Specified Drug-use Survey of the Granular Capsule Formulation of Omega-3 Fatty Acid Ethyl Esters: OCEAN3

• Sponsor: Takeda (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02285166
• Collaborator: (none)
• Enrollment: 15,330
• Locations: 2
• Actual Duration (Months): 68.8
• Patients Per Site: 7665
• Patients Per Site Per Month: 111.5

Study Details

Study Description

Brief Summary

The purpose of this survey is to determine the incidence rate of cardiovascular (CV) events associated with long-term treatment with and without omega-3 fatty acid ethyl esters (Lotriga Granular Capsules) in high-risk hyperlipidemic patients treated by statin in daily medical practice.

Condition or Disease	Intervention/Treatment	Phase
Hyperlipidemia	Drug: Omega-3 fatty acid ethyl esters; Drug: Standard antihyperlipidemic therapy other than administration of omega-3 fatty acid ethyl esters (Lotriga).

Detailed Description

This survey is planned to determine the incidence rate of cardiovascular (CV) events associated with long-term treatment with omega-3 fatty acid ethyl esters (Lotriga Granular Capsules) in high-risk hyperlipidemic patients treated by statin in daily medical practice.

The incidence rate of CV events in the participants who are treated by the standard anti-hyperlipidemic therapies other than omega-3 fatty acid ethyl esters is investigated in this survey so as to compare the events rates between two participant groups just for information.

For adults, 2 g of omega-3 fatty acid ethyl esters is usually administered orally once daily immediately after meals. However, the dose can be increased up to twice daily (to a dose of 2

1. depending on participant's triglyceride (TG) level.

Study Design

• Study Type: Observational
• Actual Enrollment: 15330 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Specified Drug-use Survey of Lotriga Granular Capsules: OCEAN3 (Outcome Prevention on Cardiovascular Events by Antihyperlipidemic Therapy With N3-fatty Acid in Japan)
• Actual Study Start Date: Oct 21, 2014
• Actual Primary Completion Date: Jul 14, 2020
• Actual Study Completion Date: Jul 14, 2020

Arms and Interventions

Arm	Intervention/Treatment
Ever User of Omega-3 fatty acid ethyl esters 2 g The usual adult dosage for oral use was 2 g of omega-3 fatty acid ethyl esters administered once daily or twice daily immediately after meals for treatment of hyperlipidemia. Participants received both interventions and standard antihyperlipidemic therapy as part of routine medical care.	Drug: Omega-3 fatty acid ethyl esters; Omega-3 fatty acid ethyl esters granular capsules; Other Names: Lotriga granular capsules
Never User of Omega-3 fatty acid ethyl esters 2 g Participants received standard antihyperlipidemic therapy without omega-3 fatty acid ethyl esters 2 g as part of routine medical care.	Drug: Standard antihyperlipidemic therapy other than administration of omega-3 fatty acid ethyl esters (Lotriga).

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User [Up to 36 months]

   Reported data was percentage of participants (cumulative incidence) with specified cardiovascular events from start of observation in population of omega-3 fatty acid ethyl esters 2 g user. Specified cardiovascular events were fatal and non-fatal, and defined as major adverse cardiovascular events (cardiovascular death [including sudden death, fatal myocardial infarction, fatal cardiac failure, fatal stroke {cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage} and other cardiovascular death], non-fatal myocardial infarction, and non-fatal stroke [cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage]), angina pectoris requiring coronary revascularization (i.e., percutaneous transluminal coronary angioplasty [PCI] or coronary artery bypass grafting [CABG]), peripheral arterial disease requiring surgery or peripheral arterial intervention.

2. Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User [Up to 36 months]

   Reported data was percentage of participants (cumulative incidence) with specified cardiovascular events from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user. Specified cardiovascular events were fatal and non-fatal, and defined as major adverse cardiovascular events (cardiovascular death [including sudden death, fatal myocardial infarction, fatal cardiac failure, fatal stroke {cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage} and other cardiovascular death], non-fatal myocardial infarction, and non-fatal stroke [cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage]), angina pectoris requiring coronary revascularization (i.e., percutaneous transluminal coronary angioplasty [PCI] or coronary artery bypass grafting [CABG]), peripheral arterial disease requiring surgery or peripheral arterial intervention.

Secondary Outcome Measures

1. Percentage of Participants (Cumulative Incidence) With Death From All Causes (Cardiovascular and Non-cardiovascular Deaths) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User [Up to 36 months]

   Reported data was percentage of participants (cumulative incidence) with death from all causes (cardiovascular and non-cardiovascular deaths) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user.

2. Percentage of Participants (Cumulative Incidence) With Death From All Causes (Cardiovascular and Non-cardiovascular Deaths) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User [Up to 36 months]

   Reported data was percentage of participants (cumulative incidence) with death from all causes (cardiovascular and non-cardiovascular deaths) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user.

3. Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User [Up to 36 months]

   Reported data was percentage of participants (cumulative incidence) with major adverse cardiovascular events (MACE) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user. MACE included cardiovascular death (including sudden death, fatal myocardial infarction, fatal cardiac failure, fatal stroke [cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage] and other cardiovascular death), non-fatal myocardial infarction, and non-fatal stroke (cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage).

4. Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User [Up to 36 months]

   Reported data was percentage of participants (cumulative incidence) with major adverse cardiovascular events (MACE) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user. MACE included cardiovascular death (including sudden death, fatal myocardial infarction, fatal cardiac failure, fatal stroke [cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage] and other cardiovascular death), non-fatal myocardial infarction, and non-fatal stroke (cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage).

5. Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events From in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User [Up to 36 months]

   Reported data was percentage of participants (cumulative incidence) with all cardiovascular events from start of observation in population of omega-3 fatty acid ethyl esters 2 g user. All cardiovascular events included MACE, angina pectoris requiring hospitalization, angina pectoris requiring coronary revascularization (i.e., PCI or CABG), cardiac failure requiring hospitalization, transient ischaemic attack requiring hospitalization, peripheral arterial disease requiring hospitalization, peripheral arterial disease requiring surgery or peripheral arterial intervention.

6. Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User [Up to 36 months]

   Reported data was percentage of participants (cumulative incidence) with all cardiovascular events from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user. All cardiovascular events included MACE, angina pectoris requiring hospitalization, angina pectoris requiring coronary revascularization (i.e., PCI or CABG), cardiac failure requiring hospitalization, transient ischaemic attack requiring hospitalization, peripheral arterial disease requiring hospitalization, peripheral arterial disease requiring surgery or peripheral arterial intervention.

7. Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User [Up to 36 months]

   Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (cardiovascular death) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user.

8. Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User [Up to 36 months]

   Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (cardiovascular death) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user.

9. Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Non-fatal Myocardial Infarction) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User [Up to 36 months]

   Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (non-fatal myocardial infarction) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user.

10. Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Non-fatal Myocardial Infarction) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User [Up to 36 months]

    Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (non-fatal myocardial infarction) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user.

11. Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Non-fatal Stroke) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User [Up to 36 months]

    Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (non-fatal stroke) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user.

12. Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Non-fatal Stroke) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User [Up to 36 months]

    Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (non-fatal stroke) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user.

13. Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Angina Pectoris Requiring Hospitalization) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User [Up to 36 months]

    Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (angina pectoris requiring hospitalization) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user.

14. Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Angina Pectoris Requiring Hospitalization) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User [Up to 36 months]

    Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (angina pectoris requiring hospitalization) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user.

15. Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Angina Pectoris Requiring Coronary Revascularization) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User [Up to 36 months]

    Reported data waspercentage of participants (cumulative incidence) with individual cardiovascular events (angina pectoris requiring coronary revascularization ) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user.

16. Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Angina Pectoris Requiring Coronary Revascularization) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User [Up to 36 months]

    Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (angina pectoris requiring coronary revascularization) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user.

17. Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiac Failure Requiring Hospitalization) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User [Up to 36 months]

    Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (cardiac failure requiring hospitalization) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user.

18. Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiac Failure Requiring Hospitalization) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User [Up to 36 months]

    Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (cardiac failure requiring hospitalization) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user.

19. Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Transient Ischaemic Attack Requiring Hospitalization) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User [Up to 36 months]

    Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (transient ischaemic attack requiring hospitalization) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user.

20. Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Transient Ischaemic Attack Requiring Hospitalization) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User [Up to 36 months]

    Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (transient ischaemic attack requiring hospitalization) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user.

21. Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Peripheral Arterial Disease Requiring Hospitalization) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User [Up to 36 months]

    Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (peripheral arterial disease requiring hospitalization) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user.

22. Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Peripheral Arterial Disease Requiring Hospitalization) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User [Up to 36 months]

    Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (peripheral arterial disease requiring hospitalization) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user.

23. Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Peripheral Arterial Disease Requiring Surgery or Peripheral Arterial Intervention) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User [Up to 36 months fatty]

    Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (peripheral arterial disease requiring surgery or peripheral arterial intervention) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user.

24. Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Peripheral Arterial Disease Requiring Surgery or Peripheral Arterial Intervention) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User [Up to 36 months]

    Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (peripheral arterial disease requiring surgery or peripheral arterial intervention) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Participants who meet all of the following criteria will be included in the survey:

1. Patients with hyperlipidemia on statin therapy

2. Outpatients

3. Male participants aged ≥ 50 years and female participants aged ≥ 60 years

4. Participants with fasting TG level ≥ 150 mg/dL (within 3 months prior to the start of the observation period)

5. Participants who have at least two of the following risk factors:

• Hypertension

• Type 2 diabetes mellitus

• Chronic kidney disease

• Prior history of myocardial infarction or angina pectoris

• Prior history of cerebral infarction

• Peripheral arterial disease

Exclusion Criteria:

-Participants who meet any of the following criteria will be excluded from the survey:

1. Participants who have experienced coronary artery disease within 1 month prior to the start of the observation period

2. Participants who have experienced cerebrovascular disease within 1 month prior to the start of the observation period

3. Participants who have undergone heart surgery or revascularization surgery (including coronary artery intervention and peripheral arterial intervention) within 1 month prior to the start of the observation period

4. Participants who plan to undergo heart surgery or revascularization surgery (including coronary artery intervention and peripheral arterial intervention)

5. Patients with malignant tumors currently under treatment

6. Participants who have received eicosapentaenoic acid (hereinafter, EPA) products within 1 month prior to the start of the observation period, or participants who plan to receive treatment with EPA products after the start of the observation period

7. Patients with hemorrhage (e.g., hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract hemorrhage, hemoptysis, or vitreous hemorrhage)

8. Participants with prior history of hypersensitivity to any ingredients in omega-3 fatty acid ethyl esters (omega-3 fatty acid ethyl esters-treated participants only)

9. Participants with prior history of treatment with omega-3 fatty acid ethyl esters

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Osaka		Japan
2		Tokyo		Japan

Sponsors and Collaborators

• Takeda

Investigators

• Study Director: Study Director, Takeda

Study Documents (Full-Text)

• Study Protocol - Jun 1, 2019
• Statistical Analysis Plan - Aug 20, 2020

More Information

Additional Information:

• To obtain more information on the study, click here/on this link

Publications

None provided.

• Responsible Party: Takeda
• ClinicalTrials.gov Identifier: NCT02285166
• Other Study ID Numbers: 142-012; JapicCTI-142680
• First Posted: Nov 6, 2014
• Last Update Posted: Feb 18, 2022
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Takeda: Pharmacological therapy
• Additional relevant MeSH terms: Hyperlipidemias; Hypolipidemic Agents

Study Results

Participant Flow

Recruitment Details

Participants took part in the survey at 1076 investigative sites in Japan, from 21 October 2014 to 14 July 2020.

Pre-assignment Detail

High-risk hyperlipidemic patients treated by statin in daily medical practice were enrolled. Participants received standard antihyperlipidemic therapy with or without intervention of omega-3 fatty acid ethyl esters as part of a routine medical care. Reported groups were combined because group assignment (With/Without intervention) was conducted after completion of data collection in this observational study and data collection for each group was not planned on the protocol of this study.

Arm/Group Title	Overall
Arm/Group Description	Participants received standard antihyperlipidemic therapy with or without intervention of omega-3 fatty acid ethyl esters by the end of surveillance as part of a routine medical care.
Period Title: Overall Study
STARTED	15330
COMPLETED	14364
NOT COMPLETED	966

