Efficacy and Safety of a Generic Rosuvastatin in a Real-world Setting

Study Overview
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Brief Summary
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This study assessed the safety and efficacy of generic Rosuvastatin in reducing plasma low density lipoprotein (LDL) cholesterol in Lebanese adult patients (18 years or older) with dyslipidemia for both primary and secondary prevention based on their total cardiovascular risk. No visits or interventions, additional to the routine clinical practice, were requested or performed.

Detailed Description
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An observational, multicenter, prospective study of Lebanese adult (18 years or older) hypercholesterolemic patients administered generic Rosuvastatin (Superstat®). Eligible newly diagnosed hypercholesterolemic patients took generic Rosuvastatin as prescribed by their treating physician. Assigning patients to generic Rosuvastatin was decided within the current practice and medical indication and was independent from the recruitment into the study. Patients were followed-up at the clinic as per the standard practice of care. Each patient was followed-up for a period of 2 months.

Official Title
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Observational Study of Superstat® (Rosuvastatin) in Hypercholesterolemia Patients in Lebanon

Conditions
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Primary Hypercholesterolemia

Intervention / Treatment
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* Drug: Rosuvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females ≥ 18 years of age Patients with dyslipidemia requiring statin therapy according to CV risk factors as per the ESC/EAS 2011 guidelines for primary or secondary prevention Patients provided written informed consent Exclusion Criteria: Age <18 years Statin use in the past 3 months Any contraindication to HMG-CoA reductase inhibitors Co-administration of non-statin lipid lowering agent (ezitimibe, fibrates, niacin, omega 3) Conditions which may cause secondary dyslipidemia Any of the following abnormal laboratory tests: TG level of > 400 mg/dL, Abnormal liver enzymes (AST or ALT) ≥ 3 ULN, Abnormal serum creatine kinase (CK) > 5 ULN

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rosuvastatin|Superstat ® Tablets 10mg, 20mg|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in mean low-density lipoproteins (LDL-C) |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in mean total cholesterol, triglycerides, high density lipoprotein (HDL-C) |  | 2 months | 
| Proportion of patients who meet their target (LDL-C) |  | 2 months | 
| Incidence rate of adverse events (AEs) in association with generic rosuvastatin | Rate of AEs which might include the worsening in baseline medical conditions, the occurrence of new conditions, or a significant change in vital signs or laboratory values. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Superstat, Rosuvastatin, Statins, LDL-C, Cholesterol, Hypercholesterolemia, Dyslipidemia, Coronary Artery Disease, Cardiovascular Disease