Abstract：
OBJECTIVE: Major adverse cardiovascular event (MACE) outcomes associated with sodium-glucose cotransporter 2 inhibitor (SGLT2i) and glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapies remain unclear in patients with type 2 diabetes and newly diagnosed diabetic foot complications (DFCs). This study examined the impact of SGLT2i and GLP-1 RA use on the rates of MACEs and amputations in patients with type 2 diabetes and without cardiovascular disease.
METHODS: Data from the Taiwan National Health Insurance Research Database (2004-2017) were analyzed, focusing on patients with type 2 diabetes without previous MACE and newly diagnosed DFCs. The primary outcome was the first MACE occurrence, and the secondary outcomes included MACE components, all-cause mortality, and lower extremity amputation (LEA) rates.
RESULTS: SGLT2i users showed a significant decrease in the MACE (hazard ratio [HR], 0.64; 95% confidence interval [CI], 0.46-0.88) and hospitalization for heart failure (HR, 0.54; 95% CI, 0.35-0.83) rates compared with dipeptidyl peptidase-4 inhibitor users. The amputation rates were also lower in SGLT2i users without LEA at the first DFC diagnosis (HR, 0.28; 95% CI, 0.10-0.75) and did not increase in those with a history of peripheral artery disease or LEA. No significant differences were observed between dipeptidyl peptidase-4 inhibitor and GLP-1 RA users in terms of the primary or secondary outcomes.
CONCLUSIONS: In patients with type 2 diabetes initially diagnosed with DFC, SGLT2i are effective in significantly reducing the hospitalization for heart failure and MACE rates. SGLT2i lower the amputation rates, especially in patients who have not previously had a LEA, than the dipeptidyl peptidase-4 inhibitor therapy.
METHODS: Data from the Taiwan National Health Insurance Research Database (2004-2017) were analyzed, focusing on patients with type 2 diabetes without previous MACE and newly diagnosed DFCs. The primary outcome was the first MACE occurrence, and the secondary outcomes included MACE components, all-cause mortality, and lower extremity amputation (LEA) rates.
RESULTS: SGLT2i users showed a significant decrease in the MACE (hazard ratio [HR], 0.64; 95% confidence interval [CI], 0.46-0.88) and hospitalization for heart failure (HR, 0.54; 95% CI, 0.35-0.83) rates compared with dipeptidyl peptidase-4 inhibitor users. The amputation rates were also lower in SGLT2i users without LEA at the first DFC diagnosis (HR, 0.28; 95% CI, 0.10-0.75) and did not increase in those with a history of peripheral artery disease or LEA. No significant differences were observed between dipeptidyl peptidase-4 inhibitor and GLP-1 RA users in terms of the primary or secondary outcomes.
CONCLUSIONS: In patients with type 2 diabetes initially diagnosed with DFC, SGLT2i are effective in significantly reducing the hospitalization for heart failure and MACE rates. SGLT2i lower the amputation rates, especially in patients who have not previously had a LEA, than the dipeptidyl peptidase-4 inhibitor therapy.
摘要：
目的：钠-葡萄糖协同转运蛋白2抑制剂（SGLT2i）和胰高血糖素样肽-1受体激动剂（GLP-1RA）治疗对2型糖尿病和新诊断的糖尿病足并发症（DFCs）患者的主要不良心血管事件（MACE）结局尚不清楚。这项研究检查了SGLT2i和GLP-1RA的使用对2型糖尿病患者和无心血管疾病（CVD）的MACE和截肢率的影响。
方法：分析了台湾国民健康保险研究数据库（2004-2017）的数据，重点关注没有既往MACE和新诊断的DFCs的2型糖尿病患者。主要结果是第一次发生MACE；次要结果包括MACE成分，全因死亡率,和下肢截肢（LEA）率。
结果：SGLT2i用户与DPP-4i用户相比，MACE（风险比[HR]=0·64，95％置信区间[CI]：0·46-0·88）和HHF（HR=0·54，95％CI：0·35-0·83）发生率显着降低。在第一次DFC诊断时，没有LEA的SGLT2i使用者的截肢率也较低（HR=0·28，95％CI：0·10-0·75），有PAD或LEA病史者的截肢率没有增加。DPP-4i和GLP-1RA使用者在主要或次要结局方面没有观察到显著差异。结论：在最初诊断为DFC的2型糖尿病患者中，SGLT2i可有效降低HHF和MACE发生率。SGLT2i降低截肢率，特别是在以前没有LEA的患者中，与DPP-4i治疗相比。
方法：分析了台湾国民健康保险研究数据库（2004-2017）的数据，重点关注没有既往MACE和新诊断的DFCs的2型糖尿病患者。主要结果是第一次发生MACE；次要结果包括MACE成分，全因死亡率,和下肢截肢（LEA）率。
结果：SGLT2i用户与DPP-4i用户相比，MACE（风险比[HR]=0·64，95％置信区间[CI]：0·46-0·88）和HHF（HR=0·54，95％CI：0·35-0·83）发生率显着降低。在第一次DFC诊断时，没有LEA的SGLT2i使用者的截肢率也较低（HR=0·28，95％CI：0·10-0·75），有PAD或LEA病史者的截肢率没有增加。DPP-4i和GLP-1RA使用者在主要或次要结局方面没有观察到显著差异。结论：在最初诊断为DFC的2型糖尿病患者中，SGLT2i可有效降低HHF和MACE发生率。SGLT2i降低截肢率，特别是在以前没有LEA的患者中，与DPP-4i治疗相比。
