强化2016年和2019年欧洲心脏病学会/欧洲动脉粥样硬化学会指南对三级医疗中2型糖尿病患者当前降脂治疗的影响评估——一项瑞士糖尿病研究
An estimation of the consequences of reinforcing the 2016 and 2019 European Society of Cardiology/European Atherosclerosis Society guidelines on current lipid-lowering treatment in patients with type 2 diabetes in tertiary care-a SwissDiab study.
作者信息
Singeisen Hélène, Renström Frida, Laimer Markus, Lehmann Roger, Bilz Stefan, Brändle Michael
机构信息
Division of Endocrinology and Diabetes, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.
Division of Endocrinology and Diabetes, Department of Internal Medicine, Cantonal Hospital Münsterlingen, Münsterlingen, Switzerland.
出版信息
Eur J Prev Cardiol. 2023 Oct 10;30(14):1473-1481. doi: 10.1093/eurjpc/zwad178.
AIMS
In 2019, the European Society of Cardiology/European Atherosclerosis Society updated the 2016 guidelines for the management of dyslipidaemias recommending more stringent low-density lipoprotein cholesterol (LDL-C) targets in diabetes mellitus type 2 (DM2). Based on a real-world patient population, this study aimed to determine the feasibility and cost of attaining guideline-recommended LDL-C targets, and assess cardiovascular benefit.
METHODS AND RESULTS
The Swiss Diabetes Registry is a multicentre longitudinal observational study of outpatients in tertiary diabetes care. Patients with DM2 and a visit between 1 January 2018 and 31 August 2019 that failed the 2016 LDL-C target were identified. The theoretical intensification of current lipid-lowering medication needed to reach the 2016 and 2019 LDL-C target was determined and the cost thereof extrapolated. The expected number of major adverse cardiovascular events (MACE) prevented by treatment intensification was estimated. Two hundred and ninety-four patients (74.8%) failed the 2016 LDL-C target. The percentage of patients that theoretically achieved the 2016 and 2019 target with the indicated treatment modifications were high-intensity statin, 21.4% and 13.3%; ezetimibe, 46.6% and 27.9%; proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i), 30.6% and 53.7%; ezetimibe and PCSK9i, 1.0% and 3.1%; whereas one (0.3%) and five patients (1.7%) failed to reach target, respectively. Achieving the 2016 vs. 2019 target would reduce the estimated 4-year MACE from 24.9 to 18.6 vs. 17.4 events, at an additional annual cost of medication of 2140 Swiss francs (CHF) vs. 3681 CHF per patient, respectively.
CONCLUSIONS
For 68% of the patients, intensifying statin treatment and/or adding ezetimibe would be sufficient to reach the 2016 target, whereas 57% would require cost-intensive PCSK9i therapy to reach the 2019 target, with limited additional medium-term cardiovascular benefit.
目的
2019年,欧洲心脏病学会/欧洲动脉粥样硬化学会更新了2016年血脂异常管理指南,建议对2型糖尿病(DM2)患者设定更严格的低密度脂蛋白胆固醇(LDL-C)目标。基于真实世界的患者群体,本研究旨在确定实现指南推荐的LDL-C目标的可行性和成本,并评估心血管获益情况。
方法与结果
瑞士糖尿病登记处是一项针对三级糖尿病护理门诊患者的多中心纵向观察性研究。确定了在2018年1月1日至2019年8月31日期间就诊且未达到2016年LDL-C目标的DM2患者。确定了达到2016年和2019年LDL-C目标所需的当前降脂药物理论强化方案,并推断其成本。估计强化治疗可预防的主要不良心血管事件(MACE)的预期数量。294名患者(74.8%)未达到2016年LDL-C目标。通过指定的治疗调整理论上达到2016年和2019年目标的患者百分比分别为:高强度他汀类药物,21.4%和13.3%;依折麦布,46.6%和27.9%;前蛋白转化酶枯草溶菌素/kexin 9型抑制剂(PCSK9i),30.6%和53.7%;依折麦布和PCSK9i,1.0%和3.1%;而分别有1名(0.3%)和5名患者(1.7%)未达到目标。实现2016年与2019年目标将使估计的4年MACE从24.9例降至18.6例与17.4例,每位患者每年额外的药物成本分别为2140瑞士法郎(CHF)与3681 CHF。
结论
对于68%的患者,强化他汀治疗和/或加用依折麦布足以达到2016年目标,而57%的患者需要成本高昂的PCSK9i治疗才能达到2019年目标,中期心血管获益有限。