Comparative effectiveness of early‐targeted use of fidaxomicin versus oral vancomycin among hospitalized veterans’ affairs patients with infections due to <i>Clostridioides difficile</i>

Patel, Nimish; Lowry, Colleen M.; Morgenson, Daralyn; Shah, Vaishali; Stornelli, Nicholas; Lodise, Thomas P.

doi:10.1002/phar.2503

Cited by 6 publications

(6 citation statements)

References 24 publications

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“…Findings from multivariable regression analysis in this study suggest it was fidaxomicin use more so than the overall treatment pathway that increased sustained response pre-post, further highlighting the important contribution of fidaxomicin. Reductions in recurrences and CDI readmissions post treatment pathway implementation demonstrate real-world experience consistent with prior literature, with the current study also Median of 5 days used for both due to non-significant difference [6 (4-10) vs. 4.5 (2-4.5), p = 0.251] c Equals savings from CDI-related readmission costs/the additional number of patients with sustained response d Equals savings from CDI-related readmission costs/the number of CDI-related readmissions avoided e Equals savings from CDI-related readmission costs/the number of bed-days saved providing a larger sample-size than available retrospective studies [17][18][19].…”

Section: Discussionmentioning

confidence: 99%

Clinical and Economic Outcomes After Implementation of a Fidaxomicin Treatment Optimization and Access Pathway at a US Hospital System

et al. 2022

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Introduction This study aimed to evaluate the clinical and economic outcomes of implementing a Clostridiodes difficile infection (CDI) Treatment Optimization and Access Pathway (treatment pathway) directing first-line use of fidaxomicin for CDI. Methods This was a retrospective, quasi-experimental study of adult patients with CDI using Electronic Health Record data from a single center. The primary intervention was implementation of a treatment pathway directing first-line use of fidaxomicin for patients with first/second CDI episode and at high risk of recurrence. The primary clinical outcome was CDI recurrence within 30 days of completing therapy in patients achieving clinical cure. Secondary clinical outcomes included clinical cure and sustained response evaluated at 90 days after completion of CDI treatment. Economic outcomes included costs associated with hospital stay at index admission and 30- and 90-day readmission. Differences between the pre- and post-implementation cohorts were assessed for baseline characteristics, CDI treatment utilization, clinical outcomes, and economic outcomes. The budget impact was calculated for the pre- vs. post-implementation cohorts, each normalized to 100 patients. Results Post- vs. pre-implementation, 30-day recurrence (6.4% vs. 18.0%., p = 0.001), 90-day recurrence (14.9% vs. 27.1%, p = 0.009), and 30-day (4.6% vs. 12.7%, p = 0.007) and 90-day CDI-related readmissions (8.5% vs. 18.9%, p = 0.007) were lower. The clinical cure (94.1% vs. 84.4%, p = 0.002) and 90-day sustained response rates were higher (73.3% vs. 55.9%, p < 0.001). Median total costs were also lower in the post- vs. pre-implementation cohorts at index admission ($11,934.64 vs. $14,523.27, p = 0.048), and 30-day ($7685.82 vs. $12,424.44, p = 0.102) and 90-day CDI-related readmission episodes ($8246.69 vs. $12,729.57, p = 0.042). The budget impact analyses of 100 patients post- vs. pre-implementation found saving of $222,895 overall and $9432 per CDI-readmission avoided. Conclusions Implementation of the CDI treatment pathway was associated with better clinical outcomes and hospital cost savings. The findings help validate real-world value of fidaxomicin for CDI disease management.

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Section: Discussionmentioning

confidence: 99%

Clinical and Economic Outcomes After Implementation of a Fidaxomicin Treatment Optimization and Access Pathway at a US Hospital System

et al. 2022

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“…Of the remaining 22 full‐text articles reviewed, 14 studies (six RCTs and eight observational trials) met eligibility criteria for the final meta‐analysis (Figure 1). 9–12,20–30 Reasons for excluding full‐text articles included an unspecified follow‐up period for recurrence, missing data, population overlap, and concomitant use of fecal microbiota transplantation 31–37 . For included RCTs, three studies were assessed to have a low risk of bias and three with some concerns, primarily due to problems related to the unblinding of standard‐of‐care treatments (Figure 2A).…”

Section: Resultsmentioning

confidence: 99%

“…[9][10][11][12][20][21][22][23][24][25][26][27][28][29][30] Reasons for excluding full-text articles included an unspecified follow-up period for recurrence, missing data, population overlap, and concomitant use of fecal microbiota transplantation. [31][32][33][34][35][36][37] For included RCTs, three studies were assessed to have a low risk of bias and three with some concerns, primarily due to problems related to the unblinding of standard-of-care treatments (Figure 2A). For observational trials, only two studies, both reporting on outcomes associated with bezlotoxumab use, were not assessed to be of "good" quality (Figure 2B).…”

