Clostridioides difficile Infection in the United States of America-A Comparative Event Risk Analysis of Patients Treated with Fidaxomicin vs. Vancomycin Across 67 Large Healthcare Providers.

IF 2.4 Q2 INFECTIOUS DISEASES
Sebastian M Wingen-Heimann, Christoph Lübbert, Davide Fiore Bavaro, Sina M Hopff
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引用次数: 0

Abstract

Background/objectives: Clostridioides difficile infection (CDI) is a major cause of infectious diarrhea in the inpatient and community setting. Real-world data outside the strict environment of randomized controlled trials (RCTs) are needed to improve the quality of evidence. The aim of this study was to compare different clinical outcomes of CDI patients treated with fidaxomicin with those treated with vancomycin using a representative patient population in the United States of America (USA).

Methods: Comprehensive real-world data were analyzed for this retrospective observational study, provided by the TriNetX database, an international research network with electronic health records from multiple USA healthcare providers. This includes in- and outpatients treated with fidaxomicin (FDX) or vancomycin (VAN) for CDI between 01/2013 and 12/2023. The following cohorts were compared: (i) patients treated with fidaxomicin within 10 days following CDI diagnosis (FDX group) vs. (ii) patients treated with vancomycin within 10 days following CDI diagnosis (VAN group). Outcomes analysis between the two cohorts was performed after propensity score matching and included event risk and Kaplan-Meier survival analyses for the following concomitant diseases/events occurring during an observational period of 12 months following CDI diagnosis: death, sepsis, candidiasis, infections caused by vancomycin-resistant enterococci, inflammatory bowel disease, cardiovascular disease, psychological disease, central line-associated blood stream infection, surgical site infection, and ventilator-associated pneumonia.

Results: Following propensity score matching, 2170 patients were included in the FDX group and VAN groups, respectively. The event risk analysis demonstrated improved outcomes of patients treated with FDX compared to VAN in 6 out of the 10 events that were analyzed. The highest risk ratio (RR) and odds ratio (OR) were found for sepsis (RR: 3.409; OR: 3.635), candidiasis (RR: 2.347; OR: 2.431), and death (RR: 1.710; OR: 1.811). The Kaplan-Meier survival analysis showed an overall survival rate until the end of the 12-month observational period of 87.06% in the FDX group and 78.49% in the VAN group (log-rank p < 0.001).

Conclusions: Our comparative event risk analysis demonstrated improved outcomes for patients treated with FDX compared to VAN in most of the observed events and underlines the results of previously conducted RCTs, highlighting the beneficial role of FDX compared to VAN. Further big data analyses from other industrialized countries are needed for comparison with our observations.

Abstract Image

美国艰难梭菌感染——67家大型医疗机构中使用非达霉素和万古霉素治疗的患者的比较事件风险分析
背景/目的:艰难梭菌感染(CDI)是住院和社区环境中感染性腹泻的主要原因。需要随机对照试验(RCTs)严格环境之外的真实数据来提高证据质量。本研究的目的是比较使用非达霉素和万古霉素治疗的CDI患者的不同临床结果,研究对象为美国(USA)具有代表性的患者群体。方法:本回顾性观察性研究分析了由TriNetX数据库提供的真实世界的综合数据,该数据库是一个国际研究网络,包含来自多家美国医疗保健提供者的电子健康记录。这包括2013年1月至2023年12月期间接受非达索霉素(FDX)或万古霉素(VAN)治疗CDI的住院和门诊患者。比较以下队列:(i) CDI诊断后10天内接受非达霉素治疗的患者(FDX组)和(ii) CDI诊断后10天内接受万古霉素治疗的患者(VAN组)。在倾向评分匹配后,对两个队列进行结果分析,包括在CDI诊断后12个月的观察期间发生的以下伴随疾病/事件的事件风险和Kaplan-Meier生存分析:死亡、败血症、念珠菌病、万古霉素耐药肠球菌引起的感染、炎症性肠病、心血管疾病、心理疾病、中央静脉相关血流感染、手术部位感染和呼吸机相关肺炎。结果:经倾向评分匹配,FDX组和VAN组分别纳入2170例患者。事件风险分析显示,与VAN相比,FDX治疗的患者在分析的10个事件中有6个改善了结果。脓毒症(RR: 3.409; OR: 3.635)、念珠菌病(RR: 2.347; OR: 2.431)和死亡(RR: 1.710; OR: 1.811)的危险比(RR)和优势比(OR)最高。Kaplan-Meier生存分析显示,到12个月观察期结束时,FDX组的总生存率为87.06%,VAN组为78.49% (log-rank p < 0.001)。结论:我们的比较事件风险分析表明,在大多数观察到的事件中,与VAN相比,FDX治疗的患者的预后有所改善,并强调了先前进行的随机对照试验的结果,强调了FDX与VAN相比的有益作用。需要其他工业化国家的进一步大数据分析来与我们的观察结果进行比较。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Infectious Disease Reports
Infectious Disease Reports INFECTIOUS DISEASES-
CiteScore
5.10
自引率
0.00%
发文量
82
审稿时长
11 weeks
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