Oral fidaxomicin versus vancomycin for the treatment of Clostridioides difficile infection: A systematic review and meta-analysis of randomized controlled trials.
Clostridioides difficile infection
Fidaxomicin
Global cure
Meta-analysis
Recurrence
Vancomycin
Journal
Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy
ISSN: 1437-7780
Titre abrégé: J Infect Chemother
Pays: Netherlands
ID NLM: 9608375
Informations de publication
Date de publication:
Nov 2022
Nov 2022
Historique:
received:
06
07
2022
revised:
27
07
2022
accepted:
04
08
2022
pubmed:
15
8
2022
medline:
14
9
2022
entrez:
14
8
2022
Statut:
ppublish
Résumé
Fidaxomicin (FDX) has received considerable attention as a novel therapeutic alternative agent to vancomycin (VCM) for Clostridioides difficile infection (CDI). However, the superiority and efficacy profile of FDX are not sufficiently determined by high-quality evidence. This study aimed to clarify the superiority of FDX for CDI treatment through a systematic review and meta-analysis. We conducted a meta-analysis of randomized controlled trials (RCTs) which evaluated the efficacy and safety of FDX and VCM in patients with CDI. Electronic databases (PubMed, Cochrane Library, Web of Science, and Clinicaltrials.gov) were searched for studies published until October 15, 2021. The primary endpoint was global cure. The secondary endpoints were clinical cure, recurrence, and adverse event. Risk ratios (RRs), risk differences (RDs), and 95% confidence intervals were calculated using Mantel-Haenszel random-effects model. The risk of bias was assessed using Cochrane Handbook for Systematic Reviews of Interventions and Assessment Criteria. Six RCTs were included in this meta-analysis. Compared to VCM, FDX was associated with significantly higher global cure rates (RR = 1.18, P < 0.00001; RD = 0.11, 95% CI = 0.07-0.16). In addition, clinical cure rates were comparable between FDX and VCM (P = 0.31). FDX was associated with significantly lower recurrence rates compared to VCM (RR = 0.59, P < 0.0001). In addition, adverse event rates were not significantly different between the drugs (P = 0.41). FDX achieves significantly higher global cure rates and lower recurrence rates and is comparable to VCM in clinical cure rates and adverse event rates in patients with CDI. Collectively, FDX is superior to VCM as a therapeutic agent for CDI.
Sections du résumé
BACKGROUND
BACKGROUND
Fidaxomicin (FDX) has received considerable attention as a novel therapeutic alternative agent to vancomycin (VCM) for Clostridioides difficile infection (CDI). However, the superiority and efficacy profile of FDX are not sufficiently determined by high-quality evidence. This study aimed to clarify the superiority of FDX for CDI treatment through a systematic review and meta-analysis.
METHODS
METHODS
We conducted a meta-analysis of randomized controlled trials (RCTs) which evaluated the efficacy and safety of FDX and VCM in patients with CDI. Electronic databases (PubMed, Cochrane Library, Web of Science, and Clinicaltrials.gov) were searched for studies published until October 15, 2021. The primary endpoint was global cure. The secondary endpoints were clinical cure, recurrence, and adverse event. Risk ratios (RRs), risk differences (RDs), and 95% confidence intervals were calculated using Mantel-Haenszel random-effects model. The risk of bias was assessed using Cochrane Handbook for Systematic Reviews of Interventions and Assessment Criteria.
RESULTS
RESULTS
Six RCTs were included in this meta-analysis. Compared to VCM, FDX was associated with significantly higher global cure rates (RR = 1.18, P < 0.00001; RD = 0.11, 95% CI = 0.07-0.16). In addition, clinical cure rates were comparable between FDX and VCM (P = 0.31). FDX was associated with significantly lower recurrence rates compared to VCM (RR = 0.59, P < 0.0001). In addition, adverse event rates were not significantly different between the drugs (P = 0.41).
CONCLUSION
CONCLUSIONS
FDX achieves significantly higher global cure rates and lower recurrence rates and is comparable to VCM in clinical cure rates and adverse event rates in patients with CDI. Collectively, FDX is superior to VCM as a therapeutic agent for CDI.
Identifiants
pubmed: 35964806
pii: S1341-321X(22)00234-3
doi: 10.1016/j.jiac.2022.08.008
pii:
doi:
Substances chimiques
Anti-Bacterial Agents
0
Vancomycin
6Q205EH1VU
Fidaxomicin
Z5N076G8YQ
Types de publication
Journal Article
Meta-Analysis
Systematic Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
1536-1545Informations de copyright
Copyright © 2022 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of competing interest Kazuaki Matsumoto received grant support from Meiji Seika Pharma Co., Ltd. and Sumitomo Pharma Co., Ltd., and speaker honoraria from Meiji Seika Pharma Co., Ltd. Hiroki Ohge received speaker honoraria from MSD K.K. Hiromichi Suzuki is advisory role of Mizuho Medy Co., Ltd. and TOYOBO Co., Ltd. Atsushi Nakamura received speaker honoraria from MSD K.K., Astellas Pharma, Inc., and Kyorin Pharmaceutical Co., Ltd. Yuka Yamagishi received speaker honoraria from MSD K.K., Taisho Toyama Pharmaceutical Co., Ltd., and Sumitomo Pharma Co., Ltd. Katsunori Yanagihara received speaker honoraria from Pfizer Japan, Inc., Daiichi Sankyo Co., Ltd., Astellas Pharma, Inc., Taisho Toyama Pharmaceutical Co., Ltd., MSD Japan, bioMerieux Japan and BD Japan, research fees from Meiji Seika Pharma Co., Ltd., Kyorin Pharmaceutical Co., Ltd., Toyama Chemical Co., Ltd.and Roche Diagnostics K.K., and research grants from Sumitomo Pharma Co., Ltd., MSD Japan, Daiichi Sankyo Co., Ltd., Pfizer Japan, Inc., and Biofermin Seiyaku Co., Ltd., BD Japan, Miyarisan Co., Ltd.and bioMerieux Japan. Hiroshige Mikamo received speaker honoraria from MSD K.K., FUJIFILM Toyama Chemical Co., Ltd., Miyarisan Pharmaceutical Co., Daiichi Sankyo Co., Ltd., Pfizer Japan Inc., Sanofi K.K., Sumitomo Pharma Co., Ltd., Kyorin Pharmaceutical Co., Ltd., Shionogi & Co., Ltd., Kowa Co. Ltd., Gilead Sciences K.K., GSK Group of Companies, Saraya Co. Ltd., Tsumura & Co., Nippon Becton Dickinson Company, Ltd., and FUKOKU Co., Ltd., grant supports from Asai Kasei Pharma Co., Shionogi & Co., Ltd., Sumitomo Pharma Co., Ltd., and FUKOKU Co., Ltd. Hiroyuki Kunishima received speaker honoraria from MSD K.K. Astellas Pharma, Inc., Shionogi & Co., Ltd.. Miyarisan Pharmaceutical Co., Ltd. Yoshitomo Morinaga received research grants from Kyorin Pharmaceutical Co., Ltd. The other authors have no conflicts of interest to declare.