CHICAGO--In people with type 2 diabetes, nonalcoholic fatty liver disease (NAFLD) is common and can progress to a severe liver disease known as nonalcoholic steatohepatitis (NASH). Now a study has found that empagliflozin, a newer treatment for type 2 diabetes, reduces liver fat in patients with NAFLD and diabetes. Results of the randomized controlled study, called the E-LIFT Trial, will be presented Monday at the Endocrine Society's 100th annual meeting in Chicago, Ill., during a late-breaking abstracts session.
Diabetes medications in the same class as empagliflozin have decreased liver fat in rodents with a buildup of fat in the liver, but in humans the effect of empagliflozin on liver fat has not been previously reported, said the study's senior investigator, Ambrish Mithal, M.D., chair of the Division of Endocrinology and Diabetes at Medanta The Medicity Hospital, Gurugram, India.
"Despite the fact that NASH may progress to cirrhosis of the liver and liver cancer, there are no approved medications for treating NASH or NAFLD, and agents like metformin, pioglitazone and vitamin E have had limited success in reducing liver fat," Mithal said. "Our results suggest that empagliflozin may help in treating NAFLD."
The study, funded by the Endocrine and Diabetes Foundation India in New Delhi, included 50 patients who were 40 years or older and had type 2 diabetes and NAFLD. The patients were randomly assigned to receive empagliflozin (10 milligrams per day) plus their standard medical treatment for type 2 diabetes, such as metformin and/or insulin, or to receive only their standard treatment without empagliflozin (control group). All patients were aware of their group assignment.
At the beginning of the study and 20 weeks later, the patients had blood tests of their liver enzyme levels, which are typically elevated in NAFLD. They also underwent measurement of their liver fat using a new, robust technique called magnetic resonance imaging (MRI)-derived proton density fat fraction.
After 20 weeks of treatment, the liver fat of patients receiving empagliflozin decreased from an average of 16.2 to 11.3 percent, whereas the control group had only a decrease from 16.4 to 15.6 percent, a statistically significant difference between groups, the researchers reported.
"While our findings do not prove that empagliflozin will help treat NAFLD or prevent NASH, the initial results are promising and open up the possibility that empagliflozin may provide additional benefits for patients with diabetes," Mithal said.
Approved by the U.S. Food and Drug Administration in 2014 for adults with type 2 diabetes, empagliflozin is in a drug class called sodium-glucose cotransporter 2, or SGLT-2, inhibitors. Empagliflozin primarily acts by increasing glucose excretion through the urine, thereby reducing blood glucose levels and body weight, research studies show.
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