Clinical and economic value of novel diabetes medications for prevention of cardiovascular disease in type 2 diabetes

新型糖尿病药物预防 2 型糖尿病心血管疾病的临床和经济价值

基本信息

批准号：
10621154
负责人：
Bart Ferket
金额：
$ 68.45万
依托单位：
ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-05-01 至 2025-04-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10621154
关键词：
Address Adherence Adoption Adult Affect Agonist Algorithms American Amputation Atherosclerosis Benchmarking Cardiovascular system Caring Cause of Death Cessation of life Chronic Kidney Failure Clinical Clinical Practice Guideline Combined Modality Therapy Cost Sharing Data Diabetes Mellitus Diabetic Ketoacidosis Disparity End stage renal failure Epidemiology Evaluation Event Fracture GLP-I receptor Glucose Glucose Transporter Glycosylated hemoglobin A Goals Guidelines Health Health system Heart failure Hospitalization Individual Insurance Coverage Kidney Kidney Diseases Knee Measures Medical Meta-Analysis Metformin Myocardial Infarction Non-Insulin-Dependent Diabetes Mellitus Outcome Patient Representative Patients Pharmaceutical Preparations Population Prevention approach Prevention strategy Public Health Recommendation Regimen Renal function Research Research Project Grants Safety Serious Adverse Event Sodium Stroke Translating United States Food and Drug Administration Woman adverse drug reaction alternative treatment atherosclerosis risk cardiovascular disorder prevention cardiovascular disorder risk cardiovascular risk factor clinical practice cohort comparative cost effectiveness cost cost effective cost effectiveness diabetes mellitus therapy drug standard economic cost economic implication economic outcome economic value effectiveness outcome epidemiologic data genital infection improved inhibitor innovation liraglutide men models and simulation mortality novel novel strategies patient population patient subsets pharmacologic prescription drug costs prognostic randomized trial randomized, controlled study rosiglitazone secondary endpoint simulation symporter treatment strategy

项目摘要

PROJECT SUMMARY/ABSTRACT Individuals with type 2 diabetes (T2D) are at substantially increased risk for atherosclerotic cardiovascular disease (ASCVD) and heart failure, as well as other important outcomes such as end-stage renal disease (ESRD). Therefore, strategies to reduce these adverse health events in the T2D population are critically important. Cardiovascular safety concerns related to rosiglitazone led the Food and Drug Administration (FDA) to mandate cardiovascular outcome trials for new glucose lowering therapies. The cardiovascular outcome trials on two recently introduced glucose lowering classes of drugs, sodium glucose transporter 2 (SGLT2) inhibitors and glucagon-like peptide 1 (GLP-1) receptor agonists unexpectedly showed cardiovascular benefits with reduced rates of myocardial infarction, stroke, heart failure, and renal outcomes, particularly in those with established ASCVD. As a result, the FDA approved a new indication for three SGLT-2 inhibitors (empagliflozin, canagliflozin and dapagliflozin) and three GLP-1 receptor agonists (liraglutide, dulaglutide and semaglutide) for reduction of cardiovascular events in those with T2D and established ASCVD. However, cardiovascular outcomes of these novel diabetes agents in T2D have only been evaluated in the context of very high ASCVD risk and as add-on treatment to standard T2D therapy. Wider use of these expensive novel medications by replacing cheaper standard drug regimens may yield uncertain effects on clinical outcomes and costs to the patient and the health system. We propose a decision-analytic approach to compare long-term clinical and economic outcomes of guideline-based and alternative treatment algorithms and identify optimal strategies for the use of SGLT2 inhibitors and GLP-1 receptor agonists. Insurance coverage and cost sharing can affect access and adherence to these agents and we will therefore additionally evaluate economic implications of their use from a patient perspective and address the potential disparities in utilization and cost-effectiveness across patients with T2D at different cardiovascular risk levels. Our specific aims are to assess differences in long-term clinical outcomes of strategies utilizing novel diabetes medications vs conventional care by combining meta- analysis of reconstructed trial survival data with prognostic and simulation modeling of epidemiologic data. First, we will compare guideline-based strategies of novel diabetes medication as second-line therapy vs alternative strategies including first-line usage and combination therapy across different target patient populations. Second, we will evaluate differences in lifetime quality-adjusted survival and costs of these various strategies utilizing novel diabetes medication with generally accepted societal benchmarks for cost-effective care as the criterion and address the impact of insurance coverage and cost sharing on treatment decisions. Thus, our research will rigorously evaluate clinical value and cost implications of novel pharmacologic approaches to prevention of ASCVD, heart failure and renal outcomes in patients with T2D. Identifying optimal prevention strategies that are economically sensible has the potential to improve public health in a cost-effective manner.

