Efficacy and safety of fidaxomicin compared with oral vancomycin for the treatment of adults with Clostridium difficile-associated diarrhea: data from the OPT-80-003 and OPT-80-004 studies.

Journal Article (Clinical Trial, Phase III;Journal Article;Multicenter Study)

Clostridium difficile is emerging as one of the most important and devastating pathogens affecting hospitalized populations around the world. The incidence of C. difficile infection is increasing and disease severity is worsening. Thus, an effective alternative to metronidazole and oral vancomycin is urgently needed. Two Phase III trials, OPT-80-003 and OPT-80-004, showed that oral fidaxomicin for 10 days was noninferior compared with treatment with oral vancomycin among adult patients with toxin-positive C. difficile-associated diarrhea (CDAD). Furthermore, fidaxomicin was associated with a lower rate of recurrence of CDAD within 4 weeks of completion of therapy. The safety and tolerability of fidaxomicin was consistent with earlier studies and established that fidaxomicin is an efficacious and well-tolerated treatment option for CDAD. Despite these potential advantages, the cost-effectiveness of this expensive agent remains poorly understood.

Full Text

Duke Authors

Cited Authors

  • Chen, LF; Anderson, DJ

Published Date

  • June 2012

Published In

Volume / Issue

  • 7 / 6

Start / End Page

  • 677 - 683

PubMed ID

  • 22702523

Electronic International Standard Serial Number (EISSN)

  • 1746-0921

Digital Object Identifier (DOI)

  • 10.2217/fmb.12.44


  • eng

Conference Location

  • England