Hypertriglyceridemia
Conditions
Interventions
Patients were randomly assigned in a 1:1 ratio to two treatments: bezafibrate of 400 mg/day or pemafibrate of 0.2 mg/day for the first 24-week treatment period.
Patients were randomly assigned in a 1
Sponsors
Department of Cardiology, Iwate Prefectural Centgral Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible patients were men and postmenopausal women aged 20-75 years with dyslipidemia treated with statin and CAD who showed fasting serum TG levels of > 150 mg/dL and HDL-C levels of < 50 mg/dL in men or < 55 mg/dL in women at entry.
Exclusion criteria
Exclusion criteria: 1.patients who required additional medication for dyslipidemia during the study period 2.fasting serum TG levels of over than 1000 mg/dl 3.type 1 diabetes mellitus or uncontrolled type 2 DM (HbA1c level of over than 8.5%) 4.familiar hypercholesterolemia 5.chronic kidney disease showing a serum creatinine level of over than 1.5 mg/dL 6.history or complication of gallbladder disease, cholelithiasis, pancreatitis, and malignant tumor 7.aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevation to a level more than two times the upper limit of normal (ULN) range 8.uncontrolled hypertension (systolic blood pressure BP ofover tahn 160 mmHg or diastolic BP of over than 100 mmHg) 9.hemoglobin level of less than 12g/dL in men or less than 11 g/dL in women 11.recent myocardial infarction or cerebrovascular disorder within 3 months before the study 12.hospitalization for worsening heart failure within 3 months 13.use of ezetimibe and supplements containing eicosapentaenoic acid, and/or docosahexaenoic acid within 3 months before the study. Patients were also prohibited from using agents that affect lipid metabolism,such as thiazolidinedione, insulin,oral corticosteroid, or protease inhibitor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To examine a percent change in the fasting serum triglyceride levels from baseline to the study endpoint after the 24-week treatment with bezafibrate or pemafibrate. | — |
Secondary
| Measure | Time frame |
|---|---|
| To examine a percent change in the fasting serum HDL-C and ApoA-1 levels from baseline to study endpoint. | — |
Countries
Japan
Contacts
Public ContactAkihiro Nakamura
Iwate Prefectural Central Hospital Department of Cardiology
Outcome results
None listed