ÿþ<!DOCTYPE HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN" "http://www.w3.org/TR/html4/loose.dtd"> <html> <head> <meta http-equiv="Content-Type" content="text/html; charset=iso-8859-1"> <title>EASL 2010 - Oral Presentations</title> <link rel="stylesheet" type="text/css" href="style.css"> </head> <body> <table width="750" align="center" border="0" cellspacing="0" cellpadding="0" class="MainTable"> <tr> <td><img src="http://www2.kenes.com/liver-congress2010/PublishingImages/top_ei.jpg" width="760" height="129" /></td> </tr> <tr> <td class="content"><h1>Oral Presentations</h1> <P><b>Session Title:</b> Parallel Session: LIVER CIRRHOSIS AND COMPLICATIONS<br><b>Presentation Date:</b> Apr 15, 2010</P><h2 align='left'><B>RIFAXIMIN TREATMENT IMPROVED QUALITY OF LIFE IN PATIENTS WITH HEPATIC ENCEPHALOPATHY: RESULTS OF A LARGE, RANDOMIZED, PLACEBO-CONTROLLED TRIAL</B></h2> <p align='left'><b>A. Sanyal</b><sup>1</sup>, N. Bass<sup>2</sup>, K. Mullen<sup>3</sup>, F. Poordad<sup>4</sup>, A. Shaw<sup>5</sup>, K. Merchant<sup>5</sup>, E. Bortey<sup>5</sup>, W.P. Forbes<sup>5</sup>, S. Huang<sup>5</sup><br> <em><sup>1</sup>Virginia Commonwealth University, Richmond, VA, <sup>2</sup>University of California, San Francisco, CA, <sup>3</sup>Case Western Reserve University, Cleveland, OH, <sup>4</sup>Cedars-Sinai Medical Center, Los Angeles, CA, <sup>5</sup>Salix Pharmaceuticals, Inc., Morrisville, NC, USA. *asanyal@mcvh-vcu.edu</em></p><br> <p align='justify'><b><b>Background and aims: </b></b> Rifaximin, a minimally absorbed, gut-selective antibiotic, significantly reduced breakthrough overt HE risk by 57.9% vs. placebo over 6 months (p< 0.0001) in patients with cirrhosis in a randomized, double-blind, placebo-controlled trial RFHE3001 (RCT). The Chronic Liver Disease Questionnaire (CLDQ), a validated, disease-specific instrument designed to assess health-related QOL in patients with chronic liver disease, was measured during this RCT, and the results are presented here.<br><b><b>Methods: </b></b> Patients with cirrhosis who had e"2 episodes of HE (Conn score e"2) within 6 months of screening and who were currently in remission, defined as a Conn score = 0 or 1, were randomized to either rifaximin 550 mg BID (N=140) or placebo (N=159) for 6 months. Concomitant lactulose therapy was permitted during the RCT. The CLDQ, administered at Baseline and every 4 weeks through the end of treatment, included 29 items in 6 domains: Abdominal symptoms; Fatigue; Systemic symptoms; Activity; Emotional function; and Worry. The overall score and domains were ranked on a 7-point scale, with higher scores indicating better QOL. Fatigue sub-domain scores were chosen as a key secondary endpoint, as clinical assessments indicated a high correlation with disease severity. An area under the curve (AUC) for CLDQ scores was normalized by exposure time (time-weighted average) for each patient. Time-weighted averages (Twa) were compared across treatment groups.<br><b><b>Results: </b></b> Mean Twa scores for the fatigue and overall domain were significantly higher in the rifaximin group vs. placebo (Fatigue: 3.2 rifaximin, 2.5 placebo, p = 0.0087; Overall 3.7, 2.9, p=0.0093). The respective mean Twa scores for other domains were also significantly higher in the rifaximin group vs. placebo (Abdominal symptoms: 4.1, 3.3, p = 0.0090; Systemic symptoms: 3.9, 3.2, p = 0.0160; Activity: 3.7, 2.8, p = 0.0022; Emotional function: 3.9, 3.0, p = 0.0065; Worry: 3.5, 2.8, p = 0.0436). Demographic and baseline disease characteristics were similar between the groups. The safety profile of rifaximin was comparable to placebo.<br><b><b>Conclusions: </b></b> Rifaximin 550 mg twice-daily significantly improved QOL overall and across individual domains over a 6 month treatment period in subjects with hepatic cirrhosis and recurrent, overt HE. <br></p> <br><a href="javascript://;" onclick="history.back()">Back</a><br> <p>&nbsp;</p> <p>&nbsp;</p></td> </tr> </table> </body> </html>