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Low-dose aspirin did not prevent cardiovascular events in patients with type 2 diabetes
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Daily low-dose aspirin did not reduce the risk for cardiovascular events in patients with type 2 diabetes compared with patients who did not receive aspirin.
Researchers conducted the Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes Trial — a multicenter, prospective, randomized, open-label, blinded trial at 163 institutions throughout Japan. The study included 2,539 patients with type 2 diabetes and no history of atherosclerotic disease.
Patients were enrolled between December 2002 and April 2008, and were followed for a median of 4.37 years. The researchers randomly assigned 1,262 patients to receive 81 mg or 100 mg per day of aspirin and the remaining patients received no aspirin. During follow-up, 154 atherosclerotic events occurred, including 68 in the aspirin group (13.6 per 1,000 person-years) and 86 in the nonaspirin group (17 per 1,000 person-years; P=.16).
For the combined endpoint of fatal coronary events and fatal cerebrovascular events, one patient in the aspirin group had a stroke, five patients in the non-aspirin group had fatal myocardial infarctions and five in the non-aspirin group had fatal strokes (P=.0037). Overall, 34 patients in the aspirin group and 38 in the nonaspirin group died from any cause (P=.67).
The researchers found no significant difference between the two groups for the composite of hemorrhagic stroke and significant gastrointestinal bleeding.
Although the overall analysis did not show a difference between the groups, a subgroup analysis of 1,363 patients aged 65 years or older revealed a lower incidence of atherosclerotic events in patients who received aspirin compared with those who did not receive aspirin — 6.3% vs. 9.2% (P=.047). – by Tina DiMarcantonio
JAMA. 2008;300:2134-2141.
The study did find a benefit in older persons with diabetes. Other recent trials have also not found clear benefits of low-dose aspirin in diabetes. For now, I will continue to recommend low dose aspirin in patients with type 2 diabetes aged 40 years or older who have no contraindications to its use and at least one other cardiac risk factor. However, I will tell them that the data is not that strong supporting its use in persons aged younger than 60 years.
– Roger S. Blumenthal, MD
Professor of Medicine and Director
The Johns Hopkins
Ciccarone Center for the Prevention of Heart Disease