Low-Dose Aspirin for Primary Prevention of Cardiovascular Events in Japanese Patients 60 Years or Older With Atherosclerotic Risk Factors: A Randomized Clinical Trial
Abstract
Importance Prevention of atherosclerotic cardiovascular diseases is an important public health priority in Japan due to an aging population. Objective To determine whether daily, low-dose aspirin reduces the incidence of cardiovascular events in older Japanese patients with multiple atherosclerotic risk factors. Design, setting, and participants The Japanese Primary Prevention Project (JPPP) was a multicenter, open-label, randomized, parallel-group trial. Patients (N = 14,464) were aged 60 to 85 years, presenting with hypertension, dyslipidemia, or diabetes mellitus recruited by primary care physicians at 1007 clinics in Japan between March 2005 and June 2007, and were followed up for up to 6.5 years, with last follow-up in May 2012. A multidisciplinary expert panel (blinded to treatment assignments) adjudicated study outcomes. Interventions Patients were randomized 1:1 to enteric-coated aspirin 100 mg/d or no aspirin in addition to ongoing medications. Main outcomes and measures Composite primary outcome was death from cardiovascular causes (myocardial infarction, stroke, and other cardiovascular causes), nonfatal stroke (ischemic or hemorrhagic, including undefined cerebrovascular events), and nonfatal myocardial infarction. Secondary outcomes included individual end points. Results The study was terminated early by the data monitoring committee after a median follow-up of 5.02 years (interquartile range, 4.55-5.33) based on likely futility. In both the aspirin and no aspir…
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The balance of benefits and hazards for the prevention of first cardiovascular events in patients with diabetes is unclear.
“Aspirin use reduces the risk of occlusive vascular events but increases the risk of bleeding; the balance of benefits and hazards for the prevention of first cardiovascular events in patients with diabetes is unclear.”
From Effects of aspirin for primary prevention in persons with diabetes mellitus (2018) · cites this paper as [7]
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References 31 · Cited by 301
- Authors
- Ikeda, Y., Shimada, K., Teramoto, T., Uchiyama, S., Yamazaki, T., Oikawa, S., Sugawara, M., Ando, K., Murata, M., Yokoyama, K., & Ishizuka, N.
- Affiliations
- Waseda University (JP)
- Shin-Oyama City Hospital (JP)
- Teikyo University (JP)
- International University of Health and Welfare (JP)
- University of Tokyo Hospital (JP)
- Fukujuji Hospital (JP)
- Department of Internal Medicine, Sugawara Medical Clinic, Tokyo, Japan
- Department of Internal Medicine, Kitamura Memorial Clinic, Tokyo, Japan
- Keio University (JP)
- Tokai University Hachioji Hospital (JP)
- The Cancer Institute Hospital (JP)
- ORCID
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2014-12-17
- Volume
- 312
- Issue
- 23
- Pages
- 2510
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W2100012557
- Cited by
- 301
- References
- 31
- Citations by year
- 2026: 11 · 2025: 7 · 2024: 15 · 2023: 20 · 2022: 21 · 2021: 22 · 2020: 21 · 2019: 47 · 2018: 27 · 2017: 26 · 2016: 42 · 2015: 37 · 2014: 5
- FWCI
- 25.15
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Japan Society for the Promotion of Science (23249030)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Antiplatelet Therapy and Cardiovascular Diseases
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Pharmacology › Inflammatory mediators and NSAID effects
- Keywords
- low-dose aspirin, primary prevention, cardiovascular events, atherosclerotic cardiovascular disease, older adults, Japanese patients, hypertension, dyslipidemia, diabetes mellitus, stroke, myocardial infarction, cardiovascular mortality, futility, antiplatelet therapy, population aging, cardiovascular risk factors
- MeSH terms
- Aged, Aged, 80 and over, Aspirin, Cardiovascular Diseases, Diabetes Mellitus, Double-Blind Method, Female, Hemorrhage, Humans, Hypertension, Japan, Male, Middle Aged, Myocardial Infarction, Platelet Aggregation Inhibitors, Primary Prevention, Risk Factors, Survival Analysis, Dyslipidemias
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