Department of Internal Medicine, Seoul National University Hospital Healthcare System Gangnam Center, Seoul, South Korea.
Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.
Cardiovasc Diabetol. 2024 Sep 3;23(1):329. doi: 10.1186/s12933-024-02422-9.
The potential preventive effect of fenofibrate on lower extremity amputation (LEA) and peripheral arterial disease (PAD) in patients with type 2 diabetes (T2D) is not fully elucidated.
We selected adult patients ≥ 20 years of age with T2D from the Korean National Health Insurance Service Database (2009-2012). The fenofibrate users were matched in a 1:4 ratio with non-users using propensity scores (PS). The outcome variables were a composite of LEA and PAD and the individual components. The risks of outcomes were implemented as hazard ratio (HR) with 95% confidence intervals (CI). For safety issues, the risks of acute kidney injury, rhabdomyolysis and resulting hospitalization were analyzed.
A total of 114,920 patients was included in the analysis with a median follow-up duration of 7.6 years (22,984 and 91,936 patients for the fenofibrate user and non-user groups, respectively). After PS matching, both groups were well balanced. The fenofibrate group was associated with significantly lower risks of composite outcome of LEA and PAD (HR 0.81; 95% CI 0.70-0.94), LEA (HR 0.76; 95% CI 0.60-0.96), and PAD (HR 0.81; 95% CI 0.68-0.96). The risk of acute kidney injury, rhabdomyolysis, or hospitalization for these events showed no significant difference between the two groups. Subgroup analyses revealed consistent benefits across age groups, genders, and baseline lipid profiles.
This nationwide population-based retrospective observational study suggests that fenofibrate can prevent LEA and PAD in patients with T2D who are on statin therapy.
非诺贝特对 2 型糖尿病（T2D）患者下肢截肢（LEA）和外周动脉疾病（PAD）的潜在预防作用尚未完全阐明。
我们从韩国国家健康保险服务数据库（2009-2012 年）中选择了年龄≥20 岁的 T2D 成年患者。使用倾向评分（PS）将非诺贝特使用者与非使用者按 1:4 的比例进行匹配。结局变量为 LEA 和 PAD 的复合结局及各组分。采用风险比（HR）及其 95%置信区间（CI）来实施结局风险。为了评估安全性问题，我们分析了急性肾损伤、横纹肌溶解症及其导致的住院风险。
共纳入 114920 例患者，中位随访时间为 7.6 年（非诺贝特使用者和非使用者分别为 22984 例和 91936 例）。经过 PS 匹配后，两组间均衡性良好。与非使用者相比，非诺贝特使用者发生 LEA 和 PAD 复合结局（HR 0.81；95%CI 0.70-0.94）、LEA（HR 0.76；95%CI 0.60-0.96）和 PAD（HR 0.81；95%CI 0.68-0.96）的风险显著降低。两组间发生急性肾损伤、横纹肌溶解症或因这些事件住院的风险无显著差异。亚组分析显示，在各年龄组、性别和基线血脂谱中均观察到一致的获益。
这项基于人群的全国性回顾性观察性研究表明，对于正在接受他汀类药物治疗的 T2D 患者，非诺贝特可预防 LEA 和 PAD。
