Patient-level pooled analysis of adjudicated gastrointestinal outcomes in celecoxib clinical trials: meta-analysis of 51,000 patients enrolled in 52 randomized trials

Table 3 GI end points

	Celecoxib (n= 28,614)	nsNSAID (n= 15,278)	Placebo (n= 5,827)	Rofecoxib (n= 1,329)	Total (n= 51,048)
CSULGIEs, n (%)	37 (0.1)	40 (0.3)	12 (0.2)	0 (0)	89 (0.2)
Incidence rate^a	0.3	0.9	0.3	0	0.4
CSULGIEs or symptomatic ulcers, n (%)	47 (0.2)	44 (0.3)	12 (0.2)	0 (0)	103 (0.2)
Incidence rate^a	0.4	1.0	0.3	0	0.5
CSULGIEs, symptomatic ulcers, or hemoglobin decrease, n (%)	281 (1.0)	343 (2.3)	52 (0.9)	4 (0.3)	680 (1.3)
Incidence rate^a	2.3	7.4	1.4	2.6	3.3

^aIncidence rate based on 100 patient-years of exposure to drug. CSULGIEs, clinically significant upper and lower GI events; nsNSAID, nonselective nonsteroidal antiinflammatory drug.

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