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降脂随机临床试验中少数民族和地区少数群体代表性不足:系统评价和荟萃分析。

Under-representation of ethnic and regional minorities in lipid-lowering randomized clinical trials: a systematic review and meta-analysis.

机构信息

Cardiology Department, Royal Prince Alfred Hospital, 50-60 Missenden Road, Australia.

School of Public Health, Imperial College London, Exhibition Road, South Kensington, London SW7 2BX, UK.

出版信息

Eur J Prev Cardiol. 2023 Aug 21;30(11):1120-1131. doi: 10.1093/eurjpc/zwad030.

DOI:10.1093/eurjpc/zwad030
PMID:36748994
Abstract

AIMS

The efficacy of lipid-lowering therapies (LLT) amongst different ethnicities and regions remains unclear. We aimed to assess cardiovascular event reductions associated with LLT according to ethnicity and region in previously published randomized clinical trials (RCTs).

METHODS AND RESULTS

Medline, EMBASE, and Cochrane CENTRAL were searched for RCTs of statins, ezetimibe, or proprotein convertase subtilisin/kexin type 9 inhibitors comparing intensive vs. less-intensive low-density lipoprotein cholesterol (LDL-C) lowering. The primary endpoint was major adverse cardiovascular events (MACE) defined as the composite of cardiovascular mortality, myocardial infarction, stroke, and revascularization. Random-effects meta-analysis was used to pool risk ratios (RRs) with 95% confidence intervals (CI) adjusted per mmol/L reduction in LDL-C. Fifty-three trials with 329 897 participants were included. Amongst participants, 39.5% were from Europe, 16.0% from North America, 9.0% from Japan, 2.8% from Australasia, 1.8% from South America, 1.1% from Asia, 0.6% from South Africa, and 29.2% were unspecified. Amongst trials reporting ethnicities, there were 60.3% White, 20.2% Japanese, 9.4% Asian, 5.5% Black, and 4.7% Latin American. There was reduction in MACE with LLT in regions including Australasia (RR 0.75, 95% CI 0.67-0.85), North America (RR 0.75, 95% CI 0.69-0.83), Europe (RR 0.78, 95% CI 0.71-0.86), and Japan (RR 0.73, 95% CI 0.63-0.85) and in Black ethnicity (RR 0.55, 95% CI 0.37-0.82). Head-to-head comparisons between regions and ethnicities revealed no significant differences in MACE reduction.

CONCLUSION

Despite under-representation in clinical trials, regional and ethnic minority groups such as Australasia and Blacks appear to derive at least as much cardiovascular benefit from LLT.

摘要

目的

降脂治疗(LLT)在不同种族和地区的疗效仍不清楚。我们旨在根据已发表的随机临床试验(RCT)评估降脂治疗与种族和地区相关的心血管事件减少情况。

方法和结果

检索了 Medline、EMBASE 和 Cochrane CENTRAL 数据库,以寻找他汀类药物、依折麦布或前蛋白转化酶枯草溶菌素 9 抑制剂的 RCT 研究,比较了强化与非强化低密度脂蛋白胆固醇(LDL-C)降低的效果。主要终点是主要不良心血管事件(MACE),定义为心血管死亡率、心肌梗死、卒中和血运重建的综合指标。采用随机效应荟萃分析,对每降低 1mmol/L LDL-C 进行调整后的风险比(RR)进行汇总,并计算 95%置信区间(CI)。共纳入 53 项包含 329897 名参与者的试验。其中,39.5%的参与者来自欧洲,16.0%来自北美,9.0%来自日本,2.8%来自澳大拉西亚,1.8%来自南美,1.1%来自亚洲,0.6%来自南非,29.2%的参与者未指定种族。在报告种族的试验中,有 60.3%是白人,20.2%是日本人,9.4%是亚洲人,5.5%是黑人,4.7%是拉丁裔。在包括澳大拉西亚(RR 0.75,95%CI 0.67-0.85)、北美(RR 0.75,95%CI 0.69-0.83)、欧洲(RR 0.78,95%CI 0.71-0.86)和日本(RR 0.73,95%CI 0.63-0.85)在内的地区以及黑人种族(RR 0.55,95%CI 0.37-0.82)中,MACE 发生率随着 LLT 而降低。在区域和种族之间的头对头比较中,MACE 减少没有发现显著差异。

结论

尽管临床试验中代表性不足,但像澳大拉西亚和黑人这样的区域和少数民族群体似乎至少从 LLT 中获得了同等的心血管益处。

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