OBJECTIVE: To evaluate the pharmacology, microbiology, safety, and efficacy of fidaxomicin for treatment of Clostridium difficile infections (CDI). DATA SOURCES: Literature was identified through Ovid MEDLINE (1948-December 2011) and International Pharmaceutical Abstracts (1970-December 2011) using the search terms fidaxomicin, OPT-80, PAR-101, OP-118, difimicin, tiacumicin, lipiarmycin, Clostridium difficile, Clostridium difficile infection, Clostridium difficile-associated diarrhea, and cost. Drug monographs were retrieved from manufacturers' Web pages, and the Red Book component of Micromedex was used for cost information. STUDY SELECTION AND DATA EXTRACTION: All pertinent Phase 1, 2, and 3 studies published in English were included. DATA SYNTHESIS: Fidaxomicin is a macrocyclic compound bactericidal against C. difficile and inhibits toxin and spore production. It has poor oral absorption with high fecal concentrations. Available Phase 2 and 3 data with fidaxomicin 200 mg orally every 12 hours demonstrate similar effectiveness in treating CDI compared to oral vancomycin. Fidaxomicin was shown to have less frequency of recurrent infections. Adverse effects are uncommon and occur at similar rates as with oral vancomycin. The most frequently reported adverse effects are gastrointestinal, hematologic, and electrolyte disorders. Available data are lacking in several areas, including the efficacy and safety of fidaxomicin compared to established regimens for mild-to-moderate, life-threatening, and recurrent CDIs. The cost of a 10-day course of fidaxomicin is significantly more than that of metronidazole and vancomycin for treatment of mild-to-moderate CDI. CONCLUSIONS: Fidaxomicin appears to be an effective and safe alternative to oral vancomycin for treatment of mild-to-moderate and severe CDI. Data on its use compared to guideline-recommended therapies for mild-to-moderate and life-threatening CDI are needed. Further data assessing the cost-effectiveness of fidaxomicin are needed. Currently, it cannot be recommended over vancomycin for treatment of CDI. However, it may be considered for treatment of recurrent infections.
OBJECTIVE: To evaluate the pharmacology, microbiology, safety, and efficacy of fidaxomicin for treatment of Clostridium difficile infections (CDI). DATA SOURCES: Literature was identified through Ovid MEDLINE (1948-December 2011) and International Pharmaceutical Abstracts (1970-December 2011) using the search terms fidaxomicin, OPT-80, PAR-101, OP-118, difimicin, tiacumicin, lipiarmycin, Clostridium difficile, Clostridium difficileinfection, Clostridium difficile-associated diarrhea, and cost. Drug monographs were retrieved from manufacturers' Web pages, and the Red Book component of Micromedex was used for cost information. STUDY SELECTION AND DATA EXTRACTION: All pertinent Phase 1, 2, and 3 studies published in English were included. DATA SYNTHESIS: Fidaxomicin is a macrocyclic compound bactericidal against C. difficile and inhibits toxin and spore production. It has poor oral absorption with high fecal concentrations. Available Phase 2 and 3 data with fidaxomicin 200 mg orally every 12 hours demonstrate similar effectiveness in treating CDI compared to oral vancomycin. Fidaxomicin was shown to have less frequency of recurrent infections. Adverse effects are uncommon and occur at similar rates as with oral vancomycin. The most frequently reported adverse effects are gastrointestinal, hematologic, and electrolyte disorders. Available data are lacking in several areas, including the efficacy and safety of fidaxomicin compared to established regimens for mild-to-moderate, life-threatening, and recurrent CDIs. The cost of a 10-day course of fidaxomicin is significantly more than that of metronidazole and vancomycin for treatment of mild-to-moderate CDI. CONCLUSIONS:Fidaxomicin appears to be an effective and safe alternative to oral vancomycin for treatment of mild-to-moderate and severe CDI. Data on its use compared to guideline-recommended therapies for mild-to-moderate and life-threatening CDI are needed. Further data assessing the cost-effectiveness of fidaxomicin are needed. Currently, it cannot be recommended over vancomycin for treatment of CDI. However, it may be considered for treatment of recurrent infections.
Authors: Alizah Rotramel; Lisa S Poritz; Evangelos Messaris; Arthur Berg; David B Stewart Journal: J Gastrointest Surg Date: 2012-09-25 Impact factor: 3.452
Authors: Regina Lamendella; Justin R Wright; Jada Hackman; Christopher McLimans; David R Toole; William Bernard Rubio; Rebecca Drucker; Hoi Tong Wong; Kate Sabey; John P Hegarty; David B Stewart Journal: mSphere Date: 2018-01-10 Impact factor: 4.389
Authors: Sameer Dhingra; Nor Azlina A Rahman; Ed Peile; Motiur Rahman; Massimo Sartelli; Mohamed Azmi Hassali; Tariqul Islam; Salequl Islam; Mainul Haque Journal: Front Public Health Date: 2020-11-04
Authors: Robert G K Donald; Mike Flint; Narender Kalyan; Erik Johnson; Susan E Witko; Cheryl Kotash; Ping Zhao; Shakuntala Megati; Irina Yurgelonis; Phillip Kwok Lee; Yury V Matsuka; Elena Severina; Anne Deatly; Mini Sidhu; Kathrin U Jansen; Nigel P Minton; Annaliesa S Anderson Journal: Microbiology (Reading) Date: 2013-04-29 Impact factor: 2.777