Reply: Potential risk associated with direct modulation of the gut flora in patients with heart failure

Mayerhofer, Cristiane C.K.; Awoyemi, Ayodeji; Hov, Johannes R.; Trøseid, Marius; Broch, Kaspar

doi:10.1002/ehf2.12437

Cited by 5 publications

(3 citation statements)

References 14 publications

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“…Safety concerns have been raised regarding treatments targeting the gut microbiota in HF [ 37 , 38 ]. Importantly, we observed no significant difference in the number or severity of serious adverse events between the intervention groups and the SoC group.…”

Section: Discussionmentioning

confidence: 99%

Rifaximin or Saccharomyces boulardii in heart failure with reduced ejection fraction: Results from the randomized GutHeart trial

et al. 2021

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Background The gut microbiota represents a potential treatment target in heart failure (HF) through microbial metabolites such as trimethylamine N-oxide (TMAO) and systemic inflammation. Treatment with the probiotic yeast Saccharomyces boulardii have been suggested to improve left ventricular ejection fraction (LVEF). Methods In a multicentre, prospective randomized open label, blinded end-point trial, we randomized patients with LVEF <40% and New York Heart Association functional class II or III, despite optimal medical therapy, to treatment (1:1:1) with the probiotic yeast Saccharomyces boulardii , the antibiotic rifaximin, or standard of care (SoC) only. The primary endpoint, the baseline-adjusted LVEF at three months, was assessed in an intention-to-treat analysis. Findings We enrolled a total of 151 patients. After three months’ treatment, the LVEF did not differ significantly between the SoC arm and the rifaximin arm (mean difference was -1•2 percentage points; 95% CI -3•2 - 0•7; p=0•22) or between the SoC arm and the Saccharomyces boulardii arm (mean difference -0•2 percentage points; 95% CI -2•2 - 1•9; p=0•87). We observed no significant between-group differences in changes in microbiota diversity, TMAO, or C-reactive protein. Interpretation Three months’ treatment with Saccharomyces boulardii or rifaximin on top of SoC had no significant effect on LVEF, microbiota diversity, or the measured biomarkers in our population with HF. Funding The trial was funded by the Norwegian Association for Public Health, the Blix foundation, Stein Erik Hagen's Foundation for Clinical Heart Research, Ada og Hagbart Waages humanitære og veldedige stiftelse, Alfasigma, and Biocodex.

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Section: Discussionmentioning

confidence: 99%

Rifaximin or Saccharomyces boulardii in heart failure with reduced ejection fraction: Results from the randomized GutHeart trial

et al. 2021

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“…Results are expected during 2020. Given the potential clinical impact of microbiota modulation, as well as the high morbidity and mortality in HF, microbiota modulation is not without risk [82], and close clinical monitoring and predefined safety measures should follow the same standards as in other clinical trials [83]. Notably, genomic and epidemiological evidence of bacterial transmission from probiotic capsules to blood was recently reported in patients in intensive care units [84].…”

Section: Probiotics and Prebioticsmentioning

confidence: 99%

The gut microbiome in coronary artery disease and heart failure: Current knowledge and future directions

et al. 2020

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Host-microbiota interactions involving inflammatory and metabolic pathways have been linked to the pathogenesis of multiple immune-mediated diseases and metabolic conditions like diabetes and obesity. Accumulating evidence suggests that alterations in the gut microbiome could play a role in cardiovascular disease. This review focuses on recent advances in our understanding of the interplay between diet, gut microbiota and cardiovascular disease, with emphasis on heart failure and coronary artery disease. Whereas much of the literature has focused on the circulating levels of the diet-and microbiota-dependent metabolite trimethylamine-N-oxide (TMAO), several recent sequencing-based studies have demonstrated compositional and functional alterations in the gut microbiomes in both diseases. Some microbiota characteristics are consistent across several study cohorts, such as a decreased abundance of microbes with capacity for producing butyrate. However, the published gut microbiota studies generally lack essential covariates like diet and clinical data, are too small to capture the substantial variation in the gut microbiome, and lack parallel plasma samples, limiting the ability to translate the functional capacity of the gut microbiomes to actual function reflected by circulating microbiota-related metabolites. This review attempts to give directions for future studies in order to demonstrate clinical utility of the gut-heart axis.

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“…However, even within a niche field like HF, it is possible to analyse which issues gain more interest and are more requested, thus partially representing the ‘news value’ of a journal. Tables 2–5 report the top 10 articles published in 2019 and 2020 in the European Journal of Heart Failure and ESC Heart Failure , according to their Altmetric Attention Score 5–44 . 2020 was the year of…”

Section: Communication Means Pointsmentioning

confidence: 99%

The Altmetric Attention Score: how science tries to meet social media

Tomasoni

Coats

2021

European J of Heart Fail

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Reply: Potential risk associated with direct modulation of the gut flora in patients with heart failure

Cited by 5 publications

References 14 publications

Rifaximin or Saccharomyces boulardii in heart failure with reduced ejection fraction: Results from the randomized GutHeart trial

Rifaximin or Saccharomyces boulardii in heart failure with reduced ejection fraction: Results from the randomized GutHeart trial

The gut microbiome in coronary artery disease and heart failure: Current knowledge and future directions

The Altmetric Attention Score: how science tries to meet social media

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