Table 2.
Numbers (percentages) of patients with diabetes who experienced primary end points, secondary end points, and specific adverse events
Variable | Aspirin plus antioxidant (n=320) | Aspirin plus placebo (n=318) | Placebo plus antioxidant (n=320) | Placebo plus placebo (n=318) | P value (interaction*) |
---|---|---|---|---|---|
Primary end points: | |||||
Composite end point† | 58 (18) | 58 (18) | 59 (18) | 57 (18) | 0.92 |
Death from coronary heart disease or stroke | 23 (7) | 20 (6) | 19 (6) | 16 (5) | 0.90 |
Secondary end points: | |||||
Death (any cause) | 56 (18) | 38 (12) | 59 (18) | 42 (13) | 0.93 |
Death from coronary heart disease | 15 (5) | 20 (6) | 15 (5) | 11 (4) | 0.24 |
Stroke death | 8 (3) | 0 (0) | 4 (1) | 5 (2) | 0.004 |
Non-fatal myocardial infarction | 21 (7) | 34 (11) | 28 (9) | 28 (9) | 0.20 |
Non-fatal stroke | 18 (6) | 11 (4) | 18 (6) | 23 (7) | 0.14 |
Above ankle amputation for critical limb ischaemia | 6 (2) | 5 (2) | 4 (1) | 5 (2) | 0.69 |
Transient ischaemic attack | 3 (1) | 11 (4) | 8 (3) | 12 (4) | 0.25 |
Coronary artery bypass surgery | 4 (1) | 6 (2) | 8 (3) | 8 (3) | 0.61 |
Coronary artery angioplasty | 3 (1) | 4 (1) | 4 (1) | 4 (1) | 0.78 |
Development of angina | 31 (10) | 39 (12) | 38 (12) | 40 (13) | 0.59 |
Peripheral arterial bypass surgery | 3 (1) | 4 (1) | 1 (0.3) | 4 (1) | 0.44 |
Peripheral arterial angioplasty | 6 (2) | 5 (2) | 6 (2) | 7 (2) | 0.71 |
Development of critical limb ischaemia | 13 (4) | 8 (3) | 9 (3) | 10 (3) | 0.37 |
Development of claudication | 39 (12) | 58 (18) | 58 (18) | 49 (15) | 0.032 |
Adverse events: | |||||
Malignancy | 29 (9) | 24 (8) | 36 (11) | 32 (10) | 0.85 |
Gastrointestinal bleeding | 15 (5) | 13 (4) | 13 (4) | 18 (6) | 0.36 |
Gastrointestinal symptoms including dyspepsia | 33 (10) | 40 (13) | 36 (11) | 58 (18) | 0.31 |
Arrhythmia | 28 (9) | 27 (9) | 22 (7) | 25 (8) | 0.67 |
Allergy, including skin rash | 34 (11) | 38 (12) | 34 (11) | 30 (9) | 0.47 |
*Test for interaction between aspirin and antioxidant.
†Death from coronary heart disease or stroke, non-fatal myocardial infarction or stroke, or above ankle amputation for critical limb ischaemia.