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JPAD: Low-dose aspirin did not prevent CV events in Japanese patients with type 2 diabetes
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Low-dose aspirin did not reduce the risk for cardiovascular events in patients with type 2 diabetes, according to results of the JPAD study.
JPAD, the Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes study, was a randomized, open-label trial that ran from December 2002 through April 2008. Researchers enrolled 2,539 patients with type 2 diabetes and with no history of atherosclerotic disease. Patients were randomly assigned to a low-dose aspirin group (n=1,262) receiving 81 mg or 100 mg of aspirin daily and a group receiving no aspirin (n=1,277). Primary endpoints were atherosclerotic events: fatal or nonfatal ischemic heart disease, fatal or nonfatal stroke and peripheral artery disease.
According to the researchers, a total of 154 atherosclerotic events occurred within the study population, with 68 (13.6 per 1,000 person years) occurring in the low-dose aspirin group and 86 (17.0 per 1,000 person years) in the non-aspirin group (HR=0.80; 95% CI, 0.58-1.10).
They also reported that the combined primary endpoint of fatal coronary events and fatal cerebrovascular events occurred in one patient (stroke) in the low-dose aspirin group and in 10 patients in the non-aspirin group (HR=0.10; 95% CI, 0.01-0.79). There were not significant differences between the two groups for secondary endpoints.
In a subgroup analysis of 1,363 patients over 65 years of age, the results suggested that the incidence of atherosclerotic events was lower in the aspirin group (45 events, 6.3%) compared with those in the non-aspirin group (59 events, 9.2%; HR=0.68; 95% CI, 0.46-0.99).
“JPAD, the largest primary prevention trial of aspirin in type 2 diabetes, although not significant for the primary endpoint, suggests an effect of low-dose aspirin on fatal events in all subjects and on total events in older patients,” Hisao Ogawa, MD, a cardiologist at Kumamato University in Kumamato, Japan, said in a press conference. “JPAD supports the safety of using low-dose aspirin in diabetics for primary prevention.”
During the discussant portion of the press conference, Marian Limacher, MD, professor of medicine at the University of Florida, emphasized the importance of studying any potential effects of aspirin in women within the JPAD population, as has been done in smaller but similar studies.
“There is the potential for a differential effect of aspirin in women and men as has been previously demonstrated, and it would be interesting to evaluate the individual effect of aspirin in the JPAD population for MI and stroke in both men and women,” Limacher said.
For more information:
- Ogawa H, Nakayama M, Uemura S, et al. Low-dose aspirin for primary prevention of atheroscoerotic events in patients with type 2 diabetes: A randomized controlled trial. JAMA. 2008;300:2134-2141.