Simvastatin plus Rifaximin to prevent ACLF in patients with decompensated cirrhosis. A randomised, double-blind, placebo-controlled, phase-3 trial: the liverhope efficacy trial

Pose, Elisa; Jimenez, César; Zaccherini, Giacomo; Campion, Daniela; Piano, Salvatore; Uschner, Frank Erhard; Wit, Koos de; Roux, Olivier; Gananandan, Kohilan; Laleman, Wim; Solé, Cristina; Alonso, Sonia; Cuyàs, Berta; Ariza, Xavier; Juanola, Adrià; T., Ann; Napoleone, Laura; Gratacós, Jordi; Tonon, Marta; Pompili, Enrico; Sánchez-Delgado, Jordi; Carol, Marta; Perez, Martina; Fabrellas, Núria; Pich, Judit; Martell, C.; Casanovas, Georgina; Doménech, Gemma; Manuel, Víctor; Blasco, Víctor; Caraceni, Paolo; Alessandria, Carlo; Angeli, Paolo; Trebicka, Jonel; Beuers, Ulrich; Francoz, Claire; Mookerjee, Rajeshwar P.; Bañares, Rafael; Soriano, Germán; Hernáez, Rubén; Allegretti, Andrew S.; Morales-Ruíz, Manuel; Serra, Miquel; Watson, Hugh; Abraldes, Juan G.; Kamath, Patrick S.; Ginès, Pere

doi:10.1016/s0168-8278(23)00452-x

Cited by 9 publications

(2 citation statements)

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“…However, combined rifaximin and simvastatin therapy for 12 months failed to prevent acute decompensations and death in patients with decompensated cirrhosis [51].…”

Section: Antibioticsmentioning

confidence: 99%

Exploring the Relationship between Liver Disease, Bacterial Translocation, and Dysbiosis: Unveiling the Gut-Liver Axis

Juanola,

Francés,

Caparrós

2024

Visc Med

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Background: The global burden of liver disease and cirrhosis has been progressively increasing in the last decade. The interplay between gut microbiota and immune system and the bidirectional relationship with the liver, known as the gut-liver axis, has arisen as a fundamental aspect of liver disease. Summary: Alterations of the gut microbiome have been described and include both dysbiotic microbial signatures and intestinal bacterial overgrowth. The integrity of the intestinal epithelial barrier is essential for preventing the access of harmful substances and bacterial products into the host. Bacterial translocation due to altered host-microbiota interactions triggers local immune cell activation and facilitates a chronic inflammatory state that can ultimately lead to immune exhaustion, characteristic of cirrhosis. In cirrhosis, breakdown of the gut vascular barrier allows access of bacterial products to portal blood circulation and facilitates their influx into the liver, further contributing to disease progression. Key Messages: A better understanding of the contributing factors to pathological bacterial translocation and the impact of dysbiosis in liver disease will lead to achieve innovative therapeutic strategies in cirrhosis.

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“…However, combined rifaximin and simvastatin therapy for 12 months failed to prevent acute decompensations and death in patients with decompensated cirrhosis [51].…”

Section: Antibioticsmentioning

confidence: 99%

Exploring the Relationship between Liver Disease, Bacterial Translocation, and Dysbiosis: Unveiling the Gut-Liver Axis

Juanola,

Francés,

Caparrós

2024

Visc Med

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“…In the efficacy study of LIVERHOPE, the combination of simvastatin with rifaximin did not prevent ACLF development, nor did it have a survival benefit in decompensated patients. 48 Therefore, statins in cirrhosis seem beneficial for the traditional indications, but not specifically in the prevention of complications of cirrhosis. 5 …”

Section: Ongoing Studies Novel Drugs and Other Applicationsmentioning

confidence: 99%

Recent advances in the prevention and treatment of decompensated cirrhosis and acute-on-chronic liver failure (ACLF) and the role of biomarkers

Trebicka,

Hernaez,

Shawcross

et al. 2024

Gut

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The progression of cirrhosis with clinically significant portal hypertension towards decompensated cirrhosis remains clinically challenging and the evolution towards acute-on-chronic liver failure (ACLF), with one or more extrahepatic organ failures, is associated with very high mortality. In the last decade, significant progress has been made in the understanding of the mechanisms leading to decompensation and ACLF. As portal hypertension advances, bacterial translocation across an impaired gut barrier culminates in endotoxaemia, systemic inflammation and cirrhosis-associated immune dysfunction (CAID). Gut-derived systemic inflammation and CAID have become the logical targets for innovative therapies that prevent hepatic decompensation episodes and the progression to ACLF.Furthermore, classification of disease and biomarker discovery to personalise care have advanced in the field. This review discusses progress in biomarker discovery and personalisation of treatment in decompensated cirrhosis and ACLF.

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Statins for Chronic Liver Disease and the Need for Randomized Controlled Trials

González-Abraldes¹,

Moctezuma‐Velázquez²

2024

Clinical Gastroenterology and Hepatology

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Simvastatin plus Rifaximin to prevent ACLF in patients with decompensated cirrhosis. A randomised, double-blind, placebo-controlled, phase-3 trial: the liverhope efficacy trial

Cited by 9 publications

References 0 publications

Exploring the Relationship between Liver Disease, Bacterial Translocation, and Dysbiosis: Unveiling the Gut-Liver Axis

Exploring the Relationship between Liver Disease, Bacterial Translocation, and Dysbiosis: Unveiling the Gut-Liver Axis

Recent advances in the prevention and treatment of decompensated cirrhosis and acute-on-chronic liver failure (ACLF) and the role of biomarkers

Statins for Chronic Liver Disease and the Need for Randomized Controlled Trials

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