Baseline characteristics and age-related macular degeneration in participants of the "ASPirin in Reducing Events in the Elderly" (ASPREE)-AMD trial

Liubov D Robman; Le Thi Phuong Thao; Robyn H Guymer; Rory Wolfe; Robyn L Woods; Lauren Ab Hodgson; James Phung; Galina A Makeyeva; Y-Anh Le-Pham; Suzanne G Orchard; Jewhara Suleiman; Emily Maguire; Ruth E Trevaks; Stephanie A Ward; Moeen Riaz; Paul Lacaze; Elsdon Storey; Walter P Abhayaratna; Mark R Nelson; Michael E Ernst; Christopher M Reid; John J McNeil; ASPREE Investigator Group

doi:10.1016/j.conctc.2020.100667

Baseline characteristics and age-related macular degeneration in participants of the "ASPirin in Reducing Events in the Elderly" (ASPREE)-AMD trial

Contemp Clin Trials Commun. 2020 Oct 11:20:100667. doi: 10.1016/j.conctc.2020.100667. eCollection 2020 Dec.

Authors

Liubov D Robman^{1

2}, Le Thi Phuong Thao¹, Robyn H Guymer², Rory Wolfe¹, Robyn L Woods¹, Lauren Ab Hodgson², James Phung¹, Galina A Makeyeva², Y-Anh Le-Pham¹, Suzanne G Orchard¹, Jewhara Suleiman¹, Emily Maguire¹, Ruth E Trevaks¹, Stephanie A Ward¹, Moeen Riaz¹, Paul Lacaze¹, Elsdon Storey¹, Walter P Abhayaratna³, Mark R Nelson⁴, Michael E Ernst⁵, Christopher M Reid¹, John J McNeil¹; ASPREE Investigator Group

Affiliations

¹ Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.
² 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.
³ College of Health and Medicine, The Australian National University, Canberra, ACT, 0200, Australia.
⁴ Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS, 7000, Australia.
⁵ Department of Pharmacy Practice and Science, College of Pharmacy, Department of Family Medicine, Carver College of Medicine, The University of Iowa, Iowa City, IA, 52242, USA.

Abstract

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 (ARMS2/HTRA1) was associated with each AMD stage (p < 0.001), risk variants rs570618 and rs10922109 (CFH) with intermediate and late AMD (p < 0.001), and rare variant rs147859257 (C3) with late AMD (p < 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.

Keywords: AMD; Age-related macular degeneration; Aspirin; Baseline characteristics; Elderly; Randomized controlled trial.

Abstract

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