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| Content Provider | World Health Organization (WHO)-Global Index Medicus |
|---|---|
| Author | Macewan, Shirley Belch, Jill Gordon, Derek O'brien, Iain Jung, Roland Lee, Robert Morris, Andrew Prescott, Robin Semple, Colin Bancroft, Jean Kelly, Christopher Pringle, Stuart Petrie, John Shepherd, James Taylor, Roy Matthews, David Macfarlane, Peter Cobbe, Stuart Jamieson, Andrew Campbell, Iain Leese, Graeme Peden, Norman Mcknight, John Connacher, Alan Macwalter, Ron Maccuish, Angus |
| Description | Author Affiliation: Belch J ( Institute of Cardiovascular Research, University of Dundee, Ninewells Hospital, Dundee DD1 9SY. J.J.F.Belch@dundee.ac.uk); |
| Abstract | Objective To determine whether aspirin and antioxidant therapy, combined or alone, are more effective than placebo in reducing the development of cardiovascular events in patients with diabetes mellitus and asymptomatic peripheral arterial disease. Design Multicentre, randomised, double blind, 2×2 factorial, placebo controlled trial. Setting 16 hospital centres in Scotland, supported by 188 primary care groups. Participants 1276 adults aged 40 or more with type 1 or type 2 diabetes and an ankle brachial pressure index of 0.99 or less but no symptomatic cardiovascular disease. Interventions Daily, 100 mg aspirin tablet plus antioxidant capsule (n=320), aspirin tablet plus placebo capsule (n=318), placebo tablet plus antioxidant capsule (n=320), or placebo tablet plus placebo capsule (n=318). Main outcome measures Two hierarchical composite primary end points of death from coronary heart disease or stroke, non-fatal myocardial infarction or stroke, or amputation above the ankle for critical limb ischaemia; and death from coronary heart disease or stroke. Results No evidence was found of any interaction between aspirin and antioxidant. Overall, 116 of 638 primary events occurred in the aspirin groups compared with 117 of 638 in the no aspirin groups (18.2% v 18.3%): hazard ratio 0.98 (95% confidence interval 0.76 to 1.26). Forty three deaths from coronary heart disease or stroke occurred in the aspirin groups compared with 35 in the no aspirin groups (6.7% v 5.5%): 1.23 (0.79 to 1.93). Among the antioxidant groups 117 of 640 (18.3%) primary events occurred compared with 116 of 636 (18.2%) in the no antioxidant groups (1.03, 0.79 to 1.33). Forty two (6.6%) deaths from coronary heart disease or stroke occurred in the antioxidant groups compared with 36 (5.7%) in the no antioxidant groups (1.21, 0.78 to 1.89). Conclusion This trial does not provide evidence to support the use of aspirin or antioxidants in primary prevention of cardiovascular events and mortality in the population with diabetes studied. Trial registration Current Controlled Trials ISRCTN53295293. |
| ISSN | 09598138 |
| e-ISSN | 17561833 |
| Journal | BMJ (British Medical Journal) |
| Volume Number | 337 |
| Language | English |
| Publisher | British Medical Journal Publishing Group |
| Publisher Date | 2008-10-01 |
| Publisher Place | Great Britain (UK) |
| Access Restriction | Open |
| Subject Keyword | Antioxidants Therapeutic Use Aspirin Diabetes Mellitus, Type 1 Prevention & Control Diabetes Mellitus, Type 2 Diabetic Angiopathies Peripheral Vascular Diseases Platelet Aggregation Inhibitors Disease Progression Double-Blind Method Drug Therapy, Combination Kaplan-Meier Estimate Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't Medicine |
| Content Type | Text |
| Resource Type | Article |
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