SurveY Followed by a Retrospective Chart Review to Describe the Key Factors Leading to Physician's Decision to Treat Patients at High and Very High Cardiovascular Risk With hyperchOlesterolemia or Mixed Dyslipidemia With NUSTENDI®

SurveY Followed by a Retrospective Chart Review to Describe the Key Factors Leading to Physician's Decision to Treat Patients at High and Very High Cardiovascular Risk With hyperchOlesterolemia or Mixed Dyslipidemia With NUSTENDI® (Fixed Dose Combination of Bempedoic Acid 180mg and Ezetimibe 10mg) as add-on to Treatment With Maximally Tolerated Statin Therapy in Routine Clinical Practice

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.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia; Mixed Dyslipidemia
• Intervention / Treatment: Other: No study drug; Drug: Bempedoic Acid 180Mg/Ezetimibe 10Mg Tab

Detailed Description

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:

• LDL-C levels at therapy decision and goal of LDL-C reduction
• Relevance of different factors and considerations
• Considerations of guidelines

The objectives of the retrospective patient chart review are to characterize the patients':

• Demographics
• LDL-C levels at therapy decisions
• Medical History
• Concomitant Diseases
• Lifestyle Modifications

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Germany
  • Arnsberg, Germany
    • Kardiologische Gemeinschaftspraxis (Bulut)
  • Bad König, Germany
    • Dr. Georg Strack
  • Berlin, 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
  • Bonn, Germany
    • Kardio Bonn
  • Chemnitz, Germany
    • Dr. Jaroslaw Sek
  • Chemnitz, Germany
    • Praxis Dipl.-med. Schermaul
  • Crivitz, Germany
    • BAG Helmecke
  • Darmstadt, Germany
    • Kardiologie Darmstadt
  • Dreieich, Germany
    • MVZ Rhein-Main GmbH (Binder)
  • Dresden, Germany
    • Cardiologicum Dresden / Pirna (Hildebrandt)
  • Dresden, Germany
    • Facharztzentrum Dresden-Neustadt GbR (Simonis)
  • Dresden, Germany
    • PD Dr. Stephan Wiedemann
  • Dresden, Germany
    • Praxis Dr. Methfessel
  • Duisburg, Germany
    • KardioPraxis Rote Straße (Stieber)
  • Gotha, Germany
    • Kardiologische Praxis (Warzok)
  • Greiz, Germany
    • Kardiopraxis Greiz (Walter)
  • Greiz, Germany
    • MVZ des Krankenhaus Greiz
  • Hamburg, Germany
    • Kardiologie am Tibarg (Twisselmann)
  • Hannover, Germany
    • Diabetiker Zentrum Hannover (Fendler)
  • Haßloch, Germany
    • Kardiologie Haßloch (Gerhards)
  • Henstedt-Ulzburg, Germany
    • Kardiologie Alsterquelle
  • Homburg, Germany
    • Praxis Dr. Lißmann
  • Köln, Germany
    • Praxis für Kardiologie und Schlafmedizin (Lichtenberg)
  • Leipzig, Germany
    • Gemeinschaftspraxis Dr. Täschner / Dr. Bonigut
  • Leipzig, Germany
    • Praxis Dr. Feige
  • Meiningen, Germany
    • Gemeinschaftspraxis Schauermann
  • Mettlach, Germany
    • Gemeinschaftspraxis Dres. med. Dittgen/Wilhelm/Rehlinger
  • Michendorf, Germany
    • Hausarztpraxis Doreen Drews
  • Michendorf, Germany
    • Hausarztpraxis Thorsten Drews
  • Mülheim, Germany
    • Kardio Praxis Mülheim (Möllenberg)
  • Münster, Germany
    • Dres. Bettenworth & Partner
  • Neu-Ulm, Germany
    • Gemeinschaftspraxis am Jahnufer (Schleß)
  • Neustadt, Germany
    • Kardiopraxis (Buchholz-Sanchez)
  • Nürnberg, Germany
    • Kardiologie am Weißen Turm (Stadelmann)
  • Nürnberg, Germany
    • Praxis für Kardiologie (Laser)
  • Oberhausen, Germany
    • Dres. Kornadt und Edel
  • Panitzsch, Germany
    • Praxis Dr. Spengler
  • Papenburg, Germany
    • Kardiologische Praxis Papenburg Dr. Denchev
  • Papenburg, Germany
    • Kardiologische Praxis Papenburg Dr. Malazhavy
  • Papenburg, Germany
    • Kardiologische Praxis Papenburg Dr. Wilke
  • Peine, Germany
    • MVZ ambulantes Kardiologisches Zentrum Peine gGmbH
  • Pfaffenhofen an der Ilm, Germany
    • Kardiologe im MVZ Pfaffenhofen
  • Pirna, Germany
    • Hausärztlich-Kardiologisches MVZ am Felsenkeller
  • Potsdam, Germany
    • Kardiologische Gemeinschaftspraxis am Park Sanssouci (Janßen)
  • Potsdam, Germany
    • Kardiologische Gemeinschaftspraxis am Park Sanssouci (Reibis)
  • Puttlingen, Germany
    • Nephrocare Püttlingen GmbH
  • Salzatal, Germany
    • Praxisklinik Salzatal
  • Schwalmtal, Germany
    • Praxis Dr. Jax
  • Stahnsdorf, Germany
    • Parkkardiologie (Wolf)
  • Stahnsdorf, Germany
    • Parkkardiologie (Wuttke)
  • Stollberg, Germany
    • Praxis Dr. Birkenhagen
  • Stuttgart, Germany
    • Kardiologische Gemeinschaftspraxis Dres. Klein & Neumann
  • Ulm, Germany
    • Studienzentrum der Herzklinik Ulm GbR
  • Villingen-Schwenningen, Germany
    • Nephrologisches Zentrum Villingen Schwenningen (Hohenstein)
  • Waghäusel, Germany
    • Kardiologische Praxis (Elmas)
  • Wiesbaden, Germany
    • Praxis am Gutenbergplatz
  • Wuppertal, Germany
    • Praxis Gerschanik
  • Würzburg, Germany
    • Dres. Herrmann/Meyer/Teschner (Meyer)
  • Zwenkau, Germany
    • Praxis für Innere Medizin (Schwarz)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Eligibility criteria for the office-based cardiologists and lipid management specialists are as follows:

