Table 1.
Comparison of trials of primary prevention for coronary heart disease in patients with diabetes mellitus
| Study | Aspirin dose (mg)* |
Follow-up (years) |
Patients with DM |
Mean age |
CHD endpoint |
CHD endpoint event rate (control % vs aspirin %) |
10-year extrapolated CHD event rates (%)‡ |
CHD events RR (95% CI)§ |
Stroke events (control vs aspirin) with RR (95% CI) |
|---|---|---|---|---|---|---|---|---|---|
| TPT9 | 75 | 6.7 | 68 | 58 | MCE | 15.4 vs 13.8 | 23.0 vs 20.6 | 0.90 (0.28–2.89) |
2 vs 1 0.67 (0.06–7.06) |
| HOT9 | 75 | 3.8 | 1,501 | 62 | MCE | 3.6 vs 2.8 | 9.5 vs 7.3 | 0.77 (0.44–1.36) |
24 vs 22 0.91 (0.52–1.61) |
| JPAD7 | 81–100 | 4.4 | 2,539 | 65 | Fatal and nonfatal MI |
1.1 vs 1.0 | 2.5 vs 2.3 | 0.87 (0.40–1.87) |
32 vs 28 0.89 (0.54–1.46) |
| POPADAD8 | 100 | 6.7 | 1,276 | 60 | CHD death and nonfatal MI |
12.9 vs 13.9 | 19.3 vs 20.7 | 1.09 (0.82–1.44) |
50 vs 37 0.74 (0.49–1.12) |
| PPP50∥ | 100 | 3.7 | 1,031 | 64 | Fatal and nonfatal MI |
2.0 vs 1.0 | 5.4 vs 2.7 | 0.49 (0.17–1.43) |
11 vs 10 0.90 (0.38–2.09) |
| WHS5∥ | 100 mg every other day |
10.1 | 1,027 | 55 | Fatal and nonfatal MI |
5.9 vs 7.9 | 5.9 vs 7.9 | 1.34 (0.85–2.12) |
31 vs 15 0.45 (0.25–0.82) |
| PHS46∥ | 325 mg every other day |
5.0 | 533 | NA | Fatal and nonfatal MI |
10.5 vs 6.2 | 21 vs 12.4 | 0.59 (0.33–1.06) |
10 vs 16 1.50 (0.69–3.25) |
| BMD9 | 500 | 5.6 | 101 | NA | MCE | 18.8 vs 18.8 | 33.48 vs 33.6 | 1.00 (0.42–2.40) |
1 vs 0 1.39 (0.15–12.86) |
| ETDRS41 | 650 | 5.0 | 3,711 | NA | Fatal and nonfatal MI |
15.3 vs 13.0 | 30.6 vs 26.0 | 0.85 (0.73–1.00) |
78 vs 92 1.18 (0.88–1.58) |
Daily dose, unless specified otherwise.
The 10-year extrapolated coronary heart disease event rate was calculated by (10 ÷ study duration) × event rate.
Based on event counts.
Values slightly different from original reports based on updated information.9
Abbreviations: BMD, British Medical Doctors study; CHD, coronary heart disease; DM, diabetes mellitus; ETDRS, Early Treatment of Diabetic Retinopathy trial; HOT, Hypertension Optimal Treatment; JPAD, Japanese Prevention of Atherosclerosis with Aspirin in Diabetes trial; MCE, major coronary event (CHD death or nonfatal MI or sudden death); MI, myocardial infarction; NA, not applicable; PHS, Physicians Health Study; POPADAD, Prevention of Progression of Arterial Disease and Diabetes trial; PPP, Primary Prevention Project; RR, relative risk; TPT, Thrombosis Prevention Trial; vs, versus; WHS, Womens Health Study. Adapted with permission from the American Diabetes Association © Pignone, M. et al. Diabetes Care 33, 1395–1402 (2010).