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Fidaxomicin versus vancomycin for Clostridium difficile infection: meta-analysis of pivotal randomized controlled trials

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posted on 2023-06-09, 03:13 authored by Derrick W Crook, A Sarah Walker, Yin Kean, Karl Weiss, Oliver A Cornely, Mark A Miller, Roberto Esposito, Thomas J Louie, Nicole E Stoesser, Bernadette C Young, Brian J Angus, Sherwood L Gorbach, Timothy E A Peto, Martin LlewelynMartin Llewelyn, et al the Optimer Study 003/004 teams
Two recently completed phase 3 trials (003 and 004) showed fidaxomicin to be noninferior to vancomycin for curing Clostridium difficile infection (CDI) and superior for reducing CDI recurrences. In both studies, adults with active CDI were randomized to receive blinded fidaxomicin 200 mg twice daily or vancomycin 125 mg 4 times a day for 10 days. Post hoc exploratory intent-to-treat (ITT) time-to-event analyses were undertaken on the combined study 003 and 004 data, using fixed-effects meta-analysis and Cox regression models. ITT analysis of the combined 003/004 data for 1164 patients showed that fidaxomicin reduced persistent diarrhea, recurrence, or death by 40% (95% confidence interval [CI], 26%-51%; P < .0001) compared with vancomycin through day 40. A 37% (95% CI, 2%-60%; P = .037) reduction in persistent diarrhea or death was evident through day 12 (heterogeneity P = .50 vs 13-40 days), driven by 7 (1.2%) fidaxomicin versus 17 (2.9%) vancomycin deaths at <12 days. Low albumin level, low eosinophil count, and CDI treatment preenrollment were risk factors for persistent diarrhea or death at 12 days, and CDI in the previous 3 months was a risk factor for recurrence (all P < .01). Fidaxomicin has the potential to substantially improve outcomes from CDI.

History

Publication status

  • Published

File Version

  • Published version

Journal

Clinical Infectious Diseases

ISSN

1537-6591

Publisher

Oxford University Press

Issue

Supp 2

Volume

55

Page range

S93-103

Department affiliated with

  • Global Health and Infection Publications

Notes

Martin Llewellyn is not one of the lead authors, but is part of the research group Optimer Study 003/004

Full text available

  • Yes

Peer reviewed?

  • Yes

Legacy Posted Date

2016-10-03

First Open Access (FOA) Date

2016-10-03

First Compliant Deposit (FCD) Date

2016-10-03

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