Currently, no medical treatment exists for nonalcoholic steatohepatitis (NASH), inflammation of the liver associated with the accumulation of fat in the liver. Recent studies indicate that NASH can result in scarring of the liver in up to 40 percent of people with the disease and cirrhosis (irreversible, advanced scarring of the liver) in approximately 25 percent of people with NASH. Researchers at Northwestern Memorial Hospital have launched a clinical trial to see if Pentoxifylline, a drug that has shown success decreasing inflammation of the liver in people with alcohol-related liver disease, can stop the progression of NASH.
"NASH is widespread and the number of cases is rising every year -- it's truly become an epidemic in this country," says Mary Rinella, MD, a hepatologist at Northwestern Memorial Hospital who is the lead investigator of the trial and an assistant professor of Medicine at Northwestern University's Feinberg School of Medicine. "Currently, we don't have anything to offer patients except to advise them to lose weight and change their diet, so many of these patients are ending up on liver transplant waiting lists. We need therapies that help keep people from reaching that point."
In developed countries, the overall prevalence of non-alcoholic fatty liver disease (NAFLD) is estimated to be approximately 20 percent of the population, with about 3 percent having NASH. NASH differs from the NAFLD, the simple accumulation of fat in the liver, in that the inflammation causes damage to the liver cells while simple fatty liver probably does not. NASH typically occurs in middle-aged, overweight, and often diabetic patients who do not drink alcohol. It has also been connected with rapid weight loss, or in women taking hormones. "Clinical studies and basic research on NAFLD are still in their infancy as compared to other common liver diseases, such as alcoholic liver disease and hepatitis C," says Dr. Rinella. "We didn't really even start understanding the gravity of this problem in our patients until about 10 years ago."
NASH is most often discovered during routine laboratory testing. Additional tests help confirm the presence of NASH and rule out other types of liver disease.
The trial, which aims to enroll 50 participants, is sponsored by Northwestern University's Department of Hepatology with support from the NIH-funded General Clinical Research Center. Northwestern Memorial is the only site for the research. The study is blinded and placebo-controlled, with two-thirds of participants receiving Pentoxifylline.
For more information about enrolling in the study, please call Northwestern Memorial's physician referral line at 312-926-8400.
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