Non-alcoholic fatty liver disease (
NAFLD) represents one of the most common causes of chronic
liver disease worldwide and is characterized by chronic liver
inflammation and
fibrosis leading to
cirrhosis and increased risk of
liver cancer in a proportion of patients. Effective
anti-fibrotic agents have yet to be approved for the treatment of
NAFLD. The present study aimed to evaluate the efficacy of
dipeptidyl peptidase 4 inhibitors (DPP4-I) in the prevention of
NAFLD progression in
NAFLD patients with
type 2 diabetes. The study was a single arm, multi-centre, non-randomised study of
NAFLD patients with
type 2 diabetes.
NAFLD was diagnosed according to ultrasonographic findings. All the patients received 25 mg/day of
alogliptin for 12 months. The efficacy of
alogliptin in preventing
NAFLD progression was assessed using overall NAFIC scores [non-
alcoholic steatohepatitis (NASH),
ferritin,
insulin and
type IV collagen 7S] and individual component scores according to baseline haemoglobin A1c (HbA1c) levels. Of the 39 patients enrolled in the study, 16 patients (40.3%) had NAFIC scores >2 points, indicating the presence of NASH. NAFIC scores markedly decreased following 12 months of
alogliptin administration, but remained >2 points in 10 patients, indicating that NASH may have persisted in these patients. The relative risks for persistent NASH were 4.92 (95% confidence interval, 0.61-40.0) in the highest HbA1c tertile group compared with those in the lowest group. However, no statistically significant linear trend was observed across all HbA1c categories (P=0.145). DPP4-I may have efficacy against
NAFLD progression in patients with
type 2 diabetes with relatively lower HbA1c levels. DPP4-I may represent a potential new therapeutic strategy for the prevention of
disease progression in
NAFLD patients with
type 2 diabetes.