Poster Presentations

Session Title: Category 2b. CIRRHOSIS AND ITS COMPLICATIONS: b. CLINICAL ASPECTS
Presentation Date: Apr 15, 2010

MILD HEPATIC ENCEPHALOPATHY (HE) ASSESSED BY THE REPEATABLE BATTERY FOR THE ASSESSMENT OF NEUROPSYCHOLOGICAL STATUS (RBANS) IS HIGHLY PREVALENT IN AMBULATORY PATIENTS WITH CIRRHOSIS

C. Randolph¹*, J. Bajaj², M.Y. Sheikh³, R. Vemuru⁴, G. Morelli⁵, L.A. Balart⁶, M. Chojkier⁷, M.S. Harris⁸, J.D. Bornstein⁸, K. Mullen^9
1Loyola University Med. Center, Chicago, IL, ²McGuire DVAMC, Richmond, VA, ³University of California at San Francisco (UCSF), Fresno Medical Educational Program, Fresno, CA, ⁴Permian Research Foundation, Odessa, TX, ⁵University of Florida, Gainesville, FL, ⁶Tulane University, New Orleans, LA, ⁷Veterans Medical Center San Diego, ⁸Ocera Therapeutics, San Diego, CA, ⁹Case Western Reserve University, Cleveland, OH, USA. *crandol@lumc.edu

Mild HE impairs quality of life and increases the risk of job loss and motor vehicle accidents. The prevalence of mild HE in cirrhotics ranges from 30%-80%. The ISHEN recommends the RBANS as the tool of choice for detecting mild HE in the United States since it has well-established population norms and correlates with impaired daily functioning and job loss. We are using RBANS to qualify subjects for the ASTUTE trial, a phase 2B study assessing the potential for AST-120 (spherical carbon adsorbent) to treat patients with mild HE, and data is now available on the prevalence of neurocognitive dysfunction by RBANS for the first 206 screened subjects.
Methods: Trained RBANS raters used the RBANS to determine eligibility for participation in the trial. Subjects with cirrhosis between 18-70 years old and with MELD scores ≤ 25 were eligible for inclusion provided they did not have a TIPS or surgical shunt, had not had an episode of overt HE in the previous 3 months or taken lactulose, rifaximin or neomycin in the previous 7 days. Subjects were eligible for randomization if they scored below the 10th percentile on the RBANS total scale score, after adjusting for age and education.
Results: Of 206 subjects screened to date, 61% were male, the mean age was 55.4 years and hepatitis C was the most common underlying liver disease. 82% of all screened subjects were high school graduates and 55% had attended college. Of the 206, 115 (56%) subjects were eligible for randomization based on a qualifying RBANS score. Qualifying rate was similar regardless of education level - 54% of college attendees, 57% of high school grads and 59% of high school dropouts qualified. RBANS total score could not be predicted based on the subject's platelet count, bilirubin, MELD score or known history of esophageal varices.
Conclusions: Using the RBANS, we found a neurocognitive impairment rate of 56% in a population of well-compensated cirrhotics, suggesting that mild HE is highly prevalent in these patients. Mild HE was not predicted by age, education, MELD score or indicators of portal hypertension.