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| Name | Class |
|---|---|
| Daiichi Sankyo Germany | UNKNOWN |
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In this study, a survey of office-based cardiologists and lipid management specialists will be conducted on treatment decisions for NUSTENDI® (bempedoic acid 180 mg fixed dose combination [FDC] with ezetimibe 10 mg) followed by a retrospective chart review of patients at high and very-high cardiovascular risk with hypercholesterolemia or mixed dyslipidemia who were treated with FDC as add-on to treatment with maximally tolerated statin therapy in routine clinical practice.
The physician survey aims to understand the context of the real-world clinical setting and shed light on the utilization of FDC treatments by the prescribing physicians. The retrospective patient chart review will gain insights in real-world data of the patient's characteristics with a treatment decision for the FDC. No study drugs will be provided or administered as part of this protocol.
The objectives of the physician survey are the evaluation of the key factors for the therapy decision for the FDC:
The objectives of the retrospective patient chart review are to characterize the patients':
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physicians | Office-based cardiologists (OBCs) and lipid management specialists (LMSs) who are qualified for study participation regarding experience in lipid management therapy and treating a sufficient number of patients. |
| |
| High and Very High Cardiovascular Patients | Patients at high and very high cardiovascular risk as assessed by the office-based cardiologists and lipid management specialists with hypercholesterolemia or mixed dyslipidemia who received a prescription of bempedoic acid 180 mg fixed dose combination with ezetimibe 10 mg (FDC). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bempedoic Acid 180Mg/Ezetimibe 10Mg Tab | Drug | No study drug was administered during this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Low density Lipoprotein-Cholesterol (LDL-C) Levels at Therapy Decision Based on Physician Survey | Physicians will be surveyed to assess the LDL-C levels at the time of a therapy decision. | Up to 6 months |
| Reductions in Low density Lipoprotein-Cholesterol (LDL-C) Levels Based on Physician Survey | Physicians will be surveyed to determine their anticipated reductions in LDL-C levels as a result of therapy. | Up to 6 months |
| Visual Analogue Scale (VAS) Score Evaluating Relevance of Decision Factors and Considerations Relevant to Therapy Decision Based on Physician Survey | Physicians will be surveyed to determine the relevance of decision factors and considerations (including guidelines) that were relevant to their therapy decision based on a VAS ranging from 0 to 10. | Up to 6 months |
| Low density Lipoprotein-Cholesterol (LDL-C) Levels at Therapy Decision Based on a Retrospective Patient Chart Review | A retrospective patient chart review will assess the LDL-C levels at the time of a therapy decision. | Up to 6 months |
| Number of Participants With Pre-specified Events in Their Medical History Based on a Retrospective Patient Chart Review | A retrospective patient chart review will assess the number of participants with pre-specified events in their medical history. | Up to 6 months |
| Number of Participants With Specific Concomitant Diseases Based on a Retrospective Chart Review | A retrospective patient chart review will assess the number of participants with specific concomitant diseases. |
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Inclusion Criteria:
Eligibility criteria for the office-based cardiologists and lipid management specialists are as follows:
The inclusion criteria for the patients are as follows:
Exclusion Criteria:
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For the physician survey, office-based cardiologists and lipid management specialists must be qualified for study participation regarding experience in lipid management therapy and treating a sufficient number of patients. The office-based cardiologists and lipid management specialists will be preselected by the Medical Science Liaison Managers of DSDE.
