Clinical trial NCT02285166: Specified Drug-use Survey of the Granular Capsule Formulation of Omega-3 Fatty Acid Ethyl Esters: OCEAN3
Official title: Specified Drug-use Survey of Lotriga Granular Capsules: OCEAN3 (Outcome Prevention on Cardiovascular Events by Antihyperlipidemic Therapy With N3-fatty Acid in Japan)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperlipidemia
Keywords: Pharmacological therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-11-06
Enrollment: 15330
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hyperlipidemia

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.

Eligibility criteria: Inclusion Criteria:

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

1. Patients with hyperlipidemia on statin therapy
2. Outpatients
3. Male participants aged ≥ 50 years and female participants aged ≥ 60 years
4. Participants with fasting TG level ≥ 150 mg/dL (within 3 months prior to the start of the observation period)
5. Participants who have at least two of the following risk factors:

   * Hypertension
   * Type 2 diabetes mellitus
   * Chronic kidney disease
   * Prior history of myocardial infarction or angina pectoris
   * Prior history of cerebral infarction
   * Peripheral arterial disease

Exclusion Criteria:

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

1. Participants who have experienced coronary artery disease within 1 month prior to the start of the observation period
2. Participants who have experienced cerebrovascular disease within 1 month prior to the start of the observation period
3. Participants who have undergone heart surgery or revascularization surgery (including coronary artery intervention and peripheral arterial intervention) within 1 month prior to the start of the observation period
4. Participants who plan to undergo heart surgery or revascularization surgery (including coronary artery intervention and peripheral arterial intervention)
5. Patients with malignant tumors currently under treatment
6. Participants who have received eicosapentaenoic acid (hereinafter, EPA) products within 1 month prior to the start of the observation period, or participants who plan to receive treatment with EPA products after the start of the observation period
7. Patients with hemorrhage (e.g., hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract hemorrhage, hemoptysis, or vitreous hemorrhage)
8. Participants with prior history of hypersensitivity to any ingredients in omega-3 fatty acid ethyl esters (omega-3 fatty acid ethyl esters-treated participants only)
9. Participants with prior history of treatment with omega-3 fatty acid ethyl esters

Primary outcomes:
measure: Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User
timeFrame: Up to 36 months
measure: Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User
timeFrame: Up to 36 months
Secondary outcomes:
measure: 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
timeFrame: Up to 36 months
measure: 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
timeFrame: Up to 36 months
measure: Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User
timeFrame: Up to 36 months
measure: Percentage of Participants (Cumulative Incidence) With Major Adverse Cardiovascular Events (MACE) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User
timeFrame: Up to 36 months
measure: Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events From in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User
timeFrame: Up to 36 months
measure: Percentage of Participants (Cumulative Incidence) With All Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User
timeFrame: Up to 36 months
measure: Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User
timeFrame: Up to 36 months
measure: Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Cardiovascular Death) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User
timeFrame: Up to 36 months
measure: 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
timeFrame: Up to 36 months
measure: 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
timeFrame: Up to 36 months
measure: Percentage of Participants (Cumulative Incidence) With Individual Cardiovascular Events (Non-fatal Stroke) in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User
timeFrame: Up to 36 months
measure: 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
timeFrame: Up to 36 months
measure: 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
timeFrame: Up to 36 months
measure: 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
timeFrame: Up to 36 months
measure: 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
timeFrame: Up to 36 months
measure: 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
timeFrame: Up to 36 months
measure: 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
timeFrame: Up to 36 months
measure: 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
timeFrame: Up to 36 months
measure: 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
timeFrame: Up to 36 months
measure: 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
timeFrame: Up to 36 months
measure: 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
timeFrame: Up to 36 months
measure: 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
timeFrame: Up to 36 months
measure: 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
timeFrame: Up to 36 months fatty
measure: 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
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Osaka
country: Japan
city: Tokyo
country: Japan
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Teramoto T, Ogawa H, Ueshima H, Okada Y, Haze K, Matsui S, Fujikawa K, Hashimoto T, Sakui S, Nishimura K, Kajita M, Horimoto A, Fernandez J. Effect of omega-3 fatty acids on cardiovascular events in high-risk patients with hypertriglyceridemia in Japan: a 3-year post-marketing surveillance study (OCEAN3 survey). Expert Opin Drug Saf. 2023 Jan;22(1):81-90. doi: 10.1080/14740338.2022.2094914. Epub 2022 Jul 8.