SAFETY PROFILE OF A SUSTAINED-RELEASE FORMULATION OF ETODOLAC IN PATIENTS WITH RHEUMATOID-ARTHRITIS AND OSTEOARTHRITIS

Etodolac is a potent nonsteroidal anti-inflammatory drug with an excellent safety profile. The primary objective of this open-label multicenter study was to establish an initial long-term safety profile of a sustained-release formulation of etodolac (etodolac SR) in the treatment of rheumatoid arthritis (RA) or osteoarthritis (OA). The 158 patients enrolled in the 52-week study had been maintained previously on the conventional oral formulation of etodolac in divided doses and had tolerated it well. The patients received either 400 mg or 600 mg of etodolac SR once daily, corresponding to the dose they had previously taken. The 400-mg dose could be increased to 600 mg or the 600-mg dose could be reduced to 400 mg to improve efficacy or tolerance, respectively. One hundred seven (68%) patients completed this study. The most frequently reported drug-related study events were dyspepsia (9% of patients) and abdominal pain (4%). Study events were similar in nature for patients aged 65 years and older (n = 54) and for patients younger than 65 years (n = 104). No patient withdrew from the study because of hematologic, hepatic, or renal events. Relief from the symptoms of RA and OA was maintained following the transition from the conventional formulation to etodolac SR. Both formulations are equally safe and effective for long-term maintenance of the therapeutic effect.