Efficacy of Simvastatin in Alcoholic Liver Fibrosis

Exclusion Criteria23

• Patients receiving statins or fibrates.
• Patients with other etiologies of liver disease in addition to alcohol: hepatitis C, hepatitis B, autoimmune hepatitis, Wilson's disease, or hemochromatosis.
• Patients in whom hepatitis C has been cured with antivirals in the 2 years prior to inclusion in the study.
• Patients with a CK elevation of 50% or more above the upper limit of normal at the time of study inclusion.
• Gastrointestinal bleeding due to portal hypertension within 12 months prior to inclusion in the study.
• Clinical hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy, in the 12 months prior to inclusion in the study.
• Patients in need of diuretic treatment in the previous 12 months to control ascites or hydrothorax.
• Spontaneous bacterial peritonitis within 12 months prior to study enrollment.
• Hepatocellular carcinoma of any stage.
• Patients with known muscle disease.
• Patients with previous rhabdomyolysis.
• Patients being treated with strong CYP3A4 enzyme inhibitors (see section 5.2: Concomitant drugs, not allowed and allowed).
• Patients being treated with drugs with possible interactions with simvastatin (see section 5.2: Concomitant drugs, not allowed and allowed).
• Patients with a history of significant extrahepatic disease with poor short-term prognosis, including New York Heart Association Grade III / V congestive heart failure, GOLD COPD> 2, chronic kidney disease with serum creatinine> 2mg / dL or under therapy of kidney replacement.
• Patients with extrahepatic malignancies, including solid tumors and hematologic malignancies.
• Patients with a history or increased risk of intestinal obstruction.
• Pregnancy or breastfeeding.
• Patients included in other clinical trials during the previous month.
• Patients with mental disabilities, language barriers, poor social support or any other reason considered by the researcher as essential for adequate understanding, cooperation or compliance with the study.
• Presence of data on alcoholic hepatitis in liver biopsy upon inclusion.
• Patients with contraindications for statins.
• Known hypersensitivity to simvastatin.
• Refusal to sign the informed consent