摘要

目的：第2 型鈉- 葡萄糖共同轉運蛋白抑制劑 (sodium-glucose co-transporter 2 inhibitors, SGLT2i) 已證實能預防心血管事件、延緩腎臟功能惡化。隨機試驗顯示SGLT2i 在不同年齡的不良反應發生率相似，然而觀察性研究為主的薈萃分析顯示高齡發生嚴重不良反應與導致停藥的比率顯著高於年輕對照組，研究結果相異。因此本研究將探討SGLT2i 使用於高齡與非高齡病人之療效與安全性。
 

方法：使用高醫體系醫院資料庫的回顧性試驗，收納首次使用SGLT2i 的第二型糖尿病門診病人，以病歷中的過敏與藥物不良反應記錄評估安全性。療效評估為治療6個月後糖化血色素 (hemoglobin A1c, HbA1c) 與基線值的差異。
 

結果：3,917 人使用過SGLT2i，高齡發生不良反應的比例 (1.65% vs. 0.91%, p = 0.040) 與因不良反應停藥的比例 (44.1% vs. 9.5%, p < 0.001) 皆顯著高於非高齡組。排除治療少於6 個月、HbA1c < 7% 與血糖併用藥有調整的病人共2,231 人進行分析。高齡與非高齡組別治療後HbA1c、空腹血糖皆與治療前下降達統計差異。其他降血糖藥物、治療前空腹血糖、HbA1c 和腎功能基線值可能皆是影響HbA1c 降低的因子。
 

結論：我們的研究證實SGLT2i 使用於高齡或非高齡組，降HbA1c、空腹血糖皆達統計差異。然而高齡病人發生不良反應的比例及因不良反應停藥的比例皆顯著高於非高齡病人。

 

ABSTRACT

Objective: Sodium-glucose co-transporter 2 inhibitors (SGLT2i) are known to reduce cardiovascular events and slow renal decline. While randomized trials indicate consistent adverse effect rates across ages, a meta-analysis of observational studies reveals a higher incidence of serious adverse effects and discontinuations among the elderly compared to younger patients. This study seeks to explore SGLT2i effectiveness and safety in both elderly and non-elderly populations.
 

Methods: A retrospective trial using Kaohsiung Medical University Hospital Research Database enrolled type 2 diabetes mellitus patients who were prescribed SGLT2i for the first time. Safety was assessed by documented allergies and adverse drug reactions in medical records. Efficacy was assessed as the difference in baseline hemoglobin A1c (HbA1c) values after 6 months of treatment.
 

Results: During the period, 3,917 individuals utilized SGLT2i. The rate of adverse events (1.65% vs. 0.91%, p = 0.040) and discontinuations due to adverse events (44.1% vs. 9.5%, p < 0.001) were significantly higher in the elderly compared to the nonelderly group. Patients with less than 6 months of treatment, HbA1c< 7% and adjusted glycaemic co-morbidities were excluded. A total of 2,231 patients were included in the final analysis. Post-treatment reductions in HbA1c and fasting plasma glucose differed significantly between elderly and non-elderly groups compared to pre-treatment levels. Other hypoglycaemic agents, pre-treatment fasting blood glucose, HbA1c and baseline renal function may all be factors influencing the reduction in HbA1c.
 

Conclusions: Our study demonstrated that SGLT2i was used in both elderly and non-elderly groups, and that there were statistical differences in the lowering of HbA1c and fasting blood glucose. However, adverse reactions and discontinuations were notably higher in the elderly, warranting increased vigilance.

 

 

Submitted for publication: 2023.12.26; Accepted for publication: 2024.10.3