Non-alcoholic fatty liver disease with hypercholesterolemia
Conditions
Interventions
rosvastatin 5mg/day
Sponsors
Juntendo University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosed as fatty liver by abdominal ultrasonography within 6 months before it registers 2) Patients with hyperlipidemia (Patient who are not treated:LDL-C level of more than 140 mg/dl) 3) No limitations on gender or hospitalization status 4) Patients giving written consent after being provided with sufficient explanation about participation in this clinical trial
Exclusion criteria
Exclusion criteria: 1) Patients with hypersensitivity to HMG-CoA reductase inhibitor (statin) 2) Uncontrolled diabetes 3) Viral or autoimmune liver disease 4) Patients with severe liver dysfunction(ALT or AST > 100 IU/L or total bilirubin > 2.5 mg/dL or ALB < 3.5g/dl or PT < 70% or PLT < 100,000/ul) 5) Patients with renal dysfunction (the serum creatinine more than 2.0 mg/dL or Ccr<30mL/min/1.73mm) 6) Patients on treatment with cyclosporine 7) Pregnant and potential pregnancy 8) Patients with hypothyroidism, hereditary myopathy (muscular dystrophy) or family history of hereditary myopathy, and drug-induced myopathy 9) Patients with drug abuse or alcoholism 10) Patients who are ineligible for any other reason in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change of liver transaminases composition in 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Percent change of lipid profile in 6 months 2) Low-density lipoprotein cholesterol goal achievement ratio recommended by the Japan Atherosclerosis Society(JAS) in 6 months | — |
Countries
Japan
Contacts
Public ContactKyoko Fukuhara
Juntendo University School of Medicine Department of Gastroenterology
Outcome results
None listed