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	Participants received standard antihyperlipidemic therapy with or without intervention of omega-3 fatty acid ethyl esters by the end of surveillance as part of a routine medical care.
Overall Participants	14364
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	70.8 (9.17)
Sex: Female, Male (Count of Participants)
Female	6499 45.2%
Male	7865 54.8%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
Japan	14364 100%
Number of Risk Factors (Count of Participants)
2	9749 67.9%
3	3532 24.6%
4	919 6.4%
5	150 1%
6	14 0.1%
Onset Time of Myocardial Infarction before Study Start (Count of Participants)
Less than 1 year	102 0.7%
More than 1 year ago	1159 8.1%
Frequency of Onset of Myocardial Infarction before Study Start (Count of Participants)
Once	1202 8.4%
Twice	47 0.3%
More than 3 times	12 0.1%
Onset Time of Cerebral Infarction before Study Start (Count of Participants)
Less than 1 year	199 1.4%
More than 1 year ago	2025 14.1%
Frequency of Onset of Cerebral Infarction before Study Start (Count of Participants)
Once	2086 14.5%
Twice	93 0.6%
More than 3 times	45 0.3%
Number of Participants Who Underwent Coronary Revascularization (Count of Participants)
Not received	12463 86.8%
Received	1901 13.2%
History of Peripheral Arterial Intervention (Count of Participants)
Not received	14207 98.9%
Received	157 1.1%
BMI (Kilogram (kg)/meter (m)^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kilogram (kg)/meter (m)^2]	25.39 (3.782)
Smoking Classification (Count of Participants)
Never Smoked	7574 52.7%
Current Smoker	1825 12.7%
Ex-Smoker	4467 31.1%
Drinking Habits (Count of Participants)
Drink 5 days or more per week	3645 25.4%
Drink less than 5 days per week or not drink	10245 71.3%
Frequency of Hospital Visit (Count of Participants)
More than twice a month	1410 9.8%
Around once a month	9191 64%
Once or twice every 3 months	3596 25%
Less than once or twice every 3 months	167 1.2%
Frequency of Fish Consumption (Count of Participants)
Almost everyday	1234 8.6%
Around once every other day	4272 29.7%
Around once or twice a week	6838 47.6%
Rarely eat	984 6.9%
Data not available	1036 7.2%
History and Complications of Cerebro-cardiovascular Disorder (Count of Participants)
Presence	11947 83.2%
Absence	2293 16%
Onset Time of Cerebral Hemorrhage before Study Start (Count of Participants)
Less than 1 year	8 0.1%
More than 1 year ago	159 1.1%
Frequency of Onset of Cerebral Hemorrhage before Study Start (Count of Participants)
Once	153 1.1%
Twice	10 0.1%
More than 3 times	1 0%
Data not available	3 0%
Onset Time of Subarachnoid Hemorrhage before Study Start (Count of Participants)
Less than 1 year	3 0%
More than 1 year ago	41 0.3%
Frequency of Onset of Subarachnoid Hemorrhage before Study Start (Count of Participants)
Once	44 0.3%
Twice	0 0%
More than 3 times	0 0%
Family History of Coronary Artery Disease (Parents, Brothers and Sisters) (Count of Participants)
No family history	12307 85.7%
Positive family history	1166 8.1%
Family History of Cerebrovascular Disease (Parents, Brothers and Sisters) (Count of Participants)
No family history	11960 83.3%
Positive family history	1508 10.5%
Consumption of Triglyceride (TG) in 3 Month Prior to the Observation Period (Milligram/deciliter (mg/dL)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Milligram/deciliter (mg/dL)]	229.2 (101.98)

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User
Description	Reported data was percentage of participants (cumulative incidence) with specified cardiovascular events from start of observation in population of omega-3 fatty acid ethyl esters 2 g user. Specified cardiovascular events were fatal and non-fatal, and defined as major adverse cardiovascular events (cardiovascular death [including sudden death, fatal myocardial infarction, fatal cardiac failure, fatal stroke {cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage} and other cardiovascular death], non-fatal myocardial infarction, and non-fatal stroke [cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage]), angina pectoris requiring coronary revascularization (i.e., percutaneous transluminal coronary angioplasty [PCI] or coronary artery bypass grafting [CABG]), peripheral arterial disease requiring surgery or peripheral arterial intervention.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.

Arm/Group Title	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g
Arm/Group Description	The usual adult dosage for oral use was 2 g of omega-3 fatty acid ethyl esters administered once daily or twice daily immediately after meals for treatment of hyperlipidemia. Participants received both interventions and standard antihyperlipidemic therapy as part of routine medical care.
Measure Participants	6580
Start of observation	0.0 0%
6 months	0.5 0%
12 months	1.1 0%
18 months	1.4 0%
24 months	1.9 0%
30 months	2.2 0%
36 months	2.5 0%

2. Primary Outcome

Title	Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User
Description	Reported data was percentage of participants (cumulative incidence) with specified cardiovascular events from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user. Specified cardiovascular events were fatal and non-fatal, and defined as major adverse cardiovascular events (cardiovascular death [including sudden death, fatal myocardial infarction, fatal cardiac failure, fatal stroke {cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage} and other cardiovascular death], non-fatal myocardial infarction, and non-fatal stroke [cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage]), angina pectoris requiring coronary revascularization (i.e., percutaneous transluminal coronary angioplasty [PCI] or coronary artery bypass grafting [CABG]), peripheral arterial disease requiring surgery or peripheral arterial intervention.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.

Arm/Group Title	Never User of Omega-3 Fatty Acid Ethyl Esters 2 g
Arm/Group Description	Participants received standard antihyperlipidemic therapy without omega-3 fatty acid ethyl esters 2 g as part of routine medical care.
Measure Participants	7784
Start of observation	0.0 0%
6 months	0.6 0%
12 months	1.2 0%
18 months	1.6 0%
24 months	1.9 0%
30 months	2.4 0%
36 months	2.7 0%

3. Secondary Outcome

Title	Percentage of Participants (Cumulative Incidence) With Death From All Causes (Cardiovascular and Non-cardiovascular Deaths) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User
Description	Reported data was percentage of participants (cumulative incidence) with death from all causes (cardiovascular and non-cardiovascular deaths) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.

