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

Completed

• Conditions: Hyperlipidemia
• Interventions: Drug: Standard antihyperlipidemic therapy other than administration of omega-3 fatty acid ethyl esters (Lotriga).; Drug: Omega-3 fatty acid ethyl esters

• Registration Number: NCT02285166
• Lead Sponsor: Takeda

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.

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

Study Timeline

• Study Start: 2014-10-21
• Study First Submitted: 2014-11-04
• Study First Submitted QC: 2014-11-04
• Study First Posted: 2014-11-06
• Primary Completion: 2020-07-14
• Study Completion: 2020-07-14
• Status Verified: 2021-07
• Results First Submitted: 2021-07-13
• Results First Submitted QC: 2021-12-02
• Last Update Submitted: 2021-12-02
• Results First Posted: 2022-02-18
• Last Update Posted: 2022-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15330

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Never User of Omega-3 fatty acid ethyl esters 2 g	Standard antihyperlipidemic therapy other than administration of omega-3 fatty acid ethyl esters (Lotriga).	Participants received standard antihyperlipidemic therapy without omega-3 fatty acid ethyl esters 2 g as part of routine medical care.
Ever User of Omega-3 fatty acid ethyl esters 2 g	Omega-3 fatty acid ethyl esters	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.

Primary Outcome Measures

Name	Time	Method
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.
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

Name	Time	Method
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.
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.
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.
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.
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.
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).
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.