Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Low-Dose Aspirin & CV Risk in T2D Patients

Circulation; 2017 Feb 14; Saito, Okada, et al

The risk for cardiovascular (CV) events in patients with type 2 diabetes (T2D) was not affected by low-dose aspirin dosage but an increased risk for gastrointestinal bleeding was observed, in a recent study. The JPAD trial was a randomized, open-label, standard-care-controlled trial examining whether low-dose aspirin affected CV events in 2,539 patients in Japan with T2D and without preexisting CV disease. Patients were randomly allocated to receive aspirin (81 or 100 mg daily; aspirin group) or no aspirin (no-aspirin group). Median follow-up was 10.3 years. Researchers found:

  • Low-dose aspirin did not reduce CV events in the per-protocol cohort (HR, 1.14); similar results were observed after adjustments for age, sex, glycemic control, kidney function, smoking status, hypertension, and dyslipidemia.
  • Gastrointestinal bleeding occurred significantly more often, in 25 patients (2%) in the aspirin group and 12 (0.9%) in the no-aspirin group (p=0.03).
  • Incidence of hemorrhagic stroke was not different between the groups.


Saito Y, Okada S, Ogawa H, et al. Low-dose aspirin for primary prevention of cardiovascular events in patients with type 2 diabetes mellitus: 10-year follow-up of a randomized controlled trial. Circulation. 2017;135:659–670. doi:10.1161/CIRCULATIONAHA.116.025760.


The US Preventive Services Task Force (USPSTF) recommends low-dose aspirin therapy for primary prevention of cardiovascular events in adults 50 to 59 years of age who have a ≥10%, 10-year cardiovascular disease risk and who are not at increased risk for bleeding.1 This recommendation is based on clinical trials for primary prevention where aspirin has shown beneficial effects in preventing cardiovascular events in general high CV risk populations. In addition to the trial in patients with diabetes reviewed above, 1 other randomized trial also failed to show efficacy of low-dose aspirin in primary prevention of CV events in patients with diabetes mellitus over 6.7 years of follow-up.2 It may be that people with diabetes respond differently to aspirin prophylaxis than people without diabetes due to increased platelet turnover and greater levels of aspirin resistance. Whatever the underlying reason may be, the current evidence does not seem to support the use of aspirin for cardiovascular risk modification in patients with diabetes. —Neil Skolnik, MD

  1. Bibbins-Domingo K; US Preventive Services Task Force. Aspirin use for the primary prevention of cardiovascular disease and colorectal cancer: US Preventive Services Task Force recommendation statement. Ann Intern Med. 2016;164:836–845. doi:10.7326/M16-0577.
  2. Belch J, MacCuish A, Campbell I, et al. Prevention of Progression of Arterial Disease and Diabetes Study Group; Diabetes Registry Group; Royal College of Physicians Edinburgh. The prevention of progression of arterial disease and diabetes (POPADAD) trial: factorial randomised placebo controlled trial of aspirin and antioxidants in patients with diabetes and asymptomatic peripheral arterial disease. BMJ. 2008;337:a1840. doi:10.1136/bmj.a1840.