Sodium-Glucose Co-transporter 2 (SGLT2) Inhibitor: Comparing Trial Data and Real-World Use.
Sodium-Glucose Co-transporter 2 (SGLT2) Inhibitor: Comparing Trial Data and Real-World Use.
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DOI：
10.1007/s13300-017-0254-7
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发表时间：
2017-04
期刊：
影响因子：
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通讯作者：
de Lusignan S
中科院分区：
文献类型：
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作者：
McGovern A;Feher M;Munro N;de Lusignan S
钠-葡萄糖协同转运蛋白-2（SGLT 2）抑制剂药物类别的首项心血管安全性试验，恩格列净2型糖尿病心血管结局和死亡率（EMPA-REG OUTCOME）试验，证明恩格列净可显著降低心血管风险。目前尚不清楚2型糖尿病（T2 DM）患者与试验中纳入的患者具有相同的高心血管风险的比例，因此可能会经历相同的心血管获益。我们的目的是确定和描述来自具有代表性的英国国家人群的T2 DM患者的比例，这些患者具有与EMPA-REG试验中纳入的患者相当的高心血管风险。一项T2 DM患者和一个亚组接受SGLT 2抑制剂处方的心血管风险的横断面分析。患者从皇家全科医师学院研究和监测中心数据库中确定。从电子病历中确定心血管风险因素。从128家全科医生诊所的1，238，909例患者中，我们确定了60，327例T2 DM成人（平均年龄66.1岁，SD 13.9），其中55.6%为男性。其中1642例（2.7%）患者开始接受SGLT 2抑制剂治疗（平均年龄58.1岁，SD 10.4; 58.8%为男性）。在完全T2 DM组中，只有15.7%（95% CI 15.5-16.0%）的患者具有与EMPA-REG试验中纳入的患者相同的高心血管风险。在已开始SGLT 2抑制剂治疗的受试者中，该比例为11.1%（95% CI 9.8-12.4%）。虽然年龄最大的年龄组的比例较高，但在70岁以上的人群中，不到四分之一的人符合EMPA-REG试验的高心血管风险标准。EMPA-REG试验结果仅适用于一小部分T2 DM患者和一小部分目前接受SGLT 2抑制剂治疗的患者。需要额外的数据来确定心血管风险较低的人的任何心血管益处。阿斯利康。本文的在线版本（doi：10.1007/s13300-017-0254-7）包含补充材料，可供授权用户使用。
The first cardiovascular safety trial in the sodium-glucose co-transporter-2 (SGLT2) inhibitor drug class, the Empagliflozin Cardiovascular Outcomes and Mortality in Type 2 Diabetes (EMPA-REG OUTCOME) trial, demonstrated significant cardiovascular risk reduction with empagliflozin. It is currently not clear what proportions of people with type 2 diabetes (T2DM) have the same high cardiovascular risk as those included in the trial, and will therefore be likely to experience the same cardiovascular benefit. We aimed to identify and describe the proportion of people with T2DM from a representative English national population who have the comparable high cardiovascular risk to those included in the EMPA-REG trial. A cross-sectional analysis of cardiovascular risk in people with T2DM and a subgroup prescribed SGLT2 inhibitors. Patients were identified from the Royal College of General Practitioners Research and Surveillance Centre database. Cardiovascular risk factors were identified from electronic patient records. From 1,238,909 patients at 128 GP practices, we identified 60,327 adults with T2DM (mean age 66.1 years, SD 13.9) of whom 55.6% were male. From these 1642 (2.7%) people had been initiated on an SGLT2 inhibitor (mean age 58.1 years, SD 10.4; 58.8% male). In the complete T2DM group only 15.7% (95% CI 15.5–16.0%) had the same high cardiovascular risk as those included in the EMPA-REG trial. In those already initiated on SGLT2 inhibitors this proportion was 11.1% (95% CI 9.8–12.4%). Whilst the proportion was higher in the oldest age groups, in those 70+ years old less than a quarter met the EMPA-REG trial high cardiovascular risk criteria. The EMPA-REG trial results are applicable only to a small proportion of people with T2DM and a smaller proportion of those currently treated with SGLT2 inhibitors. Additional data are required to identify any cardiovascular benefit in people with lower cardiovascular risk. AstraZeneca. The online version of this article (doi:10.1007/s13300-017-0254-7) contains supplementary material, which is available to authorized users.