To the Editor: The ASPREE (ASPirin in Reducing Events in the Elderly) study may provide useful data on the benefits and risks of aspirin therapy in patients aged ≥ 70 years, as described by Woods and colleagues.1 However, the decision to allow general practitioner co-investigators to “help decide whether the patient is a suitable candidate for the placebo-controlled trial” introduces a source of selection bias that may limit the generalisability of the results. Without pre-specified objective selection criteria, it is likely that primary-prevention patients assessed by GP co-investigators as being at high vascular risk will be excluded because the GPs believe they should be taking antiplatelet agents. Similarly, those at low risk may be thought inappropriate participants because the risks of random allocation to this therapy might outweigh the perceived benefits, as has been shown in previous meta-analyses.2,3 ASPREE may end up with a disproportionate number of intermediate-risk patients.
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- School of Medicine and Pharmacology, University of Western Australia, Fremantle Hospital, Fremantle, WA.
- 1. Woods RL, Tonkin AM, Nelson MR, et al. Should aspirin be used for the primary prevention of cardiovascular disease in people with diabetes [editorial]? Med J Aust 2009; 190: 614-615. <MJA full text>
- 2. Hayden M, Pignone M, Phillips C, Mulrow C. Aspirin for the primary prevention of cardiovascular events: a summary of the evidence for the US Preventive Services Task Force. Ann Intern Med 2002; 136: 161-172.
- 3. Baigent C, Blackwell L, Collins R, et al. Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials. Lancet 2009; 373: 1849-1860.
- 4. Schimke K, Chubb SA, Davis WA, et al. Antiplatelet therapy, Helicobacter pylori infection and complicated peptic ulcer disease in diabetes: the Fremantle Diabetes Study. Diabet Med 2009; 26: 70-75.
- 5. International Standard Randomised Controlled Trial Number Register. ASPirin in Reducing Events in the Elderly. http://www.controlled-trials.com/ISRCTN83 772183/ (accessed Aug 2009).