By Bruce Sylvester
SAN DIEGO -- October 30, 2009 -- Patients who receive treatment with rifaximin can maintain remission from hepatic encephalopathy symptoms, researchers stated here October 28 at the American College of Gastroenterology (ACG) 74th Annual Scientific Meeting. In addition, the drug provides protection without a significant increase in side effects.
"I believe that rifaximin treatment has the potential to become a first-line therapy for maintaining patients who have achieved remission from this condition," said Muhammed Sheikh, MD, University of California, San Francisco, Fresno Medical Education Program, Fresno, California.
"Rifaximin 550 mg twice a day significantly reduced the risk of overt hepatic encephalopathy and hepatic encephalopathy-related hospitalisations. The treatment with rifaximin had a safety profile comparable to placebo."
In his presentation, Dr. Sheikh reviewed data showing that about 80% of patients treated with rifaximin were free of relapses through 168 days after randomisation compared with about 58% of patients receiving placebo. Most patients were also treated with lactulose.
The study investigated the safety of long-term use of rifaximin, patients maintained their protection against relapse and the side-effect profile remained similar with placebo.
A total of 348 patients were eventually treated with rifaximin. Some of the patients in the randomised phase of the study and in the open-label maintenance extension study were treated for as long as 840 days. Of these, 257 patients were on rifaximin for at least 6 months and 114 patients for at least 1 year. The researchers added 128 new patients into the open-label extension.
During treatment with rifaximin, the overall profile of adverse events was consistent with expectations for patients with liver cirrhosis and a history of overt hepatic encephalopathy. For example, the per person-year rate of nausea was 0.40 among the 140 patients on rifaximin during the randomised phase compared with a rate of 0.46 for 159 patients on placebo, and a rate of 0.19 among the 348 patients in the open-label extension.
In the randomised part of the study, adverse events were reported by about 80% of patients in each group. Rifaximin did not adversely affect mortality, which occurred in 7% of patients in each group.
"We have observed that in the ongoing open-label extension, rifaximin continues to provide durable protection from recurrent over hepatic encephalopathy," Dr. Sheikh said.
Funding for this study was provided by Salix Pharmaceuticals.
[Presentation title: Rifaximin Has a Favorable Long-Term Safety Profile for Maintenance of Remission From Overt Hepatic Encephalopathy. Abstract 54]
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