Document Detail


Fidaxomicin versus vancomycin for Clostridium difficile infection: meta-analysis of pivotal randomized controlled trials.
MedLine Citation:
PMID:  22752871     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
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;
Publication Detail:
Type:  Journal Article; Meta-Analysis; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Clinical infectious diseases : an official publication of the Infectious Diseases Society of America     Volume:  55 Suppl 2     ISSN:  1537-6591     ISO Abbreviation:  Clin. Infect. Dis.     Publication Date:  2012 Aug 
Date Detail:
Created Date:  2012-07-03     Completed Date:  2012-11-08     Revised Date:  2013-07-12    
Medline Journal Info:
Nlm Unique ID:  9203213     Medline TA:  Clin Infect Dis     Country:  United States    
Other Details:
Languages:  eng     Pagination:  S93-103     Citation Subset:  IM    
Affiliation:
Nuffield Department of Medicine, Oxford University, Oxford, UK. derrick.crook@ndcls.ox.ac.uk
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MeSH Terms
Descriptor/Qualifier:
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*
Chemical
Reg. No./Substance:
0/Aminoglycosides; 0/Anti-Bacterial Agents; 1404-90-6/Vancomycin; 56645-60-4/lipiarmycin
Investigator
Investigator/Affiliation:
M Gerson / ; J Pullman / ; R Nathan / ; W Riebel / ; M Silverman / ; C Donskey / ; D Grimard / ; I Baird / ; M J Cox / ; M Tan / ; C Schrock / ; I L Gordon / ; C-B Hsiao / ; J C Jones / ; G Alangaden / ; C Lee / ; J-A Young / ; A Bressler / ; C Lucasti / ; R M Chaudhry / ; E Larkai / ; R G Ashley / ; J Berner / ; G Bochicchio / ; A Dhar / ; T Lowdermilk / ; Y Mirzanejad / ; M Nagrani / ; M F Parry / ; L E Jauregui-Peredo / ; M DiGiovanna / ; C Dallaire / ; G Donowitz / ; A McGeer / ; J Moorman / ; M Morrison / ; A Reboli / ; E Tobin / ; L Valiquette / ; A Bacon / ; R Bourdages / ; C Carpati / ; D Graham / ; T Redling / ; N Almyroudis / ; J Augustinsky / ; R Bellam / ; C Bunce / ; K Katz / ; C Ketels / ; D Maki / ; P C Lee / ; L Perez-Limonte / ; K Shivshonker / ; S L Chérifi / ; I Demeyer / ; M De Vos / ; F Fontaine / ; M Gérard / ; P Gruselle / ; F Jacobs / ; A Mast / ; M Moutschen / ; S Naegels / ; C Rossi / ; P Vergauwe / ; L Bernard / ; J-L Dupas / ; F Puisieux / ; E Senneville / ; J-P Stahl / ; K Dalhoff / ; A-J Dormann / ; W Holtmeier / ; P Kern / ; P Malfertheiner / ; B Salzberger / ; S Zeuzem / ; G Di Perri / ; T Quirino / ; E Bouza Santiago / ; J Cobo Reinoso / ; M Herrero Romeroa / ; J A Martinez / ; A Pahissa Berga / ; E Back / ; L Hagberg / ; A Guyot / ; K Kapur / ; M Llewelyn / ; Y Mahida / ; S J Smale / ; A Woodhouse / ; J Woodward /
Comments/Corrections

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