Decompensated cirrhosis (liver disease) occurs when liver function decreases to the extent that serious complications develop and can include internal bleeding, fluid buildup in the abdomen, or mental confusion. This reduced decreased liver function subsequently decreases life expectancy. There is a critical need for strategies to delay progression to decompensation and reduce the occurrence of serious complications. Currently, limited therapeutic options are available for managing decompensated liver disease, with beta-blockers (BB) being the only proven medication with significant benefits in preventing disease progression. Statins have been historically under- prescribed in cirrhosis due to concerns of liver damage. However, there is emerging evidence that statin use may be beneficial and able to lessen liver disease worsening, with studies demonstrating its safety. Thus, we aim to conduct a pilot randomized controlled trial (RCT) study of 50 subjects comparing the outcomes of decompensated cirrhotic patients receiving the statin, atorvastatin, and a non-selective beta-blocker (NSBB) versus those receiving NSBB plus placebo. Both groups will be followed for 12 months to investigate the feasibility, safety, and efficacy of combination therapy.
Patients age of 18 years or older diagnosed with any form of decompensated liver disease defined as ascites, hepatic encephalopathy, or variceal bleed presenting at Charleston Area Medical Center (CAMC) Memorial Hospital or CAMC-Gastroenterology Liver Clinic
Currently on an non-selective beta-blockers agreeing to have their liver disease managed by CAMC-Gastroenterology Liver Clinic as an outpatient for the 12-month follow-up period.
Any patient <18 years of age
Patients with hepatocellular carcinoma
Patients with ongoing alcohol use (self-reported consumption of more than one alcoholic drink per week)
Patients exhibiting high-risk behaviors that could put them at risk for complications including IV substance use and history of medication non-adherence
Parallel
Atorvastatin 20 mg
DrugAtorvastatin 20 mg Once Daily with previously prescribed Non Selective Beta-Blocker
Placebo
DrugPlacebo Once Daily along with previously prescribed Non Selective Beta Blocker
Feasibility- compare the number of participants who discontinued study medication for any reason during the 12-month follow-up period
Feasibility- compare the number of participants compliant with study treatment
Participants will be considered compliant if they attend four follow-up visits and consume ≥ 75% of study medication (determined by pill counts)
Safety - Adverse events
Rate of reported treatment-related adverse events (muscle pain, muscle injury, liver injury, kidney dysfunction, other)
New Decompensating events
Rate of new decompensating events (ascites, vatical bleeding, worsening jaundice, or encephalopathy) in each arm, time for development of new decompensating event
Hepatic transaminases levels
Number of participants with increases in transaminases by more than five times the upper limit of normal
Survival rate
Rate of survival between the two treatment arms
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