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
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- 1 Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC.
- 2 Menzies Research Institute, University of Tasmania, Hobart, TAS.
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- 2. 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).
- 3. 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.
- 4. 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. <MJA full text>
- 5. 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>