Michael E. Farkouh, MD, MSc
In patients with diabetes and asymptomatic peripheral arterial disease, do aspirin or antioxidants reduce risk for cardiovascular (CV) events?
Randomized, 2 × 2 factorial, placebo-controlled trial. Current Controlled Trials ISRCTN53295293.
Blinded (patients, clinicians, data collectors, and outcome adjudication committee).*
Median 7 years.
16 hospitals and 188 primary care groups in Scotland, UK.
1276 patients ≥ 40 years of age (mean age 60 y, 56% women) who had type 1 or 2 diabetes, asymptomatic peripheral arterial disease (ankle–brachial pressure index ≤ 0.99), and no symptomatic CV disease. Exclusion criteria included regular use of study medications, contraindication to aspirin, and serious physical or psychiatric illness.
Aspirin, 100 mg, plus antioxidant capsule (n = 320); aspirin plus placebo (n = 318); placebo plus antioxidant capsule (n = 320); or placebo plus placebo (n = 318). Additional CV risk reduction therapy, as appropriate, was encouraged.
A composite of death from coronary heart disease or stroke, nonfatal myocardial infarction (MI) or stroke, or amputation for critical limb ischemia; a composite of death from coronary heart disease or stroke; and all-cause death. The trial had 73% power to detect a 25% relative reduction in event rate.
99% (intention-to-treat analysis).
Neither aspirin nor antioxidants reduced risk for any outcome compared with the corresponding placebo group (Table). Risk for all-cause death was increased in the antioxidant group (Table). No evidence of interaction between drugs was found.
In patients with diabetes and asymptomatic peripheral arterial disease, aspirin and antioxidants (separately or combined) did not reduce risk for cardiovascular events.
Aspirin or antioxidants vs placebo in patients with diabetes and asymptomatic peripheral arterial disease†
†CHD = coronary heart disease; other abbreviations defined in Glossary. RRR, RRI, NNT, NNH, and CI calculated from hazard ratios in article.
‡Death from CHD or stroke, nonfatal myocardial infarction or stroke, or amputation for critical limb ischemia.
Farkouh ME. Aspirin and/or antioxidants did not prevent CV events in diabetes and peripheral arterial disease. Ann Intern Med. ;150:JC1–8. doi: 10.7326/0003-4819-150-2-200901200-02008
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Published: Ann Intern Med. 2009;150(2):JC1-8.
Cardiology, Coronary Risk Factors, Diabetes, Endocrine and Metabolism, Prevention/Screening.
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