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

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

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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.

Original languageEnglish
Article number100667
Number of pages34
JournalContemporary Clinical Trials Communications
Volume20
DOIs
Publication statusPublished - Dec 2020

Keywords

  • Age-related macular degeneration
  • AMD
  • Aspirin
  • Baseline characteristics
  • Elderly
  • Randomized controlled trial

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