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

J Gerontol A Biol Sci Med Sci. 2017 Oct 12;72(11):1586-1593. doi: 10.1093/gerona/glw342.

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.

Keywords: Clinical trial; Dementia; Disability; Primary prevention.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Activities of Daily Living
  • Administration, Oral
  • Aged
  • Aged, 80 and over
  • Aging / drug effects*
  • Aspirin / administration & dosage*
  • Australia / epidemiology
  • Cardiovascular Diseases / epidemiology
  • Cardiovascular Diseases / prevention & control*
  • Cyclooxygenase Inhibitors / administration & dosage
  • Dementia / epidemiology
  • Dementia / prevention & control*
  • Disability Evaluation*
  • Disabled Persons / rehabilitation
  • Disabled Persons / statistics & numerical data*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Humans
  • Incidence
  • Male
  • Prognosis
  • Quality of Life
  • United States / epidemiology

Substances

  • Cyclooxygenase Inhibitors
  • Aspirin