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

Sponsor

Hikma Pharmaceuticals LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT03516955

Collaborator

(none)

317

Enrollment

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Hypercholesterolemia	Drug: Rosuvastatin

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 Design

Study Type:

Observational

Actual Enrollment :

317 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 1, 2014

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Outcome Measures

Primary Outcome Measures

Percent change in mean low-density lipoproteins (LDL-C) [2 months]

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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: