背景:2019年,ESC/EAS更新了2016年血脂异常治疗指南,建议在2型糖尿病(DM2)中采用更严格的LDL-胆固醇(LDL-C)目标。根据真实世界的患者群体,这项研究旨在确定达到指南推荐的LDL-C目标的可行性和成本,并评估心血管获益。
方法:瑞士糖尿病登记处是一项针对三级糖尿病门诊患者的多中心纵向观察研究。确定了DM2患者和访问01.01.2018-31.08.2019未能达到2016LDL-C目标的患者。确定了达到2016年和2019年LDL-C目标所需的当前降脂药物的理论强化,并推断了其成本。估计了通过加强治疗预防的MACE的预期数量。
结果:294例患者(74.8%)未能达到2016年LDL-C指标。在理论上达到2016年和2019年目标并进行指定治疗修改的患者百分比为:高强度他汀类药物,21.4%和13.3%;依泽替米贝,46.6%和27.9%;PCSK9抑制剂(PCSK9i),30.6%和53.7%;依泽替米贝和PCSK9i,1.0%和3.1%,而1名(0.3%)和5名(1.7%)患者未能达到目标,分别。实现2016年与2019年的目标将使估计的4年MACE从24.9个事件减少到18.6个事件,而不是17.4个事件。每年的额外药物费用为2,140瑞士法郎,而每名患者为3,681瑞士法郎,分别。
结论:对于68%的患者,加强他汀类药物治疗和/或添加依泽替米贝足以达到2016年的目标,而57%的人需要成本密集型PCSK9i治疗才能达到2019年的目标,与有限的额外的中期心血管益处。
基于294名2型糖尿病和LDL-胆固醇升高的患者,这项研究着眼于患者需要加强多少降脂药才能达到新旧水平,2019年推出的LDL-胆固醇治疗目标较低,以及成本和可行性,和估计这样做的心血管益处。-通过优化他汀类药物和依泽替米贝的治疗,大多数患者将达到旧的LDL-胆固醇目标,具有明显的预期心血管益处。然而,大多数患者很难达到新的,降低LDL-胆固醇目标,因为这需要用PCSK9抑制剂治疗。这种昂贵的治疗不会为大多数需要它们的患者报销。额外的预期心血管益处也不太清楚。-帮助医生权衡通过达到新的而不是旧的LDL-胆固醇目标而不是针对其他重要风险因素的已知益处(例如吸烟,缺乏身体活动,超重和肥胖)将有助于指导有效的心血管风险管理,并确定将从PCSK9抑制剂治疗中获益最大的患者。
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.
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.
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.
Based on 294 patients with type 2 diabetes and elevated low-density lipoprotein (LDL) cholesterol, this study looked at how much patients’ lipid-lowering medication would need to be intensified for them to be able to reach the old and the new, lower treatment target for LDL-cholesterol that was introduced in 2019, along with the cost and feasibility, and estimated cardiovascular benefits of doing so. The majority of patients would reach the old LDL-cholesterol target by optimizing therapy with statin and ezetimibe, with a clear expected cardiovascular benefit. It would however be difficult for the majority of patients to reach the new, lower LDL-cholesterol target, as this would require treatment with a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor. This expensive treatment would not be reimbursed for the majority of patients that would need them. The additional expected cardiovascular benefit was also less clear. Tools that help physicians to weigh the additional reduction in cardiovascular risk that the patient might benefit from by reaching the new rather than the old LDL-cholesterol target against known benefits of targeting other important risk factors (e.g. smoking, physical inactivity, overweight, and obesity) would help guide efficient cardiovascular risk management, and identify patients that would most benefit from PCSK9 inhibitor therapy.