Trial Outcomes & Findings for Specified Drug-use Survey of the Granular Capsule Formulation of Omega-3 Fatty Acid Ethyl Esters: OCEAN3 (NCT NCT02285166)

Last Updated: 2022-02-18

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

15330 participants

Primary outcome timeframe

Up to 36 months

Results posted on

2022-02-18

Participant Flow

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

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.

Participant milestones

Participant milestones
Measure	Overall 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 Study STARTED	15330
Overall Study COMPLETED	14364
Overall Study NOT COMPLETED	966

Reasons for withdrawal

Reasons for withdrawal
Measure	Overall 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 Study Case Report Forms Uncollected	564
Overall Study Protocol Deviation	402

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=14364 Participants 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.
Age, Continuous	70.8 Years STANDARD_DEVIATION 9.17 • n=14364 Participants
Sex: Female, Male Female	6499 Participants n=14364 Participants
Sex: Female, Male Male	7865 Participants n=14364 Participants
Region of Enrollment Japan	14364 Participants n=14364 Participants
Number of Risk Factors 2	9749 Participants n=14364 Participants
Number of Risk Factors 3	3532 Participants n=14364 Participants
Number of Risk Factors 4	919 Participants n=14364 Participants
Number of Risk Factors 5	150 Participants n=14364 Participants
Number of Risk Factors 6	14 Participants n=14364 Participants
Onset Time of Myocardial Infarction before Study Start Less than 1 year	102 Participants n=1261 Participants • The number analyzed is the number of participants with data available for analysis who experienced myocardial infarction before study start as past medical history.
Onset Time of Myocardial Infarction before Study Start More than 1 year ago	1159 Participants n=1261 Participants • The number analyzed is the number of participants with data available for analysis who experienced myocardial infarction before study start as past medical history.
Frequency of Onset of Myocardial Infarction before Study Start Once	1202 Participants n=1261 Participants • The number analyzed is the number of participants with data available for analysis who experienced myocardial infarction before study start as past medical history.
Frequency of Onset of Myocardial Infarction before Study Start Twice	47 Participants n=1261 Participants • The number analyzed is the number of participants with data available for analysis who experienced myocardial infarction before study start as past medical history.
Frequency of Onset of Myocardial Infarction before Study Start More than 3 times	12 Participants n=1261 Participants • The number analyzed is the number of participants with data available for analysis who experienced myocardial infarction before study start as past medical history.
Onset Time of Cerebral Infarction before Study Start Less than 1 year	199 Participants n=2224 Participants • The number analyzed is the number of participants with data available for analysis who experienced cerebral infarction before study start as past medical history.
Onset Time of Cerebral Infarction before Study Start More than 1 year ago	2025 Participants n=2224 Participants • The number analyzed is the number of participants with data available for analysis who experienced cerebral infarction before study start as past medical history.
Frequency of Onset of Cerebral Infarction before Study Start Once	2086 Participants n=2224 Participants • The number analyzed is the number of participants with data available for analysis who experienced cerebral infarction before study start as past medical history.
Frequency of Onset of Cerebral Infarction before Study Start Twice	93 Participants n=2224 Participants • The number analyzed is the number of participants with data available for analysis who experienced cerebral infarction before study start as past medical history.
Frequency of Onset of Cerebral Infarction before Study Start More than 3 times	45 Participants n=2224 Participants • The number analyzed is the number of participants with data available for analysis who experienced cerebral infarction before study start as past medical history.
Number of Participants Who Underwent Coronary Revascularization Not received	12463 Participants n=14364 Participants
Number of Participants Who Underwent Coronary Revascularization Received	1901 Participants n=14364 Participants
History of Peripheral Arterial Intervention Not received	14207 Participants n=14364 Participants
History of Peripheral Arterial Intervention Received	157 Participants n=14364 Participants
BMI	25.39 Kilogram (kg)/meter (m)^2 STANDARD_DEVIATION 3.782 • n=12982 Participants • The number analyzed is the number of participants with data available for analysis.
Smoking Classification Never Smoked	7574 Participants n=13866 Participants • The number analyzed is the number of participants with data available for analysis.
Smoking Classification Current Smoker	1825 Participants n=13866 Participants • The number analyzed is the number of participants with data available for analysis.
Smoking Classification Ex-Smoker	4467 Participants n=13866 Participants • The number analyzed is the number of participants with data available for analysis.
Drinking Habits Drink 5 days or more per week	3645 Participants n=13890 Participants • The number analyzed is the number of participants with data available for analysis.
