antibioticos macrolidos - Farmacologia Virtual

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• Nature Reviews Drug Discovery 9, 260 (April 2010) | • Trial watch: Phase III success for novel Clostridium difficile antibiotic • Abstract • The results of the second of two Phase III trials evaluating the macrocyclic antibiotic fidaxomicin (OPT-80, PAR-101), developed by Optimer Pharmaceuticals, confirm that it is as efficacious as vancomycin for treating patients with Clostridium difficile infection (CDI). It is also associated with a lower incidence of recurrence of CDI.
C difficile organism (National Institutes of Health) February 4, 2011 — Compared with vancomycin, fidaxomicin (Optimer Pharmaceuticals, Inc) produces noninferior rates of clinical cure in adults with Clostridium difficile infection. In addition, for some strains, fidaxomicin is associated with a significantly lower rate of recurrence, according to the findings of a randomized trial. Thomas J. Louie, MD, with the University of Calgary, in Calgary, Alberta, Canada, reported the study findings of the randomized phase 3 trial in the February 3 issue of theNew England Journal of Medicine. According to the researchers, fidaxomicin is a macrocyclic antibiotic that is more active in vitro than vancomycin in clinical isolates of C difficile, including the NAP1/BI/027 strain. "This activity, in combination with minimal systemic absorption, high fecal concentrations, and limited activity in vitro and in vivo against components of the normal gut flora, makes fidaxomicin a promising candidate that may provide highly active but more selective therapy for C. difficile infection," the study authors write. The current study included 629 adults with acute symptoms of C difficile infection, with a positive result on a stool toxin test. Patients were randomly assigned to receive fidaxomicin at a dose of 200 mg twice daily or vancomycin at a dose of 125 mg 4 times daily. Both medicines were taken orally for 10 days. Of the patients, 548 (87.1%) could be evaluated for the per-protocol analysis. The rates of clinical cure with fidaxomicin were noninferior to those observed with vancomycin in both the modified intent-to-treat analysis (88.2% vs 85.8% with fidaxomicin vs vancomycin, respectively) and the perprotocol analysis (92.1% and 89.8%, respectively).
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Page 23 and 24: LINCOSAMIDAS ESPECTRO ANTIBACTERIAN
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