Summary of relevant trials studying the GI complications of NSAID therapy.

Table 4: Summary of relevant trials studying the GI complications of NSAID therapy.

Trial Name	CLASS [9]	VIGOR [10]	PRECISION [57]
Year of publication	2000	2000	2016
Patient population	Osteoarthritis or rheumatoid arthritis; patients were allowed to take aspirin (< 325 mg/day)	Rheumatoid arthritis; excluded those on aspirin	Rheumatoid or osteoarthritis with a history of CV disease (CVD) or at high risk for CVD
Mean follow-up (months)	6 and 12	9	34
Intervention	Celecoxib at 2-4x maximum dose (400 mg BID) vs. ibuprofen 800 mg TID vs. diclofenac 75 mg BID	Rofecoxib 50 mg daily (2x max dose) vs. naproxen 500 mg BID	Celecoxib 100 mg BID vs. ibuprofen 600 mg TID vs. naproxen 375 mg BID
Primary endpoint	Ulcer development and ulcer complications (bleeding, perforation, gastric outlet obstruction)	Clinical upper GI events (perforation, bleeding, obstruction, symptomatic ulcers)	CV death, nonfatal MI, nonfatal stroke
Outcomes	At 6 months for all patients combined (with and without aspirin) Incidence of UGI ulcer complications Celecoxib: 0.76% NSAIDs: 1.45% P = 0.09 (50% non-significant reduction in risk with COX-2 inhibitor) Incidence of UGI ulcer complications and symptomatic ulcers Celecoxib: 2.08% NSAIDs: 3.54% P = 0.02	Rofecoxib: 2.1 GI events per 100 patient years Naproxen: 4.5 per 100 RR 0.5, [C.I. 0.3-0.6, p < 0.001] Rofecoxib: 0.6 per 100 patient years (complications of ulcers/severe bleeding) Naproxen: 1.4 per 100 RR 0.4 [C.I. 0.2-0.8, p = 0.005]	Celecoxib vs. Naproxen (2.3% vs. 2.5%) [C.I. 0.76-1.13, p < 0.001]; Celecoxib vs. Ibuprofen (2.3% vs. 2.7%) [C.I. 0.7-1.04, p < 0.001]. Celecoxib is non-inferior to Naproxen/Ibuprofen.