San Diego—Although it showed promise in previous studies as an effective treatment for nonalcoholic fatty liver disease (NAFLD), a new study reports that sitagliptin works no better than a placebo.
The report in the Journal of Hepatology found that the oral antihyperglycemic, marketed as Januvia, was not significantly better than a placebo in reducing liver fat, as measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) and other technologies.
The results were based on the first randomized, double-blind, controlled clinical trial of sitagliptin by a study team led by University of California San Diego School of Medicine researchers.
Background information in the article explains that NAFLD, the accumulation of fat in the livers of people who drink little or no alcohol, is the leading cause of chronic liver disease in the United States. In fact, the study notes that about one-fourth of Americans have NAFLD, which can progress to nonalcoholic steatohepatitis, which in turn can develop into cirrhosis, liver cancer and liver failure.
NAFLD has no approved, specific therapies, but, because of its association with diabetes, researchers often test diabetes medications, such as metformin, rosiglitazone and liraglutide as potential treatments, according to the report.
In clinical trials conducted in patients with type 2 diabetes, sitagliptin has been shown to be effective in improving glycemic control, cholesterol, lipoproteins, and other health measures compared to placebo.
“But human trials of sitagliptin have been limited to date because they have lacked important tools like a placebo arm and allocation concealment,” said senior author Rohit Loomba, MD.
In the new study, 50 NAFLD patients with prediabetes or early diabetes were randomized into two groups: one received a 100 milligram oral dose of sitagliptin daily for 24 weeks, while the other received a placebo. At end-of-treatment, the researchers found no significant differences between sitagliptin and placebo when imaging was used.
In a bit of good news, however, study authors pointed out that their research “demonstrates that noninvasive magnetic resonance imaging (MRI) imaging techniques, including MRI-proton density fat fraction (MRI-PDFF) and magnetic resonance elastography (MRE), can be used to assess treatment response in NAFLD clinical trials.”
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