PROUD48
- Conditions
- Dyslipidemic patients
- Registration Number
- JPRN-jRCTs071200011
- Lead Sponsor
- Takeda Yasutaka
- Brief Summary
The rate of change in fasting apoB48 from baseline to week 16 in pemafibrate treated group and omega-3 fatty acid ethyl were -50.8%(IQR-62.9,-30.3) and -17.5%(IQR -38.3, 15.3) (p<0.001),respectively. We concluded that pemafibrate was superior to omega-3 fatty acid ethyl in lowering effect of fasting apo B48.Pemafibrate is expected to reduce the residual risk for atherosclerotic cardiovascular disease with statin treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 129
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method