Key result
Low-dose aspirin lowers stroke risk in women but fails to reduce MI or CV death.
Why the study?
The effectiveness of low-dose aspirin for primary prevention of cardiovascular disease in women was uncertain.
Does low-dose aspirin prevent cardiovascular disease in women without a history of cardiovascular disease?
RCT (n=39,876)
Quadruple-blind
concealed
Yes
Does low-dose aspirin prevent cardiovascular disease in women without a history of cardiovascular disease?
In women aged 45 and older, low-dose aspirin every other day for primary prevention lowers the risk of stroke but does not significantly reduce the risk of myocardial infarction or cardiovascular death.
Supports targeted aspirin for stroke prevention in women; challenges uniform primary CVD prevention guidelines across sexes.
Ridker PM, Cook NR, Lee IM, et al . A randomized trial of low-dose aspirin in the primary prevention of cardiovascular disease in women. N Engl J Med 2005;352:1293–304. [OpenUrl][1][CrossRef][2][PubMed][3][Web of Science][4] Q Is low dose aspirin effective for the primary prevention of cardiovascular disease in women? Clinical impact ratings GP/FP/Primary care ★★★★★★☆ IM/Ambulatory care ★★★★★☆☆ Neurology ★★★★★★☆ Haematology ★★★★★★☆ ### ![Graphic][5] Design: randomised, placebo controlled trial (Women’s Health Study). ### ![Graphic][6] Allocation: {concealed*}†. ### ![Graphic][7] Blinding: blinded {healthcare providers, participants, data collectors, and outcome assessors}†.* ### ![Graphic][8] Follow up period: mean 10 years. ### ![Graphic][9] Setting: USA and Puerto Rico. ### ![Graphic][10] Participants: 39 876 women ⩾45 years of age (mean age 55 y) who had no history of coronary artery disease, cerebrovascular disease, cancer (except non-melanoma skin cancer), or other major chronic illness; contraindication to the study medications; were not taking aspirin, non-steroidal anti-inflammatory drugs, anticoagulants, or corticosteroids; and were not taking vitamin A or E, or ß carotene supplements more than once per week. ### ![Graphic][11] Intervention: aspirin, 100 mg every other day (n = 19 934) or placebo (n = 19 942). ### ![Graphic][12] Outcomes: first major cardiovascular event (non-fatal myocardial infarction, non-fatal stroke, or cardiovascular death); individual cardiovascular endpoints; and adverse events. ### ![Graphic][13] Patient follow up: 97% (intention to treat analysis). The table shows … [1]: {openurl}?query=rft.jtitle%253DN%2BEngl%2BJ%2BMed%26rft_id%253Dinfo%253Adoi%252F10.1056%252FNEJMoa050613%26rft_id%253Dinfo%253Apmid%252F15753114%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [2]: /lookup/external-ref?access_num=10.1056/NEJMoa050613&link_type=DOI [3]: /lookup/external-ref?access_num=15753114&link_type=MED&atom=%2Febmed%2F10%2F5%2F137.atom [4]: /lookup/external-ref?access_num=000227998300006&link_type=ISI [5]: /embed/inline-graphic-1.gif [6]: /embed/inline-graphic-2.gif [7]: /embed/inline-graphic-3.gif [8]: /embed/inline-graphic-4.gif [9]: /embed/inline-graphic-5.gif [10]: /embed/inline-graphic-6.gif [11]: /embed/inline-graphic-7.gif [12]: /embed/inline-graphic-8.gif [13]: /embed/inline-graphic-9.gif
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John W. Eikelboom (2005) conducted an RCT in primary prevention of cardiovascular disease (n=39,876). aspirin vs. placebo was evaluated on first major cardiovascular event (non-fatal myocardial infarction, non-fatal stroke, or cardiovascular death). Low dose aspirin lowered stroke risk but not risks of myocardial infarction or cardiovascular deaths in women.
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