Ann Intern Med:他汀类药物用于老年和高龄成人一级预防的益处和风险:来自一项目标试验仿真研究的真实世界证据

2024-05-30 来源:Ann Intern Med

本文由小咖机器人翻译整理

期刊来源:Ann Intern Med

原文链接:https://doi.org/10.7326/M24-0004

摘要内容如下:

背景

由于在随机对照试验中这一人群的代表性不足,在使用他汀类药物对75岁及以上人群进行心血管疾病(CVD)和全因死亡率的一级预防方面几乎没有达成共识。

客观

调查在老年(75至84岁)和高龄(≥85岁)成人中使用他汀类药物进行一级预防的益处和风险。

设计

序贯目标试验仿真比较开始与未开始他汀类药物治疗的匹配队列。

设置

香港全港公共电子医疗记录。

参与者

纳入2008年1月至2015年12月期间符合他汀类药物适应症的75岁及以上人群。基线时已确诊患有心血管疾病(如冠心病(CHD))的参与者被排除在分析之外。在69981名年龄在75岁至84岁之间的合格人员和14555名年龄在85岁或以上的合格人员中,41884名和9457名在各自的年龄组中有相当于CHD的病史(例如糖尿病)。

干预

开始他汀类药物治疗。

测量

主要心血管疾病(中风、心肌梗死或心力衰竭)的发病率、全因死亡率和主要不良事件(肌病和肝功能障碍)。

结果

在42680个年龄在75至84岁的匹配人群试验和5390个年龄在85岁或以上的匹配人群试验(平均随访5.3年)中,每个年龄组分别有9676人和1600人发生了心血管疾病。在年龄为75至84岁的成人中,发现开始他汀类治疗可降低总体CVD发病率的风险(在意向治疗[ITT]分析中,5年标准化风险降低1.20%[95%CI为0.57%至1.82%];在符合方案[PP]分析中为5.00%[CI,1.11%至8.89%])和85岁或以上的患者(ITT:4.44%[CI,1.40%至7.48%];PP:12.50%[CI,4.33%至20.66%])。在两个年龄组中均未发现肌病和肝功能障碍的风险显著增加。

局限性

可能存在无法测量的混杂因素,如饮食和体力活动的生活方式因素。

结论

在75岁或以上的患者中,他汀类药物治疗后心血管疾病的减少没有增加严重不良反应的风险。值得注意的是,他汀类药物治疗的益处和安全性在85岁及以上的成年人中得到了一致的发现。

主要资金来源

中国香港特别行政区政府卫生局及国家自然科学基金委员会。

英文原文如下:

Abstracts

BACKGROUND  There is little consensus on using statins for primary prevention of cardiovascular diseases (CVDs) and all-cause mortality in adults aged 75 years or older due to the underrepresentation of this population in randomized controlled trials.

OBJECTIVE  To investigate the benefits and risks of using statins for primary prevention in old (aged 75 to 84 years) and very old (aged ≥85 years) adults.

DESIGN  Sequential target trial emulation comparing matched cohorts initiating versus not initiating statin therapy.

SETTING  Territory-wide public electronic medical records in Hong Kong.

PARTICIPANTS  Persons aged 75 years or older who met indications for statin initiation from January 2008 to December 2015 were included. Participants with preexisting diagnosed CVDs at baseline, such as coronary heart disease (CHD), were excluded from the analysis. Among 69 981 eligible persons aged 75 to 84 years and 14 555 persons aged 85 years or older, 41 884 and 9457 had history of CHD equivalents (for example, diabetes) in the respective age groups.

INTERVENTION  Initiation of statin therapy.

MEASUREMENTS  Incidence of major CVDs (stroke, myocardial infarction, or heart failure), all-cause mortality, and major adverse events (myopathies and liver dysfunction).

RESULTS  Of 42 680 matched person-trials aged 75 to 84 years and 5390 matched person-trials aged 85 years or older (average follow-up, 5.3 years), 9676 and 1600 of them developed CVDs in each age group, respectively. Risk reduction for overall CVD incidence was found for initiating statin therapy in adults aged 75 to 84 years (5-year standardized risk reduction, 1.20% [95% CI, 0.57% to 1.82%] in the intention-to-treat [ITT] analysis; 5.00% [CI, 1.11% to 8.89%] in the per protocol [PP] analysis) and in those aged 85 years or older (ITT: 4.44% [CI, 1.40% to 7.48%]; PP: 12.50% [CI, 4.33% to 20.66%]). No significantly increased risks for myopathies and liver dysfunction were found in both age groups.

LIMITATION  Unmeasured confounders, such as lifestyle factors of diet and physical activity, may exist.

CONCLUSION  Reduction for CVDs after statin therapy were seen in patients aged 75 years or older without increasing risks for severe adverse effects. Of note, the benefits and safety of statin therapy were consistently found in adults aged 85 years or older.

PRIMARY FUNDING SOURCE  Health Bureau, the Government of Hong Kong Special Administrative Region, China, and National Natural Science Foundation of China.

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