Statins for Primary Prevention in Older Adults-Moving Toward Evidence-Based Decision-Making.
Statins for Primary Prevention in Older Adults-Moving Toward Evidence-Based Decision-Making.
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DOI：
10.1111/jgs.15449
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发表时间：
2018-11
影响因子：
6.3
通讯作者：
Gurwitz JH
中科院分区：
文献类型：
--
作者：
Singh S;Zieman S;Go AS;Fortmann SP;Wenger NK;Fleg JL;Radziszewska B;Stone NJ;Zoungas S;Gurwitz JH
确定他汀类药物用于老年人动脉粥样硬化性心血管疾病（ASCVD）事件一级预防的有效性和安全性，尤其是80岁及以上的老年人和多发性硬化患者。国家老龄化研究所和国家心脏，肺和血液研究所于2017年7月31日至8月1日召集了一个多学科专家小组，以审查现有证据，确定知识差距，并考虑他汀类药物在75岁及以上无ASCVD人群中的安全性和有效性数据是否足够;现有数据是否可以为未来老年人他汀类药物试验的可行性、设计和实施提供信息;以及解决知识缺口的临床试验选择和设计。本文总结了研讨会上的演讲和讨论。关于他汀类药物在老年人中的益处和危害的证据不足，特别是那些伴随虚弱，多种药物，合并症和认知障碍的人;缺乏评估80岁及以上人群ASCVD风险的工具;缺乏他汀类药物对老年人重要结局的影响的证据，如他汀类药物相关的肌肉症状，认知功能和糖尿病事件。前瞻性的、传统的、安慰剂对照的随机临床试验（RCT）和务实的RCT似乎是解决这些关键知识差距的合适选择。未来的试验必须考虑更多的老年人，妇女，代表性不足的少数民族，以及不同健康，认知，社会经济和教育背景的个人。现有大型医疗保健网络的可行性分析证实了该领域未来RCT对死亡和心血管结局的适当把握度。现有数据无法解决他汀类药物在75岁及以上成人（尤其是合并症、虚弱和认知障碍的患者）中用于ASCVD一级预防的益处和危害的不确定性。来自1个或多个RCT的证据可以解决这些重要的知识差距，为以人为本的决策提供信息。
To determine the efficacy and safety of statins for primary prevention of atherosclerotic cardiovascular disease (ASCVD) events in older adults, especially those aged 80 and older and with multimorbidity. The National Institute on Aging and the National Heart, Lung and Blood Institute convened A multidisciplinary expert panel from July 31 to August 1, 2017, to review existing evidence, identify knowledge gaps, and consider whether statin safety and efficacy data in persons aged 75 and older without ASCVD are sufficient; whether existing data can inform the feasibility, design, and implementation of future statin trials in older adults; and clinical trial options and designs to address knowledge gaps. This article summarizes the presentations and discussions at that workshop. There is insufficient evidence regarding the benefits and harms of statins in older adults, especially those with concomitant frailty, polypharmacy, comorbidities, and cognitive impairment; a lack of tools to assess ASCVD risk in those aged 80 and older; and a paucity of evidence of the effect of statins on outcomes of importance to older adults, such as statin-associated muscle symptoms, cognitive function, and incident diabetes mellitus. Prospective, traditional, placebo-controlled, randomized clinical trials (RCTs) and pragmatic RCTs seem to be suitable options to address these critical knowledge gaps. Future trials have to consider greater representation of very old adults, women, underrepresented minorities, and individuals of differing health, cognitive, socioeconomic, and educational backgrounds. Feasibility analyses from existing large healthcare networks confirm appropriate power for death and cardiovascular outcomes for future RCTs in this area. Existing data cannot address uncertainties about the benefits and harms of statins for primary ASCVD prevention in adults aged 75 and older, especially those with comorbidities, frailty, and cognitive impairment. Evidence from 1 or more RCTs could address these important knowledge gaps to inform person-centered decision-making.
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影响因子：
6.3
作者：
Case SM;O'Leary J;Kim N;Tinetti ME;Fried TR
通讯作者：
Fried TR
影响因子：
168.9
作者：
Ridker, Paul M.;Pradhan, Aruna;MacFadyen, Jean G.;Libby, Peter;Glynn, Robert J.
通讯作者：
Glynn, Robert J.
影响因子：
6.3
作者：
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通讯作者：
Driver, Jane A.
影响因子：
3.7
作者：
Cholesterol Treatment Trialists' (CTT) Collaboration;Emberson JR;Kearney PM;Blackwell L;Newman C;Reith C;Bhala N;Holland L;Peto R;Keech A;Collins R;Simes J;Baigent C
通讯作者：
Baigent C
影响因子：
39.2
作者：
Odden MC;Pletcher MJ;Coxson PG;Thekkethala D;Guzman D;Heller D;Goldman L;Bibbins-Domingo K
通讯作者：
Bibbins-Domingo K