Table 3.
Rate per 1000 patient months exposure and relative risks†(95% confidence interval) for selected gastrointestinal (GI) events and anaemia according to response to additional questions‡.
| Event | Numberof events | Rate | Relative risk(95% CI) | χ2P-value* |
|---|---|---|---|---|
| Past history of dyspeptic symptoms and other upper GI conditions | ||||
| Dyspepsia | ||||
| Yes | 611 | 18.19 | 2.69 (2.21, 3.26) | < 0.0001 |
| No | 123 | 6.77 | 1 | |
| Pain abdomen | ||||
| Yes | 242 | 7.20 | 1.87 (1.43, 2.44) | < 0.0001 |
| No | 70 | 3.85 | 1 | |
| GI unspecified | ||||
| Yes | 93 | 2.77 | 4.19 (2.30, 7.65) | < 0.0001 |
| No | 12 | 0.66 | 1 | |
| NSAIDs had been prescribed in the 3 months prior to rofecoxib | ||||
| Dyspepsia | ||||
| Yes | 373 | 12.48 | 0.79 (0.68, 0.91) | 0.0015 |
| No | 360 | 15.80 | 1 | |
| Nausea, vomiting | ||||
| Yes | 137 | 4.58 | 0.68 (0.54, 0.86) | 0.001 |
| No | 153 | 6.71 | 1 | |
| Use of concomitant gastroprotective drugs (misoprostol, antacids, proton-pump Inhibitors/H2antagonists) | ||||
| Dyspepsia | ||||
| Yes | 329 | 23.34 | 2.44 (2.09, 2.85) | < 0.0001 |
| No | 317 | 9.56 | 1 | |
| Pain abdomen | ||||
| Yes | 125 | 8.87 | 1.84 (1.46, 2.33) | < 0.0001 |
| No | 160 | 4.83 | 1 | |
| Age:≥65 years, compared with≤64 years | ||||
| Diarrhoea | ||||
| ≥ 65 years | 199 | 5.31 | 1.42 (1.12, 1.80) | 0.003 |
| ≤ 64 years | 105 | 3.73 | 1 | |
| Haemorrhage GI | ||||
| ≥ 65 years | 1 | 0.03 | 0.04 (0.01, 0.33) | 0.002 |
| ≤ 64 years | 17 | 0.60 | 1 | |
*
Bonferroni's correction for 12 tests comparing event rates of 12 selected events of interest per additional questions: adjusted P-value for statistical significance, P < 0.004.
†
Calculated using Poisson regression.
‡
Use of concomitant drugs leading to increased risk of bleeding (NSAIDs, aspirin, anticoagulants, antiplatelet drugs); none of selected events achieved statistical significance after introducing Bonferroni's correction.