Ezetimibe-Rosuvastatin Evaluation Study

Study Overview
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Brief Summary
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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
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Additional study objectives: 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). Evaluation of the efficacy of the stable ezetimibe-rosuvastatin combination in patients with primary hypercholesterolemia in altering non-HDL cholesterol (non-HDL - cholesterol) levels. The assessment of the achievement of the LCL-C target of patients receiving the stable ezetimibe-rosuvastatin combination according to their cardiovascular risk category. Assessing patient safety throughout treatment.

Official Title
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An Observational Clinical Study to Evaluate the Effectiveness of Fixed-dose Combination of eZEtimibe-rosUvaStatin.

Conditions
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Hypercholesterolemia, Hyperlipidemias, Combinations of Drugs; Dependence

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-C | Levels of LDL-C | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipidemic profile | HDL-C↑ T-CHOL, Triglycerides measurements | 12 months | 
| Cardiovascular risk factor | Response of patients vs target of total cardiovascular risk to which they belong. | 12 months | 
| Adverse Events | Number of Adverse Events during the study. | 12 months |