SGLT2 抑制剂可减少 2 型糖尿病患者的心脏自主神经病变功能障碍和血管迷走神经性晕厥复发：SCAN 研究。
SGLT2-inhibitors reduce the cardiac autonomic neuropathy dysfunction and vaso-vagal syncope recurrence in patients with type 2 diabetes mellitus: the SCAN study.
机构信息
Department of Advanced Medical and Surgical Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy.
Cardiovascular and Arrhythmias Department "Gemelli Molise", Campobasso, Italy; Department of Cardiovascular and Thoracic Sciences, Catholic University of the Sacred Heart, Rome, Italy.
出版信息
Metabolism. 2022 Dec;137:155243. doi: 10.1016/j.metabol.2022.155243. Epub 2022 Jun 19.
BACKGROUND
In patients with type 2 diabetes mellitus (T2DM) the vaso-vagal syncope (VVS) recurrence could be due to the alteration of autonomic system function, evaluated by heart rate variability (HRV), and by 123I-metaiodobenzylguanidine (123I-mIBG) myocardial scintigraphy indexes: Heart to Mediastinum ratio (H/M), and Washout rate (WR). The SGLT2-I could modulate/reduce autonomic dysfunction in T2DM patients with VVS. This effect could reduce the VVS recurrence in T2DM patients.
METHODS
In a prospective multicenter study, after propensity score matching, we studied a population of 324 T2DM patients with VVS, divided into 161 SGLT2-I-users vs. 163 Non-SGLT2-I users. In these patients as SGLT2-I-users vs. Non-SGLT2-I users, we investigated the HRV and 123I-MIBG modifications and VVS recurrence at 12 months of follow-up.
RESULTS
At follow-up end, the SGLT2-I-users vs. Non-SGLT2-I users had best glucose homeostasis and lower values of inflammatory markers, and resting heart rate (p < 0.05). The SGLT2-I-users vs. Non-SGLT2-I users evidenced the lowest low frequency/high frequency ratio (LF/HFr), a significant difference for all the indexes of autonomic dysfunction via ECG Holter analysis, and higher values of H/M (p < 0.05). Finally, comparing SGLT2-I-users vs. Non-SGLT2-I users, we found a higher rate of VVS recurrence events, specifically of the vasodepressor VVS recurrence at 1-year follow-up (p < 0.05). We did not find a significant difference of mixed and cardio-inhibitory VVS recurrence events at 1 year of follow-up in the study cohorts (p > 0.05). At the Cox regression analysis H/M (0.710, [0.481-0.985]), and SGLT2-I therapy (0.550, [0.324-0.934]) predicted all causes of syncope recurrence at 1 year of follow-up.
CONCLUSIONS
Non-SGLT2-I users vs. SGLT2-I-users had alterations of the autonomic nervous system, with a higher rate of VVS recurrence at 1 year of follow-up. The indexes of cardiac denervation predicted the VVS recurrence, while the SGLT2-I reduced the risk of VVS recurrence.
CLINICAL TRIAL REGISTRATION NUMBER
NCT03717207.
背景
在 2 型糖尿病（T2DM）患者中，血管迷走神经性晕厥（VVS）的复发可能是由于自主神经系统功能的改变，通过心率变异性（HRV）和 123I-间位碘苄胍（123I-mIBG）心肌闪烁显像指标评估：心-纵隔比（H/M）和洗脱率（WR）。SGLT2-I 可调节/降低 VVS 伴 T2DM 患者的自主神经功能障碍。这种作用可以降低 T2DM 患者 VVS 的复发率。
方法
在一项前瞻性多中心研究中，通过倾向评分匹配后，我们研究了 324 例 VVS 的 T2DM 患者，分为 SGLT2-I 使用者 161 例和非 SGLT2-I 使用者 163 例。在这些患者中，SGLT2-I 使用者与非 SGLT2-I 使用者相比，我们在 12 个月的随访中观察了 HRV 和 123I-MIBG 变化以及 VVS 复发情况。
结果
随访结束时，SGLT2-I 使用者与非 SGLT2-I 使用者的血糖稳态最佳，炎症标志物和静息心率值较低（p<0.05）。SGLT2-I 使用者与非 SGLT2-I 使用者的低频/高频比值（LF/HFr）最低，通过心电图 Holter 分析发现所有自主神经功能障碍指标均有显著差异，H/M 值较高（p<0.05）。最后，与 SGLT2-I 使用者相比，非 SGLT2-I 使用者在 1 年随访时出现 VVS 复发事件的比例更高，特别是血管扩张性 VVS 复发事件（p<0.05）。在研究队列中，1 年随访时混合性和心脏抑制性 VVS 复发事件无显著差异（p>0.05）。在 Cox 回归分析中，H/M（0.710，[0.481-0.985]）和 SGLT2-I 治疗（0.550，[0.324-0.934]）可预测 1 年随访时所有原因引起的晕厥复发。
结论
非 SGLT2-I 使用者与 SGLT2-I 使用者的自主神经系统发生改变，1 年随访时 VVS 复发率较高。心脏去神经支配的指标预测了 VVS 的复发，而 SGLT2-I 降低了 VVS 复发的风险。
临床试验注册号
NCT03717207。
Zotero 插件