Evaluation of the Safety and Efficacy of Long-term Use of Omega-3 Fatty Acid Ethyl Esters

Takeda

Status: Completed

Conditions: Hyperlipidemia

Treatments: Drug: Omega-3 fatty acid ethyl esters

Study type: Observational

Funder types: Industry

Identifiers

NCT02153073

142-011

JapicCTI-142457 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of long-term use of granular capsule formulation of omega-3 fatty acid ethyl esters (Lotriga Granular Capsules) in patients with hyperlipidemia in daily medical practice

Full description

This special drug use surveillance on long-term use of granular capsule formulation of omega-3 fatty acid ethyl esters (Lotriga Granular Capsules) was designed to investigate the frequency of adverse events in patients with hyperlipidemia The usual adult dosage is 2 g of omega-3 fatty acid ethyl esters administered orally once daily after meals. However, the dosage can be increased up to twice daily (at a dose of 2 g) depending on the participant's triglyceride level.

Enrollment: 3,084 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with hyperlipidemia

Exclusion criteria

1. Patients with hemorrhage (e.g., hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract hemorrhage, hemoptysis, or vitreous hemorrhage)
2. Patients with a history of hypersensitivity to ingredients in granular capsule formulation of omega-3 fatty acid ethyl esters

Trial design

3,084 participants in 1 patient group

Omega-3 fatty acid ethyl esters 2 g

Description:

Omega-3 fatty acid ethyl esters 2 g, administered orally once or twice daily after meals

Treatment:

Drug: Omega-3 fatty acid ethyl esters