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秋水仙碱对心血管疾病患者的获益时间:随机对照试验的汇总分析

Time to benefit of colchicine in patients with cardiovascular disease: A pooled analysis of randomized controlled trials.

作者信息

Sun Haonan, Huang Chuanyi, Li Linjie, Zhu Wenjun, Li Jingge, Sun Pengfei, A Geru, Fonarow Gregg C, Yang Qing, Zhou Xin

机构信息

Department of Cardiology, Tianjin Medical University General Hospital, 154 Anshan Road, Heping District, Tianjin 300052, China.

Division of Cardiology, David Geffen School of Medicine at University of California, Geffen Hall 885 Tiverton Drive Los Angeles, CA 90095, USA.

出版信息

Heliyon. 2024 Apr 29;10(9):e30408. doi: 10.1016/j.heliyon.2024.e30408. eCollection 2024 May 15.

DOI:10.1016/j.heliyon.2024.e30408
PMID:38726146
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11079085/
Abstract

BACKGROUND

Low-dose colchicine has been shown to lower major adverse cardiovascular events (MACE) among those with cardiovascular disease (CVD). It remains unclear how long a CVD patient needs to live to potentially benefit from colchicine. Our study aimed to determine the time to benefit (TTB) of colchicine in individuals with CVD.

METHODS

Literature searches were performed in PubMed for the cardiovascular outcome trial of colchicine in patients with CVD until October 12, 2023. The primary outcome measured was MACE. Reconstructed individual participant data (IPD) and the stratified Cox proportional hazards model were used to calculate the hazard ratio (HR) and 95 % confidence interval (CI) to estimate the efficacy of colchicine, and Weibull survival curves were fitted to estimate TTB for specific absolute risk reduction (ARR) thresholds (0.002, 0.005, and 0.01).

RESULTS

Four trials randomizing 11,594 adults aged between 59.8 and 66.5 years were included (follow-up duration: 12-28.6 months). Compared with placebo, colchicine reduced the risk of MACE (HR 0.68, 95 % CI: 0.60 to 0.78) but had no impact on cardiovascular and all-cause mortality. A TTB of 11.0 months (95 % CI: 0.59 to 21.3) was estimated to be needed to prevent 1 MACE in 100-colchicine-treated patients. The TTB for acute coronary syndrome was similar compared to stable coronary artery disease (10.7 vs. 11.2 months for ARR = 0.010).

CONCLUSIONS

By using reconstructed IPD, this pooled analysis demonstrated that colchicine was associated with reduced nonfatal MACE, and the TTB was approximately 11.0 months to prevent 1 MACE per 100 patients.

摘要

背景

低剂量秋水仙碱已被证明可降低心血管疾病(CVD)患者的主要不良心血管事件(MACE)。目前尚不清楚CVD患者需要存活多长时间才能从秋水仙碱中潜在获益。我们的研究旨在确定秋水仙碱在CVD患者中的获益时间(TTB)。

方法

在PubMed中检索截至2023年10月12日秋水仙碱在CVD患者中的心血管结局试验。测量的主要结局是MACE。使用重建的个体参与者数据(IPD)和分层Cox比例风险模型来计算风险比(HR)和95%置信区间(CI)以估计秋水仙碱的疗效,并拟合Weibull生存曲线以估计特定绝对风险降低(ARR)阈值(0.002、0.005和0.01)时的TTB。

结果

纳入了四项试验,共11594名年龄在59.8至66.5岁之间的成年人(随访时间:12至28.6个月)。与安慰剂相比,秋水仙碱降低了MACE风险(HR 0.68,95%CI:0.60至0.78),但对心血管和全因死亡率没有影响。估计每100名接受秋水仙碱治疗的患者中预防1例MACE需要11.0个月的TTB(95%CI:0.59至21.3)。与稳定型冠状动脉疾病相比,急性冠状动脉综合征的TTB相似(ARR = 0.010时为10.7个月对11.2个月)。

结论

通过使用重建的IPD,这项汇总分析表明秋水仙碱与非致命性MACE的降低相关,每100名患者预防1例MACE的TTB约为11.0个月。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/af41/11079085/8b1ee3f6dd15/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/af41/11079085/172e84ca1634/ga1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/af41/11079085/8b1ee3f6dd15/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/af41/11079085/172e84ca1634/ga1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/af41/11079085/8b1ee3f6dd15/gr1.jpg

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