Patients with a diagnosed hyperlipidemia treated with statins (with either simvastatin =40 mg or rosuvastatin >=20mg (random allocation) will be investigated. Additionally patients who are treated with a combination therapy of statins with PCSK-9 inhibitors or treated with a monotherapy with PCSK-9 inhibitors will be investigated.
Conditions
Interventions
Product Name: Statin therapy
Pharmaceutical Form: Tablet
Trade Name: Alirocumab, Praluent
Product Name: Praluent
Pharmaceutical Form: Solution for injection
Trade Name: Evolocumab, Repatha
Product N
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for all cohorts except the new-onset low-dose statin therapy patient group: - Age 18–75 years - LDL cholesterol levels >116 mg/dl - Previously prescribed dyslipidemia treatment according to the ESC/EAS guidelines with either atorvastatin >=40 mg, rosuvastatin >=20 mg or PCSK-9 inhibitors such as Praluent, Repatha or Inclisiran. Inclusion criteria for the new-onset low-dose statin therapy patient group: - No history of statin treatment - Age 18–75 years - LDL cholesterol levels >116 mg/dl before statin treatment - Previously prescribed dyslipidemia treatment according to the ESC/EAS guidelines with simvastatin =65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: - Severe liver disease - Pregnancy - Malignant disorders - Hepatitis B and Hepatitis C - HIV - Primary psychiatric disorder other than depression (ICD-10: F32 and F33) - Exclusion criteria for the MR investigations: claustrophobia, implants in the human body that do not fit to the guidelines on the feasibility of MR measurements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the present trial is to investigate whether cholesterol lowering drugs are related to alterations of steroid hormones.;Secondary Objective: • Is there a reduction of bile acids, Vitamin D under cholesterol-lowering drugs (CLD)? • Are there changes in immunological parameters under CLD? • Is there a relationship between CLD with lipidomics, proteomics and metabolomics? • Are there differences in the changes in the lipid composition under different cholesterol lowering drugs? • How are the concentrations of statins in the blood of the patients? • How are the concentrations of the enzymes CYP3A4 and CYP2C9 in the blood of the patients? • Is there a change in bone turnover markers or bone density under CLD? • Is there a relationship between cholesterol lowering drugs and the development of depression? • Do cholesterol-lowering drugs affect gray matter microstructural reorganization or neuroplasticity, measured by BDNF levels? • Do cholesterol-lowering drugs affect general health and wellbeing? • Do cholesterol-lowering drugs affect cognitive and executive functioning? • Is there a relation of CLD with blood sugar?;Primary end point(s): - Estrogen - Testosterone - Aldosterone - Cortisol;Timepoint(s) of evaluation of this end point: The time points of evaluation will be at baseline, at 3-, 6- and 12 months after the baseline examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.) Bile acids 2.) Vitamin-D 3.) bone turnover markers 4.) bone density 5.) osteoporosis 6.) immunological parameters 7.) lipidomics 8.) proteomics 9.) metabolomics 10.) statin concentrations 11.) concentrations of the metabolizers of statins 12.) depression 13.) aggression 14.) lipid composition in the liver 15.) gray matter microstructural reorganization 16.) Body composition 17.) blood sugar concentrations ;Timepoint(s) of evaluation of this end point: Secondary end points 1-3, 6, 7-13, 16-17 will be examined at baseline, 3-, 6-, and 12 months after baseline. Secondary endpoints 4, 5, 14 and 15 will be examined at baseline, 6- and 12 months after baseline. | — |
Countries
Austria
Contacts
Public ContactDivision of Endocrinology, 6J
Medical University of Vienna
Outcome results
None listed