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

Conditions

Hyperlipidemia

Keywords

Pharmacological therapy

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.

Related papers

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Interventions

DRUGOmega-3 fatty acid ethyl esters

Omega-3 fatty acid ethyl esters granular capsules

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

No

Inclusion criteria

* Patients with hyperlipidemia

Exclusion criteria

1. Patients with hemorrhage (e.g., hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract hemorrhage, hemoptysis, or vitreous hemorrhage) 2. Patients with a history of hypersensitivity to ingredients in granular capsule formulation of omega-3 fatty acid ethyl esters

Design outcomes

Primary

Measure	Time frame
Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE)	Up to Month 12

Secondary

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

Countries

Japan

Participant flow

Recruitment details

Participants took part in the study at 570 investigative sites in Japan, from 29 May 2013 to 31 May 2017.

Pre-assignment details

Participants with a historical diagnosis of hyperlipidemia were enrolled. Participants received interventions as part of routine medical care.

Participants by arm

Arm	Count
Omega-3 Fatty Acid Ethyl Esters 2 g Oral administration with granular capsule formulation of 2 g of omega-3 fatty acid ethyl esters once daily for 12 months. Participants received interventions as part of routine medical care.	2,786
Total	2,786

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Case Report Forms Uncollected	230
Overall Study	Protocol Deviation	68

Baseline characteristics

Characteristic	Omega-3 Fatty Acid Ethyl Esters 2 g	—
Age, Continuous	66.2 Years STANDARD_DEVIATION 13.27	—
BMI	24.94 Kilograms (kg)/meter (m)^2 STANDARD_DEVIATION 4.097	—
Drinking Habits No	1609 Participants	—
Drinking Habits Unknown	490 Participants	—
Drinking Habits Yes	687 Participants	—
Duration of Diagnosis of Hyperlipidemia	3.13 Years STANDARD_DEVIATION 4.755	—
Healthcare Category Inpatient	21 Participants	—
Healthcare Category Outpatient	2765 Participants	—
Medical Complications Had No Presence of Medical Complications	566 Participants	—
Medical Complications Had Presence of Medical Complications	2220 Participants	—
Predisposition to Hypersensitivity Had No Predisposition to Hypersensitivity	2520 Participants	—
Predisposition to Hypersensitivity Had Predisposition to Hypersensitivity	133 Participants	—
Predisposition to Hypersensitivity Unknown	133 Participants	—
Pregnancy Status during the Administration Period Not Pregnant	1381 Participants	—
Pregnancy Status during the Administration Period Pregnant	1 Participants	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment Japan	2786 Participants	—
Sex: Female, Male Female	1382 Participants	—
Sex: Female, Male Male	1404 Participants	—
Smoking Classification Current Smoker	307 Participants	—
Smoking Classification Ex-Smoker	496 Participants	—
Smoking Classification Never Smoked	1430 Participants	—
Smoking Classification Unknown	553 Participants	—
Surgery within One Month before Dosing Had No Surgery within One Month before Dosing	2762 Participants	—
Surgery within One Month before Dosing Had Surgery within One Month before Dosing	24 Participants	—
TG in Non-Fasted Condition (mg/dL) < 150 mg/dL	287 Participants	—
TG in Non-Fasted Condition (mg/dL) >= 150 mg/dL and < 400 mg/dL	762 Participants	—
TG in Non-Fasted Condition (mg/dL) >= 400 mg/dL and < 500mg/dL	78 Participants	—
TG in Non-Fasted Condition (mg/dL) >= 500 mg/dL and < 750mg/dL	82 Participants	—
TG in Non-Fasted Condition (mg/dL) >= 750mg/dL	31 Participants	—
TG in Non-Fasted Condition (mg/dL) Not Measured	1546 Participants	—
Triglycerides (TG) in Fasted Condition [Milligrams (mg)/ Deciliter (dL)] < 150 mg/dL	298 Participants	—
Triglycerides (TG) in Fasted Condition [Milligrams (mg)/ Deciliter (dL)] >= 150 mg/dL and < 400 mg/dL	824 Participants	—
Triglycerides (TG) in Fasted Condition [Milligrams (mg)/ Deciliter (dL)] >= 400 mg/dL and < 500mg/dL	64 Participants	—
Triglycerides (TG) in Fasted Condition [Milligrams (mg)/ Deciliter (dL)] >= 500 mg/dL and < 750mg/dL	43 Participants	—
Triglycerides (TG) in Fasted Condition [Milligrams (mg)/ Deciliter (dL)] >= 750mg/dL	16 Participants	—
Triglycerides (TG) in Fasted Condition [Milligrams (mg)/ Deciliter (dL)] Not Measured	1541 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	10 / 2,786
other Total, other adverse events	38 / 2,786
serious Total, serious adverse events	26 / 2,786

Outcome results

Primary

Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE)

Time frame: Up to Month 12

Population: Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Omega-3 Fatty Acid Ethyl Esters 2 g	Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE)	AE	130 Participants
Omega-3 Fatty Acid Ethyl Esters 2 g	Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE)	SAE	26 Participants

Secondary

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.