Arm/Group Title	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g
Arm/Group Description	The usual adult dosage for oral use was 2 g of omega-3 fatty acid ethyl esters administered once daily or twice daily immediately after meals for treatment of hyperlipidemia. Participants received both interventions and standard antihyperlipidemic therapy as part of routine medical care.
Measure Participants	6580
Start of observation	0.0 0%
6 months	0.1 0%
12 months	0.4 0%
18 months	0.7 0%
24 months	0.9 0%
30 months	1.1 0%
36 months	1.4 0%

4. Secondary Outcome

Title	Percentage of Participants (Cumulative Incidence) With Death From All Causes (Cardiovascular and Non-cardiovascular Deaths) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User
Description	Reported data was percentage of participants (cumulative incidence) with death from all causes (cardiovascular and non-cardiovascular deaths) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.

Arm/Group Title	Never User of Omega-3 Fatty Acid Ethyl Esters 2 g
Arm/Group Description	Participants received standard antihyperlipidemic therapy without omega-3 fatty acid ethyl esters 2 g as part of routine medical care.
Measure Participants	7784
Start of observation	0.0 0%
6 months	0.2 0%
12 months	0.5 0%
18 months	0.7 0%
24 months	0.9 0%
30 months	1.2 0%
36 months	1.4 0%

5. Secondary Outcome

Title	Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User
Description	Reported data was percentage of participants (cumulative incidence) with major adverse cardiovascular events (MACE) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user. MACE included cardiovascular death (including sudden death, fatal myocardial infarction, fatal cardiac failure, fatal stroke [cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage] and other cardiovascular death), non-fatal myocardial infarction, and non-fatal stroke (cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage).
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.

Arm/Group Title	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g
Arm/Group Description	The usual adult dosage for oral use was 2 g of omega-3 fatty acid ethyl esters administered once daily or twice daily immediately after meals for treatment of hyperlipidemia. Participants received both interventions and standard antihyperlipidemic therapy as part of routine medical care.
Measure Participants	6580
Start of observation	0.0 0%
6 months	0.3 0%
12 months	0.7 0%
18 months	0.9 0%
24 months	1.2 0%
30 months	1.3 0%
36 months	1.5 0%

6. Secondary Outcome

Title	Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User
Description	Reported data was percentage of participants (cumulative incidence) with major adverse cardiovascular events (MACE) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user. MACE included cardiovascular death (including sudden death, fatal myocardial infarction, fatal cardiac failure, fatal stroke [cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage] and other cardiovascular death), non-fatal myocardial infarction, and non-fatal stroke (cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage).
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.

Arm/Group Title	Never User of Omega-3 Fatty Acid Ethyl Esters 2 g
Arm/Group Description	Participants received standard antihyperlipidemic therapy without omega-3 fatty acid ethyl esters 2 g as part of routine medical care.
Measure Participants	7784
Start of observation	0.0 0%
6 months	0.2 0%
12 months	0.6 0%
18 months	0.8 0%
24 months	1.0 0%
30 months	1.2 0%
36 months	1.4 0%

7. Secondary Outcome

Title	Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events From in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User
Description	Reported data was percentage of participants (cumulative incidence) with all cardiovascular events from start of observation in population of omega-3 fatty acid ethyl esters 2 g user. All cardiovascular events included MACE, angina pectoris requiring hospitalization, angina pectoris requiring coronary revascularization (i.e., PCI or CABG), cardiac failure requiring hospitalization, transient ischaemic attack requiring hospitalization, peripheral arterial disease requiring hospitalization, peripheral arterial disease requiring surgery or peripheral arterial intervention.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.

Arm/Group Title	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g
Arm/Group Description	The usual adult dosage for oral use was 2 g of omega-3 fatty acid ethyl esters administered once daily or twice daily immediately after meals for treatment of hyperlipidemia. Participants received both interventions and standard antihyperlipidemic therapy as part of routine medical care.
Measure Participants	6580
Start of observation	0.0 0%
6 months	0.7 0%
12 months	1.4 0%
18 months	1.8 0%
24 months	2.3 0%
30 months	2.7 0%
36 months	3.1 0%

8. Secondary Outcome

Title	Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User
Description	Reported data was percentage of participants (cumulative incidence) with all cardiovascular events from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user. All cardiovascular events included MACE, angina pectoris requiring hospitalization, angina pectoris requiring coronary revascularization (i.e., PCI or CABG), cardiac failure requiring hospitalization, transient ischaemic attack requiring hospitalization, peripheral arterial disease requiring hospitalization, peripheral arterial disease requiring surgery or peripheral arterial intervention.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.

Arm/Group Title	Never User of Omega-3 Fatty Acid Ethyl Esters 2 g
Arm/Group Description	Participants received standard antihyperlipidemic therapy without omega-3 fatty acid ethyl esters 2 g as part of routine medical care.
Measure Participants	7784
Start of observation	0.0 0%
6 months	0.7 0%
12 months	1.6 0%
18 months	2.1 0%
24 months	2.6 0%
30 months	3.1 0%
36 months	3.6 0%

9. Secondary Outcome

Title	Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User
Description	Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (cardiovascular death) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.

