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Clinical Infectious Diseases Publishes Subgroup Analysis Showing Optimer's DIFICID™ (fidaxomicin) Tablets Exhibited Higher Clinical Cure and Global Cure Rates Than Vancomycin in Patients with Clostridium difficile-Associated Diarrhea (CDAD) Receivin
Date:8/16/2011

200 mg twice daily) or oral vancomycin (125 mg four times daily) for 10 days. If patients achieved clinical cure, they were followed for recurrence for 4 weeks. Patients were considered to have taken concomitant antibiotics if they received one or more oral or IV doses of antibiotics during the treatment or follow-up periods.  Eligible patients had received a diagnosis of first episode of CDAD or a first recurrence of CDAD within the previous three months and had received no more than 24 hours of pretreatment with vancomycin or metronidazole. Treatment with other therapies potentially effective for CDAD, such as oral bacitracin, fusidic acid and rifaximin were not allowed. Topical antibiotics, treatments for CDAD and antifungal and antiviral agents with no antibacterial activity were not included as concomitant antibiotics. Patients were excluded if diagnosed with immediately life-threatening CDAD.

Clinical cure was defined as resolution of diarrhea (less than or equal to three unformed stools for two consecutive days) maintained until the end of therapy and for two days afterward. Recurrence was defined as the reappearance of symptoms of CDAD within four weeks after completing treatment, the presence of C. difficile toxin A, toxin B, or both in stool, and the need for retreatment.  Global cure was defined as clinical cure with no recurrence during the follow-up period.

About CDAD

Clostridium difficile-associated diarrhea (CDAD) has become a significant medical problem in hospitals, long-term care facilities and in the community. CDAD is a serious illness resulting from infection of the inner lining of the colon by C. difficile bacteria, which produce toxins that cause inflammation of the colon, severe diarrhea and, in the most serious cases, death. Patients typically develop CDAD from the use of broad-spectrum antibiotics that disrupt normal gastrointestinal (gut) flora, possibly allowing C. difficile'/>"/>

SOURCE Optimer Pharmaceuticals, Inc.
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