{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T22:14:14Z","timestamp":1792793654240,"version":"4.5.0"},"reference-count":39,"publisher":"American Medical Association (AMA)","issue":"10","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA"],"published-print":{"date-parts":[[2025,3,11]]},"abstract":"<jats:sec><jats:title>Importance<\/jats:title><jats:p>There are no useful treatments to prevent the development of severe complications of liver cirrhosis. Simvastatin and rifaximin have shown beneficial effects in liver cirrhosis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>To assess whether simvastatin combined with rifaximin improves outcomes in patients with decompensated cirrhosis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design, Setting, and Participants<\/jats:title><jats:p>Double-blind, placebo-controlled, phase 3 trial conducted among patients with decompensated cirrhosis in 14 European hospitals between January 2019 and December 2022. The last date of follow-up was December 2022.<\/jats:p><\/jats:sec><jats:sec><jats:title>Interventions<\/jats:title><jats:p>Patients were randomly assigned to receive simvastatin, 20 mg\/d, plus rifaximin, 1200 mg\/d (n\u2009=\u2009117), or identical-appearing placebo (n\u2009=\u2009120) for 12 months in addition to standard therapy, stratified according to Child-Pugh class B or C.<\/jats:p><\/jats:sec><jats:sec><jats:title>Main Outcomes and Measures<\/jats:title><jats:p>The primary end point was incidence of severe complications of liver cirrhosis associated with organ failure meeting criteria for acute-on-chronic liver failure. Secondary outcomes included transplant or death and a composite end point of complications of cirrhosis (ascites, hepatic encephalopathy, variceal bleeding, acute kidney injury, and infection).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Among the 237 participants randomized (Child-Pugh class B: n\u2009=\u2009194; Child-Pugh class C: n\u2009=\u200943), 72% were male and the mean age was 57 years. There were no differences between the 2 groups in terms of development of acute-on-chronic liver failure (21 [17.9%] vs 17 [14.2%] patients in the treatment and placebo groups, respectively; hazard ratio, 1.23; 95% CI, 0.65-2.34; <jats:italic>P<\/jats:italic>\u2009=\u2009.52); transplant or death (22 [18.8%] vs 29 [24.2%] patients in the treatment and placebo groups, respectively; hazard ratio, 0.75; 95% CI, 0.43-1.32; <jats:italic>P<\/jats:italic>\u2009=\u2009.32); or development of complications of cirrhosis (50 [42.7%] vs 55 [45.8%] patients in the treatment and placebo groups, respectively; hazard ratio, 0.93; 95% CI, 0.63-1.36; <jats:italic>P<\/jats:italic>\u2009=\u2009.70). Incidence of adverse events was similar in both groups (426 vs 419; <jats:italic>P<\/jats:italic>\u2009=\u2009.59), but 3 patients in the treatment group (2.6%) developed rhabdomyolysis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions and Relevance<\/jats:title><jats:p>The addition of simvastatin plus rifaximin to standard therapy does not improve outcomes in patients with decompensated liver cirrhosis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial Registration<\/jats:title><jats:p>ClinicalTrials.gov Identifier: <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\/study\/NCT03780673\">NCT03780673<\/jats:ext-link><\/jats:p><\/jats:sec>","DOI":"10.1001\/jama.2024.27441","type":"journal-article","created":{"date-parts":[[2025,2,5]],"date-time":"2025-02-05T16:00:47Z","timestamp":1738771247000},"page":"864","source":"Crossref","is-referenced-by-count":49,"title":["Simvastatin and Rifaximin in Decompensated Cirrhosis"],"prefix":"10.1001","volume":"333","author":[{"given":"Elisa","family":"Pose","sequence":"first","affiliation":[{"name":"Liver Unit, Hospital Cl\u00ednic de Barcelona, Barcelona, Spain"},{"name":"Institut d\u2019Investigacions Biom\u00e8diques August Pi i Sunyer (IDIBAPS), Barcelona, Spain"},{"name":"Centro de Investigaci\u00f3n Biom\u00e9dica en Red de Enfermedades Hep\u00e1ticas y Digestivas (CIBEReHD), Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C\u00e9sar","family":"Jim\u00e9nez","sequence":"additional","affiliation":[{"name":"Liver Unit, Hospital Universitari Vall d\u2019Hebron, Barcelona, Spain"},{"name":"Vall d\u2019Hebron Institut de Recerca, Liver Unit, Universitat Autonoma de Barcelona, Department of Medicine, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giacomo","family":"Zaccherini","sequence":"additional","affiliation":[{"name":"Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy"},{"name":"Unit of Semeiotics, Liver and Alcohol-Related Diseases, IRCCS Azienda Ospedaliero\u2013Universitaria di Bologna, Bologna, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniela","family":"Campion","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology, A. 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