Hyperlipidemia
Conditions
Interventions
Administration of pemafibrate first, then change to ethyl icosapentate
Administration of ethyl icosapentate first, then change to pemafibrate
Sponsors
National Defense Medical College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Hypertriglycemia patients whose fasting blood triglyceride levels greater than 150mg/dl. 2) Outpatients 3) Subjects who gave written informed consent
Exclusion criteria
Exclusion criteria: 1) Allergy against pemafibrate/ethyl icosapentate 2) Poor-controlled diabetes (HbA1c>10.0 %) 3) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months 4) Either level of aspartate aminotransaminase or alanine aminotransferase exceed three-fold of the normal limits 5) End stage renal failure 6) Symptomatic (NYHA III or IV) congestive heart failure 7) Malignancies or other diseases with poor prognosis 8) Pregnant 9) Subjects whose doctor in charge do not agree to join the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Flow-mediated vasodilation in forearm Six weeks after administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemoglobin A1C levels, glycoalbumin levels, fasting blood glucose, lipids levels, HDL function, markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), oxidative stress (8-OHdG/ MDA-LDL), early-staged kidney diseases (microalbuminuria/L-FABP) Six weeks after administration | — |
Countries
Japan
Contacts
Public ContactMakoto Sasaki
National Defense Medical College Division of Anti-aging and Vascular Medicine, Department of Internal Medicine,
Outcome results
None listed