2型糖尿病患者中钠-葡萄糖协同转运蛋白2抑制剂（SGLT2i）的可推广性及治疗：基于意大利基层医疗数据库的评估
Generalizability and treatment with sodium-glucose co-trasporter-2 inhibitors (SGLT2i) among patients with type 2 diabetes: an assessment using an Italian primary care database.
作者信息
Antonazzo Ippazio Cosimo, Rozza Davide, Cortesi Paolo Angelo, Fornari Carla, Zanzottera Ferrari Elena, Paris Claire, Eteve-Pitsaer Caroline, Gnesi Marco, Mele Silvia, D'Amelio Marco, Maurizi Anna Rita, Palladino Pasquale, Mantovani Lorenzo Giovanni, Mazzaglia Giampiero
机构信息
Research Centre on Public Health (CESP), University of Milano-Bicocca, Via Pergolesi 33, Monza, MB, Italy.
Unit of Medical Statistics, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, 56126, Italy.
出版信息
Acta Diabetol. 2025 Mar;62(3):343-351. doi: 10.1007/s00592-024-02359-1. Epub 2024 Aug 29.
AIMS
This study aimed to assess the proportions of type 2 diabetes (T2D) subjects meeting cardiovascular outcome trials (CVOTs) criteria for sodium-glucose cotransporter-2 inhibitors (SGLT-2i) and estimate SGLT2i utilization, along with associated demographic and clinical characteristics, in a primary care setting.
METHODS
T2D patients in Italy were selected between January 1, 2021, and December 31, 2022, from The Health Improvement Network (THIN) database. Representativeness was determined by dividing patients meeting key inclusion criteria for four CVOTs (CANVAS, DECLARE-TIMI 58, EMPA-REG OUTCOME, VERTIS-CV) to the total T2D population. Demographic and clinical characteristics of eligible T2D subjects and SGLT2i users were compared, and logistic regression models assessed the likelihood of receiving SGLT2i.
RESULTS
Out of 17,102 T2D patients, 8,828 met eligibility criteria for at least one CVOT. DECLARE-TIMI 58 exhibited the highest representativeness (51.1%), compared to CANVAS (21.1%), EMPA-REG OUTCOME (5.5%), and VERTIS-CV (4.9%) trials. Eligible CVOTs patients were older (74.6 vs. 68.3 years), with a longer disease duration (10.2 vs. 9.7 years), and higher established cardiovascular disease (CVD) prevalence (36.0 vs. 27.3%) compared to SGLT2i users. Less than 10% of eligible T2D patients received SGLT2i. Males (OR: 1.43; 95%CI: 1.24-1.66) were more likely to be prescribed SGLT2i than other antidiabetic drugs, while the elderly (80 + vs. 40-64 years, OR: 0.17; 95% CI: 0.14-0.22) were less likely. Eligible T2D patients with CVD reported an increased likelihood of receiving SGLT2is compared to other antidiabetics.
CONCLUSION
This study highlights significant variability in the proportion of T2D subjects meeting SGLT2i CVOT inclusion criteria, with DECLARE-TIMI-58 being the most represented. Low SGLT2i prescription rates in the Italian primary care setting, along with substantial demographic and clinical differences between SGLT-2i users and T2D eligible patients, emphasize the need for targeted interventions to optimize the use of these medications in primary care settings.
目的
本研究旨在评估2型糖尿病（T2D）患者中符合心血管结局试验（CVOTs）中钠-葡萄糖协同转运蛋白2抑制剂（SGLT-2i）标准的比例，并估计在初级保健环境中SGLT2i的使用情况以及相关的人口统计学和临床特征。
方法
从健康改善网络（THIN）数据库中选取2021年1月1日至2022年12月31日期间意大利的T2D患者。通过将符合四项CVOTs（CANVAS、DECLARE-TIMI 58、EMPA-REG OUTCOME、VERTIS-CV）关键纳入标准的患者数量除以T2D患者总数来确定代表性。比较符合条件的T2D患者和SGLT2i使用者的人口统计学和临床特征，并使用逻辑回归模型评估接受SGLT2i的可能性。
结果
在17102例T2D患者中，8828例符合至少一项CVOTs的资格标准。与CANVAS（21.1%）、EMPA-REG OUTCOME（5.5%）和VERTIS-CV（4.9%）试验相比，DECLARE-TIMI 58的代表性最高（51.1%）。符合CVOTs条件的患者年龄更大（74.6岁对68.3岁），病程更长（10.2年对9.7年），已确诊的心血管疾病（CVD）患病率更高（36.0%对27.3%）。符合条件的T2D患者中接受SGLT2i的不到10%。男性（OR：1.43；95%CI：1.24 - 1.66）比其他抗糖尿病药物更有可能被处方使用SGLT2i，而老年人（80岁及以上对40 - 64岁，OR：0.17；95%CI：0.14 - 0.22）则可能性较小。与其他抗糖尿病药物相比，符合条件的患有CVD的T2D患者接受SGLT2i的可能性增加。
结论
本研究强调了符合SGLT2i CVOT纳入标准的T2D患者比例存在显著差异，其中DECLARE-TIMI-58试验的代表性最高。意大利初级保健环境中SGLT2i的处方率较低，以及SGLT-2i使用者与符合T2D条件患者之间存在显著的人口统计学和临床差异，强调了需要有针对性的干预措施，以优化这些药物在初级保健环境中的使用。
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