Daily low-dose aspirin and incident type 2 diabetes in community-dwelling healthy older adults: a post-hoc analysis of efficacy and safety in the ASPREE randomised placebo-controlled trial
Primary result · Incident T2DResult — go to the resultHazard ratio 0.85 95% CI 0.75–0.97Authors' conclusion
Aspirin treatment reduced the incidence of type 2 diabetes and slowed the increase in FPG concentration but increased major bleeding among community-dwelling older adults. Given the increasing prevalence of type 2 diabetes among older adults, the potential for anti-inflammatory agents such as aspirin to prevent type 2 diabetes or improve glucose levels warrants further study with a comprehensive assessment of all potential safety events of interest.
Study context
- Population
- Community-dwelling adults aged ≥70 years (≥65 years for US minority ethnic groups), USA and Australia, free of CVD, independence-limiting physical disability or dementia; without diabetes at baseline
- Participants
- 16,209 adults
- Comparison
- Daily low-dose aspirin vs placebo
- Aspirinn = 8,086
- Placebon = 8,123reference
- Primary endpoint
- Incident T2D (self-reported diabetes, commencement of glucose-lowering medication, or fasting plasma glucose (FPG) ≥7.0 mmol/L at annual visits)
- Follow-up
- Median 4.7 years (IQR 3.6-5.7)
Methodological detailsdouble-blind, Enrolment between March 10, 2010, and Dec 24, 2014
- Double-blind
- Enrolment between March 10, 2010, and Dec 24, 2014
Primary result
Incident T2D · median follow-up 4.7 years
Hazard ratio
0.85
95% CI 0.75–0.97
P = 0.013
Events by treatment group
Aspirin
459
events
Placebo
536
events
Aspirinvs Placebo
HR 0.85 (95% CI 0.75–0.97); P = 0.013
As reported in the abstract
Further findings
| Outcome | Between-group difference estimate (mmol/L) (95% CI) | P value | |
|---|---|---|---|
| Rate of increase in FPG · year 5Slower increase with aspirin | −0.048 (−0.079 to −0.018) | P = 0.0017 | |
| −0.1−0.0500.05Difference, mmol/L (linear scale) |
Safety
| Outcome | Aspirin | Placebo | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Major bleeding (major gastrointestinal, intracranial, clinically significant bleeding at other sites)44% increase in risk | 3.7% | 2.6% | 1.44 (1.21–1.72) | P < 0.0001 | |
| 0.512Hazard ratio (log scale) |
- Major bleeding (major gastrointestinal, intracranial, clinically significant bleeding at other sites): participants who took ≥1 dose of study medication (n=16 104)
Original publication
Daily low-dose aspirin and incident type 2 diabetes in community-dwelling healthy older adults: a post-hoc analysis of efficacy and safety in the ASPREE randomised placebo-controlled trial. Lancet Diabetes Endocrinol. Published 21 December 2023. doi:10.
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