College of Pharmacy, Sookmyung Women's University, Seoul, Republic of Korea.
Drug Information Research Institute, Sookmyung Women's University, Seoul, Republic of Korea.
PLoS One. 2023 Nov 22;18(11):e0294423. doi: 10.1371/journal.pone.0294423. eCollection 2023.
Nonalcoholic fatty liver disease (NAFLD) is a growing health concern with increasing prevalence and associated health impacts. Although no approved drugs are available for the NAFLD treatment, several hypoglycemic agents have been investigated as promising therapeutic agents. We aimed to compare the risk of occurrence of NAFLD with respect to the use of different hypoglycemic agents in patients with type 2 diabetes. This retrospective cohort study used data from the National Health Insurance Service-National Sample Cohort of South Korea. Participants newly diagnosed with type 2 diabetes (2003-2019) were included in this study. Two new user-active comparator cohorts were assembled: Cohort 1, new users of thiazolidinediones (TZD) and dipeptidyl peptidase-4 inhibitors (DPP-4i), and Cohort 2, new users of sodium-glucose cotransporter-2 inhibitors (SGLT-2i) and DPP-4i. The occurrence of NAFLD was defined based claims that include diagnostic codes. Hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated using Cox proportional hazard models in 1:3 propensity score (PS)-matched cohorts. For 65,224 patients newly diagnosed with type 2 diabetes, the overall prevalence of NAFLD was 42.6%. The PS-matched Cohort 1 included 6,351 and 2,117 new users of DPP-4i and TZD, respectively. Compared to DPP-4i, TZD use was associated with the decreased risk of NAFLD (HR, 0.66; 95% CI: 0.55-0.78). Cohort 2 consisted of 6,783 and 2,261 new users of DPP-4i and SGLT-2i, respectively; SGLT-2i use was associated with a decreased risk of NAFLD (HR, 0.93; 95% CI: 0.80-1.08). This population-based cohort study supports the clinical implications of prioritizing TZD and SGLT-2i over DPP-4i in reducing the risk of occurrence of NAFLD in patients with type 2 diabetes. However, the findings lacked statistical significance, highlighting the need for further verification studies.
非酒精性脂肪性肝病（NAFLD）是一种日益严重的健康问题，其患病率不断增加，且与健康影响相关。尽管目前尚无针对 NAFLD 的批准药物，但已有多种降糖药物被研究为有前途的治疗药物。我们旨在比较不同降糖药物在 2 型糖尿病患者中治疗 NAFLD 的发生风险。本回顾性队列研究使用了来自韩国国家健康保险服务-国家样本队列的数据。本研究纳入了 2003 年至 2019 年新诊断为 2 型糖尿病的患者。建立了两个新的使用者-活性对照队列：队列 1，使用噻唑烷二酮（TZD）和二肽基肽酶-4 抑制剂（DPP-4i）的新使用者；队列 2，使用钠-葡萄糖协同转运蛋白-2 抑制剂（SGLT-2i）和 DPP-4i 的新使用者。NAFLD 的发生根据包含诊断代码的索赔来定义。使用 Cox 比例风险模型在 1:3 倾向评分（PS）匹配队列中估计风险比（HR）和 95%置信区间（CI）。对于 65224 名新诊断为 2 型糖尿病的患者，NAFLD 的总体患病率为 42.6%。PS 匹配的队列 1 包括分别使用 DPP-4i 和 TZD 的 6351 名和 2117 名新使用者。与 DPP-4i 相比，TZD 治疗与 NAFLD 风险降低相关（HR，0.66；95%CI：0.55-0.78）。队列 2 分别由使用 DPP-4i 和 SGLT-2i 的 6783 名和 2261 名新使用者组成；SGLT-2i 治疗与 NAFLD 风险降低相关（HR，0.93；95%CI：0.80-1.08）。这项基于人群的队列研究支持在降低 2 型糖尿病患者 NAFLD 发生风险方面，优先选择 TZD 和 SGLT-2i 而不是 DPP-4i 的临床意义。然而，这些发现缺乏统计学意义，突出了进一步验证研究的必要性。
