The clinical trial, carried out in 14 European centres as part of the LIVERHOPE project, concluded that this combination does not reduce the risk of serious complications, mortality or the need for liver transplantation.
The study, published in the journal JAMA, was coordinated by Elisa Pose and Pere Ginès, from the Clínic Hepatology Service and the Chronic liver diseases: molecular mechanisms and clinical consequences research group at IDIBAS and CIBEREHD.
A global problem requiring new strategies
Liver cirrhosis is one of the main causes of death worldwide. When the disease progresses to the decompensated stage, the risk of serious complications such as infections, haemorrhages or liver failure, which pose a risk to patients, increases significantly. Currently, there are few effective therapeutic options to prevent these complications.
Evaluating the combination of simvastatin and rifaximin
The study included 227 patients with decompensated cirrhosis, who were randomly assigned to receive simvastatin and rifaximin, or a placebo, for 12 months. The safe dose of the combination of these drugs was established in a previous study by the same group, which was published in The Lancet Gastroenterology & Hepatology. The researchers analysed the incidence of serious complications, as well as mortality and need for liver transplantation.
The results showed that the combined treatment did not reduce these risks in the patients studied. However, the study provides important data allowing for a better understanding of the progression of cirrhosis and for advancing towards new lines of research.
The future of cirrhosis research
Although the results do not confirm the efficacy of the treatment studied, this type of study is essential for identifying new therapeutic options and gaining a better understanding of the needs of patients with decompensated cirrhosis.
It is possible that these drugs could be useful in the earlier stages of liver disease, to prevent the progression and appearance of clinical complications in patients with compensated cirrhosis, or even to favour the regression of liver fibrosis, a central phenomenon in the progression of chronic liver disease. This same research group is currently developing a clinical trial with simvastatin in patients with compensated chronic liver disease funded by a Spanish Health Research Fund (FIS) project, the SIMFIB study, the results of which we hope to receive soon.
The researchers stress the importance of continuing to explore new strategies to improve the quality of life and survival of patients with chronic liver disease, since the lack of effective treatments to halt the progression of the disease currently determines the poor prognosis in many cases.
About the LIVERHOPE project
LIVERHOPE is a European project funded by the Horizon 2020 programme, and aims to evaluate the efficacy of the combination of simvastatin, a frequently used statin, and rifaximin, an antibiotic that modulates the intestinal microbiota, in patients with liver cirrhosis.
Pere Ginès, head of the IDIBAPS Chronic liver diseases: molecular mechanisms and clinical consequences group and hepatologist at the Clínic, coordinating this initiative in which a total of 16 institutions are participating, including European clinical centres, universities and companies.
Study reference:
Pose E, Jiménez C, Zaccherini G, et al. Simvastatin and Rifaximin in Decompensated Cirrhosis: A Randomized Clinical Trial. JAMA. Published online February 05, 2025. doi:10.1001/jama.2024.27441
