This article is part of MPR‘s coverage of the American Diabetes Association’s 77th Scientific Sessions (ADA 2017), taking place in San Diego, CA. Our staff will report on medical research and technological advances in diabetes and diabetes education, conducted by experts in the field. Check back regularly for more news from ADA 2017.
Intercept Pharmaceuticals released a retrospective analysis from their Phase 2 ‘FLINT’ trial, which assessed the use of obeticholic acid (OCA) in patients with nonalcoholic steatohepatitis (NASH) and type 2 diabetes.
The trial lasted for 72 weeks and enrolled 283 adult NASH patients, 149 (53%) of whom also had type 2 diabetes and within this group, 67 (45%) had advanced bridging fibrosis (≥F3). Type 2 diabetes and advanced fibrosis are associated with lower transplant-free survival in patients with NASH.
Results showed that 57% of the OCA-treated group reached the primary endpoint of a ≥2-point improvement in NAFLD activity score (NAS) without worsening fibrosis, compared to 21% in the placebo group (P<0.01). Among patients with fibrosis (F1–F3), 41% in the OCA-treated group had ≥1 stage of fibrosis improvement compared to 19% in the placebo group (P<0.05).
“These data from the FLINT trial add to our understanding of OCA’s potential to help those in the NASH patient population with diabetes who are at the highest risk of progressing to cirrhosis and adverse outcomes,” said Arthur J. McCullough, MD, Department of Gastroenterology and Hepatology, Cleveland Clinic.
Most of the patients in the study were on concomitant anti-diabetic medications and were generally well controlled at baseline (HbA1c of 7.0–7.2%); OCA administration did not impact glycemic control over the course of the trial (HbA1c unchanged).
Obeticholic acid, a farnesoid X receptor agonist, is currently available under the brand name Ocaliva for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.
For more information visit InterceptPharma.com.
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