NCT05546398

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 500 (actual)
• Sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Hypercholesterolemia
• Mixed Dyslipidemia

Interventions

Type	Name	Description
DRUG	Bempedoic Acid 180Mg/Ezetimibe 10Mg Tab	No study drug was administered during this study.
OTHER	No study drug	No study drug was administered during this study.

Timeline

• Start date: 2022-04-22
• Primary completion: 2022-11-17
• Completion: 2022-11-17
• First posted: 2022-09-19
• Last updated: 2022-12-01

Locations

63 sites across 1 country: Germany