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

Hikma

Status: Completed

Conditions: Primary Hypercholesterolemia

Treatments: Drug: Rosuvastatin

Study type: Observational

Funder types: Industry

Identifiers

NCT03516955

SPS-LBN-2014-05

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 317 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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