Department of Epidemiology and Preventive Medicine, School of Public Health, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
Leviev Heart Center, Sheba Medical Center, Ramat-Gan, Israel.
Cardiovasc Diabetol. 2023 Jan 24;22(1):16. doi: 10.1186/s12933-023-01743-5.
As indications for sodium-glucose co-transporter-2 inhibitors (SGLT2i) are expanding, a growing number of older adults have become candidates for treatment. We studied the safety profile of SGLT2i among older adults.
A retrospective, pharmacovigilance study of the FDA's global database of safety reports. To assess reporting of pre-specified adverse events following SGLT2i among adults (< 75 years) and older adults (≥ 75), we performed a disproportionality analysis using the sex-adjusted reporting odds ratio (adj.ROR).
We identified safety reports of 129,795 patients who received non-insulin anti-diabetic drugs (NIAD), including 24,253 who were treated with SGLT2i (median age 60 [IQR: 51-68] years, 2,339 [9.6%] aged ≥ 75 years). Compared to other NIAD, SGLT2i were significantly associated with amputations (adj.ROR = 355.1 [95%CI: 258.8 - 487.3] vs adj.ROR = 250.2 [79.3 - 789.5]), Fournier gangrene (adj.ROR = 45.0 [34.5 - 58.8] vs adj.ROR = 88.0 [27.0 - 286.6]), diabetic ketoacidosis (adj.ROR = 32.3 [30.0 - 34.8] vs adj.ROR = 23.3 [19.2 - 28.3]), genitourinary infections (adj.ROR = 10.3 [9.4 - 11.2] vs adj.ROR = 8.6 [7.2 - 10.3]), nocturia (adj.ROR = 5.5 [3.7 - 8.2] vs adj.ROR = 6.7 [2.8 - 15.7]), dehydration (adj.ROR = 2.5 [2.3 - 2.8] vs adj.ROR = 2.6 [2.1 - 3.3]), and fractures (adj.ROR = 1.7 [1.4 - 2.1] vs adj.ROR = 1.5 [1.02 - 2.1]) in both adults and older adults, respectively. None of these safety signals was significantly greater in older adults (P threshold of 0.05). Acute kidney injury was associated with SGLT2i in adults (adj.ROR = 1.97 [1.85 - 2.09]) but not in older adults (adj.ROR = 0.71 [0.59 - 0.84]). Falls, hypotension, and syncope were not associated with SGLT2i among either adults or older adults.
In this global post-marketing study, none of the adverse events was reported more frequently among older adults. Our findings provide reassurance regarding SGLT2i treatment in older adults, although careful monitoring is warranted.
随着钠-葡萄糖协同转运蛋白 2 抑制剂（SGLT2i）的适应证不断扩大，越来越多的老年人成为治疗的候选人群。我们研究了 SGLT2i 在老年人中的安全性特征。
这是一项使用 FDA 全球安全性报告数据库进行的回顾性药物警戒研究。为了评估 SGLT2i 在成年（<75 岁）和老年（≥75 岁）患者中的特定不良事件报告情况，我们使用性别调整后的报告比值比（adj.ROR）进行了不成比例性分析。
我们确定了 129795 名接受非胰岛素类抗糖尿病药物（NIAD）治疗的患者的安全性报告，其中 24253 名患者接受了 SGLT2i 治疗（中位年龄 60[IQR：51-68]岁，2339 名[9.6%]≥75 岁）。与其他 NIAD 相比，SGLT2i 与截肢（adj.ROR=355.1[95%CI：258.8-487.3]与 adj.ROR=250.2[79.3-789.5]）、Fournier 坏疽（adj.ROR=45.0[34.5-58.8]与 adj.ROR=88.0[27.0-286.6]）、糖尿病酮症酸中毒（adj.ROR=32.3[30.0-34.8]与 adj.ROR=23.3[19.2-28.3]）、尿路感染（adj.ROR=10.3[9.4-11.2]与 adj.ROR=8.6[7.2-10.3]）、夜尿症（adj.ROR=5.5[3.7-8.2]与 adj.ROR=6.7[2.8-15.7]）、脱水（adj.ROR=2.5[2.3-2.8]与 adj.ROR=2.6[2.1-3.3]）和骨折（adj.ROR=1.7[1.4-2.1]与 adj.ROR=1.5[1.02-2.1]）在成年和老年患者中均显著相关。这些安全性信号在老年患者中均无显著增加（P<0.05）。急性肾损伤与 SGLT2i 在成年患者中相关（adj.ROR=1.97[1.85-2.09]），但在老年患者中不相关（adj.ROR=0.71[0.59-0.84]）。在成年和老年患者中，跌倒、低血压和晕厥与 SGLT2i 无关。
在这项全球上市后研究中，没有任何不良事件在老年患者中报告得更频繁。我们的研究结果为 SGLT2i 在老年患者中的治疗提供了保证，尽管需要谨慎监测。
