Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

New drug for common liver disease improves liver health

07.11.2014

An experimental drug aimed at treating a common liver disease showed promising results and potential problems in a multicenter clinical trial funded by the National Institutes of Health.

The FLINT study found that people with nonalcoholic steatohepatitis (NASH) who took obeticholic acid (OCA) had improved liver health during that period, including decreased inflammation and fat in the liver and decreased body weight versus people receiving a placebo. OCA was also associated with increases in itching and total cholesterol.

The findings of FLINT, or the Farnesoid X Receptor Ligand Obeticholic Acid in NASH Treatment Trial, were published online Nov. 6 in The Lancet. FLINT was sponsored by the NIH's National Institute of Diabetes and Digestive and Kidney Diseases.

"NASH is a common and potentially serious disease that currently has no approved treatment. Management typically includes weight loss through diet and exercise," said Averell Sherker, M.D., NIDDK program official for the NASH Clinical Research Network (NASH CRN), which performed the FLINT study.

Liver health improved in 45 percent of people on OCA versus 21 percent of the placebo group. "Although obeticholic acid did not eliminate liver disease in FLINT participants, it demonstrated a promising effect. Larger studies will be required to determine the drug's safety and efficacy," Sherker said.

FLINT enrolled 283 people at eight centers across the country. At the study's start, participants were 18 and older and had been diagnosed with definite or borderline NASH. They were randomly assigned to one of two groups: one took 25 milligrams of OCA daily and one received a placebo that resembled the OCA pill. The study was double-blinded, so neither participants nor investigators knew which person was in which group.

Trial investigators intended for the groups to receive the drug or placebo for 72 weeks, with an additional 24 weeks of follow-up off treatment. However, planned interim analysis for safety and efficacy showed that OCA had significant beneficial effects on NASH-related liver health.

The analysis also found unanticipated increases in total cholesterol in the OCA group. They had increased LDL cholesterol ("bad" cholesterol) and decreased HDL cholesterol ("good" cholesterol) - notable because NASH patients are already at higher risk for cardiovascular diseases. As cholesterol treatment was not standardized as part of the study, further research is needed to fully understand the potential effect of OCA on cholesterol.

Because of both factors, and with the concurrence of the Data Safety and Monitoring Board, NIDDK decided to stop treatment but continue the study, move all patients into the follow-up phase, and perform no additional liver biopsies - which carry their own risks. Adverse cholesterol increases were not sustained after stopping OCA.

"The FLINT trial represents an important advance in the search for treatments of NASH. The causes of NASH are not fully understood, and causes and treatments may be different among patients," said the study's lead author, Brent Neuschwander-Tetri, M.D., a professor at St. Louis University. "We need to study the changes in cholesterol levels more to know if the increases caused by obeticholic acid increase the risk of hardening of the arteries. We found that the improvement in liver enzymes with obeticholic acid were not sustained after treatment was stopped, so we would expect that treatment would need to be indefinite, much like the medications for diabetes and hypertension."

The major feature of NASH is fat in the liver, along with inflammation and damage. Over time, these may lead to loss of liver function, the need for liver transplantation and death. NASH may have no symptoms and can only be diagnosed with a liver biopsy. Beyond maintaining a healthy weight, people with NASH are advised to avoid alcohol and unnecessary medications. New cases of NASH have grown alongside the obesity epidemic. NASH is the third leading diagnosis requiring U.S. liver transplantation.

The FLINT trial (Clinical Trials No. NCT01265498) was supported by the NIDDK, National Cancer Institute and National Center for Advancing Translational Sciences, all part of NIH. Intercept Pharmaceuticals, Inc. provided partial funding and supplies.

The NIDDK, a component of the NIH, conducts and supports research on diabetes and other endocrine and metabolic diseases; digestive diseases, nutrition and obesity; and kidney, urologic and hematologic diseases. Spanning the full spectrum of medicine and afflicting people of all ages and ethnic groups, these diseases encompass some of the most common, severe and disabling conditions affecting Americans. For more information about the NIDDK and its programs, see http://www.niddk.nih.gov 

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov 

NIH...Turning Discovery Into Health ®

Media Office | EurekAlert!

Further reports about: Diabetes Digestive Health NIDDK NIH cholesterol diseases liver liver disease treatments

More articles from Health and Medicine:

nachricht Team discovers how bacteria exploit a chink in the body's armor
20.01.2017 | University of Illinois at Urbana-Champaign

nachricht Rabies viruses reveal wiring in transparent brains
19.01.2017 | Rheinische Friedrich-Wilhelms-Universität Bonn

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Traffic jam in empty space

New success for Konstanz physicists in studying the quantum vacuum

An important step towards a completely new experimental access to quantum physics has been made at University of Konstanz. The team of scientists headed by...

Im Focus: How gut bacteria can make us ill

HZI researchers decipher infection mechanisms of Yersinia and immune responses of the host

Yersiniae cause severe intestinal infections. Studies using Yersinia pseudotuberculosis as a model organism aim to elucidate the infection mechanisms of these...

Im Focus: Interfacial Superconductivity: Magnetic and superconducting order revealed simultaneously

Researchers from the University of Hamburg in Germany, in collaboration with colleagues from the University of Aarhus in Denmark, have synthesized a new superconducting material by growing a few layers of an antiferromagnetic transition-metal chalcogenide on a bismuth-based topological insulator, both being non-superconducting materials.

While superconductivity and magnetism are generally believed to be mutually exclusive, surprisingly, in this new material, superconducting correlations...

Im Focus: Studying fundamental particles in materials

Laser-driving of semimetals allows creating novel quasiparticle states within condensed matter systems and switching between different states on ultrafast time scales

Studying properties of fundamental particles in condensed matter systems is a promising approach to quantum field theory. Quasiparticles offer the opportunity...

Im Focus: Designing Architecture with Solar Building Envelopes

Among the general public, solar thermal energy is currently associated with dark blue, rectangular collectors on building roofs. Technologies are needed for aesthetically high quality architecture which offer the architect more room for manoeuvre when it comes to low- and plus-energy buildings. With the “ArKol” project, researchers at Fraunhofer ISE together with partners are currently developing two façade collectors for solar thermal energy generation, which permit a high degree of design flexibility: a strip collector for opaque façade sections and a solar thermal blind for transparent sections. The current state of the two developments will be presented at the BAU 2017 trade fair.

As part of the “ArKol – development of architecturally highly integrated façade collectors with heat pipes” project, Fraunhofer ISE together with its partners...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Sustainable Water use in Agriculture in Eastern Europe and Central Asia

19.01.2017 | Event News

12V, 48V, high-voltage – trends in E/E automotive architecture

10.01.2017 | Event News

2nd Conference on Non-Textual Information on 10 and 11 May 2017 in Hannover

09.01.2017 | Event News

 
Latest News

Helmholtz International Fellow Award for Sarah Amalia Teichmann

20.01.2017 | Awards Funding

An innovative high-performance material: biofibers made from green lacewing silk

20.01.2017 | Materials Sciences

Ion treatments for cardiac arrhythmia — Non-invasive alternative to catheter-based surgery

20.01.2017 | Life Sciences

VideoLinks
B2B-VideoLinks
More VideoLinks >>>