Comparable initial response at day 10>1 Superior sustained efficacy at 25 days post treatment1

DIFICID® VS VANCOMYCIN FOR THE TREATMENT OF C. DIFFICILE-ASSOCIATED DIARRHEA (CDAD) IN ADULTS AGED ≥18 YEARS1

 

Efficacy only measured at study days 10 and 35

 

STUDY DESCRIPTION: Pooled results from two phase 3, randomized, double-blind, non-inferiority studies comparing the effi cacy and safety of oral DIFICID (N=542) 200 mg twice daily versus oral vancomycin (N=563) 125 mg four times daily for 10 days in the treatment of adults ≥18 years of age with CDAD1

 

* In patients with a BI isolate, DIFICID ( daxomicin) did not demonstrate superiority in sustained clinical response when compared with vancomycin1

 

*

Proven or suspected.

† 

Confidence interval was derived using Wilson’s score method. Approximately 5% to 9% of the data in each trial and treatment arm were missing sustained response data and were imputed using a multiple imputation method.1

 

Important Safety Information

  • DIFICID is contraindicated in patients with hypersensitivity to fidaxomicin
  • DIFICID should not be used for systemic infections
  • Acute hypersensitivity reactions (angioedema, dyspnea, pruritus, and rash) have been reported. In the event of a severe reaction, discontinue DIFICID.
  • Only use DIFICID for infection proven or strongly suspected to be caused by C. difficile.
    Prescribing DIFICID in the absence of a proven or strongly suspected C. difficile infection is unlikely to provide benefit to the patient and increases the risk of the development of drug- resistant bacteria.
  • The most common adverse reactions reported in clinical trials are nausea (11%), vomiting (7%), abdominal pain (6%), gastrointestinal hemorrhage (4%), anemia (2%), and neutropenia (2%)

 

Indications and Usage

  • DIFICID is a macrolide antibacterial drug indicated in adults ≥18 years of age for treatment of Clostridium difficile-associated diarrhea
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of DIFICID and other antibacterial drugs, DIFICID should be used only to treat infections that are proven or strongly suspected to be caused by Clostridium difficile

 

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