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Primary prevention with daily low-dose aspirin did not reduce the overall risk for atherosclerotic events in elderly Japanese patients with cardiovascular (CV) risk factors, new data presented at the American Heart Association’s Scientific Sessions 2014 indicate.
Prevention of atherosclerotic cardiovascular diseases (ASCVD) has been an important public health issue because of the aging of the population and changes in lifestyle, the researchers noted.
Therefore, Yasuo Ikeda, MD, PhD, of the Waseda University in Tokyo, Japan, and colleagues conducted a multicenter, open-label, randomized, parallel-group trial that evaluated primary prevention of cardiovascular disease (CVD) with low-dose aspirin in older patients.
They included patients aged 60 to 85 years with hypertension, dyslipidemia and/or diabetes at 1,007 centers in Japan. The study was stopped early before the number of primary endpoint events was sufficient for the study to reach statistical power.
Specifically, the study was stopped once 400 of the estimated 624 events had occurred.
The researchers reported that their results suggest that the clinical importance of aspirin in the primary prevention of CV events is less than originally anticipated in this patient population.
Study Specifics
The new findings come from the Japanese Primary Prevention Project (JPPP), which included 14,464 older adults who were randomly selected to receive enteric-coated aspirin 100 mg/day (n=7,220) or no aspirin (n=7,244). Mean age was about 70 years at the time of randomization.
For this investigation, the composite primary endpoint was death from CV causes, nonfatal stroke and nonfatal MI. Researchers conducted their final analysis after a median follow-up of 5.02 years.
Overall, aspirin was not associated with a significant reduction in total CV events in older patients with multiple CV risk factors.
Fifty-six events occurred in both the aspirin and no-aspirin groups. Results indicated that 5-year primary endpoint event rates were also not significantly different between groups (aspirin, 2.77% vs. no aspirin, 2.96%; HR=0.94 [95% CI, 0.77-1.15]).
