Table 1.

General description of main large-scale safety trials with selective COX2 inhibitors and description of patients excluded from participating in the studies

Drug (reference)	Study	Diagnoses and patients (n)	Duration (months)	Comparator drug	Risk patients excluded GI history	CV history
Rofecoxib (Bombardier 2000)	VIGOR	RA (8 076)	12	Naproxen	GI surgery, current B, IBD, previous or current PPI	History of CV last 2 yrs, MI or coronary bypass last yr, previous or current aspirin
Celecoxib (Silverstein 2000)	CLASS	OA, RA (8 059)	6	Ibuprofen, diclofenacv	Active GI, U last 30 d, any GI surgery	No exclusion criteria
Etoricoxib (Cannon 2006; Laine 2007)	MEDAL	OA, RA (37 701)	36	Diclofenac	No exclusion PPI or misoprostol recommended if at GI risk	MI or coronary bypass or percutaneous coronary intervention during last 6 mo, aspirin recommended if at CV risk
Lumiracoxib (Schnitzer 2004; Farkouh 2004)	TARGET	OA (18 325)	12	Ibuprofen, naproxen	On GI protection, U last 3 mo, B last yr, any P or O	MI (clinical, on ECG), stroke, coronary bypass graft surgery, new angina during last 6 mo, high CV risk without aspirin, severe heart failure, on anticoagulation therapy

Abbreviations: B, bleeding; CV, cardiovascular; GI, gastrointestinal; IBD, infl ammatory bowel disease; MI, myocardial infarction; O, obstruction; OA, osteoarthritis; P, perforation; RA, rheumatoid arthritis; PPI, proton pump inhibitors; U, ulcer.