Real-life experience with fidaxomicin in Clostridioides difficile infection: a multicentre cohort study on 244 episodes

Ruiz-Ruigómez, María; Valencia-Alijo, Ángela; Tovar, Sandra Cuéllar; Merino, Esperanza; García‐Fernández, Sergio; Gutiérrez-Rojas, Ángela; Ramos‐Martínez, Antonio; Lletí, Miguel Salavert; Hernández, Iván Castro; Giner, Livia; Cobo, Javier

doi:10.1007/s15010-020-01567-5

Cited by 9 publications

(8 citation statements)

References 21 publications

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“…Another study [ 14 ] with a higher percentage of patients treated in the first episode replicated the results of the pivotal trials. Nevertheless, all these post-authorization studies [ 12 , 14 , 26 , 27 ] confirmed the outcomes in both clinical cure and recurrence rate that appeared in the RCT [ 9 , 10 ] varying from 82% to 92% cure [ 12 , 14 , 26 , 27 ], with recurrence rate from 15% to 28% [ 12 , 14 , 16 , 26 , 28 ], similar to our results (cure 84% and recurrence 33% in fidaxomicin group). In addition, Gentry et al reported higher failure rates in patients with severe CDI treated with fidaxomicin compared to vancomycin (9.39% vs. 1.41%), as well as higher combined outcome clinical failure or recurrence at 12 weeks (32% in fidaxomicin vs 25% in vancomycin) [ 16 ].…”

Section: Discussionsupporting

confidence: 91%

“…Neither, in Tieu et al's study, which compared the use of fidaxomicin or vancomycin for treating the first or second recurrent CDI episode, found no significant differences between the two treatments in the combined outcome of clinical failure or recurrence at 90 days [ 28 ]. In our series, 40% of patients treated with fidaxomicin had a severe episode of CDI, a rate similar to those reported by Escudero et al [ 12 ] or Guery et al [ 14 ], but higher than Giacobbe et al's (28%) [ 27 ]. Probably, in our series, the better outcomes observed in vancomycin-treated patients compared to those treated with fidaxomicin were due, in part, to the fact that the vancomycin group had less severe disease and higher first episodes.…”

Section: Discussionsupporting

confidence: 90%

“…In the DAFNE study, 12-week mortality was 12%, with a CDI-attributable mortality of 1.3% (3 patients) [ 14 ]. In another study, 11.8% died at 12 weeks among those treated with fidaxomicin [ 12 ]. In a report of long-term mortality analysis of patients with severe CDI, no significant differences in mortality were observed between the two treatment groups at day 30, day 90 and day 180 [ 16 ].…”

Section: Discussionmentioning

confidence: 99%

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A Comparison of the Efficacy of Treatment With Fidaxomicin Versus Vancomycin in Clostridioides difficile Infection

Diaz-Pollan,

Carrasco Molina,

Marcelo

et al. 2023

Cureus

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Background Clostridioides difficile infection (CDI) is a major cause of diarrhea in hospitalized adult patients. This study aims to evaluate the clinical characteristics, clinical cure, recurrence and mortality in patients with CDI treated with either fidaxomicin or vancomycin. Methods A retrospective case-control study was conducted on patients with CDI treated with either fidaxomicin or vancomycin at a hospital from January 2019 to March 2022. Results We assessed 140 patients with CDI episodes, 70 patients treated with fidaxomicin and 70 with vancomycin. Seventy (50%) were male. Median age was 70 years old (IQR: 56-81). Fidaxomicin group had more recurrent CDI episodes within six months (59% vs 11%, p ≤ 0.001), more severity (43% vs 16%, p ≤ 0.001) and less treatment response (84% vs 100%, p ≤ 0.002) compared with vancomycin group. Recurrence and mortality rates in the follow-up period did not differ in both groups. Conclusions Our study found fidaxomicin treatment had worse outcomes due to restricted usage, potentially impacting its effectiveness in CDI. This finding is especially significant for patients with severe or recurrent CDI, as prescribing of the drug was limited until May 2022 in Spain with the lifting of this restriction, further research is necessary to better understand the potential benefits of fidaxomicin in treating CDI.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionsupporting

confidence: 90%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

A Comparison of the Efficacy of Treatment With Fidaxomicin Versus Vancomycin in Clostridioides difficile Infection

Diaz-Pollan,

Carrasco Molina,

Marcelo

et al. 2023

Cureus

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“…Escudero-Sánchez and colleagues conducted a retrospective, matched-cohort study in Spain using data from two previously published reports [ 50 , 55 ] comparing FDX monotherapy with SoC combined with BEZ. Three hundred and thirty-five participants were evaluated.…”

Section: Trials Not Included In the 2021 Focused CDI Guideline Updatementioning

confidence: 99%

The Role of Bezlotoxumab for the Prevention of Recurrent Clostridioides difficile Infections: A Review of the Current Literature and Paradigm Shift after 2021

et al. 2022

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Clostridioides difficile infections (CDIs), and particularly recurrent infections, cause a significant burden on the health-care system. Bezlotoxumab is a new agent for the prevention of recurrent CDIs that has shown strong efficacy and high tolerability in clinical trials. The purpose of this review is to evaluate the published literature for bezlotoxumab, with a focus on literature published since the release of the 2021 focused update to the CDI treatment guidelines. A Medline/PubMed search for “bezlotoxumab” was conducted, resulting in 152 articles. Seventeen studies are included in this review, after excluding non-English-language papers, phase I and II trials, and review articles. Studies published since the 2021 focused update support the recommendations in those guidelines. Furthermore, real-world studies have shown similar results to larger clinical trials. Those with more risk factors for recurrent CDI appear to benefit most from bezlotoxumab. Currently, there are no data to support the use of bezlotoxumab outside current guideline recommendations, but future trials may build on the data seen in real-world studies to further elucidate the place in therapy for bezlotoxumab.

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“…From observational studies, both FDX and BZL show lower efficacy from the first and, definitely, the second recurrence [10][11][12]; hence, probably positioning these drugs in the second recurrence and thereafter, provides a sign of their lower efficiency. In the event of a second recurrence and particularly in the subsequent ones, the most effective treatment today is FMT.…”

Section: Recommended Treatmentsmentioning

confidence: 99%

Treatment of Clostridioides difficile infection: from guidelines to clinical practice

Merino¹,

Salavert²

2022

Rev Esp Quimioter

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The Clostridioides difficile Infection (CDI) treatment guidelines were published in 2021; however, the incorporation of these recommendations into clinical practice was rather irregular and inconsistent. The differences in the implementation of these new guidelines were due, in part, to the variety in the different professionals who provided patient care, as well as to the issues involved in either their accessibility or availability or both. The main requirements for implementation include appropriate reflection on patient stratification, drug positioning, accessibility to drugs, as well as the organization of structured clinical pathways that can facilitate the functionality and evaluation of the management of CDI.

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Real-life experience with fidaxomicin in Clostridioides difficile infection: a multicentre cohort study on 244 episodes

Cited by 9 publications

References 21 publications

A Comparison of the Efficacy of Treatment With Fidaxomicin Versus Vancomycin in Clostridioides difficile Infection

A Comparison of the Efficacy of Treatment With Fidaxomicin Versus Vancomycin in Clostridioides difficile Infection

The Role of Bezlotoxumab for the Prevention of Recurrent Clostridioides difficile Infections: A Review of the Current Literature and Paradigm Shift after 2021

Treatment of Clostridioides difficile infection: from guidelines to clinical practice

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