Role of fidaxomicin for the treatment of Clostridium difficile infection.

Clostridium difficile is a gram-negative, anaerobic, spore-forming emerging pathogen within health care systems and community-based populations that has a high associated morbidity and mortality as well as cost for the health care system. Recent studies reported high rates of recurrence thus a need for new pharmacological agents to treat C difficile infections (CDIs). Fidaxomicin is a novel macrocyclic antibiotic, originally isolated from fermentation broth of Dactylosporangium aurantiacum spp Hamdenensis, with selective spectrum, unique pharmacokinetic and pharmacodynamics profile, adverse effect profile, efficacy, and role in the treatment of and time to recurrent CDI. Fidaxomicin data have similar clinical cure, when compared to vancomycin, with lower recurrence rates and higher global cure rates in non-BI/NAP1/027 strains. Fidaxomicin also lacks activity against gram-negative bacteria; hence, its potential effect on resistance development among enteric bacteria appears to be low. It appears to have minimal need for renal or hepatic adjustments and minimal concerns for drug-drug interactions. Overall, fidaxomicin has been generally well tolerated with the most common adverse effects reported as mild gastrointestinal complaints. Fidaxomicin appears to have a role in the treatment of CDI with potential lower rates of recurrence, especially in patients with severe disease or risk factors for recurrent CDI.

Fidaxomicin: a macrocyclic antibiotic for the treatment of Clostridium difficile infection.

Clostridium difficile is an emerging pathogen in certain health care systems and community-based populations that is associated with high rates of morbidity and mortality, as well as increased costs for the health care system. As recurrence rates increase, new pharmacologic agents to treat C. difficile infection are needed. Fidaxomicin, a novel macrocyclic antibiotic, was recently approved by the United States Food and Drug Administration for the treatment of C. difficile-associated diarrhea. Originally isolated from fermentation broth of Dactylosporangium aurantiacum subspecies hamdenensis, the drug has a selective spectrum, distinctive pharmacokinetic and pharmaco-dynamic properties, and a favorable adverse-effect profile. Fidaxomicin has demonstrated similar clinical cure rates (i.e., resolution of diarrhea) compared with vancomycin, with lower recurrence rates and higher global cure rates (i.e., resolution of diarrhea without recurrence) in non-restriction endonuclease analysis type BI, North American Pulsed Field type 1 (NAP1), polymerase chain reaction ribotype 027 (or non-BI/NAP1/027) strains. Overall, fidaxomicin has been generally well tolerated, with the most common adverse effects reported as mild gastrointestinal complaints. Fidaxomicin appears to be a useful agent in the treatment of severe C. difficile infection, demonstrating decreased rates of recurrence.