Decompensated Liver cirrhosis Atorvastatin, liver cirrhosis, transient elastography
Conditions
Interventions
Patients were randomized to receive either atorvastatin 20 mg or placebo. We performed 1 to 1 randomization as a block of 4 with a computer-generated sequence provided by RedCap. A unique 4-digit num
Active Comparator Drug,Placebo Comparator Drug
Sponsors
Faculty of Medicine Research Grant Khon Kaen University
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Out-patients older than 18 years to 65 years diagnosed with compensated liver cirrhosis Child Turcotte Pugh Score A and B (CTP score less than 8) with high risk features of cirrhotic decompensation as defined by any of the following 1.1 History of small esophageal varices (F1) on previous endoscopy within 3 months. 1.2 Presence of portosystemic collaterals on imaging 1.3 History of previous VCTE more than 20kPa within 3 months 1.4 History of previous Platelet count less than 150 K per mm3 within 3 months.
Exclusion criteria
Exclusion criteria: 1.Patients with Laboratory: aminotransferases levels more than 3 times above the upper limit of normal 2.Patients on the waiting list for liver transplantation. 3.Patients with acute on chronic liver failure (defined by APASL) 4.Serum creatinine 2.5 mg per dL or greater or eGFR less than 45 ml per min per 1.73m2 5.Serum total bilirubin greater than 3.0 mg per dL 6.International normalized ratio (INR) greater than 2.3 7.Creatine kinase more than 2 times above the upper limit of the normal 8.Spontaneous bacterial peritonitis or active bacterial infection within 30 days before study inclusion 9.History of variceal hemorrhage. 10.History of previous overt ascites or treatment with diuretics for ascites. 11.History of previous chronic, recurrent or episodic overt hepatic encephalopathy. 12.Patients with HIV infection 13.Patients with hepatocellular carcinoma or other malignancy. 14.Patients with on antiviral treatment for hepatitis C virus less than 6 months 15.Patients with on antiviral treatment for hepatitis B virus less than 6 months 16.Patients with history of myopathy 17.Patients with BMI more than 35 kg per m2 18.Patients with diabetes mellitus with poor control HbA1C more than 9% with LDL C levels more than 130 mg per dl 19.Patients with hypothyroidism 20.Patients with clinical atherosclerotic cardiovascular disease LDL-C levels more than 190 mg per dl 21.Patients with concomitant administration of potent inhibitors of CYP3A4 enzymes medications or other supplements that should not be taken with atorvastatin, including cyclosporine, danazol, gemfibrozil, fenofibrate, extended-release niacin, itraconazole, ketoconazole, voriconazole, HIV protease inhibitors, boceprevir, telaprevir, macrolide antibiotics erythromycin, clarithromycin, amlodipine, verapamil, diltiazem, amiodarone and cobicistat 22.Patients with concomitant administration of warfarin, digoxin due to increase levels of warfarin and digoxin. 23.Patients with concomitant administration of colchicine due to risk for rhabdomyolysis in elderly or renal dysfunction 24.Patients with ongoing other clinical trials. 25.Patients receiving new beta-blockers therapy less than 3 months or current use of beta-blockers more than 3 month with unstable drugs per doses 26.Patients with current alcohol consumption of more than three units per day or severe alcoholic hepatitis requiring corticosteroid therapy. 27.History of stopping alcohol use within 3 months. 28.Patients with hemodialysis 29.Patients with life expectancy less than 3 years due to comorbid conditions 30.Patients with psychiatric or social conditions precluding adequate understanding or compliance with the study 31.Patients had known hypersensitivity to atorvastatin 32.Patients with pregnancy or breast feeding, 33.Refusal to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dynamic reducing liver stiffness measurement(LSM) 3 months, 6 months,12 months A 20 percent regression in dynamic LSM indicates reduced risk of hepatic decompensation. Positive result decrease in LSM more than and equal 20 percent from baseline or LSM less than 20 kPa. | — |
Secondary
| Measure | Time frame |
|---|---|
| Decompensation of liver cirrhosis 6 months, 12 months, 24 months Ascites, hepatic encephalopathy, Varies bleeding | — |
Countries
Thailand
Contacts
Public ContactTanapon Jeerawattansuk
Khon Kaen university
Outcome results
None listed