Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, 67 Asahi-machi, Kurume, 830-0011, Japan.
Taisho Pharmaceutical Co., Ltd., Tokyo, Japan.
J Gastroenterol. 2024 Dec;59(12):1120-1132. doi: 10.1007/s00535-024-02158-z. Epub 2024 Oct 11.
BACKGROUND & AIM: SGLT2 inhibitors (SGLT2i) improve hepatic steatosis in patients with type 2 diabetes mellitus (T2DM) and MASLD. We aimed to investigate the impact of SGLT2i on the incidence of liver-related events and extrahepatic cancer compared to DPP4 inhibitors (DPP4i) in patients with T2DM and suspected MASLD using a medical claims database in Japan.
We conducted a retrospective study using a Japanese medical claims database. Among patients with T2DM who were prescribed SGLT2i or DPP4i (n = 1,628,656), patients with suspected MASLD were classified into SGLT2i (n = 4204) and DPP4i (n = 4204) groups. Effects of SGLT2i on the following outcomes were compared to DPP4i: (1) changes in HbA1c and ALT levels after 6 months, (2) changes in hepatic fibrosis index, and (3) the incidence of liver-related events/extrahepatic cancer over 12 months.
After 6 months, DPP4i significantly decreased HbA1c levels compared to SGLT2i. In contrast, SGLT2i significantly decreased ALT levels compared to DPP4i. SGLT2i significantly decreased FIB-4 index compared to DPP4i over 12 months. Although no significant difference was observed in the incidence of overall liver-related events between the two groups, SGLT2i significantly reduced the incidence of esophageal varices (HR 0.12, 95%CI 0.01-0.95, P = 0.044). Moreover, SGLT2i significantly suppressed the incidence of extrahepatic cancer (HR 0.50, 95%CI 0.30-0.84, P = 0.009) compared to DPP4i.
SGLT2i was more beneficial than DPP4i in improving the hepatic inflammation and fibrosis indices. Moreover, SGLT2i suppressed the incidence of esophageal varices and extrahepatic cancer compared to DPP4i. SGLT2i may suppress life-threatening events in patients with T2DM and suspected MASLD.
SGLT2 抑制剂(SGLT2i)可改善 2 型糖尿病(T2DM)和代谢相关脂肪性肝病(MASLD)患者的肝脂肪变性。我们旨在使用日本医疗索赔数据库,研究与 DPP4 抑制剂(DPP4i)相比,SGLT2i 对 T2DM 合并疑似 MASLD 患者的肝脏相关事件和肝外癌症发生率的影响。
我们进行了一项回顾性研究,使用日本医疗索赔数据库。在接受 SGLT2i 或 DPP4i 治疗的 T2DM 患者(n=1,628,656)中,疑似 MASLD 患者分为 SGLT2i 组(n=4204)和 DPP4i 组(n=4204)。与 DPP4i 相比,比较 SGLT2i 对以下结局的影响:(1)6 个月后 HbA1c 和 ALT 水平的变化,(2)肝纤维化指数的变化,以及(3)12 个月内肝脏相关事件/肝外癌症的发生率。
6 个月后,DPP4i 显著降低 HbA1c 水平,而 SGLT2i 显著降低 ALT 水平。此外,与 DPP4i 相比,SGLT2i 在 12 个月内显著降低 FIB-4 指数。虽然两组间总体肝脏相关事件的发生率无显著差异,但 SGLT2i 显著降低食管静脉曲张的发生率(HR 0.12,95%CI 0.01-0.95,P=0.044)。此外,与 DPP4i 相比,SGLT2i 显著降低肝外癌症的发生率(HR 0.50,95%CI 0.30-0.84,P=0.009)。
与 DPP4i 相比,SGLT2i 更有利于改善肝脏炎症和纤维化指标。此外,与 DPP4i 相比,SGLT2i 可降低食管静脉曲张和肝外癌症的发生率。SGLT2i 可能会抑制 T2DM 和疑似 MASLD 患者的危及生命的事件。