American Diabetes Association
DiabetesCare_ADAPTABLE-DM_Supplementary_Appendix.pdf (282.6 kB)

Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease and Diabetes Mellitus: A Subgroup Analysis of the ADAPTABLE Trial

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posted on 2023-09-15, 17:35 authored by Dennis I Narcisse, Hwasoon Kim, Lisa M. Wruck, Amanda L. Stebbins, Daniel Muñoz, Sunil Kripalani, Mark B. Effron, Kamal Gupta, R. David Anderson, Sandeep K. Jain, Saket Girotra, Jeff Whittle, Catherine P. Benziger, Peter Farrehi, Li ZhouLi Zhou, Tamar S Polonsky, Faraz S. Ahmad, Matthew T. Roe, Russell L. Rothman, Robert A. Harrington, Adrian F Hernandez, W. Schuyler Jones

Background: Patients with diabetes mellitus and concomitant atheterosclerotic cardiovascular disease (ASCVD) must be on the most effective dose of aspirin to mitigate risk of future adverse cardiovascular events.

Methods: ADAPTABLE, an open-label, pragmatic study, randomized patients with stable, chronic ASCVD to 81 mg or 325 mg of daily aspirin. The effects of aspirin dosing was assessed on the primary effectiveness outcome, a composite of all-cause death, hospitalization for myocardial infarction, or hospitalization for stroke, and the primary safety outcome of hospitalization for major bleeding. In this pre-specified analysis, we used Cox proportional hazards models to compare aspirin dosing in patients with and without DM for the primary effectiveness and safety outcome.

Results: Of 15,076 patients, 5,676 (39%) had DM of which 2,820 (49.7%) were assigned to 81 mg and 2,856 (50.3%) to 325 mg of aspirin. Patients with vs. without DM had higher rates of the composite cardiovascular outcome (9.6% vs 5.9%, p < 0.001) and bleeding events (0.78% vs 0.50%, p < 0.001). When comparing 81 mg vs. 325 mg of aspirin, patients with DM had no difference in the primary effectiveness outcome (9.3% vs 10.0%; HR 0.98; 95% CI 0.83-1.16, p = 0.265) or safety outcome (0.87% vs 0.69%; subdistribution HR 1.25; 95% CI 0.72 – 2.16, p = 0.772).

Conclusions: This study confirms the inherently higher risk of patients with DM irrespective of aspirin dosing. Our findings suggest higher dose of aspirin yields no added clinical benefit even in a more vulnerable population


This work was supported through a Patient-Centered Outcomes Research Institute (PCORI) Award (ASP-1502-27029). All statements in this report, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors, or its Methodology Committee.