Section: Re Sultsmentioning

confidence: 99%

“…The sensitivity analysis for removal of individual studies found over 10% reductions in heterogeneity with the removal of the Guery study (the only RCT evaluating fidaxomicin extended-pulsed dosing and the Polivkova study). 9,24 While these studies had the lowest Reports excluded: Adjunctive fecal microbiota transplantation (n=2) 32,33 Population overlap (n=1) 31 Missing data (n=3) 34,35,37 Unclear follow-up period (n=1) 36 Studies included in review (n=14) [9][10][11][12][21][22][23][24][25][26][27][28][29][30] Controlled trials (n=6) Observational trials (n=8)…”

Section: Sensitivity Analysesmentioning

confidence: 99%

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Path of least recurrence: A systematic review and meta‐analysis of fidaxomicin versus vancomycin for Clostridioides difficile infection

et al. 2022

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Study Objective Current Clostridioides difficile infection (CDI) treatment guidelines recommend either fidaxomicin or vancomycin as first‐line therapy for initial and recurrent CDI. The objective of this study was to compare recurrence rates of fidaxomicin and vancomycin for the treatment of CDI in clinically relevant and real‐world subgroups via systematic review and meta‐analysis. Design & Data Sources A systematic literature review was performed by searching PubMed, EMBASE, Cochrane Central Register of Controlled Trials, and http://clinicaltrials.gov from inception to September 1, 2021, for randomized and observational studies comparing vancomycin and fidaxomicin for CDI treatment in adults. The meta‐analysis was performed with Review Manager 5.4 software (Cochrane Library, Oxford, United Kingdom) using a random‐effects model. The primary end point was CDI recurrence after treatment with fidaxomicin or vancomycin. Subgroup analyses were conducted. Patients, Intervention, Measurements & Main Results The literature search identified six randomized controlled trials and eight observational trials, with a total of 3944 patients (fidaxomicin 32%; vancomycin 68%) included in the meta‐analysis. The mean age of study patients ranged from 46 to 75 years. The CDI recurrence rate was 22.4% (fidaxomicin 16.1%, vancomycin 25.4%). Compared to vancomycin, treatment with fidaxomicin was associated with a 31% reduction in the risk of recurrence (risk ratio 0.69; 95% confidence interval: 0.52–0.91, I2 = 62%). This reduction in recurrence risk was also seen in subgroup analyses for patients with initial CDI, first recurrent CDI, non‐severe and severe CDI, and in both inpatient and outpatient settings. Conclusion Our systematic review and meta‐analysis found fidaxomicin was consistently associated with a lower risk of CDI recurrence than vancomycin. These results confirm CDI guideline recommendations and indicate that fidaxomicin may be preferred over vancomycin to minimize CDI recurrence across multiple clinical scenarios, although further studies are warranted.

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“… 51 . Recently it has been reported that administration of Vancomycin in patients at Veterans Affair Hospitals have been ineffective against these clinically important bacteria and causing nephrotoxicity 52 – 55 . Increased glycopeptide resistance as detected in our GW Veteran samples might be suggestive of the reason behind the ineffectiveness of Vancomycin antibiotic used to treat a section of Veterans.…”

Section: Discussionmentioning

confidence: 99%

Host gut resistome in Gulf War chronic multisymptom illness correlates with persistent inflammation

et al. 2022

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Chronic multisymptom illness (CMI) affects a subsection of elderly and war Veterans and is associated with systemic inflammation. Here, using a mouse model of CMI and a group of Gulf War (GW) Veterans’ with CMI we show the presence of an altered host resistome. Results show that antibiotic resistance genes (ARGs) are significantly altered in the CMI group in both mice and GW Veterans when compared to control. Fecal samples from GW Veterans with persistent CMI show a significant increase of resistance to a wide class of antibiotics and exhibited an array of mobile genetic elements (MGEs) distinct from normal healthy controls. The altered resistome and gene signature is correlated with mouse serum IL-6 levels. Altered resistome in mice also is correlated strongly with intestinal inflammation, decreased synaptic plasticity, reversible with fecal microbiota transplant (FMT). The results reported might help in understanding the risks to treating hospital acquired infections in this population.

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Comparative effectiveness of early‐targeted use of fidaxomicin versus oral vancomycin among hospitalized veterans’ affairs patients with infections due to Clostridioides difficile

Abstract: Study Objectives: This study sought to compare real-world effectiveness outcomes between hospitalized patients with Clostridioides difficile infections (CDIs) who received early-targeted fidaxomicin or oral vancomycin at two Veterans Affairs Medical Centers (VAMCs).

Cited by 6 publications

References 24 publications

Clinical and Economic Outcomes After Implementation of a Fidaxomicin Treatment Optimization and Access Pathway at a US Hospital System

Clinical and Economic Outcomes After Implementation of a Fidaxomicin Treatment Optimization and Access Pathway at a US Hospital System

Path of least recurrence: A systematic review and meta‐analysis of fidaxomicin versus vancomycin for Clostridioides difficile infection

Host gut resistome in Gulf War chronic multisymptom illness correlates with persistent inflammation

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