项目概要/摘要 2 型糖尿病 (T2D) 患者患动脉粥样硬化性心血管疾病的风险显着增加疾病（ASCVD）和心力衰竭，以及其他重要的结局，例如终末期肾病（终末期肾病）。因此，减少 T2D 人群中这些不良健康事件的策略至关重要重要的。美国食品和药物管理局 (FDA) 对罗格列酮相关的心血管安全问题表示担忧强制对新的降糖疗法进行心血管结果试验。心血管结果试验关于最近推出的两种降血糖药物：钠葡萄糖转运蛋白 2 (SGLT2) 抑制剂胰高血糖素样肽 1 (GLP-1) 受体激动剂出乎意料地显示出心血管益处降低心肌梗塞、中风、心力衰竭和肾脏结局的发生率，特别是对于患有以下疾病的患者成立ASCVD。因此，FDA 批准了三种 SGLT-2 抑制剂（恩格列净、卡格列净和达格列净）和三种 GLP-1 受体激动剂（利拉鲁肽、度拉鲁肽和索马鲁肽）减少 T2D 和确诊 ASCVD 患者的心血管事件。然而，心血管这些新型糖尿病药物治疗 T2D 的结果仅在 ASCVD 非常高的情况下进行了评估风险和作为标准 T2D 治疗的附加治疗。这些昂贵的新型药物的更广泛使用替代更便宜的标准药物治疗方案可能会对临床结果和成本产生不确定的影响患者和卫生系统。我们提出了一种决策分析方法来比较长期临床和基于指南和替代治疗算法的经济结果，并确定最佳策略 SGLT2抑制剂和GLP-1受体激动剂的使用。保险范围和费用分摊可能会影响获得服务的机会并坚持使用这些药物，因此我们将另外评估其使用的经济影响从患者的角度出发，解决不同医疗机构在利用和成本效益方面的潜在差异不同心血管风险水平的 T2D 患者。我们的具体目标是评估长期差异使用新型糖尿病药物与传统治疗相结合的策略的临床结果通过流行病学数据的预后和模拟模型来分析重建的试验生存数据。第一的，我们将比较基于指南的新型糖尿病药物作为二线治疗与替代疗法的策略策略包括针对不同目标患者群体的一线使用和联合治疗。第二，我们将评估这些不同策略的终生质量调整生存率和成本的差异以公认的社会成本效益护理基准为标准的新型糖尿病药物并解决保险范围和费用分摊对治疗决策的影响。因此，我们的研究将严格评估预防疾病的新药理学方法的临床价值和成本影响 T2D 患者的 ASCVD、心力衰竭和肾脏结局。确定最佳预防策略经济上合理的做法有可能以具有成本效益的方式改善公共卫生。

项目成果

期刊论文数量（1）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Cardiovascular and Renal Benefits of Novel Diabetes Drugs by Baseline Cardiovascular Risk: A Systematic Review, Meta-analysis, and Meta-regression.

新型糖尿病药物对心血管和肾脏的益处（按基线心血管风险划分）：系统评价、荟萃分析和荟萃回归。

DOI：
发表时间：
2023-06-01
期刊：
影响因子：
16.2
作者：
Rodriguez;Tahsin, Malak;Fleischmann, Kirsten E;Masharani, Umesh;Yeboah, Joseph;Park, Meyeon;Li, Lihua;Weber, Ellerie;Li, Yan;Berkalieva, Asem;Max, Wendy;Hunink, M G Myriam;Ferket, Bart S
通讯作者：
Ferket, Bart S