Drinking Habits Drink less than 5 days per week or not drink	10245 Participants n=13890 Participants • The number analyzed is the number of participants with data available for analysis.
Frequency of Hospital Visit More than twice a month	1410 Participants n=14364 Participants
Frequency of Hospital Visit Around once a month	9191 Participants n=14364 Participants
Frequency of Hospital Visit Once or twice every 3 months	3596 Participants n=14364 Participants
Frequency of Hospital Visit Less than once or twice every 3 months	167 Participants n=14364 Participants
Frequency of Fish Consumption Almost everyday	1234 Participants n=14364 Participants
Frequency of Fish Consumption Around once every other day	4272 Participants n=14364 Participants
Frequency of Fish Consumption Around once or twice a week	6838 Participants n=14364 Participants
Frequency of Fish Consumption Rarely eat	984 Participants n=14364 Participants
Frequency of Fish Consumption Data not available	1036 Participants n=14364 Participants
History and Complications of Cerebro-cardiovascular Disorder Presence	11947 Participants n=14240 Participants • The number analyzed is the number of participants with data available for analysis.
History and Complications of Cerebro-cardiovascular Disorder Absence	2293 Participants n=14240 Participants • The number analyzed is the number of participants with data available for analysis.
Onset Time of Cerebral Hemorrhage before Study Start Less than 1 year	8 Participants n=167 Participants • The number analyzed is the number of participants with data available for analysis who experienced cerebral hemorrhage before study start as past medical history.
Onset Time of Cerebral Hemorrhage before Study Start More than 1 year ago	159 Participants n=167 Participants • The number analyzed is the number of participants with data available for analysis who experienced cerebral hemorrhage before study start as past medical history.
Frequency of Onset of Cerebral Hemorrhage before Study Start Once	153 Participants n=167 Participants • The number analyzed is the number of participants with data available for analysis who experienced cerebral hemorrhage before study start as past medical history.
Frequency of Onset of Cerebral Hemorrhage before Study Start Twice	10 Participants n=167 Participants • The number analyzed is the number of participants with data available for analysis who experienced cerebral hemorrhage before study start as past medical history.
Frequency of Onset of Cerebral Hemorrhage before Study Start More than 3 times	1 Participants n=167 Participants • The number analyzed is the number of participants with data available for analysis who experienced cerebral hemorrhage before study start as past medical history.
Frequency of Onset of Cerebral Hemorrhage before Study Start Data not available	3 Participants n=167 Participants • The number analyzed is the number of participants with data available for analysis who experienced cerebral hemorrhage before study start as past medical history.
Onset Time of Subarachnoid Hemorrhage before Study Start Less than 1 year	3 Participants n=44 Participants • The number analyzed is the number of participants with data available for analysis who experienced subarachnoid hemorrhage before study start as past medical history.
Onset Time of Subarachnoid Hemorrhage before Study Start More than 1 year ago	41 Participants n=44 Participants • The number analyzed is the number of participants with data available for analysis who experienced subarachnoid hemorrhage before study start as past medical history.
Frequency of Onset of Subarachnoid Hemorrhage before Study Start Once	44 Participants n=44 Participants • The number analyzed is the number of participants with data available for analysis who experienced subarachnoid hemorrhage before study start as past medical history.
Frequency of Onset of Subarachnoid Hemorrhage before Study Start Twice	0 Participants n=44 Participants • The number analyzed is the number of participants with data available for analysis who experienced subarachnoid hemorrhage before study start as past medical history.
Frequency of Onset of Subarachnoid Hemorrhage before Study Start More than 3 times	0 Participants n=44 Participants • The number analyzed is the number of participants with data available for analysis who experienced subarachnoid hemorrhage before study start as past medical history.
Family History of Coronary Artery Disease (Parents, Brothers and Sisters) No family history	12307 Participants n=13473 Participants • The number analyzed is the number of participants with data available for analysis.
Family History of Coronary Artery Disease (Parents, Brothers and Sisters) Positive family history	1166 Participants n=13473 Participants • The number analyzed is the number of participants with data available for analysis.
Family History of Cerebrovascular Disease (Parents, Brothers and Sisters) No family history	11960 Participants n=13468 Participants • The number analyzed is the number of participants with data available for analysis.
Family History of Cerebrovascular Disease (Parents, Brothers and Sisters) Positive family history	1508 Participants n=13468 Participants • The number analyzed is the number of participants with data available for analysis.
Consumption of Triglyceride (TG) in 3 Month Prior to the Observation Period	229.2 Milligram/deciliter (mg/dL) STANDARD_DEVIATION 101.98 • n=14364 Participants

