title: Efficacy of alogliptin in preventing non-alcoholic fatty liver disease progression in patients with type 2 diabetes.
abstract: 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.
authors.affiliation: Third Department of Internal Medicine, Nara Medical University, Kashihara, Nara 634-8521, Japan; Department of Diabetology, Nara Medical University, Kashihara, Nara 634-8521, Japan.
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Mashitani
authors.affiliation: Third Department of Internal Medicine, Nara Medical University, Kashihara, Nara 634-8521, Japan.
authors.forename: Ryuichi
authors.initials: R
authors.lastname: Noguchi
authors.affiliation: Third Department of Internal Medicine, Nara Medical University, Kashihara, Nara 634-8521, Japan.
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Okura
authors.affiliation: Third Department of Internal Medicine, Nara Medical University, Kashihara, Nara 634-8521, Japan.
authors.forename: Tadashi
authors.initials: T
authors.lastname: Namisaki
authors.affiliation: Third Department of Internal Medicine, Nara Medical University, Kashihara, Nara 634-8521, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Mitoro
authors.affiliation: Department of Diabetology, Nara Medical University, Kashihara, Nara 634-8521, Japan.
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Ishii
authors.affiliation: Department of Gastroenterology, Nara Prefecture General Medical Center, Nara 631-846, Japan.
authors.forename: Toshiya
authors.initials: T
authors.lastname: Nakatani
authors.affiliation: Department of Gastroenterology, Nara Prefecture General Medical Center, Nara 631-846, Japan.
authors.forename: Eiryo
authors.initials: E
authors.lastname: Kikuchi
authors.affiliation: Department of Gastroenterology, Nara Prefectural Gojo Hospital, Gojo, Nara 637-8511, Japan.
authors.forename: Hiroto
authors.initials: H
authors.lastname: Moriyasu
authors.affiliation: Department of Gastroenterology, Nara Prefectural Gojo Hospital, Gojo, Nara 637-8511, Japan.
authors.forename: Masami
authors.initials: M
authors.lastname: Matsumoto
authors.affiliation: Department of Gastroenterology, Belland General Hospital, Sakai, Osaka 599-8247, Japan.
authors.forename: Shinya
authors.initials: S
authors.lastname: Sato
authors.affiliation: Department of Gastroenterology, Belland General Hospital, Sakai, Osaka 599-8247, Japan.
authors.forename: Tatsuichi
authors.initials: T
authors.lastname: An
authors.affiliation: Department of Internal Medicine, Takamiya Hospital, Tenri, Nara 632-0052, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Morita
authors.affiliation: Department of Gastroenterology, Nara Prefecture Western Medical Center, Nara 636-0802, Japan.
authors.forename: Sigeyuki
authors.initials: S
authors.lastname: Aizawa
authors.affiliation: Department of Internal Medicine, Kokuho Chuo Hospital, Nara 636-0302, Japan.
authors.forename: Yasunori
authors.initials: Y
authors.lastname: Tokuoka
authors.affiliation: Department of Gastroenterology, Ishinkai Yao General Hospital, Yao, Osaka 581-0036, Japan.
authors.forename: Masatoshi
authors.initials: M
authors.lastname: Ishikawa
authors.affiliation: Department of Gastroenterology, Ishinkai Yao General Hospital, Yao, Osaka 581-0036, Japan.
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Matsumura
authors.affiliation: Department of Gastroenterology and Rheumatology, School of Medicine, Fukushima Medical University, Fukushima 960-1295, Japan.
authors.forename: Hiromasa
authors.initials: H
authors.lastname: Ohira
authors.affiliation: Department of Gastroenterology, Fujita General Hospital, Fukusima 969-1793, Japan.
authors.forename: Atsuko
authors.initials: A
authors.lastname: Kogure
authors.affiliation: Department of Gastroenterology, Fujita General Hospital, Fukusima 969-1793, Japan.
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Noguchi
authors.affiliation: Third Department of Internal Medicine, Nara Medical University, Kashihara, Nara 634-8521, Japan.
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Yoshiji
keywords: diabetes; dipeptidyl peptidase 4 inhibitor; non-alcoholic fatty liver disease