Hypercholesterolemia, Mixed Dyslipidemia
Conditions
Keywords
Hypercholesterolemia, Mixed dyslipidemia, NUSTENDI®, Statin therapy
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
Interventions
DRUGBempedoic Acid 180Mg/Ezetimibe 10Mg Tab
No study drug was administered during this study.
OTHERNo study drug
No study drug was administered during this study.
Sponsors
Daiichi Sankyo Germany
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Germany
Outcome results
None listed