Long-term Therapy with Norfloxacin Improves Advanced Liver Disease Prognosis
APRIL 20, 2017
According to a joint news release from The International Liver Congress and The European Association for the Study of the Liver, the leading liver association in Europe, the multicenter, randomized, controlled phase 3 trial by French researchers assigned 291 patients with Child-Pugh class C cirrhosis to receive either a 400-mg norfloxacin tablet or a placebo once a day for 6 months. The team demonstrated that the administration of norfloxacin for the 6-month period was associated with a reduced risk of death compared with the placebo group (22 [15.3%] vs 36 [24.5%]).
At the 6-month follow-up after treatment was terminated, the cumulative incidence of death was lower in the norfloxacin group than the placebo group (15.5% vs 24.8%), but at 12 months the incidence of death between the 2 groups was similar.
The infection rates were lower in the norfloxacin group than the placebo group at 6 (30 [20.8% vs 46 [31.3%]) and the cumulative incidence of infection remained lower at 12 months.
“This study shows that long-term oral antibiotic therapy may improve the prognosis of patients with life-threatening liver disease. However, overuse of broad spectrum antibiotics is a subject that has been thoroughly debated over the years,” said Dr Richard Moreau, Beaujon, Hospital, Clichy, France, and lead author of the study. “The results from this study provide evidence that 6 months of norfloxacin therapy reduces the risk of infections and death in the short-term, but not in the longer-term.”
The Child-Pugh Classification is a staging system that assigns a patient’s cirrhosis a level from A to C, with C being the most advance disease and an indication of decompensation of the liver. Class C is life-threatening, because extensive scarring has occurred, interfering with the organ’s ability to function properly. It is the leading reason for liver transplantation. According to data from the American Liver Foundation, more than 17,000 adults and children in the United States are currently on the waiting list for a liver transplant; every year, more than 1500 die waiting for a liver to become available.
“Abnormal bacterial translocation from the gut not only favours the development of bacterial infections, but also contributes to the chronic pro-inflammatory state that characterises advanced cirrhosis, which is responsible for multi-organ dysfunction and, ultimately, failure,” said Prof Mauro Bernardi, Department of Medical and Surgical Sciences, University of Bologna, Italy, and member of the EASL Governing Board.
“Thus, long-term norfloxacin administration can be seen as treatment acting against a core pathophysiological mechanism. Indeed, until this antibiotic was administered, not only the incidence of bacterial infections, but also mortality was reduced. This favourable result, however, should be weighed against the risk of selecting antibiotic-resistant bacterial strains and studies devoted to this topic are warranted,” he concluded.
The study abstract was titled, “A randomized trial of 6-month norfloxacin therapy in patients with Child-Pugh class C cirrhosis.”
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