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是否需要改变处方模式?根据 2019 年欧洲心脏病学会制定的关于糖尿病、糖尿病前期和心血管疾病的指南,评估钠-葡萄糖共转运蛋白 2 抑制剂或胰高血糖素样肽 1 受体激动剂作为苏格兰 2 型糖尿病一线单药治疗(或二甲双胍单药治疗的附加治疗)的适用性。

Prescribing Paradigm Shift? Applying the 2019 European Society of Cardiology-Led Guidelines on Diabetes, Prediabetes, and Cardiovascular Disease to Assess Eligibility for Sodium-Glucose Cotransporter 2 Inhibitors or Glucagon-Like Peptide 1 Receptor Agonists as First-Line Monotherapy (or Add-on to Metformin Monotherapy) in Type 2 Diabetes in Scotland.

机构信息

MRC Institute of Genetic and Molecular Medicine, University of Edinburgh, Edinburgh, U.K.

Diabetes Centre, Victoria Hospital, Kirkcaldy, U.K.

出版信息

Diabetes Care. 2020 Sep;43(9):2034-2041. doi: 10.2337/dc20-0120. Epub 2020 Jun 24.

DOI:10.2337/dc20-0120
PMID:32581068
Abstract

OBJECTIVE

In 2019, the European Society of Cardiology led and released new guidelines for diabetes cardiovascular risk management, reflecting recent evidence of cardiovascular disease (CVD) reduction with sodium-glucose cotransporter 2 inhibitors (SGLT-2is) and some glucagon-like peptide 1 receptor agonists (GLP-1RAs) in type 2 diabetes (T2D). A key recommendation is that all those with T2D who are (antihyperglycemic) drug naïve or on metformin monotherapy should be CVD risk stratified and an SGLT-2i or a GLP-1RA initiated in all those at high or very high risk, irrespective of glycated hemoglobin. We assessed the impact of these guidelines in Scotland were they introduced as is.

RESEARCH DESIGN AND METHODS

Using a nationwide diabetes register in Scotland, we did a cross-sectional analysis, using variables in our register for risk stratification at 1 January 2019. We were conservative in our definitions, assuming the absence of a risk factor where data were not available. The risk classifications were applied to people who were drug naïve or on metformin monotherapy and the anticipated prescribing change calculated.

RESULTS

Of the 265,774 people with T2D in Scotland, 53,194 (20.0% of those with T2D) were drug naïve, and 56,906 (21.4%) were on metformin monotherapy. Of these, 74.5% and 72.4%, respectively, were estimated as at least high risk given the guideline risk definitions.

CONCLUSIONS

Thus, 80,830 (30.4%) of all those with T2D ( = 265,774) would start one of these drug classes according to table 7 and figure 3 of the guideline. The sizeable impact on drug budgets, enhanced clinical monitoring, and the trade-off with reduced CVD-related health care costs will need careful consideration.

摘要

目的

2019 年,欧洲心脏病学会主导并发布了新的糖尿病心血管风险管理指南,反映了最近在 2 型糖尿病(T2D)中使用钠-葡萄糖共转运蛋白 2 抑制剂(SGLT-2i)和一些胰高血糖素样肽 1 受体激动剂(GLP-1RAs)降低心血管疾病(CVD)的证据。一个关键建议是,所有新诊断或正在接受二甲双胍单药治疗的 T2D 患者,均应进行 CVD 风险分层,并在所有高危或极高危患者中启动 SGLT-2i 或 GLP-1RA,无论糖化血红蛋白水平如何。我们评估了这些指南在苏格兰实施时的影响。

研究设计和方法

我们使用苏格兰全国性糖尿病登记处进行了一项横断面分析,使用登记处中的变量在 2019 年 1 月 1 日进行风险分层。我们的定义较为保守,即数据不可用时,假设不存在风险因素。将风险分类应用于新诊断或正在接受二甲双胍单药治疗的患者,并计算预期的处方改变。

结果

在苏格兰的 265774 名 T2D 患者中,53194 名(T2D 患者的 20.0%)为新诊断患者,56906 名(21.4%)正在接受二甲双胍单药治疗。根据指南的风险定义,这些患者中分别有 74.5%和 72.4%被认为至少为高危。

结论

因此,根据指南表 7 和图 3,所有 T2D 患者(=265774 人)中有 80830 人(30.4%)将开始使用这些药物类别之一。这对药物预算、强化临床监测以及与降低 CVD 相关医疗保健成本的权衡产生了重大影响,需要仔细考虑。

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