Arm/Group Title	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g
Arm/Group Description	The usual adult dosage for oral use was 2 g of omega-3 fatty acid ethyl esters administered once daily or twice daily immediately after meals for treatment of hyperlipidemia. Participants received both interventions and standard antihyperlipidemic therapy as part of routine medical care.
Measure Participants	6580
Start of observation	0.0 0%
6 months	0.0 0%
12 months	0.3 0%
18 months	0.4 0%
24 months	0.5 0%
30 months	0.5 0%
36 months	0.7 0%

10. Secondary Outcome

Title	Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User
Description	Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (cardiovascular death) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.

Arm/Group Title	Never User of Omega-3 Fatty Acid Ethyl Esters 2 g
Arm/Group Description	Participants received standard antihyperlipidemic therapy without omega-3 fatty acid ethyl esters 2 g as part of routine medical care.
Measure Participants	7784
Start of observation	0.0 0%
6 months	0.1 0%
12 months	0.3 0%
18 months	0.3 0%
24 months	0.4 0%
30 months	0.5 0%
36 months	0.6 0%

11. Secondary Outcome

Title	Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Non-fatal Myocardial Infarction) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User
Description	Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (non-fatal myocardial infarction) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.

Arm/Group Title	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g
Arm/Group Description	The usual adult dosage for oral use was 2 g of omega-3 fatty acid ethyl esters administered once daily or twice daily immediately after meals for treatment of hyperlipidemia. Participants received both interventions and standard antihyperlipidemic therapy as part of routine medical care.
Measure Participants	6580
Start of observation	0.0 0%
6 months	0.0 0%
12 months	0.1 0%
18 months	0.1 0%
24 months	0.3 0%
30 months	0.3 0%
36 months	0.3 0%

12. Secondary Outcome

Title	Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Non-fatal Myocardial Infarction) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User
Description	Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (non-fatal myocardial infarction) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.

Arm/Group Title	Never User of Omega-3- Fatty Acid Ethyl Esters 2 g
Arm/Group Description	Participants received standard antihyperlipidemic therapy without omega-3 fatty acid ethyl esters 2 g as part of routine medical care.
Measure Participants	7784
Start of observation	0.0 0%
6 months	0.1 0%
12 months	0.1 0%
18 months	0.2 0%
24 months	0.2 0%
30 months	0.2 0%
36 months	0.3 0%

13. Secondary Outcome

Title	Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Non-fatal Stroke) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User
Description	Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (non-fatal stroke) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.

Arm/Group Title	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g
Arm/Group Description	The usual adult dosage for oral use was 2 g of omega-3 fatty acid ethyl esters administered once daily or twice daily immediately after meals for treatment of hyperlipidemia. Participants received both interventions and standard antihyperlipidemic therapy as part of routine medical care.
Measure Participants	6580
Start of observation	0.0 0%
6 months	0.2 0%
12 months	0.3 0%
18 months	0.3 0%
24 months	0.4 0%
30 months	0.5 0%
36 months	0.5 0%

14. Secondary Outcome

Title	Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Non-fatal Stroke) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User
Description	Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (non-fatal stroke) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.

Arm/Group Title	Never User of Omega-3 Fatty Acid Ethyl Esters 2 g
Arm/Group Description	Participants received standard antihyperlipidemic therapy without omega-3 fatty acid ethyl esters 2 g as part of routine medical care.
Measure Participants	7784
Start of observation	0.0 0%
6 months	0.1 0%
12 months	0.2 0%
18 months	0.3 0%
24 months	0.3 0%
30 months	0.4 0%
36 months	0.5 0%

15. Secondary Outcome

Title	Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Angina Pectoris Requiring Hospitalization) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User
Description	Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (angina pectoris requiring hospitalization) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.

Arm/Group Title	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g
Arm/Group Description	The usual adult dosage for oral use was 2 g of omega-3 fatty acid ethyl esters administered once daily or twice daily immediately after meals for treatment of hyperlipidemia. Participants received both interventions and standard antihyperlipidemic therapy as part of routine medical care.
Measure Participants	6580
Start of observation	0.0 0%
6 months	0.3 0%
12 months	0.5 0%
18 months	0.6 0%
24 months	0.8 0%
30 months	0.9 0%
36 months	1.1 0%

16. Secondary Outcome

Title	Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Angina Pectoris Requiring Hospitalization) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User
Description	Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (angina pectoris requiring hospitalization) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.

