Volume 191 - Issue 6
Should aspirin be used for the primary prevention of cardiovascular disease in people with diabetes?
Authors: Robyn L Woods, Mark R Nelson, Andrew M Tonkin and Christopher M Reid
Med J Aust 2009; 191 (6): 356-357. || doi: 10.5694/j.1326-5377.2009.tb02827.x
Published online: 21 September 2009
Published online: 21 September 2009
In reply: Recruitment to clinical trials through general practice is representative of the population, as a high proportion of all Australians regularly attend their general practitioners.1 GP co-investigators are appropriate to decide whether their patients are suitable for the ASPREE (ASPirin in Reducing Events in the Elderly) study because their assessment includes objective inclusion and exclusion criteria that must be satisfied before enrolment in the study (clinical trial registration number ISRCTN83772183),2 as well as patient-specific potential risks with using aspirin, and known medical factors likely to influence patient survival during the trial. These include the risk of complicated peptic ulcer disease in patients with diabetes treated with a sulfonylurea.3 GP co-investigators support participation in ASPREE by eligible patients because of aspirin’s therapeutic equipoise for primary prevention in older patients4 and in those with diabetes.5
Because of age alone, ASPREE participants will be at least at intermediate risk of cardiovascular disease and also at increased risk of bleeding. Determining the aspirin balance underpins the importance of collecting more data in older people, who have been under-represented in previous primary prevention trials.
ASPREE is a superiority trial with pre-specified subgroup analyses, including for the subgroup with diabetes.2 The study is powered to address the primary question reliably in the total cohort rather than subgroups. To date, fewer than 500 participants have been randomly allocated, with recruitment slowed subject to National Institutes of Health funding deliberations. Recruitment will be reinvigorated in late 2009, and will continue to include people with diabetes.
References
- Knox SA, Harrison CM, Britt HC, Henderson JV. Estimating prevalence of common chronic morbidities in Australia. Med J Aust 2008; 189: 66-70.
- Monash University. Medicine, Nursing and Health Sciences. ASPREE (ASPirin in Reducing Events in the Elderly). A placebo controlled trial of low dose aspirin in the elderly. http://www.med.monash.edu.au/epidemiology/cardiores/aspree.html (accessed Jul 2009).
- 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. 0_CBBCIGGC
- Nelson MR, Reid CM, Ames DA, et al. Feasibility of conducting a primary prevention trial of low-dose aspirin for major adverse cardiovascular events in older people in Australia: results from the ASPirin in Reducing Events in the Elderly (ASPREE) pilot study. Med J Aust 2008; 189: 105-109. 0_i1091861
- 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. 0_i1091863