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Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia
Sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Summary
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. Systematic Coronary Risk Estimation (SCORE) system, 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.
Official title: Non-interventional Study on the Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Routine Clinical Practice in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia (MILOS)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
5000
Start Date
2021-01-15
Completion Date
2026-10-30
Last Updated
2026-09-30
Healthy Volunteers
No
Conditions
Interventions
Bempedoic acid and/or its fixed-dose combination with ezetimibe
This is a non-interventional study. No study medication will be provided to the patients. Medication will be prescribed by the treating physician in line with the clinical practice.
Locations (443)
Dr. Armin Öhlinger Kardiologe & innere Medizin
Dornbirn, Austria
Landeskrankenhaus Feldkirch
Feldkirch, Austria
LKH-Univ. Klinikum Graz
Graz, Austria
Medizinische Universität Graz
Graz, Austria
Internist Dr. med. univ. Stefan Moser
Hörsching, Austria
Medizinische Universität Innsbruck
Innsbruck, Austria
KABEG Klinikum Klagenfurt am Wörthersee
Klagenfurt, Austria
Konventhospital der Barmherzigen Brüder Linz
Linz, Austria
Ordination Dr. Johannes Föchterle
Linz, Austria
Ordination Frau Prof. Dr. Yvonne Winhofer-Stöckl
Mattersburg, Austria
Kompetenz-Zentrum Diabetes
Salzburg, Austria
Ordination Universitätsdozent Dr. Alexander Kober
Sankt Aegyd am Neuwalde, Austria
Ordination Dr. med. univ. Evelyn Fließer-Görzer
Sankt Stefan ob Stainz, Austria
Ordination Dr. Thomas Maca
Vienna, Austria
Klinik Hietzing, Wiener Gesundheitsverbund
Vienna, Austria
Zentrum für Klinische Studien Dr. Hanusch GmbH
Vienna, Austria
Allgemeines Krankenhaus der Stadt Wien
Vienna, Austria
Univ.-Prof. Dr. Thomas Stulnig
Vienna, Austria
Herz Zentrum Währing
Vienna, Austria
Karl Landsteiner Institut für kardiovaskuläre und intensivmedizinische Forschung
Vienna, Austria
ASZ
Aalst, Belgium
Clinique Saint-Luc Bouge Namur
Bouge, Belgium
Epicura Hornu
Boussu, Belgium
A.Z. KLINA Brasschaat
Brasschaat, Belgium
Clinique Saint-Jean Bruxelles
Brussels, Belgium
CHU Brugman
Brussels, Belgium
CUB-Hôpital Erasme
Brussels, Belgium
UZ Brussel
Brussels, Belgium
Clinique de l'Europe Saint Elisabeth
Brussels, Belgium
UCL Saint-Luc Woluwé Bruxelles
Brussels, Belgium
Private Practice
Ciney, Belgium
Az Sint Blazius
Dendermonde, Belgium
UZ Antwerpen
Edegem, Belgium
Z.O.L - Campus St. Jan
Genk, Belgium
AZ St-Lucas & Volkskliniek
Ghent, Belgium
UZ Gent
Ghent, Belgium
GHDC Charleroi - Site Hôpital Saint-Joseph
Gilly, Belgium
Private Practice
Gribomont, Belgium
Pôle hospitalier Jolimont
Haine-Saint-Paul, Belgium
BVBA Med Kab
Halen, Belgium
Jessa Ziekenhuis
Hasselt, Belgium
CHR Huy
Huy, Belgium
JAN YPERMAN Ziekenhuis
Ieper, Belgium
AZ Groeninge Kortrijk
Kortrijk, Belgium
CHU Tivoli
La Louvière, Belgium
UZ Leuven
Leuven, Belgium
CHR Citadelle de Liège
Liège, Belgium
CHU Liège
Liège, Belgium
CHU Charleroi Hopital civil Marie-Curie
Lodelinsart, Belgium
CHU Mons Ambroise Paré
Mons, Belgium
AZ Sint Jan
Ostend, Belgium
AZ Delta
Roeselare, Belgium
AZ Glorieux
Ronse, Belgium
Sint Trudo
Sint-Truiden, Belgium
Sint-Andriesziekenhuis Tielt
Tielt, Belgium
CHU UCL Mont-Godinne
Yvoir, Belgium
Downtown Clinic Aachen
Aachen, Germany
Praxis Delonge
Aachen, Germany
Praxis Osterziel
Amberg, Germany
MVZ Helios Aue
Aue, Germany
Kardiologische Praxis Enders
Bad Elster, Germany
SLK-Klinikum am Plattenwald
Bad Friedrichshall, Germany
Herzcarre Praxis
Bad Homburg, Germany
Kardiologische Praxis
Bad Homburg, Germany
Zentrum für klinische Forschung
Bad Homburg, Germany
Universitätsklinikum Freiburg - Universitäts-Herzzentrum
Bad Krozingen, Germany
Praxis am Landratspark
Bad Segeberg, Germany
Hausärzte am Spritzenhaus
Baiersbronn, Germany
CIMS Studienzentrum Bamberg GmbH Drs. Kirschner/Haas/Ritzel
Bamberg, Germany
Kardiologische Praxis
Bechhofen, Germany
Praxis Rankestraße
Berlin, Germany
SKP Studienzentrum der kardiologischen Praxisgemeinschaft Rankestrasse GmbH
Berlin, Germany
Herzpraxis Berlin MVZ
Berlin, Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany
Dres. Seeger & Partner
Berlin, Germany
Diabetespraxis Dr. Braun
Berlin, Germany
Lipidambulanz Charite
Berlin, Germany
Praxiszentrum Biedenkopf
Biedenkopf, Germany
Praxis Dr. A. Biedermann
Blankenhain, Germany
Kardiologische Gemeinschaftspraxis Bremerhaven
Bremerhaven, Germany
Kardiologie im Friedrichspalast Bruchsal
Bruchsal, Germany
MediClin Reha-Zentrum Spreewald
Burg, Germany
Studiengesellschaft Könemann und Steinmann GbR
Bünde, Germany
MVZ am Küchwald
Chemnitz, Germany
Kardiologische Praxis Stellmach
Chemnitz, Germany
MVZ Polymed
Chemnitz, Germany
Uniklinik Köln
Cologne, Germany
Zentrum für klinische Forschung
Cologne, Germany
IKAPP
Cologne, Germany
Praxis Dr. Menzel
Dessau, Germany
Klinikum Lippe GmbH
Detmold, Germany
Kardiologische Gemeinschaftspraxis
Dortmund, Germany
Cardiologicum Dresden/Pirna
Dresden, Germany
Hausärztliche Gemeinschaftspraxis mit diabetologischem Schwerpunkt
Dresden, Germany
Dres. Günther/Kolschmann
Dresden, Germany
Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden
Dresden, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, Germany
DZDM Diabeteszentrum Duisburg Mitte
Duisburg, Germany
Nierenzentrum Düren
Düren, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Germany