N/A
Completed N=15,330
Specified Drug-use Survey of the Granular Capsule Formulation of Omega-3 Fatty Acid Ethyl Esters: OCEAN3
Source: ClinicalTrials.gov NCT02285166 ↗Enrolled (actual)
15,330
Serious AEs
—
Results posted
Feb 2022
Primary outcomePrimary: Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User — 0.0; 0.5; 1.1; 1.4 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User |
0.0; 0.5; 1.1; 1.4; 1.9; 2.2 | — |
| PRIMARY Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User |
0.0; 0.6; 1.2; 1.6; 1.9; 2.4 | — |
| SECONDARY 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 |
0.0; 0.1; 0.4; 0.7; 0.9; 1.1 | — |
| SECONDARY 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 |
0.0; 0.2; 0.5; 0.7; 0.9; 1.2 | — |
| SECONDARY Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User |
0.0; 0.3; 0.7; 0.9; 1.2; 1.3 | — |
| SECONDARY Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User |
0.0; 0.2; 0.6; 0.8; 1.0; 1.2 | — |
| SECONDARY Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events From in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User |
0.0; 0.7; 1.4; 1.8; 2.3; 2.7 | — |
| SECONDARY Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User |
0.0; 0.7; 1.6; 2.1; 2.6; 3.1 | — |
| SECONDARY Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User |
0.0; 0.0; 0.3; 0.4; 0.5; 0.5 | — |
| SECONDARY Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User |
0.0; 0.1; 0.3; 0.3; 0.4; 0.5 | — |
| SECONDARY 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 |
0.0; 0.0; 0.1; 0.1; 0.3; 0.3 | — |
| SECONDARY 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 |
0.0; 0.1; 0.1; 0.2; 0.2; 0.2 | — |
| SECONDARY Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Non-fatal Stroke) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User |
0.0; 0.2; 0.3; 0.3; 0.4; 0.5 | — |
| SECONDARY 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 |
0.0; 0.1; 0.2; 0.3; 0.3; 0.4 | — |
| SECONDARY 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 |
0.0; 0.3; 0.5; 0.6; 0.8; 0.9 | — |
| SECONDARY 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 |
0.0; 0.3; 0.6; 0.9; 1.0; 1.2 | — |
| SECONDARY 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 |
0.0; 0.2; 0.4; 0.5; 0.7; 0.8 | — |
| SECONDARY 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 |
0.0; 0.3; 0.5; 0.8; 0.9; 1.1 | — |
| SECONDARY 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 |
0.0; 0.1; 0.1; 0.2; 0.2; 0.4 | — |
| SECONDARY 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 |
0.0; 0.1; 0.3; 0.4; 0.5; 0.6 | — |
| SECONDARY 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 |
0.0; 0.0; 0.0; 0.0; 0.0; 0.1 | — |
| SECONDARY 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 |
0.0; 0.0; 0.0; 0.1; 0.1; 0.1 | — |
| SECONDARY 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 |
0.0; 0.0; 0.0; 0.1; 0.1; 0.1 | — |
| SECONDARY 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 |
0.0; 0.0; 0.1; 0.1; 0.1; 0.2 | — |
| SECONDARY 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 |
0.0; 0.0; 0.0; 0.0; 0.0; 0.1 | — |
| SECONDARY 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 |
0.0; 0.0; 0.1; 0.1; 0.1; 0.2 | — |
Eligibility Criteria
Inclusion Criteria
Participants who meet all of the following criteria will be included in the survey:
- Patients with hyperlipidemia on statin therapy
- Outpatients
- Male participants aged ≥ 50 years and female participants aged ≥ 60 years
- Participants with fasting TG level ≥ 150 mg/dL (within 3 months prior to the start of the observation period)
- Participants who have at least two of the following risk factors:
- Hypertension
- Type 2 diabetes mellitus
- Chronic kidney disease
- Prior history of myocardial infarction or angina pectoris
- Prior history of cerebral infarction
- Peripheral arterial disease
Exclusion Criteria
-Participants who meet any of the following criteria will be excluded from the survey:
- Participants who have experienced coronary artery disease within 1 month prior to the start of the observation period
- Participants who have experienced cerebrovascular disease within 1 month prior to the start of the observation period
- 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
- Participants who plan to undergo heart surgery or revascularization surgery (including coronary artery intervention and peripheral arterial intervention)
- Patients with malignant tumors currently under treatment
- 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
- Patients with hemorrhage (e.g., hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract hemorrhage, hemoptysis, or vitreous hemorrhage)
- 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)
- Participants with prior history of treatment with omega-3 fatty acid ethyl esters
Data sourced from ClinicalTrials.gov (NCT02285166). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.