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

Launched by HIKMA PHARMACEUTICALS LLC · Apr 24, 2018

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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