Table 1 Characteristics of patients in the ibuprofen and naproxen substudies stratified by cardiovascular risk.
| Low CV risk without aspirin | Low CV risk with aspirin | High CV risk without aspirin | High CV risk with aspirin | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Ibuprofen (n = 3181) | Lumiracoxib (n = 3075) | Ibuprofen (n = 593) | Lumiracoxib (n = 581) | Ibuprofen (n = 250) | Lumiracoxib (n = 326) | Ibuprofen (n = 373) | Lumiracoxib (n = 394) | ||
| Age (years) | 62.3 | 62.3 | 65.6 | 65.3 | 64.6 | 64.3 | 67.6 | 68.0 | |
| Female sex (%) | 78.7 | 77.9 | 73.4 | 75.0 | 70.0 | 69.9 | 78.3 | 73.9 | |
| Body mass index (kg/m2) | 29.5 | 29.7 | 29.6 | 29.8 | 32.0 | 32.0 | 30.9 | 30.4 | |
| Hypertension (%) | 36.5 | 38.7 | 57.2 | 56.1 | 68.8 | 66.6 | 78.3 | 73.9 | |
| Diabetes mellitus (%) | 0.8 | 1.2 | 1.2 | 0.9 | 64.8 | 63.8 | 36.7 | 36.0 | |
| Dyslipidaemia (%) | 18.7 | 18.8 | 30.0 | 28.7 | 34.4 | 31.9 | 44.8 | 45.9 | |
| Current smoker (%) | 9.6 | 10.6 | 7.1 | 6.5 | 13.2 | 16.0 | 13.9 | 11.9 | |
| History of angina pectoris (%) | 0.0 | 0.0 | 0.0 | 0.0 | 4.8 | 6.4 | 11.8 | 14.7 | |
| Prior myocardial infarction (%) | 0.0 | 0.0 | 0.0 | 0.0 | 5.6 | 4.0 | 13.7 | 11.2 | |
| Prior cardiac revascularisation (%) | 0.0 | 0.0 | 0.0 | 0.0 | 3.2 | 1.5 | 7.5 | 6.9 | |
| Prior cardiac catheterisation (%) | 0.0 | 0.0 | 0.0 | 0.0 | 0.8 | 0.3 | 0.8 | 1.5 | |
| History of cerebrovascular disease (%) | 0.0 | 0.0 | 0.0 | 0.0 | 4.8 | 4.3 | 14.2 | 14.0 | |
| High CV risk (Framingham) (%) | 0.0 | 0.0 | 0.0 | 0.0 | 17.2 | 16.0 | 10.7 | 9.9 | |
| Prior CCV history (%) | 0.0 | 0.0 | 0.0 | 0.0 | 29.2 | 31.0 | 71.6 | 74.1 | |
| CCV history or high CV risk (%) | 0.0 | 0.0 | 0.0 | 0.0 | 46.4 | 46.9 | 82.3 | 84.0 | |
| Total cholesterol (mg/l) | 217.9 | 217.5 | 211.0 | 212.3 | 217.1 | 216.3 | 209.4 | 209.5 | |
| Baseline systolic BP (mm Hg) | 130.0 | 129.9 | 131.4 | 131.8 | 134.3 | 134.5 | 137.8 | 135.8 | |
| Baseline diastolic BP (mm Hg) | 79.0 | 79.3 | 78.5 | 78.7 | 79.2 | 79.5 | 80.4 | 79.0 | |
| Low‐dose aspirin (%) | 0.0 | 0.0 | 100.0 | 100.0 | 0.0 | 0.0 | 100.0 | 100.0 | |
| Study completed (%) | 56.9 | 61.6 | 58.0 | 60.9 | 48.4 | 54.6 | 53.6 | 56.6 | |
| Naproxen (n = 3202) | Lumiracoxib (n = 3231) | Naproxen (n = 688) | Lumiracoxib (n = 651) | Naproxen (n = 335) | Lumiracoxib (n = 318) | Naproxen (n = 505) | Lumiracoxib (n = 541) | ||
| Age (years) | 62.5 | 62.6 | 65.0 | 64.9 | 65.6 | 65.5 | 66.8 | 67.0 | |
| Female sex (%) | 78.5 | 78.3 | 76.3 | 77.6 | 72.5 | 77.7 | 67.7 | 70.6 | |
| Body mass index (kg/m2) | 28.9 | 29.0 | 29.0 | 29.6 | 30.8 | 30.3 | 30.1 | 30.4 | |
| Hypertension (%) | 34.7 | 36.5 | 60.0 | 61.4 | 66.3 | 66.4 | 69.5 | 74.5 | |
| Diabetes mellitus (%) | 1.1 | 0.8 | 1.2 | 0.9 | 54.3 | 52.5 | 23.4 | 28.1 | |
| Dyslipidaemia (%) | 12.3 | 13.4 | 24.3 | 22.1 | 26.9 | 21.7 | 31.5 | 28.5 | |
| Current smoker (%) | 9.4 | 10.2 | 8.7 | 7.8 | 12.5 | 10.7 | 10.1 | 9.1 | |
| History of angina pectoris (%) | 0.0 | 0.0 | 0.0 | 0.0 | 8.1 | 9.1 | 23.8 | 25.7 | |
| Prior myocardial infarction (%) | 0.0 | 0.0 | 0.0 | 0.0 | 4.2 | 4.1 | 11.7 | 14.8 | |
| Prior cardiac revascularisation (%) | 0.0 | 0.0 | 0.0 | 0.0 | 0.6 | 0.9 | 5.9 | 5.2 | |
| Prior cardiac catheterisation (%) | 0.0 | 0.0 | 0.0 | 0.0 | 1.2 | 0.9 | 0.4 | 0.4 | |
| History of cerebrovascular disease (%) | 0.0 | 0.0 | 0.0 | 0.0 | 8.1 | 7.5 | 15.8 | 15.5 | |
| High CV risk (Framingham) (%) | 0.0 | 0.0 | 0.0 | 0.0 | 15.5 | 12.9 | 6.3 | 5.2 | |
| Prior CCV history (%) | 0.0 | 0.0 | 0.0 | 0.0 | 41.8 | 45.3 | 83.0 | 82.1 | |
| CCV history or high CV risk (%) | 0.0 | 0.0 | 0.0 | 0.0 | 57.3 | 58.2 | 89.3 | 87.2 | |
| Total cholesterol (mg/l) | 221.9 | 221.1 | 216.7 | 214.5 | 218.1 | 218.8 | 216.5 | 219.9 | |
| Baseline systolic BP (mm Hg) | 132.7 | 132.7 | 134.8 | 134.1 | 138.4 | 135.6 | 138.5 | 138.5 | |
| Baseline diastolic BP (mm Hg) | 80.1 | 80.3 | 80.8 | 80.7 | 81.2 | 80.6 | 81.6 | 81.5 | |
| Low‐dose aspirin (%) | 0.0 | 0.0 | 100.0 | 100.0 | 0.0 | 0.0 | 100.0 | 100.0 | |
| Study completed (%) | 63.2 | 65.6 | 63.8 | 61.1 | 55.2 | 61.9 | 62.6 | 60.1 | |
CV, cardiovascular; CCV, cerebrovascular; BP, blood pressure.