“老年人使用阿司匹林降低事件风险”（ASPREE）-年龄相关性黄斑变性试验参与者的基线特征与年龄相关性黄斑变性
Baseline characteristics and age-related macular degeneration in participants of the "ASPirin in Reducing Events in the Elderly" (ASPREE)-AMD trial.
作者信息
Robman Liubov D, Phuong Thao Le Thi, Guymer Robyn H, Wolfe Rory, Woods Robyn L, Hodgson Lauren Ab, Phung James, Makeyeva Galina A, Le-Pham Y-Anh, Orchard Suzanne G, Suleiman Jewhara, Maguire Emily, Trevaks Ruth E, Ward Stephanie A, Riaz Moeen, Lacaze Paul, Storey Elsdon, Abhayaratna Walter P, Nelson Mark R, Ernst Michael E, Reid Christopher M, McNeil John J
机构信息
Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.
Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Department of Surgery (Ophthalmology), University of Melbourne, 32 Gisborne Street, East Melbourne, VIC, 3002, Australia.
出版信息
Contemp Clin Trials Commun. 2020 Oct 11;20:100667. doi: 10.1016/j.conctc.2020.100667. eCollection 2020 Dec.
PURPOSE
To describe the baseline participant characteristics in the ASPREE-AMD study, investigating the effect of aspirin on AMD incidence and progression.
METHODS
Australian participants from the ASPirin in Reducing Events in the Elderly (ASPREE) trial, randomized to 100 mg aspirin daily or placebo, had non-mydriatic, digital color fundus images graded according to the Beckman AMD classification. Associations with AMD were determined for baseline characteristics and genetic risk variants.
RESULTS
ASPREE-AMD sub-study enrolled 4993 participants with gradable macular images. Median age was 73.4 years (IQR, 71.5, 76.6), 52% were female, 10% had diabetes mellitus, 73% had hypertension, and 44% were former/current smokers. Early, intermediate and late AMD (detected in 20.6%, 16.1%, 1.1%, respectively), significantly associated with age, were also associated with increasing HDL levels: OR = 1.52 (95%CI, 1.26, 1.84), OR = 1.43 (1.17, 1.77) and OR = 1.96 (1.02, 3.76), respectively. Female sex was associated with early [OR = 1.37 (1.16, 1.62)], and intermediate [OR = 1.35 (1.12, 1.63)] AMD, as was previous regular use of aspirin, with OR = 1.46 (1.11, 1.92) and OR = 1.37 (1.01, 1.85), respectively. Current smoking had increased odds for late AMD, OR = 4.02 (1.42, 11.36). Genetic risk variant rs3750846 () was associated with each AMD stage ( < 0.001), risk variants rs570618 and rs10922109 ( with intermediate and late AMD ( < 0.001), and rare variant rs147859257 () with late AMD ( < 0.001). The randomized groups were well balanced for all analyzed AMD risk factors.
CONCLUSIONS
Observed associations are typical of AMD. The ASPREE-AMD clinical trial provides a unique opportunity to determine the risks and benefits of low-dose aspirin for AMD incidence and progression in elderly population.
TRIAL REGISTRATION
Australian New Zealand Clinical Trial Registry: ACTRN 12613000755730.
目的
描述阿司匹林减少老年人事件（ASPREE）-年龄相关性黄斑变性（AMD）研究中的基线参与者特征，该研究旨在探究阿司匹林对AMD发病率和病情进展的影响。
方法
来自ASPREE试验的澳大利亚参与者被随机分为每日服用100毫克阿司匹林组或安慰剂组，他们接受了非散瞳数码彩色眼底图像检查，并根据贝克曼AMD分类法进行分级。确定了基线特征和基因风险变异与AMD的关联。
结果
ASPREE-AMD子研究招募了4993名有可分级黄斑图像的参与者。中位年龄为73.4岁（四分位间距，71.5，76.6），52%为女性，10%患有糖尿病，73%患有高血压，44%为既往/当前吸烟者。早期、中期和晚期AMD（分别占20.6%、16.1%、1.1%）与年龄显著相关，也与高密度脂蛋白（HDL）水平升高相关：比值比（OR）分别为1.52（95%置信区间，1.26，1.84）、1.43（1.17，1.77）和1.96（1.02，3.76）。女性性别与早期AMD [OR = 1.37（1.16，1.62）]和中期AMD [OR = 1.35（1.12，1.63）]相关，既往规律服用阿司匹林也与之相关，OR分别为1.46（1.11，1.92）和1.37（1.01，1.85）。当前吸烟会增加晚期AMD的发病几率，OR = 4.02（1.42，11.36）。基因风险变异rs3750846（）与各AMD阶段相关（P < 0.001），风险变异rs570618和rs10922109（）与中期和晚期AMD相关（P < 0.001），罕见变异rs147859257（）与晚期AMD相关（P < 0.001）。随机分组在所有分析的AMD风险因素方面平衡良好。
结论
观察到的关联是AMD的典型特征。ASPREE-AMD临床试验为确定低剂量阿司匹林对老年人群AMD发病率和病情进展的风险和益处提供了独特机会。
试验注册
澳大利亚新西兰临床试验注册中心：ACTRN 12613000755730。
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