Forbes Anna K, Hinton William, Feher Michael D, Elson William, Joy Mark, Ordóñez-Mena José M, Fan Xuejuan, Cole Nicholas I, Banerjee Debasish, Suckling Rebecca J, de Lusignan Simon, Swift Pauline A
Renal Services, Epsom & St. Helier University Hospitals NHS Trust, London, United Kingdom.
Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.
EClinicalMedicine. 2024 Jan 19;68:102426. doi: 10.1016/j.eclinm.2024.102426. eCollection 2024 Feb.
The cardiovascular and kidney benefits of sodium-glucose co-transporter-2 (SGLT2) inhibitors in people with chronic kidney disease (CKD) are well established. The implementation of updated SGLT2 inhibitor guidelines and prescribing in the real-world CKD population remains largely unknown.
A cross-sectional study of adults with CKD registered with UK primary care practices in the Oxford-Royal College of General Practitioners Research and Surveillance Centre network on the 31st December 2022 was undertaken. Pseudonymised data from electronic health records held securely within the Oxford-Royal College of General Practitioners Clinical Informatics Digital Hub (ORCHID) were extracted. An update to a previously described ontological approach was used to identify the study population, using a combination of Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) indicating a diagnosis of CKD and laboratory confirmed CKD based on Kidney Disease: Improving Global Outcomes (KDIGO) diagnostic criteria. We examined the extent to which SGLT2 inhibitor guidelines apply to and are then implemented in adults with CKD. A logistic regression model was used to identify factors associated with SGLT2 inhibitor prescribing, reported as odds ratios (ORs) with 95% confidence intervals (CI). The four guidelines under investigation were the United Kingdom Kidney Association (UKKA) Clinical Practice Guideline SGLT2 Inhibition in Adults with Kidney Disease (October 2021), American Diabetes Association (ADA) and KDIGO Consensus Report on Diabetes Management in CKD (October 2022), National Institute for Health and Care Excellence (NICE) Guideline Type 2 Diabetes in Adults: Management (June 2022), and NICE Technology Appraisal Dapagliflozin for Treating CKD (March 2022).
Of 6,670,829 adults, we identified 516,491 (7.7%) with CKD, including 32.8% (n = 169,443) who had co-existing type 2 diabetes (T2D). 26.8% (n = 138,183) of the overall CKD population had a guideline directed indication for SGLT2 inhibitor treatment. A higher proportion of people with CKD and co-existing T2D were indicated for treatment, compared to those without T2D (62.8% [n = 106,468] vs. 9.1% [n = 31,715]). SGLT2 inhibitors were prescribed to 17.0% (n = 23,466) of those with an indication for treatment, and prescriptions were predominantly in those with co-existing T2D; 22.0% (n = 23,464) in those with T2D, and <0.1% (n = 2) in those without T2D. In adjusted multivariable analysis of people with CKD and T2D, females (OR 0.69, 95% CI 0.67-0.72, p <0.0001), individuals of Black ethnicity (OR 0.84, 95% CI 0.77-0.91, p <0.0001) and those of lower socio-economic status (OR 0.72, 95% CI 0.68-0.76, p <0.0001) were less likely to be prescribed an SGLT2 inhibitor. Those with an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m had a lower likelihood of receiving an SGLT2 inhibitor, compared to those with an eGFR ≥60 mL/min/1.73 m (eGFR 45-60 mL/min/1.73 m OR 0.65, 95% CI 0.62-0.68, p <0.0001, eGFR 30-45 mL/min/1.73 m OR 0.73, 95% CI 0.69-0.78, p <0.0001, eGFR 15-30 mL/min/1.73 m OR 0.52, 95% CI 0.46-0.60, p <0.0001, eGFR <15 mL/min/1.73 m OR 0.03, 95% CI 0.00-0.23, p = 0.0037, respectively). Those with albuminuria (urine albumin-to-creatinine ratio 3-30 mg/mmol) were less likely to be prescribed an SGLT2 inhibitor, compared to those without albuminuria (OR 0.78, 95% CI 0.75-0.82, p <0.0001).
