Promising initial results not confirmed by randomised controlled study, but research confirms utility of non-invasive imaging techniques for measuring liver changes
April 16, 2016, Barcelona, Spain: New data presented today at The International Liver Congress™ 2016 in Barcelona, Spain, demonstrates that the drug sitagliptin – more commonly used to treat diabetes – was no more effective than placebo for reducing non-alcoholic fatty liver disease (NAFLD). However, researchers did demonstrate that nonvasive imaging techniques based on Magnetic Resonance Imaging (MRI) were useful for measuring changes in liver fat and fibrosis, a finding that can inform future clinical trials in the disease.
NAFLD is the world’s most common liver disease and shares many features of metabolic syndrome, including obesity, insulin resistance and diabetes.1 Previous research had suggested that sitagliptin was able to improve some aspects of NAFLD, such as liver histology, but these studies had not tested the drug against a placebo control.
“We had hoped that results from some promising initial research around the use of sitagliptin in NAFLD could be confirmed in a randomised, double-blinded, placebo-controlled study,” says study author Dr Jeffrey Cui, MD, with the NAFLD Research Center, University of California, San Diego, USA. “NAFLD is a leading cause of liver disease in the Western world so new methods to reduce this disease burden are much needed.” The study’s lead author Dr Rohit Loomba, MD, Director, NAFLD Research Center, University of California, USA continues, “However, this trial does provide data on advanced MRI and MRE based measures to non-invasively assess treatment response, which would be very useful for the design of future trials.”
In the randomised, double-blind, allocation-concealed, placebo-controlled clinical trial of 50 American NAFLD patients with pre or early diabetes, patients were randomised to receive sitagliptin (100 mg/day orally) or placebo for 24 weeks. The primary outcome was liver fat change (measured by MRI) in regions within each of the nine liver segments. Changes in hepatic fibrosis (scarring of the liver) were assessed using magnetic resonance elastography (MRE).
There was no significant difference in liver fat change in the group receiving sitagliptin (18.1% to 16.9%, p=0.2673) or the placebo group (16.6% to 14.0%, p=0.0729), and also no significant difference in mean liver fat change between the two groups (-1.3%, p=0.4096).
“Non-alcoholic fatty liver disease represents a significant problem worldwide. It is always disappointing when initial research cannot be replicated in a more rigorous trial setting, but we hope that the experiences shared of the imaging techniques employed in this study will help introduce novel, non-invasive imaging techniques into the clinical management of patients,” said Professor Frank Tacke, EASL Governing Board member.
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About The International Liver Congress™
This annual congress is the biggest event in the EASL calendar, attracting scientific and medical experts from around the world to learn about the latest in liver research. Attending specialists present, share, debate and conclude on the latest science and research in hepatology, working to enhance the treatment and management of liver disease in clinical practice. This year, the congress is expected to attract approximately 10,000 delegates from all corners of the globe. The International Liver Congress™ takes place from April 13 – 17, 2016, at the Fira Barcelona Gran Via, Barcelona, Spain.
About EASL (www.easl.eu)
Since EASL’s foundation in 1966, this not-for-profit organisation has grown to over 4,000 members from all over the world, including many of the leading hepatologists in Europe and beyond. EASL is the leading liver association in Europe, having evolved into a major European Association with international influence, with an impressive track record in promoting research in liver disease, supporting wider education and promoting changes in European liver policy.
For more information, please contact the ILC Press Office at:
- Email: ILCpressoffice@ruderfinn.co.uk
- Telephone: +44 (0)7841 009 252
Onsite location reference
Fatty liver disease: clinical, Hall 8.0-A1
Saturday 16 April, 11:30 – 13:30
Presenter: Jeffrey Y Cui, United States
Abstract: PS112, Sitagliptin versus placebo in the treatment of Nonalcoholic Fatty Liver Disease: A randomized controlled trial
Author disclosures of interest
This study was supported by an investigator initiated grant by Merck Inc
1 Gastaldelli A, et al. Fatty liver is associated with insulin resistance, risk of coronary heart disease, and early atherosclerosis in a large European population. Hepatology. 2009;49:1537-1544.