Data Demonstrate Protective Effect and Durability of Rifaximin forMaintenance of Remission of Hepatic Encephalopathy Data Demonstrate Rifaximin Significantly Improved Critical FlickerFrequency and Time-Weighted CFF Correlated with Overt HepaticEncephalo
Nov. 2, 2009 (Business Wire) -- Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announces that the 60th Annual Meeting of the American Association for the Study of Liver Diseases is the venue for two presentations describing the investigation of rifaximin for the maintenance of remission from hepatic encephalopathy. The Liver Meeting® is being held in Boston, Saturday, October 31 – Tuesday, November 3, 2009.
The Protective Role of Rifaximin (550 mg tablet, 1100 mg daily) from Hepatic Encephalopathy Observed in a Double-Blind Placebo-Controlled Study is Substantiated and Durable Over the Long Term
(Poster Presentation # 305, F. Poordad, et al.)
Dr. Fred Poordad and colleagues presented the results of an analysis of the protective effect and the durability analyses of rifaximin treatment in the maintenance of remission in hepatic encephalopathy (HE) in an open label maintenance study (OLM). A randomized, double-blind trial (RCT) of 299 subjects demonstrated that rifaximin 550 mg BID significantly reduced the risk of a breakthrough HE episode by 57.9% (p<0.0001) in cirrhotic patients with a history of two or more overt HE episodes (Conn score equal to or greater than two) within 12 months before study enrollment. Subjects from the RCT, as well as new subjects (with a history of one or more HE episodes with Conn score equal to or greater than two within 12 months), were enrolled in the OLM. Patients received 550 mg rifaximin BID and lactulose use was permitted. Breakthrough HE as defined as an increase to a Conn score equal to or more than two; or, if the baseline Conn score was zero, an increase of 1 each in Conn score and asterixis grade. In the OLM 266 patients had post baseline data (70 rifaximin and 82 placebo patients from the RCT and 114 new patients.) In the OLM rifaximin demonstrated a significantly protective effect (p<0.0001) compared to prior placebo experience in the time to first HE breakthrough for the 82 placebo patients from the RCT. Additionally, the estimates of time to first HE breakthrough for the 196 patients new to rifaximin (114 new plus 82 PBO from RCT) were equivalent to estimates of time for patients who had HE breakthrough in the RCT rifaximin group. 60 rifaximin patients who maintained remission throughout the RCT were followed in the OLM for up to 680 days of rifaximin therapy with a mean exposure of 482 days.
"Phase 3 study results have clearly demonstrated that rifaximin is effective in the treatment of hepatic encephalopathy (HE)," said Fred Poordad, M.D., Chief of Hepatology and Liver Transplantation at the Comprehensive Transplant Center at Cedars-Sinai Medical Center in Los Angeles. "The data from this particular analysis further substantiate the highly significant protective effect of rifaximin in minimizing breakthrough HE episodes and show that the effect from rifaximin was durable over the long term for the maintenance of HE remission. These promising results suggest that rifaximin will be an important addition to the treatment arena of hepatic encephalopathy.”
Rifaximin (550 mg, twice daily) Significantly Improved Critical Flicker Frequency and Time-Weighted CFF Correlated with Overt Hepatic Encephalopathy as Assessed by Conn Score in a Six-Month Study
(Poster Presentation # 306, M.R.