The cyclooxygenase-2 inhibitor etoricoxib caused fewer clinically important upper GI events than the traditional NSAID diclofenac in a large study designed to reflect the real-world experience of treating osteoarthritis and rheumatoid arthritis.
The Multinational Etoricoxib and Diclofenac Arthritis Long-Term Program (MEDAL) pooled the results of three large randomized clinical trials involving nearly 35,000 patients treated at 1,380 sites in 46 countries. Unlike in most clinical trials, subjects in the MEDAL program were encouraged to use proton pump inhibitor therapy to protect against GI damage, and those at cardiovascular risk were encouraged to add low-dose aspirin to their regimens, investigators reported.
Etoricoxib and diclofenac had similar efficacy against arthritis. Upper GI events, primarily uncomplicated ulcers, were significantly less frequent with etoricoxib than with diclofenac. There was no difference between the two drugs in rates of more serious complicated events, reported Dr. Loren Laine and associates in the MEDAL program (Lancet 2007;369:465–73).
Significantly fewer patients taking etoricoxib discontinued treatment because of dyspepsia, compared with those taking diclofenac.
This study was sponsored by Merck Research Laboratories, which conducted the statistical analyses and was involved in data analysis, safety monitoring, and reporting.