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®

Completed

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

• Registration Number: NCT05546398
• Lead Sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Brief Summary

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.

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 Timeline

• Study Start: 2022-04-22
• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-09-14
• Study First Posted: 2022-09-19
• Status Verified: 2022-11
• Primary Completion: 2022-11-17
• Study Completion: 2022-11-17
• Last Update Submitted: 2022-11-30
• Last Update Posted: 2022-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High and Very High Cardiovascular Patients	Bempedoic Acid 180Mg/Ezetimibe 10Mg Tab	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).
Physicians	No study drug	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Implementing Specific Lifestyle Modifications Based on a Retrospective Patient Chart Review	Up to 6 months	A retrospective patient chart review will assess the number of participants with specific lifestyle modifications.
Low density Lipoprotein-Cholesterol (LDL-C) Levels at Therapy Decision Based on Physician Survey	Up to 6 months	Physicians will be surveyed to assess the LDL-C levels at the time of a therapy decision.
Visual Analogue Scale (VAS) Score Evaluating Relevance of Decision Factors and Considerations Relevant to Therapy Decision Based on Physician Survey	Up to 6 months	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.
Low density Lipoprotein-Cholesterol (LDL-C) Levels at Therapy Decision Based on a Retrospective Patient Chart Review	Up to 6 months	A retrospective patient chart review will assess the LDL-C levels at the time of a therapy decision.
Reductions in Low density Lipoprotein-Cholesterol (LDL-C) Levels Based on Physician Survey	Up to 6 months	Physicians will be surveyed to determine their anticipated reductions in LDL-C levels as a result of therapy.
Number of Participants With Pre-specified Events in Their Medical History Based on a Retrospective Patient Chart Review	Up to 6 months	A retrospective patient chart review will assess the number of participants with pre-specified events in their medical history.
Number of Participants With Specific Concomitant Diseases Based on a Retrospective Chart Review	Up to 6 months	A retrospective patient chart review will assess the number of participants with specific concomitant diseases.

Trial Locations

Locations (63)

Kardiologische Gemeinschaftspraxis (Bulut); 🇩🇪 Arnsberg, Germany

Dr. Georg Strack; 🇩🇪 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

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