Blood Pressure Control and Antihypertensive Drugs in ALLHAT Trial Participants and the Risk of Alzheimers Disease and Related dementias

ALLHAT 试验参与者的血压控制和抗高血压药物以及阿尔茨海默病和相关痴呆的风险

• 批准号: 10121251
• 负责人: XIANGLIN DU
• 金额: $ 29.92万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-01 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10121251
• 关键词: Address; Administrative Supplement; Adrenergic alpha-Antagonists; Adult; Adverse event; Affect; Age-associated memory impairment; Alzheimer' s Disease; Alzheimer' s disease related dementia; Alzheimer' s disease risk; American; Amlodipine; Angiotensin-Converting Enzyme Inhibitors; Antihypertensive Agents; Calcium Channel Blockers; Cardiovascular Diseases; Cessation of life; Chlorthalidone; Chronic Disease; Clinical Treatment; Cognition; Confidence Intervals; Coronary heart disease; Data; Dementia; Disease; Disease Outcome; Diuretics; Double-Blind Method; Doxazosin; Elderly; End stage renal failure; Event; Follow-Up Studies; Goals; Heart failure; High Prevalence; Hip Fractures; Hypertension; Impaired cognition; Incidence; Intervention Trial; Link; Lipids; Lisinopril; Longterm Follow-up; Malignant Neoplasms; Marketing; Medicare; Medicare claim; Memory; Mental Depression; Monitor; Myocardial Infarction; Participant; Patients; Persons; Pharmaceutical Preparations; Pharmacotherapy; Pharmacy facility; Population; Prevention strategy; Randomized; Randomized Clinical Trials; Recommendation; Recording of previous events; Reporting; Risk; Risk Factors; Stroke; Stroke prevention; Time; United States Centers for Medicare and Medicaid Services; United States Food and Drug Administration; aged; arm; base; blood pressure intervention; blood pressure regulation; comorbidity; follow-up; hazard; heart disease risk; mild cognitive impairment; mortality; mortality risk; parent grant; pelvis fracture; prevent; primary outcome; public health relevance; recruit; secondary outcome; side effect; thiazide; treatment arm

Abstract The focus of the active parent grant (Long-term Benefits & Harms of Antihypertensive Drugs in the Elderly: Up to 22-year Follow-Up of ALLHAT Trial Participants) is to determine if there are any long-term benefits for the reduced risk of coronary heart disease (CHD), cardiovascular disease (CVD), stroke, and mortality in those receiving diuretics as compared to those receiving other antihypertensive drugs into next 15-year post-trial surveillance period after taking into consideration post-trial antihypertensive medication usage from Medicare Part-D pharmacy data; and if long-term side effects, such as cancer and depression which are identifiable from post-marketing surveillance of Medicare claims, are similar among the 3 arms of antihypertensive drugs. The goal will be achieved by linking the data of ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) participants with their Medicare data up to 2017, making the total follow-up time up to 23 years (including 8-year in-trial and 15-year post-trial follow-up). Antihypertensive drug therapies have recently been associated with a lower risk of developing dementia and early cognitive impairment. For example, in 2019 the Systolic Blood Pressure Intervention Trial (SPRINT) Memory and Cognition in Decreased Hypertension (MIND) study reported that intensive blood pressure (BP) control significantly reduced the risk of mild cognitive impairment. This was the first trial to demonstrate an effective strategy for the prevention of age-related cognitive impairment. Given a high prevalence of hypertension in adult population, adequate utilization of disease- modifying drugs may provide an effective strategy for prevention of Alzheimer’s disease (AD) and related dementias (ADRD). However, there is no large and long-term follow-up study monitoring and assessing the effects of antihypertensive medications on the risk of ADRD. Therefore, with the detailed blood pressure control data available during the trial follow-up in ALLHAT participants and with the data of those participants linked with their Medicare Part-D drug data up to 2017, we will be able to determine whether blood pressure control and antihypertensive drugs are associated with the decreased risk of ADRD during the 23 years of follow-up from 1994 to 2017. We will address the following specific aims in this Alzheimers-focused Administrative Supplement: 1) to determine the risk of ADRD in association with blood pressure control and antihypertensive treatments (diuretics, ACE inhibitors, and calcium channel blockers) in ALLHAT participants; and 2) to examine whether and to what extent the post-trial antihypertensive medication usage from Medicare Part-D data affect the risk of ADRD in ALLHAT participants with 3 trial treatment arms (diuretics, ACE inhibitors, and calcium channel blockers), while taking into consideration death as a competing risk and adjusting for comorbid conditions and other confounders.

抽象的 主动家长资助的重点（老年人抗高血压药物的长期益处和危害：向上 对 ALLHAT 试验参与者进行 22 年随访）的目的是确定是否有任何长期益处 降低冠心病 (CHD)、心血管疾病 (CVD)、中风和死亡率的风险 进入下一个 15 年试验后，接受利尿剂与接受其他抗高血压药物的患者进行比较 考虑到 Medicare 试验后抗高血压药物的使用情况后的监测期 D 部分药房数据；以及是否存在可识别的长期副作用，例如癌症抑郁症 医疗保险索赔的上市后监测在 3 个抗高血压药物中是相似的。 该目标将通过链接ALLHAT（抗高血压和降脂治疗以预防 心脏病发作试验）参与者提供截至 2017 年的医疗保险数据，使总随访时间长达 23 年 （包括8年试验中和15年试验后随访）最近已进行抗高血压药物治疗。 例如，2019 年，患痴呆症和早期认知障碍的风险较低。 收缩压干预试验 (SPRINT) 降低高血压的记忆和认知 (MIND) 研究报告称，强化血压（BP）控制可显着降低轻度认知障碍的风险 这是第一个证明预防与年龄相关的认知障碍的有效策略的试验。 鉴于成年人高血压患病率较高，因此应充分利用疾病。 改良药物可能为预防阿尔茨海默病（AD）及相关疾病提供有效策略 然而，目前还没有大规模、长期的后续研究来监测和评估痴呆症（ADRD）。 抗高血压药物对 ADRD 风险的影响因此，需要详细控制血压。 ALLHAT 参与者试验随访期间可获得的数据以及与这些参与者相关的数据 他们截至 2017 年的 Medicare Part-D 药物数据，我们将能够确定是否可以控制血压和 在 23 年的随访中，抗高血压药物与 ADRD 风险降低相关 1994 年至 2017 年。我们将在这份以阿尔茨海默病为重点的行政补充文件中实现以下具体目标： 1) 确定与血压控制和抗高血压治疗相关的 ADRD 风险 （利尿剂、ACE 抑制剂和钙通道阻滞剂）在 ALLHAT 参与者中；2) 检查是否 以及 Medicare Part-D 数据中试验后抗高血压药物的使用在多大程度上影响以下风险： 接受 3 个试验治疗组（利尿剂、ACE 抑制剂和钙通道剂）的 ALLHAT 参与者出现 ADRD 阻滞剂），同时将死亡视为竞争风险并针对共病情况进行调整， 其他混杂因素。