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®

Daiichi Sankyo

Status: Completed

Conditions: Mixed Dyslipidemia; Hypercholesterolemia

Treatments: Drug: Bempedoic Acid 180Mg/Ezetimibe 10Mg Tab; Other: No study drug

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05546398

SYROS-DSE-BMP-01-21-EU

Details and patient eligibility

About

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.

Full 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

Enrollment: 500 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 2 patient groups

Physicians

Description:

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.

Treatment:

Other: No study drug

High and Very High Cardiovascular Patients

Description:

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).

Treatment:

Drug: Bempedoic Acid 180Mg/Ezetimibe 10Mg Tab