Public Release: 

Spotlight on liver disease: Improving today's treatments

American Gastroenterological Association

WASHINGTON, D.C. (May 20, 2007) -- Patients with liver disease often suffer from other related illnesses, including type-2 diabetes, obesity and high blood pressure, among others. Research presented today at Digestive Disease Week® 2007 (DDW®) explores the many unknowns of liver disease by examining new liver biomarkers, understanding disease complications and assessing novel treatments for their disease-fighting potential. DDW is the largest international gathering of physicians and researchers in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.

"There is still so much that researchers need to understand about the liver and its related diseases," said Jacquelyn J. Maher, M.D., University of California, San Francisco. "Studies like these help us recognize important connections between the liver and other organs and highlight creative approaches to liver disease treatment that promise to improve the outcome of the most seriously ill patients."

Prediction of Coronary Atherosclerosis Disease with Liver Transaminases Level (Abstract #T1082)

Recent studies have shown that non-alcoholic fatty liver disease (NAFLD) is associated with a condition known as the metabolic syndrome, which includes central obesity, type-2 diabetes, dyslipidemia and high blood pressure. However, the direct influence of NAFLD on coronary atherosclerotic disease (CAD, plaque build up in arteries) has not been investigated. This study, conducted by researchers at Isfahan University of Medical Sciences and Health Services in Isfahan, Iran, evaluated the predictive value of liver biomarkers for coronary atherosclerosis in patients with coronary heart disease (CHD).

The study enrolled 630 patients with suspicious CAD who were candidates for a coronary angiography. To assess the predictive risk of CAD, all study participants were measured for serum AST (aspartate transaminase) and ALT (alanine transaminase) concentrations - commonly measured to determine liver health - as well as C-reactive protein level and traits for metabolic syndrome.

Following the analysis, researchers found ALT and ALT/AST ratio were significantly correlated with angiographic atherosclerosis score in women (r=0.17 and r=0.24, respectively). Logistic regression analysis showed that ALT/AST ratio in women could predict severe CAD (OR 3.39, 95% CI 1.76-8.76). Although significant in univariate analysis, neither ALT (OR 0.98, 95% CI 0.77-1.15) nor AST (OR 0.99, 95% CI 0.72-1.22) could predict severe CAD in men.

"We found that an elevated ALT/AST ratio in women could predict coronary atherosclerotic disease that is independent of the metabolic syndrome and serum C-reactive protein concentration," said Peyman Adibi, M.D., of Isfahan University of Medical Sciences and Health Services, and lead investigator for this study. "Therefore, further diagnostic and therapeutic interventions need to be conducted to understand the value of projecting liver biomarkers in CAD patients."

Dr. Adibi will present this study on Tuesday, May 22, at 8:00 a.m. in Hall E.

Recombinant Factor Vlla (rFVlla) for Active Variceal Bleeding in Patients with Advanced Cirrhosis: A Multicenter Randomized Double-Blind Placebo-Controlled Trial (Abstract #1)

Variceal bleeding (abnormal bleeding from ruptured blood vessels) is a severe and frequent complication of cirrhosis, a condition in which scarring and damage to the liver reduces its function. Previous studies have suggested that recombinant factor Vlla (rFVlla), an agent used to control bleeding, may reduce the number of failures and improve 24-hour bleeding control in Child-Pugh B and C-classified cirrhotic patients with variceal bleeding. Cirrhotic patients classified in class B or C under the Child-Pugh score have a one-year survival of 81 percent and 45 percent, respectively. The current trial, conducted by researchers from several European expert centers in liver disease, was aimed at determining the efficacy and safety of rFVlla in patients with advanced cirrhosis and active variceal bleeding.

To evaluate the therapy, 256 patients with advanced cirrhosis and active bleeding from gastroesophageal varices were randomized to placebo, 600 ìg/kg rFVlla or 300 ìg/kg rFVlla. In addition to standard treatment, study participants were given the first dose at baseline and after endoscopy; further doses were provided at two, eight, 14 and 20 hours. Researchers observed failure rates (bleeding) within 24 hours, failure to prevent clinically significantly rebleeding or death within five days. They also monitored adverse events and 42-day mortality.

While results showed that rFVlla as a treatment option did not improve efficacy of standard treatment, the treatment-related failures were lower than expected. While there was no significant difference in five-day mortality between groups (12% in the 600 ìg/kg rFVlla group vs.13% in placebo), the 42-day mortality was significantly lower in the 600 ìg/kg rFVlla group compared with placebo (15% in the 600 ìg/kg rFVlla group vs. 29% in placebo) and deaths due to bleeding were reduced (15% in the 600 ìg/kg rFVlla group vs. 40% in placebo). In addition, adverse events were comparable between groups.

"While there was no significant difference in the primary endpoint between treatment groups, the current trial did provide insight into the potential value and function of rFVlla," said Flemming Bendtsen, M.D., of Hvidovre Hospital in Hvidovre, Denmark, and co-author of this study. "Subgroup analysis of the two trials of rFVIIa in variceal bleeding are planned in order to identify characteristics of patients, who in the future may potentially benefit from this treatment."

Dr. Bendtsen will present this study on Sunday, May 20, at 8:30 a.m. in Room 207.

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Digestive Disease Week® (DDW®) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 19-24, 2007 in Washington, D.C. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology.

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