Tolerability of Rofecoxib and Naproxen for Osteoarthritis


Rofecoxib (Vioxx®, Merck) works as well as naproxen (e.g., Drug Naprosyn®, Roche) at controlling the symptoms of osteoarthritis and is also effective at a much lower dose and with less severe adverse gastrointestinal (GI) effects. The ADVANTAGE (Assessment of Differences between Vioxx And Naproxen To Ascertain Gastrointestinal tolerability and Effectiveness) Study Group compared the use of rofecoxib 25 mg/day with that of naproxen 500 mg twice daily in 5,557 older patients with osteoarthritis. This is thought to be the largest trial to compare GI symptoms that prompt patients to discontinue treatment.

Overall, a statistically significant lower number of patients stopped taking rofecoxib (5.9%) because of GI adverse drug events (ADEs) compared with the naproxen group (8.1%). A similar risk of ending treatment was noted among subgroups of patients using low-dose aspirin and among those who had previously ceased to use their arthritis medication because of GI symptoms. Improved GI tolerability was confirmed by the decreased use of gastroprotective medications and by a reduced incidence of serious GI events, such as perforations, ulcers, and bleeding. No significant differences were observed in general, cardiovascular, or hypertension-related ADEs.