Table 2.

Gastrointestinal endpoints in studies of selective COX2 inhibitors

Drug (reference)	Study	GI protection allowed in study	GI endpoints		Hazard ratios, relative risks (RR) or incidence (%) of upper GI risk endpoints
					All	No aspirin	On aspirin
Rofecoxib (Bombardier 2000)	VIGOR	Yes	Confirmed POBU		0.5 (0.3–0.6)v	Idem	Excluded
			Complicated GI (POB)		0.4 (0.2–0.8)	Idem	Excluded
Celecoxib (Silverstein 2000)	CLASS	No	POB		RR: 0.53 (0.26–1.11)	RR: 0.35 (0.14–0.98)	1.0% vs 2.1, NS
			Symptomatic U + POB		RR: 0.59 (0.38–0.94)	RR: 0.48 (0.28–0.89)	4.7% vs 6.0%, NS
Etoricoxib (Cannon 2006; Laine 2007)	MEDAL	Yes	Clinical POBUa	All	0.69 (0.57–0.83)	0.60 (0.45–0.80)	0.78 (0.60–1.01)
				No PPI	0.62 (0.45–0.83)	0.60 (0.43–0.86)	0.93 (0.65–1.35)
				+ PPI	0.74 (0.58–0.95)	0.59 (0.36–0.98)	0.64 (0.44–0.93)
			Complicated GI (POB)a	All	0.91 (0.67–1.24)	0.90 (0.53–1.50)	0.93 (0.63–1.36)
				No PPI	1.03 (0.70–1.52)	0.96 (0.52–1.79)	1.09 (0.66–1.77)
				+ PPI	0.72 (0.42–1.22)	0.77 (0.30–1.95)	0.70 (0.37–1.34)
			Uncomplicated Ua	All	0.57 (0.45–0.74)	0.50 (0.35–0.71)	0.67 (0.47–0.96)
				No PPI	0.58 (0.41–0.81)	0.49 (0.32–0.75)	0.77 (0.44–1.34)
				+ PPI	0.57 (0.39–0.83)	0.53 (0.29–0.98)	0.61 (0.38–0.97)
Lumiracoxib (Schnitzer 2004; Farkouh 2004)	TARGET	No	Definite or probable complicated U (POB)
				vs ibuprofen + naproxen	0.34 (0.22–0.52)	0.21 (0.12–0.37)	0.79 (0.40–1.55)
				vs ibuprofen	0.29 (0.14–0.59)	0.17 (0.07–0.45)	0.92 (0.27–3.20)
				vs naproxen	0.37 (0.22–0.63)	0.24 (0.12–0.50)	0.73 (0.32–1.65)

^aNo treatment-by-subgroup interaction.

Abbreviations: B, bleeding; GI, gastrointestinal; O, obstruction; P, perforation; PPI, proton pump inhibitors; U, ulcer.