Baseline Characteristics of Participants in the ASPREE (ASPirin in Reducing Events in the Elderly) Study

John J McNeil, Robyn L Woods, Mark R Nelson, Anne M Murray, Christopher M Reid, Brenda Kirpach, Elsdon Storey, Raj C Shah, Rory S Wolfe, Andrew M Tonkin, Anne B Newman, Jeff D Williamson, Jessica E Lockery, Karen L Margolis, Michael E Ernst, Walter P Abhayaratna, Nigel Stocks, Sharyn M Fitzgerald, Ruth El Trevaks, Suzanne G OrchardLawrence J Beilin, Geoffrey A. Donnan, Peter Gibbs, Colin I Johnston, Richard H Grimm, on behalf of the ASPREE Investigator Group

Research output: Contribution to journalArticleResearchpeer-review

70 Citations (Scopus)

Abstract

Background: There are no primary prevention trials of aspirin with relevant geriatric outcomes in elderly people. ASPirin in Reducing Events in the Elderly (ASPREE) is a placebo-controlled trial of low-dose aspirin that will determine whether 5 years of daily 100-mg enteric-coated aspirin extends disability-free and dementia-free life in a healthy elderly population and whether these benefits outweigh the risks.

Methods: Set in primary care, this randomized double-blind placebo-controlled trial has a composite primary endpoint of death, incident dementia or persistent physical disability. Participants aged 70+ years (non-minorities) or 65+ years (U.S. minorities) were free of cardiovascular disease, dementia, or physical disability and without a contraindication to, or indication for, aspirin. Baseline data include physical and lifestyle, personal and family medical history, hemoglobin, fasting glucose, creatinine, lipid panel, urinary albumin:creatinine ratio, cognition (3MS, HVLT-R, COWAT, SDMT), mood (CES-D-10), physical function (gait speed, grip strength), Katz activities of daily living and quality of life (SF-12).

Results: Recruitment ended in December 2014 with 16,703 Australian and 2,411 U.S. participants, a median age of 74 (range 65-98) years and 56% women. Approximately 55% of the U.S. cohort were from minority groups; 9% of the total cohort. Proportions with hypertension, overweight, and chronic kidney disease were similar to age-matched populations from both countries although lower percentages had diabetes, dyslipidemia, and osteoarthritis.

Discussion: Findings from ASPREE will be generalizable to a healthier older population in both countries and will assess whether the broad benefits of daily low-dose aspirin in prolonging independent life outweigh the risks.

Original languageEnglish
Pages (from-to)1586-1593
Number of pages8
JournalJournals of Gerontology: Biological Sciences and Medical Sciences
Volume72
Issue number11
DOIs
Publication statusPublished - 12 Oct 2017

Keywords

  • Clinical trial
  • Dementia
  • Disability
  • Primary prevention

Cite this