Combinations of Drugs; Dependence, Hypercholesterolemia, Hyperlipidemias
Conditions
Brief summary
Evaluation of the efficacy of the stable ezetimibe-rosuvastatin combination in patients with primary hypercholesterolemia in achieving the target plasma LCL-C level.
Detailed description
Additional study objectives: 1. Evaluation of the efficacy of the stable ezetimibe-rosuvastatin combination in patients with primary hypercholesterolemia with respect to changes in the rest of the lipid profile (HDL-C, TC, TG). 2. Evaluation of the efficacy of the stable ezetimibe-rosuvastatin combination in patients with primary hypercholesterolemia in altering non-HDL cholesterol (non-HDL - cholesterol) levels. 3. The assessment of the achievement of the LCL-C target of patients receiving the stable ezetimibe-rosuvastatin combination according to their cardiovascular risk category. 4. Assessing patient safety throughout treatment.
Interventions
None listed
Sponsors
Elpen Pharmaceutical Co. Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients who have voluntarily consented to participate in the study. * Adult patients who are already on treatment with the stable combination of ezetimibe-rosuvastatin (Lipopen), at the discretion of the treating physician. * Adult patient adequately controlled with rosuvastatin and ezetimibe according to ESC / EAS 2019 guidelines.
Exclusion criteria
* Patients who have not fully understood the study procedures and have not signed the consent form. * Patients who are contraindicated for taking the drug according to the Summary of Product Characteristics (MSF) of the study drug. Hypersensitivity to the active substances or to any of the excipients of Lipopen. * Pregnancy and breastfeeding. * Active liver disease involving unexplained, persistent increases in serum transaminases and any increase in serum transaminases that exceeds 3 times the normal upper limit (ULN) or unexplained persistent increases in serum transaminases. * Patient with severe renal impairment (creatinine clearance \<30 ml / min). * Patient with myopathy * Patient receiving concomitant treatment with cyclosporine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL-C | 12 months | Levels of LDL-C |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lipidemic profile | 12 months | HDL-C↑ T-CHOL, Triglycerides measurements |
| Cardiovascular risk factor | 12 months | Response of patients vs target of total cardiovascular risk to which they belong. |
| Adverse Events | 12 months | Number of Adverse Events during the study. |
Countries
Greece
Outcome results
None listed