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. Mullen9
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. *firstname.lastname@example.org
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.