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
Primary result · CV eventsResult — go to the resultHazard ratio 1.14 95% CI 0.91–1.42Authors' conclusion
Low-dose aspirin did not affect the risk for cardiovascular events but increased risk for gastrointestinal bleeding in patients with type 2 diabetes mellitus in a primary prevention setting.
Study context
- Population
- Japanese patients with T2DM without preexisting CVD (primary prevention)2,160 (85%) per-protocol
- Participants
- 2,539 patients
- Comparison
- Low-dose aspirin vs no aspirin
- Primary endpoint
- CV events:
- Sudden death
- Fatal or nonfatal CAD
- Fatal or nonfatal stroke
- Peripheral vascular disease
- Follow-up
- Median 10.3 years
Methodological detailsopen-label, standard care-controlled, 1621 patients (64%) followed up throughout the study, Trial ended 2008; follow-up continued until 2015 without changing assigned therapy
- Open-label
- Standard care-controlled
- 1621 patients (64%) followed up throughout the study
- Trial ended 2008; follow-up continued until 2015 without changing assigned therapy
Primary result
CV events · median 10.3 years
Hazard ratio
1.14
95% CI 0.91–1.42
Aspirin vs No-aspirin
HR 1.14 (95% CI 0.91–1.42)
As reported in the abstract
Further findings
Cardiovascular events, multivariable Cox model (per-protocol cohort)
- Adjusted for age, sex, glycemic control, kidney function, smoking status, hypertension, dyslipidemia: similar results, HR
- 1.04 (0.83-1.30) (95% CI)
- No heterogeneity of efficacy in subgroup analyses by each factor
- all interaction P>0.05
Cardiovascular events, sensitivity analysis (ITT cohort)
- Consistent results, HR
- 1.01 (0.82-1.25) (95% CI)
- Intention-to-treat
Safety
Gastrointestinal bleeding
P = 0.03
Gastrointestinal bleeding
- Hemorrhagic stroke incidence not different between groups
Original publication
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. Published 15 November 2016. doi:10.
Summarised from the published abstract; every number is checked against it