SGLT2 inhibitor guidelines in CKD have not yet been successfully implemented into clinical practice, most notably in those without co-existing T2D. Individuals at higher risk of adverse outcomes are paradoxically less likely to receive SGLT2 inhibitor treatment. The timeframe between the publication of guidelines and data extraction may have been too short to observe changes in clinical practice. Enhanced efforts to embed SGLT2 inhibitors equitably into routine care for people with CKD are urgently needed, particularly in those at highest risk of adverse outcomes and in the absence of T2D.
None.
钠-葡萄糖协同转运蛋白2（SGLT2）抑制剂对慢性肾脏病（CKD）患者的心血管和肾脏有益作用已得到充分证实。在现实世界的CKD人群中，更新后的SGLT2抑制剂指南的实施情况及处方情况仍 largely未知。
对2022年12月31日在牛津-皇家全科医师学院研究与监测中心网络的英国基层医疗诊所注册的成年CKD患者进行了一项横断面研究。从牛津-皇家全科医师学院临床信息数字中心（ORCHID）安全保存的电子健康记录中提取了化名数据。使用先前描述的本体论方法的更新版本，结合表明CKD诊断的医学系统命名法临床术语（SNOMED CT）和基于《肾脏病：改善全球预后》（KDIGO）诊断标准的实验室确诊的CKD，来确定研究人群。我们研究了SGLT2抑制剂指南适用于CKD成人并随后在其临床中实施的程度。使用逻辑回归模型确定与SGLT2抑制剂处方相关的因素，以比值比（OR）和95%置信区间（CI）报告。所研究的四项指南分别是英国肾脏协会（UKKA）《成人肾脏病患者SGLT2抑制临床实践指南》（2021年10月）、美国糖尿病协会（ADA）和KDIGO《CKD糖尿病管理共识报告》（2022年10月）、英国国家卫生与临床优化研究所（NICE）《成人2型糖尿病：管理指南》（2022年6月）以及NICE《达格列净治疗CKD技术评估》（2022年3月）。
在6670829名成年人中，我们确定了516491名（7.7%）患有CKD，其中32.8%（n = 169443）同时患有2型糖尿病（T2D）。在整个CKD人群中，26.8%（n = 138183）有SGLT2抑制剂治疗的指南指导指征。与没有T2D的人相比，患有CKD且同时患有T2D的人中有更高比例被建议接受治疗（62.8% [n = 106468] 对9.1% [n = 31715]）。有治疗指征的患者中，17.0%（n = 23466）接受了SGLT2抑制剂处方，且处方主要开给同时患有T2D的患者；患有T2D的患者中为22.0%（n = 23464），没有T2D的患者中<0.1%（n = 2）。在对患有CKD和T2D的患者进行的多变量校正分析中，女性（OR 0.69，95% CI 0.67 - 0.72，p <0.0001）、黑人种族个体（OR 0.***，95% CI 0.77 - 0.91，p <0.0001）以及社会经济地位较低的个体（OR 0.72，95% CI 0.68 - 0.76，p <0.0001）接受SGLT2抑制剂处方的可能性较小。与估计肾小球滤过率（eGFR）≥60 mL/min/1.73 m²的患者相比，eGFR <60 mL/min/1.73 m²的患者接受SGLT2抑制剂的可能性较低（eGFR 45 - 60 mL/min/1.73 m²时OR 0.65，95% CI 0.62 - 0.68，p <0.0001；eGFR 30 - 45 mL/min/1.73 m²时OR 0.73，95% CI 0.69 - 0.78，p <0.0001；eGFR 15 - 30 mL/min/1.73 m²时OR 0.52, 95% CI 0.46 - 0.60，p <0.0001；eGFR <15 mL/min/1.73 m²时OR 0.03，95% CI 0.00 - 0.23，p = 0.0037）。与没有蛋白尿（尿白蛋白与肌酐比值3 - 30 mg/mmol）的患者相比，有蛋白尿的患者接受SGLT2抑制剂处方的可能性较小（OR 0.78，95% CI 0.75 - 0.82, p <0.0001）。
CKD患者的SGLT2抑制剂指南尚未成功应用于临床实践，在没有合并T2D的患者中尤为明显。具有更高不良结局风险的个体反而接受SGLT2抑制剂治疗的可能性较小。指南发布与数据提取之间的时间间隔可能过短，无法观察到临床实践中的变化。迫切需要加大力度，将SGLT2抑制剂公平地纳入CKD患者的常规治疗中，特别是在那些不良结局风险最高且没有T2D的患者中。
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