Evaluation of the Safety and Efficacy of Long-term Use of Omega-3 Fatty Acid Ethyl Esters

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of long-term use of granular capsule formulation of omega-3 fatty acid ethyl esters (Lotriga Granular Capsules) in patients with hyperlipidemia in daily medical practice

Detailed Description
-----------------
This special drug use surveillance on long-term use of granular capsule formulation of omega-3 fatty acid ethyl esters (Lotriga Granular Capsules) was designed to investigate the frequency of adverse events in patients with hyperlipidemia The usual adult dosage is 2 g of omega-3 fatty acid ethyl esters administered orally once daily after meals. However, the dosage can be increased up to twice daily (at a dose of 2 g) depending on the participant's triglyceride level.

Official Title
-----------------
Omega-3 Fatty Acid Ethyl Esters (Lotriga) Granular Capsules Special Drug Use Surveillance (Long-term Use Survey)

Conditions
-----------------
Hyperlipidemia

Intervention / Treatment
-----------------
* Drug: Omega-3 fatty acid ethyl esters


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with hyperlipidemia Exclusion Criteria: Patients with hemorrhage (e.g., hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract hemorrhage, hemoptysis, or vitreous hemorrhage) Patients with a history of hypersensitivity to ingredients in granular capsule formulation of omega-3 fatty acid ethyl esters
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Omega-3 fatty acid ethyl esters 2 g<br>Omega-3 fatty acid ethyl esters 2 g, administered orally once or twice daily after meals | Drug: Omega-3 fatty acid ethyl esters<br>* Omega-3 fatty acid ethyl esters granular capsules<br>* Other names: Lotriga Granular Capsules;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE) |  | Up to Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Lipid Parameters - Triglycerides (TG) | Percent change from baseline in TG values as one of lipid parameters in fasted condition at final assessment point (up to Month 12) was reported. | Baseline, up to 12 months (Final Assessment Point) | 
| Percent Change From Baseline in Lipid Parameters - LDL Cholesterol (LDL-C) | Percent change from baseline in LDL-C values as one of lipid parameters in fasted condition at final assessment point (up to Month 12) was reported. | Baseline, up to 12 months (Final Assessment Point) | 
| Percent Change From Baseline in Lipid Parameters - VLDL Cholesterol (VLDL-C) | Percent change from baseline in VLDL-C values as one of lipid parameters in fasted condition at final assessment point (up to Month 12) was reported. | Baseline, up to 12 months (Final Assessment Point) | 
| Percent Change From Baseline in Lipid Parameters - Apo-B | Percent change from baseline in Apo-B values as one of lipid parameters in fasted condition at final assessment point (up to Month 12) was reported. | Baseline, up to 12 months (Final Assessment Point) | 
| Percent Change From Baseline in Lipid Parameters - Apo-CIII | Percent change from baseline in Apo-CIII values as one of lipid parameters in fasted condition at final assessment point (up to Month 12) was reported. | Baseline, up to 12 months (Final Assessment Point) | 
| Percent Change From Baseline in Lipid Parameters - Lipoprotein | Percent change from baseline in Lipoprotein values as one of lipid parameters in fasted condition at final assessment point (up to Month 12) was reported. | Baseline, up to 12 months (Final Assessment Point) | 
| Percent Change From Baseline in Lipid Parameters -Remnant-Like Particles-Cholesterol (RLP-C) | Percent change from baseline in RLP-C values as one of lipid parameters in fasted condition at final assessment point (up to Month 12) was reported. | Baseline, up to 12 months (Final Assessment Point) | 
| Percent Change From Baseline in Lipid Parameters - Total Cholesterol (TC) | Percent change from baseline in TC values as one of lipid parameters at final assessment point (up to Month 12) was reported. | Baseline, up to 12 months (Final Assessment Point) | 
| Percent Change From Baseline in Lipid Parameters - Non-HDL Cholesterol (Non-HDL-C) | Percent change from baseline in Non-HDL-C values as one of lipid parameters at final assessment point (up to Month 12) was reported. | Baseline, up to 12 months (Final Assessment Point) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacological therapy