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

NCT03516955 | Completed

• 1 other identifier: SPS-LBN-2014-05
• Study Type: observational
• Target: 317
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Primary Hypercholesterolemia

Keywords

Superstat; Rosuvastatin; Statins; LDL-C; Cholesterol; Hypercholesterolemia; Dyslipidemia; Coronary Artery Disease; Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• Percent change in mean low-density lipoproteins (LDL-C)

  2 months

Secondary Outcomes (3)

• 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

Interventions

Rosuvastatin DRUG

Superstat ® Tablets 10mg, 20mg

Also known as: Superstat ®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients were recruited from 24 cardiology, endocrinology and general practitioner outpatient clinics in Lebanon

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hikma Pharmaceuticals LLC: lead

MeSH Terms

Conditions

Hypercholesterolemia; Dyslipidemias; Coronary Artery Disease; Cardiovascular Diseases

Interventions

Rosuvastatin Calcium; superstat

Condition Hierarchy (Ancestors)

Hyperlipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 7, 2018
• Study Start: November 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 7, 2018

Record last verified: 2018-04