PRIMARY outcome

Timeframe: Up to 36 months

Population: 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.

Outcome measures

Outcome measures
Measure	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g n=6580 Participants 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.
Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User Start of observation	0.0 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User 6 months	0.5 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User 12 months	1.1 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User 18 months	1.4 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User 24 months	1.9 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User 30 months	2.2 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User 36 months	2.5 Percentage of participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g n=7784 Participants 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.
Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User Start of observation	0.0 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User 6 months	0.6 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User 12 months	1.2 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User 18 months	1.6 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User 24 months	1.9 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User 30 months	2.4 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User 36 months	2.7 Percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g n=6580 Participants 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.
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 Start of observation	0.0 Percentage of participants
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 6 months	0.1 Percentage of participants
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 12 months	0.4 Percentage of participants
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 18 months	0.7 Percentage of participants
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 24 months	0.9 Percentage of participants
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 30 months	1.1 Percentage of participants
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 36 months	1.4 Percentage of participants

SECONDARY outcome

Timeframe: Up to 36 months

Outcome measures

Outcome measures
Measure	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g n=7784 Participants 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.
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 36 months	1.4 Percentage of participants
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 Start of observation	0.0 Percentage of participants
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 6 months	0.2 Percentage of participants
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 12 months	0.5 Percentage of participants
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 18 months	0.7 Percentage of participants
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 24 months	0.9 Percentage of participants
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 30 months	1.2 Percentage of participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g n=6580 Participants 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.
Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User Start of observation	0.0 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User 6 months	0.3 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User 12 months	0.7 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User 18 months	0.9 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User 24 months	1.2 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User 30 months	1.3 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User 36 months	1.5 Percentage of participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g n=7784 Participants 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.
Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User Start of observation	0.0 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User 6 months	0.2 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User 12 months	0.6 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User 18 months	0.8 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User 24 months	1.0 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User 30 months	1.2 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User 36 months	1.4 Percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g n=6580 Participants 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.
Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events From in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User Start of observation	0.0 Percentage of participants
Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events From in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User 6 months	0.7 Percentage of participants
Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events From in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User 12 months	1.4 Percentage of participants
Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events From in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User 18 months	1.8 Percentage of participants
Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events From in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User 24 months	2.3 Percentage of participants
Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events From in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User 30 months	2.7 Percentage of participants
Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events From in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User 36 months	3.1 Percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g n=7784 Participants 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.
Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User Start of observation	0.0 Percentage of participants
Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User 6 months	0.7 Percentage of participants
Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User 12 months	1.6 Percentage of participants
Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User 18 months	2.1 Percentage of participants
Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User 24 months	2.6 Percentage of participants
Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User 30 months	3.1 Percentage of participants
Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User 36 months	3.6 Percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g n=6580 Participants 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.
Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User Start of observation	0.0 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User 6 months	0.0 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User 12 months	0.3 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User 18 months	0.4 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User 24 months	0.5 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User 30 months	0.5 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User 36 months	0.7 Percentage of participants

