Royal Stoke University Hospital, University Hospitals of North Midlands NHS Trust, Stoke on Trent, ST4 6QG, UK.
Populations, Evidence and Technologies, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.
Clin Drug Investig. 2022 Feb;42(2):113-125. doi: 10.1007/s40261-021-01105-7. Epub 2022 Feb 2.
The American Diabetes Association guidelines for the management of type 2 diabetes mellitus recommends treating patients with atherosclerotic cardiovascular diseases, heart failure or diabetic kidney disease with sodium-glucose co-transporter-2 inhibitors or glucagon-like peptide-1 receptor agonists, irrespective of the baseline HbA1c, to reduce adverse renal and cardiovascular outcomes. Initiation of such therapies have a significant cost impact on health economies. Cost of gain in quality-adjusted life-years is normally used for cost effectiveness for a particular drug. In the absence of head-to-head comparisons, prescribers may go for the cheapest option, which may not necessarily be the right decision. We propose using the calculated 'YoDa' (Years of Drug administration) as an easily comparable metric between the drug accrual cost and clinical outcomes. YoDa is calculated as a product of numbers needed to treat and the median duration in years that the trial ran over, to accrue the positive clinical outcomes. Clinical phenotyping of the patient to the specific inclusion and exclusion criteria of relevant clinical trials could guide the clinician to choose the most appropriate therapy. We also propose a series of steps or 'deliberations', which a clinician should consider in making a final choice of sodium-glucose co-transporter-2 inhibitor therapy. A comprehensive summary of the sodium-glucose co-transporter-2 inhibitor trials, clinical phenotyping and YoDa calculations for various significant clinical outcomes could assist making evidence-based, patient-individualised and cost-effective management plans for diabetes care. Informing and Empowering Patients and Clinicians to Make Evidence-Supported Outcome-Based Decisions in Relation to SGLT2 Inhibitor Therapies: The Use of The Novel Years of Drug administration (YoDa) Concept.
美国糖尿病协会(ADA)关于 2 型糖尿病管理的指南建议,对于伴有动脉粥样硬化性心血管疾病、心力衰竭或糖尿病肾病的患者,无论基线糖化血红蛋白(HbA1c)水平如何,均应使用钠-葡萄糖共转运蛋白-2 抑制剂(SGLT2i)或胰高血糖素样肽-1 受体激动剂(GLP-1RA)进行治疗,以降低不良肾脏和心血管结局。这些治疗方案的启动对卫生经济会产生重大的成本影响。通常使用质量调整生命年(QALY)的增量成本来评估特定药物的成本效益。在缺乏头对头比较的情况下,临床医生可能会选择最便宜的方案,但这不一定是正确的决策。我们建议使用计算得出的“YoDa”(药物管理年数)作为药物累积成本和临床结局之间的一个易于比较的指标。YoDa 是根据需要治疗的人数(NNT)和试验持续的中位年数(用于获得阳性临床结局)计算得出的。根据患者的临床表型对特定的纳入和排除标准进行临床分析,可以指导临床医生选择最合适的治疗方法。我们还提出了一系列步骤或“审议”,临床医生在做出 SGLT2i 治疗的最终选择时应考虑这些步骤。对各种重要临床结局的 SGLT2i 试验、临床表型和 YoDa 计算的全面总结,可以帮助制定基于证据、个体化和具有成本效益的糖尿病管理计划。告知和授权患者和临床医生根据 SGLT2i 治疗的基于证据的结果做出决策:使用新颖的 YoDa 概念。