoprotein A (Lp[a]) compared to 1 year follow-up and subsequent data collection points, if applicable. Changes in the levels of inflammatory marker hsCRP compared to 1 year follow-up and subsequent data collection points, if applicable. Adverse Drug Reactions associated to bempedoic acid and/or its fixed-dose combination with ezetimibe. Changes in uric acid levels compared to 1 year follow-up and subsequent data collection points, if applicable. Relevant CV events: Myocardial infarction Unstable angina Coronary artery bypass graft surgery (CABG) Percutaneous transluminal coronary angioplasty (PTCA) Stroke Transient ischemic attack (TIA) Acute peripheral arterial occlusion All-cause death Cardiovascular (CV)-death Adverse effects associated with lipid-modifying treatment (LMT) Laboratory abnormalities Muscle-associated symptoms New onset and/or worsening diabetes Changes in the patients´ glycemic status over time Site characteristics (sites and practitioners) caring for patients treated with bempedoic acid and/or its fixed-dose combination with ezetimibe. Use of LMTs prior or concomitantly to receiving bempedoic acid and/or its fixed-dose combination with ezetimibe (therapies including combination treatments). Bempedoic acid and/or its fixed-dose combination with ezetimibe treatment parameters such as treatment duration by therapy, dosage, prescription intervals, permanent discontinuations, switches and reasons for these, (concomitant medication, additional therapy/interventions). Healthcare resource use especially consultation visits with specialist, nurse time and hospitalizations as well as patient-reported outcome using EQ-5D-5L and PAM-13.
Start: January 2021