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

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

Author information

1
Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
2
Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia.
3
Berman Center for Outcomes and Clinical Research, Minneapolis Medical Research Foundation, Hennepin County Medical Center, Minnesota.
4
Division of Geriatrics, Department of Medicine, Hennepin County Medical Center and University of Minnesota, Minneapolis.
5
School of Public Health, Curtin University, Perth, Western Australia, Australia.
6
Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago, Illinois.
7
Center for Aging and Population Health, University of Pittsburgh, Pennsylvania.
8
Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Department of Internal Medicine, Winston-Salem, North Carolina.
9
HealthPartners Institute, Minneapolis, Minnesota.
10
Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa.
11
Cardiovascular Medicine, College of Medicine, Biology and Environment, Australian National University, Canberra, Australian Capital Territory, Australia.
12
Discipline of General Practice, University of Adelaide, South Australia, Australia.
13
School of Medicine and Pharmacology, Royal Perth Hospital Unit, University of Western Australia, Perth, Australia.
14
Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, Victoria, Australia.
15
The Walter and Eliza Hall Institute of Medical Research, Melbourne, Victoria, Australia.

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

PMID:
28329340
PMCID:
PMC5861878
DOI:
10.1093/gerona/glw342
[Indexed for MEDLINE]
Free PMC Article

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