, Volume 73, Issue 15, pp 1733-1747

Fidaxomicin: A Review of Its Use in Patients with Clostridium difficile Infection

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Abstract

Oral fidaxomicin (Dificid®; Dificlir®) is a first-in-class macrocyclic antibacterial that is approved in several countries for the treatment of adult patients with Clostridium difficile-associated diarrhoea. Fidaxomicin 200 mg twice daily for 10 days was an effective and generally well tolerated treatment in adult patients with a first episode or first recurrence of C. difficile infection. In two multinational phase III trials, fidaxomicin treatment was noninferior to vancomycin treatment with regard to clinical cure rates and was associated with statistically significantly lower C. difficile infection recurrence rates and statistically significantly higher global cure rates than vancomycin. The drug has a favourable pharmacological profile, including having a narrow spectrum of activity that targets relevant pathogens, minimal impact on normal faecal microflora, a convenient treatment regimen and attainment of very high faecal concentrations. Albeit further clinical experience is required to fully define the position of fidaxomicin, it is a valuable emerging option for the treatment of first episode and recurrent episodes of C. difficile-associated diarrhoea.

The manuscript was reviewed by: E. M. Billaud, Paris Descartes University, School of Medicine, Paris, France; J. M. Blondeau, Royal University Hospital, Department of Clinical Microbiology Saskatoon Health Region and the University of Saskatchewan Saskatoon, Saskatoon, SK, Canada; T. Cai, Santa Chiara Regional Hospital, Department of Urology, Florence, Italy; D. M. Cappelletty, University of Toledo, College of Pharmacy and Pharmaceutical Sciences, Toledo, OH, USA; V. Carboni, San Sebastiano Matire Hospital, Department of Dermatology, Frascati, Rome, Italy; K. M. Mullane, University of Chicago, Department of Medicine, Section of Infectious Diseases, Chicago, IL, USA.