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Clinical Trial
. 2024 May 10;8(6):e0436.
doi: 10.1097/HC9.0000000000000436. eCollection 2024 Jun 1.

Rifaximin plus lactulose versus lactulose alone for reducing the risk of HE recurrence

Arun J Sanyal  1 , Kris V Kowdley  2 , Nancy S Reau  3 , Nikolaos T Pyrsopoulos  4 , Christopher Allen  5 , Zeev Heimanson  5 , Jasmohan S Bajaj  1   6
Affiliations
Clinical Trial

Rifaximin plus lactulose versus lactulose alone for reducing the risk of HE recurrence

Arun J Sanyal et al. Hepatol Commun. .

Abstract

Background: The aim was to examine rifaximin plus lactulose efficacy in patients with cirrhosis at a risk of developing overt HE who were stratified by important baseline characteristics such as comorbid ascites or diabetes.

Methods: Pooled post hoc subgroup analysis of adults receiving rifaximin 550 mg twice daily plus lactulose or lactulose alone for 6 months in a phase 3 randomized, double-blind trial and a phase 4 open-label trial was conducted.

Results and conclusion: Rifaximin plus lactulose was more efficacious than lactulose alone for reducing the risk of overt HE recurrence and HE-related hospitalization in adults grouped by select baseline disease characteristics.

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Conflict of interest statement

Arun J. Sanyal consults and received grants from Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Gilead, Intercept, Inventiva, Madrigal, Mallinckrodt, Merck, Novartis, Novo Nordisk, and Pfizer. He consults and owns stock in GENFIT and HemoShear. He consults for 89bio, Albireo, Alnylam, Amgen, AstraZeneca, Covance, Genentech, HistoIndex, Janssen, NGM Bio, PathAI, Poxel, ProSciento, Regeneron, Roche, Salix, Siemens, and Terns. He received grants from Fractyl. He owns stock in Durect, Exhalenz, Indalo, NorthSea, Rivus, and Tiziana. He receives royalties from Elsevier and UpToDate. Kris V. Kowdley consults, is on the speakers' bureau, and received grants from Gilead and Intercept. He consults and received grants from 89bio, CymaBay, GENFIT, Madrigal, Mirum, NGM, and Pfizer. He consults and owns stock in Inipharm. He consults for Enanta, HighTide, and Salix. He is on speakers' bureau for AbbVie. He received grants from Corcept, GlaxoSmithKline, Hanmi, Novo Nordisk, Pliant, Terns, and Viking. Nancy S. Reau consults for AbbVie, Gilead, Intercept, and Salix. She received grants from Eiger. Nikolaos T. Pyrsopoulos consults for Salix. Christopher Allen is employed by Salix. Zeev Heimanson is employed by Salix. Jasmohan S. Bajaj consults for Merz. He received grant from Cosmo, Grifols, Mallinckrodt, Salix, and Sequana Medical.

Figures

None
Graphical abstract
FIGURE 1
FIGURE 1
Time to first breakthrough OHE episode in (A) the overall population and patients, (B) with or without baseline ascites, and (C) with or without baseline diabetes, and time to first HE-related hospitalization in (D) the overall population and patients, (E) without or without baseline ascites, and (F) with or without baseline diabetes. Triangles indicate censored observation(s). Abbreviations: NNT, number needed to treat; OHE, overt hepatic encephalopathy.
FIGURE 1
FIGURE 1
Time to first breakthrough OHE episode in (A) the overall population and patients, (B) with or without baseline ascites, and (C) with or without baseline diabetes, and time to first HE-related hospitalization in (D) the overall population and patients, (E) without or without baseline ascites, and (F) with or without baseline diabetes. Triangles indicate censored observation(s). Abbreviations: NNT, number needed to treat; OHE, overt hepatic encephalopathy.
See this image and copyright information in PMC

References

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