Antidementia medication use, safety, and effectiveness among nursing home residents with Alzheimer's disease

患有阿尔茨海默病的疗养院居民的抗痴呆药物使用、安全性和有效性

• 批准号: 10034697
• 负责人: Matthew Alcusky
• 金额: $ 74.01万
• 依托单位: UNIV OF MASSACHUSETTS MED SCH WORCESTER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-01 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10034697
• 关键词: Acute; Address; Admission activity; Adverse drug event; Alzheimer' s Disease; Alzheimer' s disease diagnosis; American; Anti-Cholinergics; Antidepressive Agents; Antipsychotic Agents; Behavioral Symptoms; Cardiovascular system; Caring; Cause of Death; Characteristics; Cholinesterase Inhibitors; Clinical; Clinical Trials; Cognitive; Combined Modality Therapy; Communities; Comparative Study; Conduct Clinical Trials; Data; Data Set; Data Sources; Decision Making; Dementia; Diarrhea; Disease; Distant; Dose; Drug usage; Effectiveness; Elderly; Eligibility Determination; Event; Fracture; Galantamine; Goals; Hospitalization; Impaired cognition; Kidney; Learning; Link; Longitudinal Studies; Measures; Medicare; Medicare Part A; Memantine; Minority; National Institute on Aging; Nursing Homes; Outcome; Patients; Pattern; Pharmaceutical Preparations; Polypharmacy; Population; Prevalence; Process; Psychotropic Drugs; Public Health; Quality of Care; Quality of life; Research; Risk; Safety; Severities; Therapeutic; Time; Vomiting; advanced disease; aged; clinical risk; cognitive function; comorbidity; crosslink; daily functioning; design; disability-adjusted life years; donepezil; effectiveness evaluation; end stage disease; evidence base; fall risk; falls; follow-up; functional status; high risk; improved; instrument; mortality; nursing home length of stay; rivastigmine; safety outcomes; sedative; virtual; years of life lost

PROJECT SUMMARY/ABSTRACT This proposal is responsive to PA-17-088. The number of Americans living with Alzheimer’s disease is projected to more than double from 5.6 million in 2019 to 13.8 million by 2050. This rise in Alzheimer’s disease prevalence represents a serious public health concern. In 2019, Alzheimer’s disease was estimated to be the sixth leading cause of death in the US and the fourth leading cause of disability adjusted life years lost. Half of the nursing home population has a diagnosis of Alzheimer’s disease or another dementia. Only two available classes of medications, cholinesterase inhibitors (ChEIs) and memantine have been demonstrated to slow symptomatic progression of Alzheimer’s disease. Donepezil (the most widely used ChEI) has FDA indications for mild, moderate, and severe Alzheimer’s disease, while memantine is indicated for moderate to severe Alzheimer’s disease and has evidence supporting possible benefits in mild disease. Only ~40% of residents were treated with either medication class at the time of nursing home admission historically (2006), and a small minority (10%) received combination therapy. Nursing home residents may be at higher risk for adverse drug events from drug- drug and drug-disease interactions due to a high burden of polypharmacy and comorbidities. Yet in the DOMINO clinical trial conducted among community dwelling patients, discontinuation of a ChEI before the end stages of the disease was associated with worse clinical outcomes. Nearly a quarter of nursing home residents treated with ChEIs and/or memantine at the time of admission discontinued treatment shortly after admission (regardless of dementia severity) and were potentially at risk for clinical worsening and the need to use more hazardous drugs such as antipsychotics. Using contemporaneous, national, federally-mandated Minimum Data Set 3.0 linked to Medicare Part A and D claims, study aims are to: 1) examine contemporary patterns of ChEI, memantine, and psychotropic medication use in NH residents with Alzheimer’s disease; 2) compare long-term effectiveness, safety, and survival between residents initiating combination therapy, monotherapy, and no treatment with ChEIs and memantine; and 3) identify resident characteristics (e.g., dosing, comorbid conditions, concurrent medications, dementia stage) for whom treatment with ChEIs and/or memantine confers a net clinical benefit. The proposed R01 is responsive to calls for well-designed long-term studies of ChEIs and memantine. By expanding the evidence base to facilitate a dynamic resident-centered decision-making process regarding Alzheimer’s disease treatment in an aged nursing home population, this proposal fulfills the goals of The National Plan to Address Alzheimer’s Disease to effectively treat Alzheimer’s disease and to optimize care quality and efficiency. This research is also closely aligned with the National Institute on Aging’s Strategic Goal to improve the safe use of medications.

项目概要/摘要 该提案是对 PA-17-088 的回应。预计患有阿尔茨海默病的美国人人数 到 2050 年，这一数字将增加一倍以上，从 2019 年的 560 万增加到 1,380 万。阿尔茨海默病患病率的上升 代表了严重的公共卫生问题。 2019年，阿尔茨海默病估计成为第六大疾病 调整后生命年是美国死亡原因和第四大残疾原因。一半的护理 家庭人口被诊断患有阿尔茨海默病或其他痴呆症。只有两个可用类别 药物、胆碱酯酶抑制剂 (ChEI) 和美金刚已被证明可以减缓症状 阿尔茨海默病的进展。多奈哌齐（最广泛使用的 ChEI）已获得 FDA 适应症用于轻度、 中度和重度阿尔茨海默病，而美金刚适用于中度至重度阿尔茨海默病 疾病，并有证据支持对轻度疾病可能有益。只有约 40% 的居民得到了治疗 历史上（2006 年）在入住疗养院时使用过任一药物类别，并且少数（10%） 接受联合治疗。疗养院居民因药物引起的药物不良事件的风险可能更高 由于多重用药和合并症的高负担而导致药物和药物与疾病的相互作用。然而在多米诺骨牌中 在社区居住患者中进行的临床试验，在治疗结束前停止 ChEI 该疾病与较差的临床结果相关。近四分之一的疗养院居民接受了治疗 入院时服用 ChEI 和/或美金刚 入院后不久即停止治疗（无论 痴呆症严重程度），并且有潜在的临床恶化风险，需要使用更危险的药物 抗精神病药等药物。使用同期、国家、联邦规定的最低数据集 3.0 与 Medicare A 部分和 D 部分索赔相关，研究目的是：1) 检查 ChEI 的当代模式， 患有阿尔茨海默病的新罕布什尔州居民使用美金刚和精神药物； 2）长期比较 开始联合治疗、单一治疗和无治疗的居民之间的有效性、安全性和生存率 ChEI 和美金刚治疗； 3) 确定居民特征（例如剂量、合并症、 并发药物治疗（痴呆阶段），使用 ChEI 和/或美金刚治疗可带来净临床效果 益处。拟议的 R01 响应了对 ChEI 和美金刚进行精心设计的长期研究的呼吁。 通过扩大证据基础，促进以居民为中心的动态决策过程 阿尔茨海默氏病在老年疗养院人群中的治疗，该提案实现了国家的目标 解决阿尔茨海默病计划，以有效治疗阿尔茨海默病并优化护理质量和 效率。这项研究也与国家老龄化研究所的战略目标紧密结合，以改善 安全使用药物。