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

• Status: Completed
• Trial end date: 2020-07-14
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Hypolipidemic Agents

Criteria

Inclusion Criteria:

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

1. Patients with hyperlipidemia on statin therapy

2. Outpatients

3. Male patients aged ≥ 50 years and female patients aged ≥ 60 years

4. Patients with fasting TG level ≥ 150 mg/dL (within 3 months prior to the start of the observation period)

5. Patients 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:

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

1. Patients who have experienced coronary artery disease within 1 month prior to the start of the observation period

2. Patients who have experienced cerebrovascular disease within 1 month prior to the start of the observation period

3. Patients 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. Patients 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. Patients who have received eicosapentaenoic acid (hereinafter, EPA) products within 1 month prior to the start of the observation period, or patients who plan to received 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. Patients with prior history of hypersensitivity to any ingredients in Lotriga (Lotriga-treated patients only)

9. Patients with prior history of treatment with Lotriga