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


CONCLUSIONS
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.
Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
John J
JJ
McNeil
Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
Robyn L
RL
Woods
Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.|Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia.
Mark R
MR
Nelson
Berman Center for Outcomes and Clinical Research, Minneapolis Medical Research Foundation, Hennepin County Medical Center, Minnesota.|Division of Geriatrics, Department of Medicine, Hennepin County Medical Center and University of Minnesota, Minneapolis.
Anne M
AM
Murray
Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.|School of Public Health, Curtin University, Perth, Western Australia, Australia.
Christopher M
CM
Reid
Berman Center for Outcomes and Clinical Research, Minneapolis Medical Research Foundation, Hennepin County Medical Center, Minnesota.
Brenda
B
Kirpach
Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
Elsdon
E
Storey
Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago, Illinois.
Raj C
RC
Shah
Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
Rory S
RS
Wolfe
Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
Andrew M
AM
Tonkin
Center for Aging and Population Health, University of Pittsburgh, Pennsylvania.
Anne B
AB
Newman
Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Department of Internal Medicine, Winston-Salem, North Carolina.
Jeff D
JD
Williamson
Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
Jessica E
JE
Lockery
HealthPartners Institute, Minneapolis, Minnesota.
Karen L
KL
Margolis
Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa.
Michael E
ME
Ernst
Cardiovascular Medicine, College of Medicine, Biology and Environment, Australian National University, Canberra, Australian Capital Territory, Australia.
Walter P
WP
Abhayaratna
Discipline of General Practice, University of Adelaide, South Australia, Australia.
Nigel
N
Stocks
Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
Sharyn M
SM
Fitzgerald
Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
Ruth E
RE
Trevaks
Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
Suzanne G
SG
Orchard
School of Medicine and Pharmacology, Royal Perth Hospital Unit, University of Western Australia, Perth, Australia.
Lawrence J
LJ
Beilin
Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, Victoria, Australia.
Geoffrey A
GA
Donnan
The Walter and Eliza Hall Institute of Medical Research, Melbourne, Victoria, Australia.
Peter
P
Gibbs
Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
Colin I
CI
Johnston
Berman Center for Outcomes and Clinical Research, Minneapolis Medical Research Foundation, Hennepin County Medical Center, Minnesota.
Richard H
RH
Grimm
D000203:Activities of Daily Living; D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000375:Aging / Q000187:drug effects*; D001241:Aspirin / Q000008:administration & dosage*; D001315:Australia / Q000453:epidemiology; D002318:Cardiovascular Diseases / Q000453:epidemiology / Q000517:prevention & control*; D016861:Cyclooxygenase Inhibitors / Q000008:administration & dosage; D003704:Dementia / Q000453:epidemiology / Q000517:prevention & control*; D004185:Disability Evaluation; D006233:Persons with Disabilities / Q000534:rehabilitation / Q000706:statistics & numerical data*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D011379:Prognosis; D011788:Quality of Life; D014481:United States / Q000453:epidemiology
D016861:Cyclooxygenase Inhibitors; D001241:Aspirin
Clinical trial; Dementia; Disability; Primary prevention