dyslipidemia
Conditions
Interventions
In this study, patients will switch from a conventional EPA formulation to a self-emulsifying high-purity EPA formulation (2 g once daily) and continue the treatment for six months. Evaluations will
Sponsors
National Kohnodai Medical Center, Japan Institute for Health Security
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who have received a full explanation of the purpose and details of the study, have provided written informed consent, and are able to sign the consent form themselves. Patients aged 18 years or older at the time of obtaining consent. Patients who regularly visit the National Kokuritsu Kokubunji Medical Center and have been diagnosed with dyslipidemia. Patients who have been continuously taking an existing eicosapentaenoic acid ethyl ester (EPA) formulation for at least four weeks.
Exclusion criteria
Exclusion criteria: Patients with a history of hypersensitivity to EPA formulations (eicosapentaenoic acid ethyl ester) or to any emulsifier components. Patients currently taking mifepristone or misoprostol. Patients who are continuously taking EPA-containing supplements or other omega-3 fatty acid preparations. Patients with severe hepatic impairment (AST or ALT >= 3 times the upper limit of normal) or renal impairment (eGFR < 30 mL/min/1.73 m2). Patients with unstable oral drug absorption due to gastrointestinal surgery or gastrointestinal malabsorption disorders. Patients who are expected to have difficulty maintaining regular outpatient visits or adhering to the evaluation schedule due to transfer to another hospital or hospitalization during the study period. Patients who are pregnant, breastfeeding, or considered by the investigator to have the potential for pregnancy during the study period. Patients deemed by the principal investigator to be unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in baPWV before and 6 months after switching from a conventional EPA formulation to a self-emulsifying high-purity EPA formulation | — |
Countries
Japan
Contacts
Public ContactMariko Hakoshima
National Kohnodai Medical Center, Japan Institute for Health Security Department of Diabetes, Endocrinology and Metabolism
Outcome results
None listed