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Fidaxomicin in Clostridium difficile infection: added benefit not proven
Date:7/2/2013

The antibiotic fidaxomicin (trade name: Dificlir) has been approved in Germany since December 2011 for the treatment of adults who have diarrhoea caused by Clostridium difficile. In an early benefit assessment pursuant to the "Act on the Reform of the Market for Medicinal Products" (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined the added benefit of fidaxomicin in comparison with current standard therapy. According to this, there is currently no proof of an added benefit. The manufacturer did not submit any studies on non-severe cases. It cited studies on severe courses of disease and recurrences, but did not process the results in a way that would make it possible to draw reliable overall conclusions on benefit and harm of fidaxomicin.

G-BA distinguished between three treatment situations

For this benefit assessment, the Federal Joint Committee (G-BA) distinguished between three treatment situations, and hence also specified different drugs as appropriate comparator therapy: in courses of the disease that were not severe, but required treatment, fidaxomicin was to be compared with the antibiotic metronidazole; in severe cases and in patients with recurrence, with vancomycin, another antibiotic.

No studies on comparison with metronidazole

Results of two randomized controlled trials (RCTs), both approval studies on fidaxomicin, were available for IQWiG's assessment (studies 101.1.C.003 and 101.1.C.004). In these studies, fidaxomicin was tested against the drug vancomycin in patients with all courses of the disease, i.e. including patients who were not severely affected.

Moreover, the manufacturer did not cite any additional studies for patients with non-severe course of the disease, in whom fidaxomicin was to be compared with metronidazole. So no data were available for this appropriate comparator therapy. Hence an added benefit for this subpopulation is n
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Contact: Dr. Anna-Sabine Ernst
presse@iqwig.de
49-022-135-6850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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