Patients with one or more Serious Adverse Event (FDA data)
| Outcome | CLASS trials* | VIGOR trial | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Celecoxib % | Other NSAIDs % | RR (95% CI) | ARR ARI % | NNT NNH 9 mo | Rofecoxib % | Naproxen % | RR (95% CI) | ARR ARI % | NNT NNH 9 mo | |
| Mortality | 0.48 | 0.43 | 1.12 (0.58 – 2.14) | NS | NS | 0.54 | 0.37 | 1.46 (0.76 – 2.81) | NS | NS |
| Complicated ulcers | 0.50 | 0.60 | 0.83 (0.46 –1.5) | NS | NS | 0.40 | 0.92 | 0.43 (0.24 – 0.78) | 0.52 | 192 |
| Other serious adverse events | 5.8 | 4.8 | 1.22 (1.01–1.47) | 1.0 | 100 | 8.4 | 6.5 | 1.28 (1.10 –1.50) | 1.9 | 53 |
| Total serious adverse events | 6.8 | 5.8 | 1.17 (0.99 –1.39) | NS | NS | 9.3 | 7.8 | 1.21 (1.04 – 1.40) | 1.5 | 67 |
Because the two trials comparing celecoxib with ibuprofen and diclofenac are of different duration, and the FDA data provide only the combined celecoxib data, the trials cannot be reported separately.
NS = Not statistically Significant. RR = Relative Risk. CI = Confidence Interval. ARR = Absolute Risk Reduction. NNT = Number Needed to Treat to prevent one event. ARI = Absolute Risk Increase. NNH = Number Needed to treat to cause one Harmful event.
From: Letter 43, COX-2 inhibitors update
This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.