SECONDARY outcome

Timeframe: Up to 36 months

Outcome measures

Outcome measures
Measure	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g n=7784 Participants 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.
Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User Start of observation	0.0 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User 6 months	0.1 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User 12 months	0.3 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User 18 months	0.3 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User 24 months	0.4 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User 30 months	0.5 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User 36 months	0.6 Percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g n=6580 Participants 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.
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 Start of observation	0.0 Percentage of participants
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 6 months	0.0 Percentage of participants
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 12 months	0.1 Percentage of participants
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 18 months	0.1 Percentage of participants
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 24 months	0.3 Percentage of participants
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 30 months	0.3 Percentage of participants
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 36 months	0.3 Percentage of participants

SECONDARY outcome

Timeframe: Up to 36 months

Outcome measures

Outcome measures
Measure	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g n=7784 Participants 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.
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 Start of observation	0.0 Percentage of participants
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 6 months	0.1 Percentage of participants
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 12 months	0.1 Percentage of participants
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 18 months	0.2 Percentage of participants
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 24 months	0.2 Percentage of participants
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 30 months	0.2 Percentage of participants
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 36 months	0.3 Percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g n=6580 Participants 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.
Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Non-fatal Stroke) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User Start of observation	0.0 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Non-fatal Stroke) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User 6 months	0.2 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Non-fatal Stroke) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User 12 months	0.3 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Non-fatal Stroke) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User 18 months	0.3 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Non-fatal Stroke) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User 24 months	0.4 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Non-fatal Stroke) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User 30 months	0.5 Percentage of participants
Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Non-fatal Stroke) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User 36 months	0.5 Percentage of participants

SECONDARY outcome

Timeframe: Up to 36 months

Outcome measures

Outcome measures
Measure	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g n=7784 Participants 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.
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 Start of observation	0.0 Percentage of participants
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 6 months	0.1 Percentage of participants
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 12 months	0.2 Percentage of participants
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 18 months	0.3 Percentage of participants
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 24 months	0.3 Percentage of participants
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 30 months	0.4 Percentage of participants
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 36 months	0.5 Percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g n=6580 Participants 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.
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 Start of observation	0.0 Percentage of participants
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 6 months	0.3 Percentage of participants
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 12 months	0.5 Percentage of participants
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 18 months	0.6 Percentage of participants
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 24 months	0.8 Percentage of participants
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 30 months	0.9 Percentage of participants
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 36 months	1.1 Percentage of participants

SECONDARY outcome

Timeframe: Up to 36 months

Outcome measures

Outcome measures
Measure	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g n=7784 Participants 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.
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 Start of observation	0.0 Percentage of participants
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 6 months	0.3 Percentage of participants
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 12 months	0.6 Percentage of participants
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 18 months	0.9 Percentage of participants
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 24 months	1.0 Percentage of participants
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 30 months	1.2 Percentage of participants
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 36 months	1.4 Percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g n=6580 Participants 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.
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 Start of observation	0.0 Percentage of participants
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 6 months	0.2 Percentage of participants
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 12 months	0.4 Percentage of participants
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 18 months	0.5 Percentage of participants
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 24 months	0.7 Percentage of participants
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 30 months	0.8 Percentage of participants
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 36 months	0.9 Percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g n=7784 Participants 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.
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 Start of observation	0.0 Percentage of participants
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 6 months	0.3 Percentage of participants
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 12 months	0.5 Percentage of participants
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 18 months	0.8 Percentage of participants
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 24 months	0.9 Percentage of participants
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 30 months	1.1 Percentage of participants
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 36 months	1.2 Percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g n=6580 Participants 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.
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 Start of observation	0.0 Percentage of participants
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 6 months	0.1 Percentage of participants
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 12 months	0.1 Percentage of participants
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 18 months	0.2 Percentage of participants
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 24 months	0.2 Percentage of participants
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 30 months	0.4 Percentage of participants
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 36 months	0.4 Percentage of participants

