By Charlene Laino
NEW ORLEANS -- November 10, 2008 -- Low-dose aspirin significantly reduced the incidence of atherosclerotic events among patients aged 65 years and older with diabetes, investigators reported at the American Heart Association (AHA) Scientific Sessions.
Use of low-dose aspirin, however, did not reduce the risk of total atherosclerotic events in other patients enrolled in the study, said Hisao Ogawa, MD, PhD, Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
The results of the multicentre, prospective, randomised, open-label, blinded trial were presented here on November 9 and published simultaneously online in the Journal of the American Medical Association [JAMA. 2008;300(18). DOI:10.1001/jama.2008.623].
Dr. Ogawa said his group initiated the study because "clinical trial data for aspirin in the primary prevention of cardiovascular events among patients with diabetes are limited."
The study involved 2,539 patients with type 2 diabetes aged 30 to 85 years with no history of atherosclerotic disease. From December 2002 through May 2005, a total of 1,262 patients were randomised to daily low-dose aspirin (81 or 100 mg); 1,277 patients were assigned to no aspirin.
At a median follow-up of 4.37 years, 154 atherosclerotic events had occurred: 68 in the aspirin group (13.6 per 1,000 person-years) and 80 in the no-aspirin group (17.0 per 1,000 years). This translated to a nonsignificant 20% reduction in overall atherosclerotic events in the aspirin group [95% confidence interval (CI), 0.58-1.10; log-rank test, P = .16].
Among patients aged 65 and older, there was a significant 32% reduction in the risk of atherosclerotic events (HR 0.68, 95% CI 0.46-0.99).
Among all patients, there was a significant reduction in the secondary combined end point of fatal coronary and cerebrovascular events. There was 1 stroke in the aspirin group versus 5 fatal myocardial infarctions and 5 fatal strokes in the no-aspirin group (P = .0037).
In the safety evaluation, rates of the composite end point of haemorrhagic stroke and severe gastrointestinal bleeding were not significantly different between the treatment groups, Dr. Ogawa said.
"Our results indicate that aspirin is safe and effective for the primary prevention of fatal events in all subjects and of total events in older patients," Dr. Ogawa concluded.
[Presentation title: Efficacy of Low-Dose Aspirin Therapy for the Primary Prevention of Atherosclerotic Events in Type 2 Diabetes Patients: The Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) Trial. Late Breaking Abstract 163]
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