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Table 1 Summary of gastrointestinal evidence of efficacy of coxibs

From: Nonsteroidal anti-inflammatory drugs (NSAIDs), cyxlooxygenase-2 selective inhibitors (coxibs) and gastrointestinal harm: review of clinical trials and clinical practice

Reference Study design Population Main outcomes Main results Relative risk, coxib compared with NSAID (95% CI)
Large randomised trials
Bombardier et al. N Engl J Med 2000 343: 1520–1528 [17] Randomised trial powered for PUB outcome, comparing 50 mg rofecoxib with 1000 mg naproxen daily Patients with RA, at least 50 years n = 8,076 Confirmed clinical upper GI events (perforation, bleeding symptomatic ulcer) 177 events, 53 complicated
Confirmed events at 2.1/100 pt years with rofecoxib, 4.5 with naproxen
Complicated 0.6 and 1.4 per 100 pt years
0.5 (0.3 to 0.6)
0.4 (0.2 to 0.8)
Silverstein et al. JAMA 2000 284: 1247–1255 [18] Randomised trial powered for PUB outcome, comparing 800 mg celecoxib with 2400 mg ibuprofen and 150 mg diclofenac daily Patients with OA or RA, ≥ 18 years n = 8,059 Confirmed upper GI ulcers and complication (bleeding, perforation, obstruction) 83 events including symptomatic ulcers, 35 complicated
Confirmed events at 2.1/100 pt years with celecoxib, 3.5 with NSAID
Complicated at 0.8 and 1.5 per 100 pt years
0.6 (0.4 to 0.9)
0.5 (0.3 to 1.1)
Schnitzer et al. Lancet 2004 364: 665–674 [19] Randomised trial powered for PUB outcome, comparing 400 mg lumiracoxib with 2400 mg ibuprofen and 1000 mg naproxen daily Patients with OA, at least 50 years n = 18,325 Confirmed upper GI ulcers and complication (bleeding, perforation, obstruction) 283 events, 112 complicated
Confirmed events at 1.0% with lumiracoxib, 1.5% with NSAID
Complicated events at 0.3% with lumiracoxib, 0.9% with NSAID
0.7 (0.5 to 0.8)
0.3 (0.2 to 0.5)
Meta-analyses of randomised trials
Langman et al. JAMA 1999 282: 1929–1933 [20] Presecified meta-analysis of eight randomised trials of rofecoxib versus NSAIDs OA patients, mean age 63 years n = 5,435 Confirmed clinical upper GI events (perforation, bleed, ulcer) 35 confirmed complicated events
Complicated events at 1.3/100 pt years with rofecoxib, 2.6 with NSAID
0.5 (0.3 to 1.0)
Goldstein et al. Am J Gastroenterol 2000 95: 1681–1690 [21] Meta-analysis of 14 randomised trials of celecoxib versus NSAIDs OA or RA patients, mean age 60 years n = 11,008 Confirmed clinical upper GI events (perforation, bleed, ulcer) 11 confirmed complicated events
Complicated events at 0.2/100 pt years with celecoxib, 1.7 with NSAID
0.2 (0.1 to 0.5)
Edwards et al. Pain 2004 111: 286–296 [22] Meta-analysis of nine randomised trials of valdecoxib versus NSAIDs OA or RA patients, n = 5,726 Clinically significant upper GI bleed 10 confirmed complicated events
Complicated event rate 0.1% with valdecoxib, 0.4% with NSAID
0.2 (0.04 to 0.8)
Goldstein et al. Aliment Pharmacol Ther 2004 20: 527–538 [23] Meta-analysis of eight randomised trials of valdecoxib versus NSAID OA or RA patients, mean age 58 years n = 7,434 Confirmed clinical upper GI events (perforation, bleed, ulcer) 88 symptomatic ulcers, 19 complicated Symptomatic + complicated 0.8% with valdecoxib, 3.3% with NSAID
Complicated 0.2% with valdecoxib, 0.5% with NSAID
0.3 (0.2 to 0.4)
0.4 (0.1 to 0.9)
Hooper et al. BMJ 2004 329: 948–952 [24] Meta-analysis of 17 randomised trials of coxibs versus NSAIDs n = 25,564 Variety of outcomes reported, including serious gastrointestinal complications, and symptomatic ulcers 114 serious gastrointestinal complications, 0.36% with coxib, 0.73% with NSAID
288 symptomatic ulcers, 0.8% with coxib, 1.8% with NSAID
0.5 (0.4 to 0.8)
0.5 (0.4 to 0.6)
Moore et al. Arth Res Ther 2005 7:R644–R655 [25] Meta-analysis of 31 randomised trials of celecoxib versus NSAIDs OA or RA n = 39,605 (31,171 in analysis of ulcers and bleeds) Variety of outcomes reported including clinical ulcers and bleeds 184 clinical ulcers or bleeds, 0.4% with celecoxib, 0.9% with NSAID 0.6 (0.5 to 0.8)
Large observational studies
Mamdani et al. BMJ 2002 325: 624–630 [26] Observational cohort study Users of NSAID, coxib, or non users. Total population about 144,000 Hospital admission for upper gastrointestinal bleeding 82 events with controls, 17 with NSAID, 75 with coxib
Rofecoxib, but not celecoxib had significantly greater association with bleeding than controls
Celecoxib compared with NSAID 0.2 (0.1 to 0.4)
Rofecoxib compared with NSAID 0.5 (0.3 to 1.0)
MacDonald et al. Gut 2003 52: 1265–1270 [27] Retrospective cohort analysis Users of NSAID, coxibs, and non users. Total 26,000 incident cases of upper gastrointestinal haemorrhage Hospital admission for upper gastrointestinal bleeding in high risk patients 2,875 events on NSAID, 4 on coxib Adjusted relative risk 0.4 (0.1 to 1.0)
Norgard et al. Aliment Pharmacol Ther 2004 19: 817–825 [28] Population based case-control study Users of NSAID, coxibs, and non users. 780 incident cases in patients with high risk of gastrointestinal bleeding Hospital admission for upper gastrointestinal bleeding 35 patients had been exposed to coxib (4.5%)
97 patients had been exposed to NSAID (12%)
Rofecoxib, but not celecoxib had significantly greater association with bleeding than controls
0.4 (0.3 to 0.5)