Are All Oral COX-2 Selective Inhibitors the Same? A Consideration of Celecoxib, Etoricoxib, and Diclofenac

Table 2

Summary of the double-blind randomized controlled studies comparing celecoxib or etoricoxib with diclofenac. Studies are arranged in chronological order from left to right.

			CLASS	EDGE	EDGE II	MEDAL study	MEDAL program	CONDOR
			Silverstein et al, 2000 [34]	Baraf, et al, 2007 [36]	Krueger et al, 2008 [37]	Combe et al, 2009; [38]	Cannon et al, 2006 [57]	Chan et al, 2010 [43]
NSAIDs	Celecoxib	Dose	400 mg BID					200 mg BID
		N	3987					2238
	Diclofenac	Dose	75 mg BID	50 mg TID	75 mg BID	75 mg BID	50 mg TID OA or; 75 mg BID OA or RA	75 mg BID
		N	1996	3518	2032	6700	17,289	2246
	Etoricoxib	Dose		90 mg OD	90 mg OD	60 mg OD OA or; 90 mg OD OA or RA	60 mg OD OA or; 90 mg OD OA or RA
		N		3593	2054	6769	17,412
Aspirin		Allowed	YES	YES	YES	YES	YES	NO
		Dose	≤ 325 mg/day	< 100 mg/day	< 100 mg/day	< 100 mg/day	< 100 mg/day
		% Patients	~21%	~28%	~17%	~37%	~35%
PPIs		Allowed at; investigator discretion	NO	YES	YES	YES	YES	YES (part of treatment group)
GI endpoints			(i) Upper GI bleeding; (ii) GD perforation; (iii) Obstruction; (iv) Symptomatic GD ulcers	(i) Discontinuations due to clinical GI AEs; (ii) Discontinuations due to laboratory GI AEs	(i) Discontinuations due to clinical GI AEs; (ii) Discontinuations due to laboratory GI AEs	(i) Discontinuations due to clinical GI AEs; (ii) Discontinuations due to laboratory GI AEs	(i) Upper GI bleeding; (ii) GD perforation; (iii) Obstruction; (iv) Symptomatic GD ulcers	(i) Upper GI bleeding; (ii) GD perforation; (iii) Obstruction; (iv) Bleeding (≥ 2 g/dL drop in Hb with visible lesion); (v) Bleeding (≥ 2 g/dL drop in Hb of presumed GI origin [adjudicated]); (vi) Visible lesions in lower GI tract

Supratherapeutic dose of celecoxib (400 mg BID, double the maximum dose in RA and four times the maximum dose in OA).
Data combined for diclofenac- and ibuprofen-treated patients (N = 1985; 800 mg TID).
Recommended for patients at higher risk of upper GI clinical events (age > 65 years, history of ulcer or hemorrhage, concurrent use of corticosteroid, anticoagulant, or antiplatelet therapy).
OA cohort, etoricoxib 60 mg.
In patients taking diclofenac only.
NSAIDs, nonsteroidal anti-inflammatory drugs; BID, twice daily; TID, three times daily; OA, osteoarthritis; RA, rheumatoid arthritis; OD, once daily; PPIs, proton pump inhibitors; GI, gastrointestinal; GD, gastroduodenal; AEs, adverse events; Hb, hemoglobin.