A	B	C
1	Main
2		Brand Name	Arcoxia
3		Generic Name	etoricoxib
4		Mechanism	COX-2 inhibitor
5		Competition	NSAIDs (aspirin, ibuprofen, etc), which increase the risk of upper GI events such as bleeding ulcers by 2-5x compared to no-NSAID therapy.
6			PPIs are commonly used concomitantly to reduce the incidence of GI events. Misoprostol is also used.
7		Clinical Trials
8			MEDAL Phase III Program - Lancet 2/10/2007 - Laine et al - Study completed in May 2006
9			Upper GI tox of Arcoxia vs diclofenac 150mg (traditional NSAID) in patients with OA and RA.
10			Study hoped to evaluate the "real-world" efficacy of a COX-2 inhibitor including patients taking GI protective therapy.
11
12			MEDAL was a pooled, pre-specified ITT analysis of 3 trials totaling n=34,701.
13			Upper GI clinical events (bleeding, perforation, obstruction or ulcer) were examined.
14			Complicated events (perforation, obstruction, witnessed ulcer bleeding or significant bleeding) were also examined.
15			Some patients were taking PPIs or low-dose aspirin.
16
17			SS less common upper GI events with Arcoxia vs diclofenac. HR=0.69 (95% CI 0.57-0.83, p=0.0001).
18			Less fewer uncomplicated GI events. HR=0.57, p<0.0001.
19			No change in complicated events. HR=0.91, p=0.561.
20
21			PPIs were used for at least 75% of the study period by 40% of the patients.
22			Low-dose aspiring was used for at least 75% of the study by 33% of the patients.
23
24			Mean followup was 18 months.