Ezetimibe-Rosuvastatin Evaluation Study (ZEUS)

ELPEN

Status: Enrolling

Conditions: Hyperlipidemias; Hypercholesterolemia; Combinations of Drugs; Dependence

Study type: Observational

Funder types: Industry

Identifiers

NCT03947866

2022-ROSEZE-EL-160

Details and patient eligibility

About

Evaluation of the efficacy of the stable ezetimibe-rosuvastatin combination in patients with primary hypercholesterolemia in achieving the target plasma LCL-C level.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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