Arm/Group Title	Never User of Omega-3 Fatty Acid Ethyl Esters 2 g
Arm/Group Description	Participants received standard antihyperlipidemic therapy without omega-3 fatty acid ethyl esters 2 g as part of routine medical care.
Measure Participants	7784
Start of observation	0.0 0%
6 months	0.3 0%
12 months	0.6 0%
18 months	0.9 0%
24 months	1.0 0%
30 months	1.2 0%
36 months	1.4 0%

17. Secondary Outcome

Title	Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Angina Pectoris Requiring Coronary Revascularization) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User
Description	Reported data waspercentage of participants (cumulative incidence) with individual cardiovascular events (angina pectoris requiring coronary revascularization ) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.

Arm/Group Title	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g
Arm/Group Description	The usual adult dosage for oral use was 2 g of omega-3 fatty acid ethyl esters administered once daily or twice daily immediately after meals for treatment of hyperlipidemia. Participants received both interventions and standard antihyperlipidemic therapy as part of routine medical care.
Measure Participants	6580
Start of observation	0.0 0%
6 months	0.2 0%
12 months	0.4 0%
18 months	0.5 0%
24 months	0.7 0%
30 months	0.8 0%
36 months	0.9 0%

18. Secondary Outcome

Title	Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Angina Pectoris Requiring Coronary Revascularization) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User
Description	Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (angina pectoris requiring coronary revascularization) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.

Arm/Group Title	Never User of Omega-3 Fatty Acid Ethyl Esters 2 g
Arm/Group Description	Participants received standard antihyperlipidemic therapy without omega-3 fatty acid ethyl esters 2 g as part of routine medical care.
Measure Participants	7784
Start of observation	0.0 0%
6 months	0.3 0%
12 months	0.5 0%
18 months	0.8 0%
24 months	0.9 0%
30 months	1.1 0%
36 months	1.2 0%

19. Secondary Outcome

Title	Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiac Failure Requiring Hospitalization) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User
Description	Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (cardiac failure requiring hospitalization) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.

Arm/Group Title	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g
Arm/Group Description	The usual adult dosage for oral use was 2 g of omega-3 fatty acid ethyl esters administered once daily or twice daily immediately after meals for treatment of hyperlipidemia. Participants received both interventions and standard antihyperlipidemic therapy as part of routine medical care.
Measure Participants	6580
Start of observation	0.0 0%
6 months	0.1 0%
12 months	0.1 0%
18 months	0.2 0%
24 months	0.2 0%
30 months	0.4 0%
36 months	0.4 0%

20. Secondary Outcome

Title	Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiac Failure Requiring Hospitalization) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User
Description	Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (cardiac failure requiring hospitalization) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.

Arm/Group Title	Never User of Omega-3 Fatty Acid Ethyl Esters 2 g
Arm/Group Description	Participants received standard antihyperlipidemic therapy without omega-3 fatty acid ethyl esters 2 g as part of routine medical care.
Measure Participants	7784
Start of observation	0.0 0%
6 months	0.1 0%
12 months	0.3 0%
18 months	0.4 0%
24 months	0.5 0%
30 months	0.6 0%
36 months	0.7 0%

21. Secondary Outcome

Title	Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Transient Ischaemic Attack Requiring Hospitalization) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User
Description	Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (transient ischaemic attack requiring hospitalization) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.

Arm/Group Title	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g
Arm/Group Description	The usual adult dosage for oral use was 2 g of omega-3 fatty acid ethyl esters administered once daily or twice daily immediately after meals for treatment of hyperlipidemia. Participants received both interventions and standard antihyperlipidemic therapy as part of routine medical care.
Measure Participants	6580
Start of observation	0.0 0%
6 months	0.0 0%
12 months	0.0 0%
18 months	0.0 0%
24 months	0.0 0%
30 months	0.1 0%
36 months	0.1 0%

22. Secondary Outcome

Title	Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Transient Ischaemic Attack Requiring Hospitalization) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User
Description	Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (transient ischaemic attack requiring hospitalization) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.

Arm/Group Title	Never User of Omega-3 Fatty Acid Ethyl Esters 2 g
Arm/Group Description	Participants received standard antihyperlipidemic therapy without omega-3 fatty acid ethyl esters 2 g as part of routine medical care.
Measure Participants	7784
Start of observation	0.0 0%
6 months	0.0 0%
12 months	0.0 0%
18 months	0.1 0%
24 months	0.1 0%
30 months	0.1 0%
36 months	0.1 0%

23. Secondary Outcome

Title	Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Peripheral Arterial Disease Requiring Hospitalization) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User
Description	Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (peripheral arterial disease requiring hospitalization) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.

