钠-葡萄糖协同转运蛋白2（SGLT2）抑制剂：试验与实际应用比较（研究方案）
Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors: Comparing Trial and Real World Use (Study Protocol).
作者信息
McGovern Andrew, Feher Michael, Munro Neil, de Lusignan Simon
机构信息
Department of Clinical and Experimental Medicine, University of Surrey, Guildford, UK.
Beta Cell Centre for Diabetes, Chelsea and Westminster Hospital, 369 Fulham Road, London, UK.
出版信息
Diabetes Ther. 2017 Apr;8(2):355-363. doi: 10.1007/s13300-017-0229-8. Epub 2017 Jan 30.
BACKGROUND
Sodium-glucose co-transporter-2 (SGLT2) inhibitors (gliflozins) are the newest class of medication available to treat type 2 diabetes (T2DM). Recent findings from the first complete cardiovascular safety trial in SGLT2 inhibitors, the Empagliflozin, Cardiovascular Outcomes, and Mortality in type 2 diabetes (EMPA-REG OUTCOMES) trial, demonstrated reduced cardiovascular outcomes in people with high cardiovascular risk. How to apply these findings to clinical practice remains unclear, with questions remaining on who will reap this cardiovascular benefit.
AIM
To describe the proportion of people in the real world currently treated with SGLT2 inhibitors who meet the inclusion criteria of the EMPA-REG trial and therefore could expect the cardiovascular benefit identified by the trial. Similarly, to describe the proportion of people from the whole T2DM population who could also expect this same benefit.
DESIGN AND SETTING
Routinely collected data from UK primary care in the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) database will be used. The study population will include all people with T2DM within this database (approximately 60,000). We will perform a cross-sectional investigation to describe the characteristics of people currently using SGTL2 inhibitors compared with the population of the EMPA-REG trail. We will similarly compare the characteristics of the RCGP RSC T2DM cohort with the inclusion criteria of the EMPA-REG trial.
METHOD
People with T2DM using a pre-existing verified clinical ontological process will be identified, as will people with prescriptions for SGLT2 inhibitors and other medications using Read coded and other proprietary coding systems. Descriptive statistics will be used to characterise the key clinical characteristics of people with T2DM using SGLT2 inhibitors and to compare these characteristics to people included in EMPA-REG trial; the proportion of people who match the trial criteria will be reported.
PLANNED OUTPUTS
Peer review publication reporting the real world lessons for clinical practice.
FUNDING
AstraZeneca.
背景
钠-葡萄糖协同转运蛋白2（SGLT2）抑制剂（格列净类药物）是可用于治疗2型糖尿病（T2DM）的最新一类药物。SGLT2抑制剂的首个完整心血管安全性试验——恩格列净、2型糖尿病心血管结局和死亡率（EMPA-REG OUTCOMES）试验的最新研究结果表明，心血管风险较高的人群的心血管结局有所改善。如何将这些研究结果应用于临床实践仍不明确，关于谁将从这种心血管获益中受益的问题依然存在。
目的
描述现实世界中目前接受SGLT2抑制剂治疗且符合EMPA-REG试验纳入标准、因此可能预期获得该试验所确定的心血管获益的人群比例。同样，描述整个T2DM人群中也可能预期获得相同获益的人群比例。
设计与背景
将使用英国皇家全科医师学院（RCGP）研究与监测中心（RSC）数据库中从英国初级医疗保健机构常规收集的数据。研究人群将包括该数据库内所有的2型糖尿病患者（约60,000人）。我们将进行一项横断面调查，以描述目前使用SGTL2抑制剂的人群与EMPA-REG试验人群相比的特征。我们还将把RCGP RSC的2型糖尿病队列的特征与EMPA-REG试验的纳入标准进行类似比较。
方法
将识别出使用预先验证的临床本体论流程的2型糖尿病患者，以及使用Read编码和其他专有编码系统开具SGLT2抑制剂及其他药物处方的患者。描述性统计将用于描述使用SGLT2抑制剂的2型糖尿病患者的关键临床特征，并将这些特征与EMPA-REG试验纳入的人群进行比较；将报告符合试验标准的人群比例。
预期产出
同行评审出版物，报告临床实践的现实世界经验教训。
资金来源
阿斯利康公司。
Zotero 插件