Summary of data from randomised trials of gastrointestinal (GI) events with cyclofloxgenase-2 inhibitors v conventional non-steroidal anti-inflammatory drugs (NSAIDs) for patients with rheumatoidarthritis or osteoarthritis*
Outcomes at 6 to 52 wk | Study | Comparison | Event rates | RRR (95% CI) | NNT (CI) |
---|---|---|---|---|---|
*RRR, NNT, and CI calculated from data in article or provided by author (Laine). | |||||
†Simon = Simon LA, Weaver AS, Graham DY,et al.JAMA 1999;282:1921–8. (3 doses of celecoxib combined, 12 wk trial). | |||||
‡Emery = Emery P, Zeidler H, Kvien TK,et al.Lancet 1999;354:2106–11. (24 wk trial). | |||||
§Laine = Laine L, Harper S, Simon T,et al.Gastroenterology 1999;117:776–83. (24 wk trial with main analysis based on 12 wk data provided by author). | |||||
∥Langman = Langman MJ, Jensen DM, Watson DJ,et al.JAMA 1999;282:1929–33. (systematic review of 8 studies of 6 wk to 1 y of duration, drug company-funded review. NSAIDs were ibuprofen, diclofenac, and nabumetone). | |||||
Endoscopic ulcers ≥3 mm | Simon† | Celecoxibv naproxen | 5%v 26% | 79% (66 to 87) | 5 (4 to 8) |
Emery‡ | Celecoxibv diclofenac | 4%v 16% | 73% (44 to 87) | 9 (6 to 19) | |
Laine§ | Rofecoxibv ibuprofen | 5%v 25% | 79% (66 to 87) | 6 (4 to 8) | |
Dyspepsia | Simon† | Celecoxibv naproxen | 4%v 5% | 21% (−5 to 59) | Not significant |
Emery‡ | Celecoxibv diclofenac | 10%v 13% | 23%(−18 to 50) | Not significant | |
Langman∥ | Rofecoxibv 3 NSAIDs | 23.5%v 25.5% | Data not available | Data not available | |
GI events leading to discontinuation of treatment | Simon† | Celecoxibv naproxen | 1%v 2% | 54% (−35 to 85) | Not significant |
Emery‡ | Celecoxibv diclofenac | 6%v 16% | 64% (41 to 79) | 11 (7 to 19) | |
Laine§ | Rofecoxibv ibuprofen | 8%v 29% | 73% (60 to 82) | 5 (4 to 7) | |
Langman∥ | Rofecoxibv 3 NSAIDs | 5.7%v 7.8% | Data not available | Data not available | |
Major GI event or major bleeding | Simon† | Celecoxibv naproxen | 0%v 0.4% | 100% (−25 to 100) | Not significant |
Emery‡ | Celecoxibv diclofenac | 0%v 1% | 100% (37 to 100) | 82 (33 to 2360) | |
Laine§ | Rofecoxibv ibuprofen | 0.2%v 1% | 76% (−84 to 97) | Not significant | |
Langman∥ | Rofecoxibv 3 NSAIDs | 1.3%v 1.8% | Data not available | Data not available |