JPPP
(2014)Objective
Evaluate whether daily low-dose aspirin reduces cardiovascular events in elderly Japanese individuals with risk factors but no known cardiovascular disease.
Study Summary
• In elderly Japanese patients (60–85 years) with hypertension, dyslipidemia, or diabetes but no history of cardiovascular disease, low-dose aspirin did not significantly reduce the primary composite endpoint of cardiovascular death, nonfatal stroke, and nonfatal myocardial infarction. Aspirin increased the risk of gastrointestinal bleeding. These findings do not support routine aspirin use for primary prevention in similar populations.
Intervention
Randomized, open-label, blinded-endpoint trial conducted in Japan. N=14,464 patients (60–85 years) with hypertension, diabetes, or dyslipidemia and no prior cardiovascular disease. Randomized to: • Aspirin 100 mg daily • No aspirin (control group) Median follow-up: 5.02 years.
Study Design
Arms: Array
Outcome
• Primary composite outcome: 2.77% (aspirin) vs. 2.96% (control); HR 0.94; 95% CI 0.77–1.15; p=0.54
• Gastrointestinal bleeding: significantly higher in aspirin group (HR 1.85; 95% CI 1.22–2.81; p=0.004)
• No significant difference in hemorrhagic stroke or cancer incidence
• Trial was stopped early due to futility
• Supports reevaluation of aspirin use for primary prevention in elderly Asians
• Gastrointestinal bleeding: significantly higher in aspirin group (HR 1.85; 95% CI 1.22–2.81; p=0.004)
• No significant difference in hemorrhagic stroke or cancer incidence
• Trial was stopped early due to futility
• Supports reevaluation of aspirin use for primary prevention in elderly Asians