Rifaximin improves survival in cirrhotic patients with refractory ascites: A real-world study

Lv, Xinyue; Ding, Huiguo; Zheng, Jun-Fu; Li, Lei

doi:10.3748/wjg.v26.i2.199

Cited by 34 publications

(33 citation statements)

References 42 publications

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“…We believed that “compassionate use drug” can not only meet the special needs of patients but also perform clinical effectiveness observation, research and analysis, so as to enhance the efficiency of research and benefit the patients [38-42]. Also, given a large number of clinical cases have accumulated information, and using available existing data for statistics and analysis with the help of new statistical methods such as clinical data-mining [43-45] and real-world study [46-48], etc., can help in quickly obtaining some very valuable information and save research time.…”

Section: Discussionmentioning

confidence: 99%

Systematic Review of the Registered Clinical Trials of Coronavirus Disease 2019 (COVID-19)

Zhu

Gao

Robert

et al. 2020

Preprint

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Background: Since the outbreak of coronavirus diseases 2019 (COVID-19), many researchers in China have immediately carried out clinical research scheme of the COVID-19. But, there is still a lack of systematic review of registered clinical trials. Therefore, we made the first systematic review of the clinical trials of COVID-19 in order to provide evidence for the control of the COVID-19. Methods: The database from the Chinese Clinical Registration Center and the ClinicalTrials.gov were searched to collect the registered clinical trials of COVID-19. The retrieval inception date is February 9, 2020. Two evaluators independently selected literature, extracted data and evaluated the risk of bias. This study is based on the recommendations of PRISMA in Cochrane handbook. Results: A total of 75 COVID-19 registered clinical trials (63 interventional studies and 12 observational studies) were obtained. 97.3% of clinical trials were initiated by Chinese organizations. Only 11 trials have begun to recruit patients, and all registered clinical trials have not been completed. Most of the trials are early clinical exploratory trials or in pre-experiment stage (only two trials of Remdesivir in Ⅲ stage), and the sample size of subjects recruited is small. The main intervention methods include traditional Chinese medicine treatment, western medicine treatment and integrated Chinese and Western medicine treatment. The subjects were mainly non severe adult patients (≥ 18 years old). The main outcomes were clinical observation and examination. The duration of most trials was more than 5 months, and the median of the intervention study was 180 d (95% CI: 146.3 -328.9 d); the median of the observation period was 334 d (95% CI: 166.6 -363.4 d). Overall, both the methodology quality of intervention register trials and observational trials are low. Conclusions: Disorderly and intensive clinical trialsof COVID-19 using traditional Chinese medicine and Western medicine are ongoing or will be carried out in China. However, based on the poor quality and small sample size and long completion period, we will not be able to obtain reliable, high-quality clinical evidence about COVID-19 treatment for quite a long time in the future. Improving the quality of study design, prioritizing promising drugs, and using different designs and statistical methods are worth advocating and recommending for the clinical trials of COVID-19 in China.

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Section: Discussionmentioning

confidence: 99%

Systematic Review of the Registered Clinical Trials of Coronavirus Disease 2019 (COVID-19)

Zhu

Gao

Robert

et al. 2020

Preprint

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“…42 However, because of its activity against bacterial translocation and its good safety profile, the use of rifaximin as a disease-modifying agent represents an attractive option. In addition, several observational studies and a few small-scale RCTs [47][48][49][50][51][52][53][54][55][56][57][58][59] have associated rifaximin treatment with a better control of difficult-to-treat/refractory ascites, 47,48 the reduced incidence of decompensation, all-cause hospitalisations and readmissions, SBP, variceal bleeding, and acute kidney injuryhepatorenal syndrome (AKI-HRS) with a decreased risk of renal replacement therapy. [49][50][51][52][53][54][55][56] An improvement in mortality has also been suggested in some studies.…”

Section: Key Pointmentioning

confidence: 99%

“…[49][50][51][52][53][54][55][56] An improvement in mortality has also been suggested in some studies. 48,52 However, the overall low quality of the evidence available, as highlighted by several meta-analyses, [57][58][59] precludes the possibility of reaching any definite conclusion on the global impact of rifaximin on the course of decompensated cirrhosis.…”

Section: Key Pointmentioning

confidence: 99%

The search for disease-modifying agents in decompensated cirrhosis: From drug repurposing to drug discovery

