The safety profile of sustained-release etodolac.

The safety profile of a new sustained-release (SR) form of etodolac was evaluated in 539 young and elderly patients with osteoarthritis or rheumatoid arthritis. Four long-term, open-label studies were conducted in nine different countries totaling 3,827 patient-months' exposure to etodolac SR. Patients were treated with either 400 mg or 600 mg etodolac SR once a day for up to 52 weeks. Withdrawals due to adverse reactions were low, occurring in only 5% (26/539) of all patients. The most common drug-related study events were GI-related, occurring in < 8% of patients. Elderly persons (> or = 65 years of age) were not at greater risk for adverse reactions or drug-related study events than were younger patients. Serious GI-related study events were rare (0.2%). The low level of serious GI effects was consistent with a separate study measuring gastrointestinal (GI) blood loss. Etodolac SR produced significantly less GI blood loss than naproxen in normal subjects. Because of its favorable safety profile, etodolac SR can serve as an alternative to conventional etodolac, providing the convenience of once-daily administration.