Cited by 106Antiplatelet Therapy and Cardiovascular DiseasesFatty Acid Research and HealthInflammatory mediators and NSAID effects

ASCEND: A Study of Cardiovascular Events iN Diabetes: Characteristics of a randomized trial of aspirin and of omega-3 fatty acid supplementation in 15,480 people with diabetes

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Bowman, Louise, Mafham, Marion, Stevens, William, Haynes, Richard, Aung, Theingi, Chen, Fang, Buck, Georgina, Collins, Rory +1 more·2018·American Heart Journal

Abstract

OBJECTIVES: The use of aspirin for the secondary prevention of cardiovascular disease (CVD) is firmly established, and the proportional reductions in heart attacks and strokes appear to be similar in people with and without diabetes. Uncertainty remains about the role of antiplatelet treatments for primary prevention of CVD, and guidelines vary in their recommendations. It has also been hypothesized that long-term aspirin can prevent gastro-intestinal and other cancers. Observational studies suggest associations between higher intakes of omega-3 fatty acids (FA) and lower rates of CVD, but there is no large-scale randomized evidence to support using prophylactic omega-3 FA supplementation in primary prevention. ASCEND is a randomized trial assessing whether 100 mg daily aspirin safely prevents CVD and cancer in patients with diabetes without known arterial disease. It is also assessing whether supplementation with 1 g omega-3 FA daily prevents CVD. This paper describes the methods and baseline characteristics of the randomized participants. METHODS AND RESULTS: Between 2005 and 2011, using mail-based methods, 15,480 people with diabetes were randomized to aspirin versus placebo and, in a factorial design, to omega-3 FA supplementation versus placebo. Blood and urine samples were collected to allow baseline stratification by biochemical prognostic variables (e.g. HbA1c, blood lipids). Follow-up is for a median of at least 7 years. CONCLUSIONS: Demonstrating that prophylactic aspirin safely reduces the risk of CVD or cancer in the primary prevention setting, or that omega-3 FA supplementation prevents CVD, would be relevant to hundreds of millions of people worldwide who are currently not receiving such therapies. The results of ASCEND will be reported in 2018.

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  • The data analysis plan was finalized by the steering committee and was published while all the members were still unaware of the trial results according to group assignment (except for the statistician, who was aware of these assignments and who was not involved in development of the data analysis plan).

    “The data analysis plan was finalized by the steering committee and was published 16 while all the members were still unaware of the trial results according to group assignment (except for the statistician, who was aware of these assignments and who was not involved in development of the data analysis plan).”

    From Effects of aspirin for primary prevention in persons with diabetes mellitus (2018) · cites this paper as [16]

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  • The ASCEND trial, conducted in 15,480 diabetic patients without known cardiovascular disease, failed to show significant reductions in major cardiovascular events with EPA + DHA supplementation.

    “Similarly, both the ASCEND trial [90], conducted in 15,480 diabetic patients without known cardiovascular disease, and the VITAL study [91], which included > 25,000 healthy individuals, failed to show significant reductions in major cardiovascular events with EPA + DHA supplementation.”

    From Targeting triglycerides for cardiovascular risk reduction (2026) · cites this paper as [90]

    The Methods (Objectives) confirm that ASCEND enrolled people with diabetes without known arterial disease and tested EPA+DHA supplementation. But the Abstract (Conclusions) says ASCEND’s results would be reported in 2018; this paper does not report whether supplementation significantly reduced major cardiovascular events. The nonsignificant result in the omega-3 discussion concerns a meta-analysis of other trials, not ASCEND. (LLM, conf=0.90)

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Authors
Bowman, L., Mafham, M., Stevens, W., Haynes, R., Aung, T., Chen, F., Buck, G., Collins, R., & Armitage, J.
Affiliations
  • University of Oxford (GB)
  • Royal Berkshire Hospital (GB)
Corresponding author
Bowman, Louise
Venue
American Heart Journal
Publisher
Elsevier BV
Published
2018-04
Volume
198
Pages
135-144
ISSN
0002-8703 (ISSN-L)
OpenAlex
W2779357131
Cited by
106
References
39
Citations by year
2026: 5 · 2025: 13 · 2024: 14 · 2023: 11 · 2022: 16 · 2021: 13 · 2020: 13 · 2019: 12 · 2018: 8
FWCI
6.98
Type
journal article
Language
en
Open access
Locations
  • American Heart Journal (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
Funders
  • National Institute for Health and Care Research
  • British Heart Foundation (SP/08/010/25939, SP/14/3/31114)
Topics
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Antiplatelet Therapy and Cardiovascular Diseases
  • Health Sciences › Nursing › Nutrition and Dietetics › Fatty Acid Research and Health
  • Health Sciences › Medicine › Pharmacology › Inflammatory mediators and NSAID effects
Keywords
aspirin, omega-3 fatty acids, diabetes mellitus, cardiovascular disease prevention, primary prevention, antiplatelet therapy, cancer prevention, gastrointestinal bleeding, factorial trial, baseline characteristics, HbA1c, serum lipids
MeSH terms
Aged, Aspirin, Cardiovascular Diseases, Diabetes Mellitus, Dose-Response Relationship, Drug, Drug Administration Schedule, Female, United Kingdom, Humans, Male, Middle Aged, Prognosis, Reference Values, Retrospective Studies, Fatty Acids, Omega-3, Survival Rate, Treatment Outcome, Risk Assessment, Patient Selection, Secondary Prevention

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