Caraceni

Abraldes

Ginès

et al. 2021

Journal of Hepatology

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Patients with decompensated cirrhosis are currently managed through targeted strategies aimed at preventing or treating specific complications. In contrast, a disease-modifying agent should, by definition, be aimed at globally addressing 'decompensated cirrhosis'. To be defined as a disease-modifying agent in decompensated cirrhosis, interventions need to demonstrate an unequivocal benefit on the course of disease in well-designed and adequately powered randomised clinical trials with hard endpoints (i.e. patient survival). These trials also need to define the target population, dosage and timing of administration, factors guiding treatment, temporary or permanent stopping rules, transferability to daily clinical practice, cost-effectiveness, and global treatment access. By eliminating the underlying cause of cirrhosis, aetiologic treatments can still influence the course of decompensated disease by halting or slowing down disease progression or even inducing reversion to the compensated state. In contrast, there remains an unmet clinical need for disease-modifying agents which can antagonise key pathophysiological mechanisms of decompensated cirrhosis, such as portal hypertension, gut translocation, circulatory dysfunction, systemic inflammation, and immunological dysfunction. However, in the last few years, the repurposing of "old drugs" that have already been prescribed for more limited indications in hepatology or for other diseases has provided a few candidates, including human albumin, statins, and poorly absorbable oral antibiotics, which are under further evaluation in large-scale randomised clinical trials. New disease-modifying agents are also expected to be identified in the next decade through the systematic repurposing of existing drugs and the development of novel molecules which are currently undergoing pre-clinical or early clinical testing.

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“…Currently, the only recognized indication for rifaximin use in patients with cirrhosis is the prevention of recurrent hepatic encephalopathy (secondary prophylaxis) [ 2 ], mainly based on the pivotal RCT by Bass et al in 2010 [ 83 ]. However, both observational studies and a few small-scale RCTs showed an association between rifaximin treatment and important clinical outcomes, including better control of ascites [ 84 , 85 ], a reduced incidence of decompensation, hospitalizations, variceal bleeding, SBP, and HRS with a decreased risk of renal replacement therapy [ 86 , 87 , 88 , 89 , 90 , 91 , 92 , 93 ]. Some studies even suggested an improvement in mortality [ 85 , 87 , 89 ].…”

Section: Pathophysiological Treatmentsmentioning

confidence: 99%

“…However, both observational studies and a few small-scale RCTs showed an association between rifaximin treatment and important clinical outcomes, including better control of ascites [ 84 , 85 ], a reduced incidence of decompensation, hospitalizations, variceal bleeding, SBP, and HRS with a decreased risk of renal replacement therapy [ 86 , 87 , 88 , 89 , 90 , 91 , 92 , 93 ]. Some studies even suggested an improvement in mortality [ 85 , 87 , 89 ]. However, several metanalyses [ 94 , 95 , 96 ] highlighted the overall low quality of these studies precluding any generalization on the beneficial impact of rifaximin on the clinical course of decompensated cirrhosis.…”

Section: Pathophysiological Treatmentsmentioning

confidence: 99%

Prevention of Cirrhosis Complications: Looking for Potential Disease Modifying Agents

Zaccherini

Tufoni

Bernardi

et al. 2021

JCM

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The current therapeutic strategies for the management of patients with cirrhosis rely on the prevention or treatment of specific complications. The removal of the causative agents (i.e., viruses or alcohol) prevents decompensation in the vast majority of patients with compensated cirrhosis. In contrast, even when etiological treatment has been effective, a significant proportion of patients with decompensated cirrhosis remains at risk of further disease progression. Therefore, therapies targeting specific key points in the complex pathophysiological cascade of decompensated cirrhosis could represent a new approach for the management of these severely ill patients. Some of the interventions currently employed for treating or preventing specific complications of cirrhosis or used in other diseases (i.e., poorly absorbable oral antibiotics, statins, albumin) have been proposed as potential disease-modifying agents in cirrhosis (DMAC) since clinical studies have shown their capacity of improving survival. Additional multicenter, large randomized clinical trials are awaited to confirm these promising results. Finally, new drugs able to antagonize key pathophysiological mechanisms are under pre-clinical development or at the initial stages of clinical assessment.

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Rifaximin improves survival in cirrhotic patients with refractory ascites: A real-world study

Cited by 34 publications

References 42 publications

Systematic Review of the Registered Clinical Trials of Coronavirus Disease 2019 (COVID-19)

Systematic Review of the Registered Clinical Trials of Coronavirus Disease 2019 (COVID-19)

The search for disease-modifying agents in decompensated cirrhosis: From drug repurposing to drug discovery

Prevention of Cirrhosis Complications: Looking for Potential Disease Modifying Agents

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