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Rationale for a Trial of Low-Dose Aspirin for the Primary Prevention of Major Adverse Cardiovascular Events and Vascular Dementia in the Elderly

Aspirin in Reducing Events in the Elderly (ASPREE)

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Abstract

Low-dose aspirin (acetylsalicylic acid) therapy has been shown to reduce the risk of vascular events and there is increasing evidence of its potential to reduce the rate of cognitive decline in the elderly. Adverse effects including gastrointestinal and intracranial haemorrhage may offset these benefits. The balance of risks versus benefits of aspirin for the primary prevention of cardiovascular disease and vascular dementia has not been established in the elderly. There is clearly a need to conduct a study in family practice to investigate whether routine use of low-dose aspirin for the primary prevention of cardiovascular disease and vascular dementia in the elderly is beneficial or harmful.

Aspirin in reducing events in the elderly (ASPREE) is a placebo-controlled trial of low-dose aspirin for the primary prevention of major adverse cardiovascular events and vascular dementia. It will follow 15 000 subjects aged 70 years or more for an average of 5 years. This sample size has a power of 87% to detect a 15% reduction in primary events in the aspirin group, with an anticipated combined primary event rate of 20 per 1000 patient years.

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Acknowledgements

We wish to acknowledge the contributions of Dr Rory Wolfe (sample size calculations) and Dr Danny Liew (economic analysis methodology), both from the Department of Epidemiology and Preventive Medicine, Monash University.

ASPREE has received funding from the National Health and Medical Research Council and the National Heart Foundation of Australia, and is endorsed by the National Stroke Foundation and the National Heart Foundation of Australia. Bayer AG is supplying enteric coated low-dose aspirin and placebo.

The authors have no conflicts of interest that are directly relevant to the content of this manuscript.

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Authors and Affiliations

  1. Department of Epidemiology and Preventive Medicine, Monash University, Alfred Hospital, Commercial Road, Prahran, 3181, Australia

    Mark R. Nelson, Henry Krum, Andrew Tonkin & John J. McNeil

  2. Department of General Practice, Monash University, East Bentleigh, Victoria, Australia

    Mark R. Nelson

  3. CVD Prevention Unit, Baker Heart Research Institute, Alfred Hospital, Prahan, Victoria, Australia

    Christopher M. Reid

  4. Department of Internal Medicine, University of Western Australia, Royal Perth Hospital, Perth, Western Australia, Australia

    Lawrence J. Beilin

  5. National Stroke Research Institute, University of Melbourne, Austin and Repatriation Medical Centre, Heidelberg West, Victoria, Australia

    Geoffrey A. Donnan

  6. Baker Heart Research Institute, Melbourne, Victoria, Australia

    Colin I. Johnston

  7. Department of Neurosciences and Van Cleef Roet Centre for Nervous Disease, Department of Medicine, Monash University, Alfred Hospital, Prahan, Victoria, Australia

    Elsdon Storey

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  1. Mark R. Nelson
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  2. Christopher M. Reid
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  3. Lawrence J. Beilin
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  4. Geoffrey A. Donnan
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  5. Colin I. Johnston
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  6. Henry Krum
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  8. Andrew Tonkin
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  9. John J. McNeil
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Correspondence to Mark R. Nelson.

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Nelson, M.R., Reid, C.M., Beilin, L.J. et al. Rationale for a Trial of Low-Dose Aspirin for the Primary Prevention of Major Adverse Cardiovascular Events and Vascular Dementia in the Elderly. Drugs Aging 20, 897–903 (2003). https://doi.org/10.2165/00002512-200320120-00004

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  • DOI: https://doi.org/10.2165/00002512-200320120-00004

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