  • More than 10 years of experience in medical practice
  • For office-based cardiologists: Supervision of at least 200 patients at high and very high cardiovascular risk as assessed by the office-based cardiologists with hypercholesterolemia or mixed dyslipidemia. For lipid management specialists: Supervision of at least 500 patients at high and very high cardiovascular risk as assessed by the lipid management specialists with hypercholesterolemia or mixed dyslipidemia
  • Working in practices to whom patients were either referred or had direct access to.
  • Availability to share medical files of consenting patients with study personnel (e.g. Clinical Research Associates) by remote quality review
  • At least 5 patients for the retrospective chart review

The inclusion criteria for the patients are as follows:

• Written informed consent to participate
• Patients at high and very high cardiovascular risk diagnosed with hypercholesterolemia or mixed dyslipidemia and treated with bempedoic acid 180 mg fixed dose combination with ezetimibe 10 mg (FDC) for at least 4 weeks at the discretion of the physician according to the German label

Exclusion Criteria:

• Any patient who did not meet all inclusion criteria noted above

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: No study drug; No study drug was administered during this study.
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).	Drug: Bempedoic Acid 180Mg/Ezetimibe 10Mg Tab; No study drug was administered during this study.; Other Names: NUSTENDI®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
• Collaborators: Daiichi Sankyo Germany

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2022
• Primary Completion (Actual): November 17, 2022
• Study Completion (Actual): November 17, 2022

Study Registration Dates

• First Submitted: September 14, 2022
• First Submitted That Met QC Criteria: September 14, 2022
• First Posted (Actual): September 19, 2022

Study Record Updates

• Last Update Posted (Actual): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 30, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Hypercholesterolemia; Mixed dyslipidemia; Statin therapy; NUSTENDI®
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Ezetimibe; 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
• Other Study ID Numbers: SYROS-DSE-BMP-01-21-EU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No