Cirrhoses, Liver Clinical Trial
Official title:
Safety and Tolerability of the Combination of Simvastatin Plus Rifaximin in Patients With Decompensated Cirrhosis: a Multicenter, Double-blind, Placebo Controlled Randomized Clinical Trial.
The main purpose of this study is to investigate whether the combination of two different
drugs, simvastatin and rifaximin, is safe in the treatment of patients with decompensated
cirrhosis.
The secondary purpose is to see if this combination results in an improvement in inflammation
markers in patients with cirrhosis and in an improvement in analytic parameters of
progression of liver disease.
Cirrhosis is the final stage of liver diseases, and currently, there is no effective
treatment, with liver transplantation being the only curative solution in selected patients.
As the number of donor organs for liver transplantation is limited and criteria for
transplantation are strict, the current management of cirrhosis consists of treating its
complications.
However, there is no effective therapy that prevents or cures the disease itself.
Rifaximin is an antibiotic that acts in the gastrointestinal tract. It is poorly absorbed to
the general circulation and has low toxicity and good tolerability. Itis currently approved
for use in patients with cirrhosis to prevent recurrent hepatic encephalopathy. Rifaximin
decreases the transit of bacteria and bacterial products from the gut to the general
circulation, preventing the chronic inflammation that takes place in cirrhotic patients.
Recent investigations have shown that simvastatin, a drug which is widely used to treat high
cholesterol levels for the prevention of cardiovascular diseases, may have beneficial effects
in patients with cirrhosis by preventing the progression of the disease and its
complications. Although in the past decades there was a concern about its use in patients
with liver disease due to its rare adverse effects (liver and muscle toxicity), recent
clinical trials have shown that it can be safely used in patients with cirrhosis.
LIVERHOPE_SAFETY clinical trial have been designed to investigate whether the combination of
these two drugs is safe in patients with cirrhosis, and also if it has potential beneficial
effects in decreasing inflammation and improving analytical markers of progression of liver
disease.
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