Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease and Diabetes Mellitus: A Subgroup Analysis of the ADAPTABLE Trial
Primary result · Primary effectiveness outcome in patients with DMResult — go to the resultHazard ratio 0.98 95% CI 0.83–1.16Authors' conclusion
This study confirms the inherently higher risk of patients with DM irrespective of aspirin dosing. Our findings suggest that a higher dose of aspirin yields no added clinical benefit, even in a more vulnerable population.
Study context
- Population
- Patients with stable, chronic atherosclerotic cardiovascular disease (ASCVD), with and without diabetes mellitus (DM)5,676 with DM
- Participants
- 15,076 patients
- Comparison
- Aspirin 81 mg vs 325 mg daily in patients with and without DM
- 81 mgn = 2,820
- 325 mgn = 2,856reference
- Primary endpoint
- Composite of all-cause death, hospitalization for MI or hospitalization for stroke; primary safety outcome: hospitalization for major bleeding
Methodological detailsopen-label, pragmatic, prespecified subgroup analysis
- Open-label
- Pragmatic
- Prespecified subgroup analysis
Primary result
As reported in the abstract
Primary effectiveness outcome in patients with DM
Hazard ratio
0.98
95% CI 0.83–1.16
P = 0.265
By group
81 mgvs 325 mg
HR 0.98 (95% CI 0.83–1.16); P = 0.265
Further findings
Composite CV outcome, DM vs no DM
P < 0.001
Safety
| Outcome | 81 mg | 325 mg | Subdistribution HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Primary safety outcome (hospitalization for major bleeding) in patients with DM | 0.87% | 0.69% | 1.25 (0.72–2.16) | P = 0.772 | |
| 0.512Subdistribution hazard ratio (log scale) |
| Outcome | P value |
|---|---|
| Bleeding events, DM vs no DM | P < 0.001 |
- Bleeding events, DM vs no DM: DM 0.78%
- Bleeding events, DM vs no DM: No DM 0.50%
Original publication
Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease and Diabetes Mellitus: A Subgroup Analysis of the ADAPTABLE Trial. Diabetes Care. Published 15 September 2023. doi:10.
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