Decompensated cirrhosis is a condition used to describe the complications of advanced liver disease, characterized by decreased or impaired liver function. The combination of statins (improve intrahepatic circulation) and rifaximin (modulate gut microbes) is found to be effective in preventing bacterial translocation in cirrhosis patients. This study aims to evaluate the safety of simvastatin plus rifaximin in patients with decompensated cirrhosis by testing two different doses of simvastatin.
This randomized, double-blind, placebo-controlled, phase-2 trial included 44 patients aged 18 or older years with decompensated cirrhosis and moderate-severe liver failure. The patients were assigned in a 1:1:1 ratio to receive simvastatin 40g/day plus rifaximin 1,200 mg/day (n=16), simvastatin 20g/day plus rifaximin 1,200 mg/day (n=14), or placebo (n=14) for 12 weeks. The primary outcome of the study was the development of liver or muscle toxicity.
Safety analysis indicated that patients in the 40 mg simvastatin group showed significantly elevated levels of AST and ALT, as compared with the placebo group. No significant differences were discovered between the AST and ALT levels between the 20 mg simvastatin group and the placebo group.
The research concluded that the treatment of decompensated cirrhosis with 40 mg/day simvastatin plus rifaximin was associated with a higher risk of toxicity and safety concerns compared with 20 mg simvastatin and placebo.