Robman Liubov D, Wolfe Rory, Woods Robyn L, Thao Le Thi Phuong, Makeyeva Galina A, Hodgson Lauren A B, Lepham Y-Anh, Jachno Kim, Phung James, Maguire Emily, Luong Henry, Trevaks Ruth E, Ward Stephanie A, Fitzgerald Sharyn M, Orchard Suzanne G, Lacaze Paul, Storey Elsdon, Abhayaratna Walter P, Nelson Mark R, Guymer Robyn H, McNeil John J
School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
Centre for Eye Research Australia, University of Melbourne, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.
JAMA Ophthalmol. 2024 Jul 1;142(7):627-635. doi: 10.1001/jamaophthalmol.2024.1584.
Age-related macular degeneration (AMD) is the leading cause of irreversible vision loss in old age. There is no proven intervention to prevent AMD and, apart from lifestyle, nutritional, and supplement advice, there is no intervention to delay its progression.
To determine the impact of long-term low-dose aspirin on the incidence and progression of AMD.
DESIGN, SETTING AND PARTICIPANTS: The Aspirin in Reducing Events in the Elderly-AMD (ASPREE-AMD) study was an Australian-based substudy of the ASPREE trial, a multicenter, international, randomized, double-masked, placebo-clinical trial investigating the efficacy of low-dose aspirin in prolonging disability-free survival among older individuals. Retinal photography was conducted at baseline from March 2010 to January 2015, then 3 and 5 years after randomization. AMD status was determined using color retinal images and treatment records. Australian participants in ASPREE aged 70 years and older without dementia, independence-limiting physical disability, cardiovascular disease, or chronic illness limiting 5-year survival and with gradable retinal images at baseline were included. Data were analyzed from December 2022 to December 2023.
Aspirin (100 mg daily, enteric coated) or placebo.
Incidence of AMD and progression from early/intermediate to late AMD. Outcomes were analyzed by modified intention-to-treat analysis.
A total of 4993 participants were enrolled in this substudy. Baseline characteristics were similar between groups. At the time of sponsor-determined trial termination, retinal follow-up data were available for 3208 participants, 3171 of whom were analyzed for AMD incidence and progression, with a median (IQR) age of 73.5 (71.5-76.4) years and even sex distribution (1619 [51%] female). Median (IQR) follow-up time was 3.1 (3.0-3.5) years. Cumulative AMD incidence was 195 of 1004 (19.4%) in the aspirin group and 187 of 979 (19.1%) in the placebo group (relative risk [RR], 1.02; 95% CI, 0.85-1.22; P = .86). Cumulative progression from early/intermediate AMD to late AMD was observed in 14 of 615 (2.3%) participants in the aspirin group and 18 of 573 (3.1%) in the placebo group (RR, 0.72; 95% CI, 0.36-1.44; P = .36).
In this trial, low-dose aspirin administered for 3 years did not affect the incidence of AMD. The evidence was weaker for progression of AMD due to low number of progressed cases. Overall, these results do not support suggestion that low-dose daily aspirin prevents the development or progression of AMD.
anzctr.org Identifier: ACTRN12613000755730.
年龄相关性黄斑变性（AMD）是老年人不可逆视力丧失的主要原因。目前尚无经证实可预防AMD的干预措施，除生活方式、营养及补充剂建议外，也没有可延缓其进展的干预措施。
确定长期低剂量阿司匹林对AMD发病率及进展的影响。
设计、设置与参与者：老年人减少事件的阿司匹林 - AMD（ASPREE - AMD）研究是ASPREE试验的一项基于澳大利亚的子研究，ASPREE试验是一项多中心、国际、随机、双盲、安慰剂对照临床试验，旨在研究低剂量阿司匹林在延长老年人无残疾生存期方面的疗效。于2010年3月至2015年1月在基线时进行视网膜摄影，然后在随机分组后3年和5年进行。使用彩色视网膜图像和治疗记录确定AMD状态。纳入ASPREE研究中年龄在70岁及以上、无痴呆、无限制独立生活的身体残疾、无心血管疾病、无限制5年生存期的慢性疾病且基线时有可分级视网膜图像的澳大利亚参与者。数据于2022年12月至2023年12月进行分析。
阿司匹林（每日100毫克，肠溶包衣）或安慰剂。
AMD的发病率以及从早期/中期AMD进展为晚期AMD的情况。结局通过改良意向性分析进行分析。
本项子研究共纳入4993名参与者。两组间基线特征相似。在申办方确定的试验终止时，有3208名参与者可获得视网膜随访数据，其中3171名参与者被分析AMD发病率及进展情况，年龄中位数（四分位间距）为73.5（71.5 - 76.4）岁，性别分布均衡（1619名[51%]女性）。随访时间中位数（四分位间距）为3.1（3.0 - 3.5）年。阿司匹林组1004名参与者中有195名（19.4%）发生AMD，安慰剂组979名参与者中有187名（19.1%）发生AMD（相对风险[RR]，1.02；95%置信区间，0.85 - 1.22；P = 0.86）。阿司匹林组615名参与者中有14名（2.3%）从早期/中期AMD进展为晚期AMD，安慰剂组573名参与者中有18名（3.1%）进展（RR，0.72；95%置信区间，0.36 - 1.44；P = 0.36）。
在本试验中，服用3年低剂量阿司匹林并未影响AMD的发病率。由于进展病例数较少，关于AMD进展的证据较弱。总体而言，这些结果不支持每日低剂量阿司匹林可预防AMD发生或进展的观点。
anzctr.org标识符：ACTRN12613000755730。
