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

NCT02285166 | Completed Results

• 2 other identifiers: 142-012JapicCTI-142680
• Study Type: observational
• Target: 15,330
• Locations: 1 country
• Sites: 2

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.

Conditions

Hyperlipidemia

Keywords

Pharmacological therapy

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular Events in Population of Omega-3 Fatty Acid Ethyl Esters 2 g User

  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.

  Up to 36 months

• Percentage of Participants (Cumulative Incidence) With Specified Cardiovascular in Population of Omega-3 Fatty Acid Ethyl Esters 2 g Never User

  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.

  Up to 36 months

Secondary Outcomes (24)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Ever User of Omega-3 fatty acid ethyl esters 2 g

The usual adult dosage for oral use was 2 g of omega-3 fatty acid ethyl esters administered once daily or twice daily immediately after meals for treatment of hyperlipidemia. Participants received both interventions and standard antihyperlipidemic therapy as part of routine medical care.

Drug: Omega-3 fatty acid ethyl esters

Never User of Omega-3 fatty acid ethyl esters 2 g

Participants received standard antihyperlipidemic therapy without omega-3 fatty acid ethyl esters 2 g as part of routine medical care.

Drug: Standard antihyperlipidemic therapy other than administration of omega-3 fatty acid ethyl esters (Lotriga).

Interventions

Omega-3 fatty acid ethyl esters DRUG

Omega-3 fatty acid ethyl esters granular capsules

Also known as: Lotriga granular capsules

Ever User of Omega-3 fatty acid ethyl esters 2 g

Standard antihyperlipidemic therapy other than administration of omega-3 fatty acid ethyl esters (Lotriga). DRUG

Never User of Omega-3 fatty acid ethyl esters 2 g

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hyperlipidemia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Takeda: lead

Study Sites (2)

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Related Publications (1)

• 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.

  PMID: 35772177 DERIVED

Related Links

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

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Omacor

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2014
• First Posted: November 6, 2014
• Study Start: October 21, 2014
• Primary Completion: July 14, 2020
• Study Completion: July 14, 2020
• Last Updated: February 18, 2022
• Results First Posted: February 18, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

JP (2)