Arm/Group Title	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g
Arm/Group Description	The usual adult dosage for oral use was 2 g of omega-3 fatty acid ethyl esters administered once daily or twice daily immediately after meals for treatment of hyperlipidemia. Participants received both interventions and standard antihyperlipidemic therapy as part of routine medical care.
Measure Participants	6580
Start of observation	0.0 0%
6 months	0.0 0%
12 months	0.0 0%
18 months	0.1 0%
24 months	0.1 0%
30 months	0.1 0%
36 months	0.1 0%

24. Secondary Outcome

Title	Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Peripheral Arterial Disease Requiring Hospitalization) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User
Description	Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (peripheral arterial disease requiring hospitalization) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.

Arm/Group Title	Never User of Omega-3 Fatty Acid Ethyl Esters 2 g
Arm/Group Description	Participants received standard antihyperlipidemic therapy without omega-3 fatty acid ethyl esters 2 g as part of routine medical care.
Measure Participants	7784
Start of observation	0.0 0%
6 months	0.0 0%
12 months	0.1 0%
18 months	0.1 0%
24 months	0.1 0%
30 months	0.2 0%
36 months	0.2 0%

25. Secondary Outcome

Title	Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Peripheral Arterial Disease Requiring Surgery or Peripheral Arterial Intervention) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User
Description	Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (peripheral arterial disease requiring surgery or peripheral arterial intervention) from start of observation in population of omega-3 fatty acid ethyl esters 2 g user.
Time Frame	Up to 36 months fatty

Outcome Measure Data

Analysis Population Description

Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.

Arm/Group Title	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g
Arm/Group Description	The usual adult dosage for oral use was 2 g of omega-3 fatty acid ethyl esters administered once daily or twice daily immediately after meals for treatment of hyperlipidemia. Participants received both interventions and standard antihyperlipidemic therapy as part of routine medical care.
Measure Participants	6580
Start of observation	0.0 0%
6 months	0.0 0%
12 months	0.0 0%
18 months	0.0 0%
24 months	0.0 0%
30 months	0.1 0%
36 months	0.1 0%

26. Secondary Outcome

Title	Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Peripheral Arterial Disease Requiring Surgery or Peripheral Arterial Intervention) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User
Description	Reported data was percentage of participants (cumulative incidence) with individual cardiovascular events (peripheral arterial disease requiring surgery or peripheral arterial intervention) from start of observation in population of omega-3 fatty acid ethyl esters 2 g never user.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Participants in efficacy analysis set who received both interventions and standard antihyperlipidemic therapy as part of routine medical care. The efficacy analysis set was defined as all participants who completed the survey.

Arm/Group Title	Never User of Omega-3 Fatty Acid Ethyl Esters 2 g
Arm/Group Description	Participants received standard antihyperlipidemic therapy without omega-3 fatty acid ethyl esters 2 g as part of routine medical care.
Measure Participants	7784
Start of observation	0.0 0%
6 months	0.0 0%
12 months	0.1 0%
18 months	0.1 0%
24 months	0.1 0%
30 months	0.2 0%
36 months	0.2 0%

Adverse Events

Time Frame	Up to 36 months
Adverse Event Reporting Description	In this survey, only the data of mortality and cardiovascular side effects with Omega-3 fatty acid ethyl esters 2 g (see Other Adverse Event[AE]s table below) were planned to be collected and report. That is, due to observational study, the other AEs data such as serious AEs, non-cardiovascular AEs were not planned to be collected and reported. Reported data were only mortality and side effects data in the population of treatment with Omega-3 fatty acid ethyl esters 2 g.
Arm/Group Title	Omega-3 Fatty Acid Ethyl Esters 2 g
Arm/Group Description	The usual adult dosage for oral use was 2 g of omega-3 fatty acid ethyl esters administered once daily or twice daily immediately after meals for treatment of hyperlipidemia. Participants received both interventions and standard antihyperlipidemic therapy as part of routine medical care. Reported groups were combined in this section because group assignment (groups with or without intervention of omega-3 fatty acid ethyl esters) was conducted after completion of data collection (collection of Case Report Form) in this observational study and collection of data for each group during this study was not planned on the protocol of this study.
All Cause Mortality
	Omega-3 Fatty Acid Ethyl Esters 2 g
	Affected / at Risk (%)	# Events
Total	74/5859 (1.3%)
Serious Adverse Events
	Omega-3 Fatty Acid Ethyl Esters 2 g
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Omega-3 Fatty Acid Ethyl Esters 2 g
	Affected / at Risk (%)	# Events
Total	25/6867 (0.4%)
Cardiac disorders
Angina pectoris	8/6867 (0.1%)
Myocardial infarction	1/6867 (0%)
General disorders
Sudden death	7/6867 (0.1%)
Nervous system disorders
Cerebral haemorrhage	2/6867 (0%)
Cerebral infarction	2/6867 (0%)
Subarachnoid haemorrhage	3/6867 (0%)
Transient ischaemic attack	2/6867 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.