Table 3 Rates of development of congestive heart failure by cardiovascular risk.
| Without aspirin | HR | p Value | With aspirin | HR | p Value | |||
|---|---|---|---|---|---|---|---|---|
| Ibuprofen No (%) | Lumiracoxib No (%) | Ibuprofen No (%) | Lumiracoxib No (%) | |||||
| Ibuprofen substudy | ||||||||
| Overall | 6/3431 (0.17) | 9/3401 (0.26) | 0.92 (0.31 to 2.74) | 0.879 | 9/966 (0.93) | 3/975 (0.31) | 3.26 (0.88 to 12.05) | 0.077 |
| Low CV risk | 4/3181 (0.13) | 9/3075 (0.29) | 0.60 (0.18 to 2.05) | 0.414 | 3/593 (0.51) | 2/581 (0.34) | 1.48 (0.25 to 8.87) | 0.666 |
| High CV risk | 2/250 (0.80) | 0/326 (0.00) | Not applicable | 0.188 * | 6/373 (1.61) | 1/394 (0.25) | 7.19 (0.86 to 59.94) | 0.068 |
| Naproxen No (%) | Lumiracoxib No (%) | Naproxen No (%) | Lumiracoxib No (%) | |||||
| Naproxen substudy | ||||||||
| Overall | 9/3537 (0.25) | 4/3549 (0.11) | 1.86 (0.54 to 6.36) | 0.322 | 7/1193 (0.59) | 6/1192 (0.50) | 1.14 (0.38 to 3.38) | 0.818 |
| Low CV risk | 7/3202 (0.22) | 3/3231 (0.09) | 1.77 (0.42 to 7.40) | 0.435 | 2/688 (0.29) | 0/651 (0.00) | Not applicable | 0.50* |
| High CV risk | 2/335 (0.60) | 1/318 (0.31) | 2.17 (0.20 to 24.19) | 0.528 | 5/505 (0.99) | 6/541 (1.11) | 0.87 (0.26 to 2.84) | 0.814 |
*p Values from Fisher exact tests; †p values based on Wald χ2 statistics derived from Cox proportional hazards models with factors age and treatment.
‡Composite cardiovascular end point = APTC end point of confirmed or probable MI (clinical and silent), stroke or cardiovascular death.
§Hazard ratios use lumiracoxib as reference group—that is, HRs >1 favour lumiracoxib.