Clinical—Liver, Pancreas, and Biliary TractRifaximin Improves Driving Simulator Performance in a Randomized Trial of Patients With Minimal Hepatic Encephalopathy
Section snippets
Materials and Methods
The trial was conducted under a Food and Drug Administration investigational new drug number (77783) and was registered at www.clinicaltrials.gov number (NCT00533910) before enrollment was initiated. Enrollment was performed at the Medical College of Wisconsin and at McGuire Veterans Affairs Medical Center.
Results
A total of 203 patients with cirrhosis were considered for this study. The majority, 97 patients, were excluded owing to use of psychoactive drugs (lactulose alone in 45, non-selective serotonin reuptake inhibitors antidepressants in 21, rifaximin in 12, antiseizure medications in 10, and benzodiazepines in 9), 38 were excluded because of normal performance on the cognitive battery, and 26 were excluded because they were not current car drivers. Forty-two patients were ultimately included into
Discussion
The randomized, placebo-controlled, double-blind trial shows that patients randomized to rifaximin have a higher rate of improvement in total driving errors, specifically speeding tickets and navigation of illegal turns on a driving simulator compared with those on placebo. This was accompanied by improved cognitive performance and psychosocial aspects of quality of life in the rifaximin group.
Driving requires balance and integration of different cognitive inputs, most of which are affected
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Conflicts of interest The authors disclose the following: Jasmohan Bajaj has received funding and has been on advisory boards and a consultant for Salix Pharmaceuticals and Ocera Therapeutics; Arun Sanyal is a consultant and has been on advisory boards for Salix Pharmaceuticals. The remaining authors disclose no conflicts.
Funding This study was supported in part by the clinical research center grant MO1-RR00058, national center for research resources (NCRR), National Institutes of Health, and an investigator-initiated grant by Salix Pharmaceuticals (J.S.B.).
Because this was an investigator-initiated project, Salix provided funding but was not involved in protocol design and implementation, data collection, analysis, or interpretation of the study results.