Dyslipidemic patients
Conditions
Interventions
Pemafibrate group:
Take pemafibrate 0.2 mg twice a day in the morning and evening for 16 weeks.
Omega-3 fatty acids group:
Take omega-3 fatty acids 2 g twice a day immediately after meals for 16 weeks
Sponsors
Takeda Yasutaka
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients who are 20 years old or older and 79 years old or under 2)Patients who have been taking statin for more than 4 weeks 3)Patients with fasting TG levels of 177 mg/dL (2 mmol/L) or higher 4)Patients who showed written consent form
Exclusion criteria
Exclusion criteria: 1)Patients with fasting TG levels of 500 mg/dL (5.7 mmol/L) or higher 2)Diabetic patients who showed HbA1c levels of 9 % or higher and who need glycemic control with insulin treatment 3)Patients with type 1 diabetes 4)Patients who showed moderate renal dysfunction (serum creatinine levels 1.5 mg/dL or higher) 5)Patients who used fibrates and nicotinic acids within 4 weeks 6)Patients who used omega-3 fatty acids and ethyl icosapentate and the supplements that contained same ingredients within 24 weeks 7)Patients with symptomatic cardiovascular and cerebrovascular disorders 8)Patients with severe infections 9)Patients with acute hepatitis or liver cirrhosis 10)Patients with cancer 11)Patients before or after surgery 12)Women with pregnancy or during breastfeeding 13)Patients who need lipid management with PCSK9 inhibitors or MTP inhibitors 14)Others. Patients who have contraindications to pemafibrate and omega-3 fatty acids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of change of fasting apo B48 levels from baseline at 16 weeks of administration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Change from baseline in fasting apo B48 at 16 weeks of administration 2)Rate of change or amount of change at 8 and 16 weeks after administration 3)Relationship between fasting apo B48 and various indices at 16 weeks of administration 4)Incidence of adverse events and diseases | — |
Contacts
Public ContactYasutaka Takeda
Asahikawa Medical University Hospital
Outcome results
None listed