SGLT2 抑制剂心血管结局试验对 2 型糖尿病合并心血管疾病患者的外推适用性。
External applicability of SGLT2 inhibitor cardiovascular outcome trials to patients with type 2 diabetes and cardiovascular disease.
机构信息
Department of Vascular Medicine, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.
Department of Endocrinology, University Medical Center Utrecht, Utrecht, The Netherlands.
出版信息
Cardiovasc Diabetol. 2021 Sep 8;20(1):181. doi: 10.1186/s12933-021-01373-9.
BACKGROUND
Recent treatment guidelines support the use of sodium-glucose cotransporter 2 inhibitors (SGLT2i) in patients with type 2 diabetes and cardiovascular disease based on the results of cardiovascular outcome trials (CVOTs). Applicability of these trials to everyday patients with type 2 diabetes and cardiovascular disease is however unknown. The aim of this study is to assess the external applicability of SGLT2i CVOTs in daily clinical practice type 2 diabetes patients with established cardiovascular disease.
METHODS
Trial in- and exclusion criteria from EMPA-REG OUTCOME, CANVAS, DECLARE-TIMI 58 and VERTIS-CV were applied to 1389 type 2 diabetes patients with cardiovascular disease in the Utrecht Cardiovascular Cohort-Secondary Manifestations of ARTerial disease (UCC-SMART). To evaluate the difference in cardiovascular risk (MACE) and all-cause mortality between trial eligible and ineligible patients, age and sex-adjusted Cox-regression analyses were performed.
RESULTS
After applying trial in- and exclusion criteria, 48% of UCC-SMART patients with type 2 diabetes and cardiovascular disease would have been eligible for DECLARE-TIMI 58, 35% for CANVAS, 29% for EMPA-REG OUTCOME and 21% for VERTIS-CV. Without the eligibility criteria of HbA, eligibility was 58-88%. For all trials the observed risk for cardiovascular events and all-cause mortality was similar in eligible and ineligible patients after adjustment for age and gender.
CONCLUSION
A large proportion of patients with type 2 diabetes and cardiovascular disease in daily clinical practice would have been eligible for participation in the SGLT2i CVOTs. Trial eligible and ineligible patients have the same risk for MACE and all-cause mortality.
背景
基于心血管结局试验（CVOT）的结果，最近的治疗指南支持在 2 型糖尿病和心血管疾病患者中使用钠-葡萄糖共转运蛋白 2 抑制剂（SGLT2i）。然而，这些试验在日常患有 2 型糖尿病和心血管疾病的患者中的适用性尚不清楚。本研究旨在评估 SGLT2i CVOT 在日常临床实践中患有已确诊心血管疾病的 2 型糖尿病患者中的外部适用性。
方法
将 EMPA-REG OUTCOME、CANVAS、DECLARE-TIMI 58 和 VERTIS-CV 的试验纳入和排除标准应用于 1389 名患有心血管疾病的 2 型糖尿病患者（UCC-SMART）。为了评估试验合格和不合格患者之间心血管风险（MACE）和全因死亡率的差异，进行了年龄和性别调整的 Cox 回归分析。
结果
在应用试验纳入和排除标准后，48%的 UCC-SMART 患有 2 型糖尿病和心血管疾病的患者符合 DECLARE-TIMI 58 的纳入标准，35%符合 CANVAS，29%符合 EMPA-REG OUTCOME，21%符合 VERTIS-CV。如果不考虑 HbA 的纳入标准，合格比例为 58-88%。对于所有试验，在调整年龄和性别后，合格和不合格患者的心血管事件和全因死亡率观察风险相似。
结论
在日常临床实践中，很大一部分患有 2 型糖尿病和心血管疾病的患者符合 SGLT2i CVOT 的纳入标准。试验合格和不合格患者的 MACE 和全因死亡率风险相同。
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