Comparative Effectiveness of Anti-diabetic Medication Alternatives for Veterans

退伍军人抗糖尿病药物替代方案的比较有效性

基本信息

批准号：
8292942
负责人：
Steven D Pizer
金额：
--
依托单位：
VA BOSTON HEALTH CARE SYSTEM
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-04-01 至 2013-09-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8292942
关键词：
2,4-thiazolidinedione Accounting Adverse effects Affect Alcohol abuse Area Behavior Benefits and Risks Blood Glucose Cardiovascular system Case Mixes Characteristics Congestive Heart Failure Data Data Sources Dementia Diabetes Mellitus Diabetic Angiopathies Diagnosis Drug Formulations Drug Kinetics Epidemic Exercise Exposure to Eye Formularies Future Geographic Locations Glucose Health Health Status Healthcare Healthcare Systems Heart failure Hospital Formularies Hospital Referrals Hospitalization Human Hypoglycemia Hypoglycemic Agents Impaired cognition Injection of therapeutic agent Insulin Kidney Life Expectancy Long-Acting Insulin Marketing Medicare Medicare/Medicaid Mental Depression Mental Health Metformin Methods Monitor Myocardial Infarction National Formulary Nature Non-Insulin-Dependent Diabetes Mellitus Nurse Practitioners Observational Study Oral Outcome Patient Monitoring Patient Preferences Patients Pattern Pharmaceutical Preparations Pharmacists Pharmacologic Substance Pharmacy and Therapeutics Committee Pharmacy facility Physician Assistants Physicians Pioglitazone Policies Population Principal Investigator Procedures Process Property Provider Publishing RHOA gene Relative (related person)Research Risk Running Sampling Self Care Self Management Source Statistical Models Stroke Subgroup Substance Use Disorder Substance abuse problem Sulfonylurea Compounds Thiazolidinediones Time Training Translating Treatment Cost Treatment Effectiveness United States Use Effectiveness Variant Veterans alternative treatment analog blood glucose regulation cardiovascular risk factor comparative effectiveness compare effectiveness cost design diabetes amputation diabetic effective therapy effectiveness research experience flexibility glucose monitor glycemic control improved innovation interest member mortality older men pharmacy benefit preference prevent programs rosiglitazone

项目摘要

DESCRIPTION (provided by applicant): Anticipated Impacts on Veterans' Healthcare This study is designed to inform the VA formulary treatment of thiazolidinediones (TZDs) and insulin analogues, directly affecting VA patients' access and exposure to these medications. Beyond formulary policy, local P&T committees establish procedures to manage access to non-formulary medications. If this project finds evidence that TZDs or LA insulin analogues are more or less effective than alternatives in particular subpopulations, this information could be used in the non-formulary request process. The results of this study will also be of interest to VA clinicians who need to assess the risks and benefits of these medications for each patient. Research of this kind can provide valuable context in general and useful guidance for specific subgroups like patients with depression or substance use disorders. Project Background There is an epidemic of Type 2 diabetes in the general US population and 20% of VA users are estimated to have Type 2 diabetes. Long-term control of blood sugar, at least to near-normal levels, significantly reduces the microvascular complications (e.g., kidney, eye, amputation) of diabetes, and may reduce cardiovascular complications as well. In the VA, metformin is commonly used as first line therapy and the usual recommended second-line agent is a member of the sulfonylurea class. Despite the availability and function of these two classes of medication, over half of VA patients with diabetes require further blood sugar lowering medication beyond metformin and sulfonylurea (MET-SU). Unfortunately, there are few data comparing the effectiveness of various medications available for use at this treatment transition. The two most common drug classes used for patients not achieving adequate glycemic control on MET-SU are TZDs and insulin. Insulin can be further categorized into short- and long-acting, and human and analogues of human insulin. Project Objectives Objective 1: Describe the variation in glucose lowering medication prescribing patterns throughout the VA in patients who transition from MET-SU to additional treatments. Objective 2: Develop a statistical model that predicts variation in glucose lowering medication prescribing patterns. Objective 3: Estimate the relationship between glucose lowering medication prescribing patterns and short and longer-term health outcomes. Objective 4: Estimate the relationship between glucose lowering medication prescribing patterns and short and longer-term health outcomes among sub-populations. Project Methods The proposed project is a retrospective observational study of secondary data from several sources. Primary data sources include patient-level administrative and claims data from three healthcare systems: VA, Medicare, and Medicaid. This study will capitalize on variation in practice patterns to examine which diabetes medications are most effective in patients as their glucose control deteriorates over time. Using a unique national sample of veterans and instrumental variables analysis we will examine the causal relationship between prescribing patterns and risk-adjusted health outcomes.

描述（由申请人提供）：对退伍军人的医疗保健的预期影响本研究旨在为噻唑烷二酮（TZD）和胰岛素类似物的VA配方治疗提供信息，直接影响VA患者的使用和接触这些药物。除了制定政策之外，地方损益委员会还制定了管理非格式药物的程序。如果该项目发现证据表明TZD或LA胰岛素类似物比特别亚群的替代方案更有效，则可以在非格式请求过程中使用此信息。这项研究的结果也将引起VA临床医生的兴趣，他们需要评估每个患者这些药物的风险和好处。此类研究可以在一般的特定亚组（如患有抑郁症或药物使用障碍的患者）中提供宝贵的背景和有用的指导。项目背景是美国普通人群中2型糖尿病的流行病，估计有20％的VA使用者患有2型糖尿病。长期控制血糖，至少达到近非正常水平，可显着减少糖尿病的微血管并发症（例如肾脏，眼睛，截肢），并可能减少心血管并发症。在VA中，二甲双胍通常用作第一线治疗，通常推荐的二线剂是磺基脲类的成员。尽管这两种药物具有可用性和功能，但超过一半的VA糖尿病患者需要进一步的血糖降低二甲甲酸酯和磺胺尿素（MET-SU）。不幸的是，很少有数据比较在此治疗过渡时可以使用的各种药物的有效性。 TZD和胰岛素的两个最常见的药物类别用于未获得足够血糖控制的患者。胰岛素可以进一步分为短效和长效，以及人类胰岛素的人类和类似物。项目目标目标1：描述从Met-SU过渡到其他治疗的患者中，整个VA的葡萄糖降低药物处方模式的变化。目标2：开发一个统计模型，该模型可以预测降低葡萄糖药物处方模式的变化。目标3：估计降低葡萄糖处方模式与短期和长期健康结果之间的关系。目标4：估计降低葡萄糖处方模式与亚种群中短期和长期健康结果之间的关系。项目方法拟议的项目是对来自多个来源的二级数据的回顾性观察性研究。主要数据来源包括来自三个医疗保健系统的患者级行政和索赔数据：VA，Medicare和Medicaid。这项研究将利用实践模式的变化，以检查哪些糖尿病药物在患者中最有效，因为随着时间的流逝，其葡萄糖对照会恶化。使用独特的国家退伍军人和工具变量分析样本，我们将研究处方模式与风险调整的健康结果之间的因果关系。