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Cited by 776Antiplatelet Therapy and Cardiovascular DiseasesDiabetes, Cardiovascular Risks, and LipoproteinsInflammatory mediators and NSAID effects

Low-Dose Aspirin for Primary Prevention of Atherosclerotic Events in Patients With Type 2 Diabetes<subtitle>A Randomized Controlled Trial</subtitle>

Ogawa, Hisao·2008·JAMA
DOI 10.1001/jama.2008.623
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Abstract

CONTEXT: Previous trials have investigated the effects of low-dose aspirin on primary prevention of cardiovascular events, but not in patients with type 2 diabetes. OBJECTIVE: To examine the efficacy of low-dose aspirin for the primary prevention of atherosclerotic events in patients with type 2 diabetes. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, prospective, randomized, open-label, blinded, end-point trial conducted from December 2002 through April 2008 at 163 institutions throughout Japan, which enrolled 2539 patients with type 2 diabetes without a history of atherosclerotic disease and had a median follow-up of 4.37 years. INTERVENTIONS: Patients were assigned to the low-dose aspirin group (81 or 100 mg per day) or the nonaspirin group. MAIN OUTCOME MEASURES: Primary end points were atherosclerotic events, including fatal or nonfatal ischemic heart disease, fatal or nonfatal stroke, and peripheral arterial disease. Secondary end points included each primary end point and combinations of primary end points as well as death from any cause. RESULTS: A total of 154 atherosclerotic events occurred: 68 in the aspirin group (13.6 per 1000 person-years) and 86 in the nonaspirin group (17.0 per 1000 person-years) (hazard ratio [HR], 0.80; 95% confidence interval [CI], 0.58-1.10; log-rank test, P = .16). The combined end point of fatal coronary events and fatal cerebrovascular events occurred in 1 patient (stroke) in the aspirin group and 10 patients (5 fatal myocardial infarctions and 5 fatal strokes) in the nonaspirin group (HR, 0.10; 95% CI, 0.01-0.79; P = .0037). A total of 34 patients in the aspirin group and 38 patients in the nonaspirin group died from any cause (HR, 0.90; 95% CI, 0.57-1.14; log-rank test, P = .67). The composite of hemorrhagic stroke and significant gastrointestinal bleeding was not significantly different between the aspirin and nonaspirin groups. CONCLUSION: In this study of patients with type 2 diabetes, low-dose aspirin as primary prevention did not reduce the risk of cardiovascular events. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00110448.

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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 [6]

  • Several studies have suggested that a comprehensive and intensive therapy for risk factors, combined with lifestyle modification and drug therapy, has a protective effect on ASCVD.

    “Several studies have suggested that a comprehensive and intensive therapy for the risk factors, combined with lifestyle modification and drug therapy, has a protective effect on ASCVD.”

    From Japan Atherosclerosis Society (JAS) guidelines for prevention of atherosclerotic cardiovascular diseases 2017 (2018) · cites this paper as [823]

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Authors
Ogawa, H.
Affiliations
Kumamoto University (JP)
Corresponding author
Ogawa, Hisao
ORCID
Ogawa, Hisao
Venue
JAMA
Publisher
American Medical Association (AMA)
Published
2008-11-12
Volume
300
Issue
18
Pages
2134
ISSN
  • 0002-9955 (ISSN-L)
  • 0098-7484
DOI
10.1001/jama.2008.623
OpenAlex
W2050820265
Cited by
776
References
32
Citations by year
2026: 7 · 2025: 11 · 2024: 13 · 2023: 18 · 2022: 27 · 2021: 30 · 2020: 28 · 2019: 67 · 2018: 37 · 2017: 32 · 2016: 48 · 2015: 39 · 2014: 54 · 2013: 50 · 2012: 70
FWCI
58.92
Type
journal article
Language
en
Open access
closed
Locations
  • JAMA (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Antiplatelet Therapy and Cardiovascular Diseases
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
  • Health Sciences › Medicine › Pharmacology › Inflammatory mediators and NSAID effects
Keywords
low-dose aspirin, type 2 diabetes, primary prevention, atherosclerotic events, cardiovascular disease, myocardial infarction, stroke, peripheral arterial disease, hemorrhagic stroke, gastrointestinal bleeding, bleeding risk, mortality, cardiovascular risk reduction, antiplatelet therapy, statins, ACE inhibitors, beta-blockers, antihypertensive drugs, cardiovascular risk stratification
MeSH terms
Adult, Aged, Aged, 80 and over, Aspirin, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Diabetic Angiopathies, Double-Blind Method, Female, Humans, Male, Middle Aged, Platelet Aggregation Inhibitors, Atherosclerosis

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