Reference : Fidaxomicin versus vancomycin for Clostridium difficile infection: meta-analysis of p...
Scientific journals : Article
Human health sciences : Immunology & infectious disease
http://hdl.handle.net/2268/158774
Fidaxomicin versus vancomycin for Clostridium difficile infection: meta-analysis of pivotal randomized controlled trials.
English
Crook, Derrick W. [> >]
Walker, A. Sarah [> >]
Kean, Yin [> >]
Weiss, Karl [> >]
Cornely, Oliver A. [> >]
Miller, Mark A. [> >]
Esposito, Roberto [> >]
Louie, Thomas J. [> >]
Stoesser, Nicole E. [> >]
Young, Bernadette C. [> >]
Angus, Brian J. [> >]
Gorbach, Sherwood L. [> >]
Peto, Timothy E. A. [> >]
MOUTSCHEN, Michel mailto [Centre Hospitalier Universitaire de Liège - CHU > > Maladies infectieuses et médecine interne générale >]
2012
Clinical Infectious Diseases : An Official Publication of the Infectious Diseases Society of America
55 Suppl 2
S93-103
Yes (verified by ORBi)
International
1058-4838
1537-6591
United States
[en] Aminoglycosides/therapeutic use ; Anti-Bacterial Agents/therapeutic use ; Clostridium Infections/drug therapy/microbiology/mortality ; Clostridium difficile/pathogenicity ; Diarrhea/drug therapy/microbiology ; Eosinophils ; Feces/microbiology ; Humans ; Intention to Treat Analysis ; Leukocyte Count ; Proportional Hazards Models ; Prospective Studies ; Randomized Controlled Trials as Topic ; Recurrence/prevention & control ; Risk Factors ; Vancomycin/therapeutic use
[en] 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.
http://hdl.handle.net/2268/158774
10.1093/cid/cis499

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