ST LOUIS (MD Consult) - On March 24, 2010, the US Food and Drug Administration (FDA) announced its approval for the use of Xifaxan (rifaximin) as a means to reduce the risk of recurrence of overt hepatic encephalopathy (HE) in patients with advanced liver disease. Xifaxan has been previously approved for the treatment of traveler's diarrhea.

The efficacy of Xifaxan in the prevention of HE was established in a randomized placebo-controlled clinical trial of adult patients with liver disease from the United States, Canada, and Russia. Xifaxan was not studied in patients with the most severe forms of liver disease. Enrollees had experienced either no or mild symptoms of HE. Compared with placebo-treated participants, patients treated with Xifaxan were less likely to experience HE during the trial. However, because most patients were also taking lactulose during the trial, the efficacy of Xifaxan as a stand-alone treatment for HE could not be assessed.

The most common adverse reactions reported with the use of Xifaxan in patients with liver disease include peripheral edema, nausea, gas, and headache.

圣路易斯(MD Consult)——美国食品药品管理局(FDA)于2010年3月24日宣布，它已批准将Xifaxan(利福昔明) 用于晚期肝病患者，作为降低其显性肝性脑病(HE)复发风险的一种手段。Xifaxan之前曾被批准用于治疗旅行者腹泻。

一项随机安慰剂对照临床试验证实了Xifaxan用于预防HE的有效性，该试验的受试者由来自美国、加拿大和俄罗斯的成年肝病患者组成。Xifaxan在最严重肝病患者中的疗效未被研究。试验受试者从未或仅出现过轻微的HE症状。与接受安慰剂对照的受试者相比，接受Xifaxan治疗的患者在试验期间更少出现HE。然而，由于大部分患者在试验期间同时还在服用乳果糖，所以尚无法评估Xifaxan作为HE的一种独立疗法的疗效。

使用Xifaxan治疗肝病患者所报告的最常见不良反应包括外周性水肿、恶心、打嗝及头痛。