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

Completed

• Conditions: Primary Hypercholesterolemia

• Registration Number: NCT03516955
• Lead Sponsor: Hikma Pharmaceuticals LLC

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-11
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2018-04
• Study First Submitted: 2018-04-24
• Study First Submitted QC: 2018-04-24
• Last Update Submitted: 2018-04-24
• Study First Posted: 2018-05-07
• Last Update Posted: 2018-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 317

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent change in mean low-density lipoproteins (LDL-C)	2 months

Secondary Outcome Measures

Name	Time	Method
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	2 months	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.