The retrospective patient chart review will include patients at high and very high cardiovascular risk as assessed by the office-based cardiologists and lipid management specialists with hypercholesterolemia or mixed dyslipidemia who received a prescription of FDC for at least 4 weeks.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kardiologische Gemeinschaftspraxis (Bulut) | Arnsberg | Germany | ||||
| Dr. Georg Strack |
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| No study drug | Other | No study drug was administered during this study. |
|
| Up to 6 months |
| Number of Participants Implementing Specific Lifestyle Modifications Based on a Retrospective Patient Chart Review | A retrospective patient chart review will assess the number of participants with specific lifestyle modifications. | Up to 6 months |
| Bad König |
| Germany |
| Dr. J. Nothroff | Berlin | Germany |
| Kardiologie am Spreebogen (Krackhardt) | Berlin | Germany |
| Kardiologie Spreebogen Berlin (Haverkamp) | Berlin | Germany |
| Kardiologische Facharztpraxis Winkelmann | Berlin | Germany |
| SPK-Studienzentrum Rankestraße GmbH | Berlin | Germany |
| Kardio Bonn | Bonn | Germany |
| Dr. Jaroslaw Sek | Chemnitz | Germany |
| Praxis Dipl.-med. Schermaul | Chemnitz | Germany |
| Praxis für Kardiologie und Schlafmedizin (Lichtenberg) | Cologne | Germany |
| BAG Helmecke | Crivitz | Germany |
| Kardiologie Darmstadt | Darmstadt | Germany |
| MVZ Rhein-Main GmbH (Binder) | Dreieich | Germany |
| Cardiologicum Dresden / Pirna (Hildebrandt) | Dresden | Germany |
| Facharztzentrum Dresden-Neustadt GbR (Simonis) | Dresden | Germany |
| PD Dr. Stephan Wiedemann | Dresden | Germany |
| Praxis Dr. Methfessel | Dresden | Germany |
| KardioPraxis Rote Straße (Stieber) | Duisburg | Germany |
| Kardiologische Praxis (Warzok) | Gotha | Germany |
| Kardiopraxis Greiz (Walter) | Greiz | Germany |
| MVZ des Krankenhaus Greiz | Greiz | Germany |
| Kardiologie am Tibarg (Twisselmann) | Hamburg | Germany |
| Diabetiker Zentrum Hannover (Fendler) | Hanover | Germany |
| Kardiologie Haßloch (Gerhards) | Haßloch | Germany |
| Kardiologie Alsterquelle | Henstedt-Ulzburg | Germany |
| Praxis Dr. Lißmann | Homburg | Germany |
| Gemeinschaftspraxis Dr. Täschner / Dr. Bonigut | Leipzig | Germany |
| Praxis Dr. Feige | Leipzig | Germany |
| Gemeinschaftspraxis Schauermann | Meiningen | Germany |
| Gemeinschaftspraxis Dres. med. Dittgen/Wilhelm/Rehlinger | Mettlach | Germany |
| Hausarztpraxis Doreen Drews | Michendorf | Germany |
| Hausarztpraxis Thorsten Drews | Michendorf | Germany |
| Kardio Praxis Mülheim (Möllenberg) | Mülheim | Germany |
| Dres. Bettenworth & Partner | Münster | Germany |
| Gemeinschaftspraxis am Jahnufer (Schleß) | Neu-Ulm | Germany |
| Kardiopraxis (Buchholz-Sanchez) | Neustadt | Germany |
| Kardiologie am Weißen Turm (Stadelmann) | Nuremberg | Germany |
| Praxis für Kardiologie (Laser) | Nuremberg | Germany |
| Dres. Kornadt und Edel | Oberhausen | Germany |
| Praxis Dr. Spengler | Panitzsch | Germany |
| Kardiologische Praxis Papenburg Dr. Denchev | Papenburg | Germany |
| Kardiologische Praxis Papenburg Dr. Malazhavy | Papenburg | Germany |
| Kardiologische Praxis Papenburg Dr. Wilke | Papenburg | Germany |
| MVZ ambulantes Kardiologisches Zentrum Peine gGmbH | Peine | Germany |
| Kardiologe im MVZ Pfaffenhofen | Pfaffenhofen an der Ilm | Germany |
| Hausärztlich-Kardiologisches MVZ am Felsenkeller | Pirna | Germany |
| Kardiologische Gemeinschaftspraxis am Park Sanssouci (Janßen) | Potsdam | Germany |
| Kardiologische Gemeinschaftspraxis am Park Sanssouci (Reibis) | Potsdam | Germany |
| Nephrocare Püttlingen GmbH | Püttlingen | Germany |
| Praxisklinik Salzatal | Salzatal | Germany |
| Praxis Dr. Jax | Schwalmtal | Germany |
| Parkkardiologie (Wolf) | Stahnsdorf | Germany |
| Parkkardiologie (Wuttke) | Stahnsdorf | Germany |
| Praxis Dr. Birkenhagen | Stollberg | Germany |
| Kardiologische Gemeinschaftspraxis Dres. Klein & Neumann | Stuttgart | Germany |
| Studienzentrum der Herzklinik Ulm GbR | Ulm | Germany |
| Nephrologisches Zentrum Villingen Schwenningen (Hohenstein) | Villingen-Schwenningen | Germany |
| Kardiologische Praxis (Elmas) | Waghäusel | Germany |
| Praxis am Gutenbergplatz | Wiesbaden | Germany |
| Praxis Gerschanik | Wuppertal | Germany |
| Dres. Herrmann/Meyer/Teschner (Meyer) | Würzburg | Germany |
| Praxis für Innere Medizin (Schwarz) | Zwenkau | Germany |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C581236 | 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid |
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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