Hyperlipedemia in coronary artery disease
Conditions
Interventions
Group 1: Therapy escalation by adding bempedoic acid (Nilemdo®) or switching to the fixed-dose combination with ezetimibe (Nustendi®).
In this observational study, only data from routine treatment wil
Sponsors
UKGM Universitätsklinikum Gießen, Medizinische Klinik I, Innere Medizin Kardiologie am Standort Gießen
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: • written informed consent was obtained • Age 18-90 years • LDL-C target under lipid-lowering therapy consisting of a statin and ezetimibe (taken for at least 4 weeks) was not achieved (based on ESC/EAS guideline CV risk category very high risk)
Exclusion criteria
Exclusion criteria: • No written informed consent can be obtained (illiteracy or inability to understand the study) • Statin-intolerant patients (defined as intolerance to two or more statins at any dose and inability to tolerate a dose escalation of these agents to a maximal weekly dose of 70 mg atorvastatin, 140 mg simvastatin, pravastatin or lovastatin, 35 mg rosuvastatin, 280 mg fluvastatin and attenuation or disappearance of symptoms (i.e. myalgia) upon reduction or discontinuation of the statin) • Lipid-lowering therapy includes a PCSK-9 inhibitor and/or bempedoic acid • LDL-C goal of < 55 mg/dL is reached on current lipid-lowering therapy (based on ESC/ EAS guideline CV risk category very high risk) • Intake of experimental drugs within 30 days prior to screening • Patient is team member or contractor of institution where the study is conducted or family member of the principal investigator, subinvestigators • Lipid-lowering medication was changed within 4 weeks prior to study inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Attainment of a LDL-C level < 55 mg/dL (very high CV risk) within 3 months after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Absolute LDL-C reduction in mg/dl and relative (%) at follow-up within 3 months after treatment 2. Cost efficiency calculation as € saved per patient year comparing PCSK9-inhibitor therapy with bempedoic acid based on attainment of an LDL-C level < 55 mg/dL (very high CV risk) within 3 months after adding bempedoic acid or switching to the fixed-dose combination with ezetimibe | — |
Countries
Germany
Contacts
Public ContactRoland Klingenberg
Krankenhaus Nordwest GmbH, Klinik für Innere Medizin I
Outcome results
None listed