SECONDARY outcome

Timeframe: Up to 36 months

Outcome measures

Outcome measures
Measure	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g n=7784 Participants 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.
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 Start of observation	0.0 Percentage of participants
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 6 months	0.1 Percentage of participants
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 12 months	0.3 Percentage of participants
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 18 months	0.4 Percentage of participants
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 24 months	0.5 Percentage of participants
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 30 months	0.6 Percentage of participants
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 36 months	0.7 Percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g n=6580 Participants 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.
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 Start of observation	0.0 Percentage of participants
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 6 months	0.0 Percentage of participants
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 12 months	0.0 Percentage of participants
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 18 months	0.0 Percentage of participants
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 24 months	0.0 Percentage of participants
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 30 months	0.1 Percentage of participants
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 36 months	0.1 Percentage of participants

SECONDARY outcome

Timeframe: Up to 36 months

Outcome measures

Outcome measures
Measure	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g n=7784 Participants 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.
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 Start of observation	0.0 Percentage of participants
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 6 months	0.0 Percentage of participants
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 12 months	0.0 Percentage of participants
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 18 months	0.1 Percentage of participants
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 24 months	0.1 Percentage of participants
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 30 months	0.1 Percentage of participants
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 36 months	0.1 Percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g n=6580 Participants 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.
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 Start of observation	0.0 Percentage of participants
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 6 months	0.0 Percentage of participants
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 12 months	0.0 Percentage of participants
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 18 months	0.1 Percentage of participants
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 24 months	0.1 Percentage of participants
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 30 months	0.1 Percentage of participants
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 36 months	0.1 Percentage of participants

SECONDARY outcome

Timeframe: Up to 36 months

Outcome measures

Outcome measures
Measure	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g n=7784 Participants 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.
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 Start of observation	0.0 Percentage of participants
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 6 months	0.0 Percentage of participants
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 12 months	0.1 Percentage of participants
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 18 months	0.1 Percentage of participants
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 24 months	0.1 Percentage of participants
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 30 months	0.2 Percentage of participants
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 36 months	0.2 Percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g n=6580 Participants 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.
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 Start of observation	0.0 Percentage of participants
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 6 months	0.0 Percentage of participants
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 12 months	0.0 Percentage of participants
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 18 months	0.0 Percentage of participants
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 24 months	0.0 Percentage of participants
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 30 months	0.1 Percentage of participants
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 36 months	0.1 Percentage of participants

SECONDARY outcome

Timeframe: Up to 36 months

Outcome measures

Outcome measures
Measure	Ever User of Omega-3 Fatty Acid Ethyl Esters 2 g n=7784 Participants 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.
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 Start of observation	0.0 Percentage of participants
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 6 months	0.0 Percentage of participants
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 12 months	0.1 Percentage of participants
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 18 months	0.1 Percentage of participants
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 24 months	0.1 Percentage of participants
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 30 months	0.2 Percentage of participants
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 36 months	0.2 Percentage of participants

Adverse Events

Omega-3 Fatty Acid Ethyl Esters 2 g

Serious events: 0 serious events

Other events: 25 other events

Deaths: 74 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Omega-3 Fatty Acid Ethyl Esters 2 g n=6867 participants at risk 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.
Nervous system disorders Cerebral haemorrhage	0.03% 2/6867 • Up to 36 months 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.
Nervous system disorders Cerebral infarction	0.03% 2/6867 • Up to 36 months 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.
Nervous system disorders Subarachnoid haemorrhage	0.04% 3/6867 • Up to 36 months 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.
Nervous system disorders Transient ischaemic attack	0.03% 2/6867 • Up to 36 months 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.
Cardiac disorders Angina pectoris	0.12% 8/6867 • Up to 36 months 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.
Cardiac disorders Myocardial infarction	0.01% 1/6867 • Up to 36 months 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.
General disorders Sudden death	0.10% 7/6867 • Up to 36 months 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.

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER