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
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.
Study Type
OBSERVATIONAL
Enrollment
3,084
Omega-3 fatty acid ethyl esters granular capsules
Unnamed facility
Osaka, Japan
Unnamed facility
Tokyo, Japan
Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE)
Time frame: Up to Month 12
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, up to 12 months (Final Assessment Point)
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, up to 12 months (Final Assessment Point)