The efficacy and safety of a sustained-release (SR) formulation of
etodolac were compared with those of conventional
etodolac in two separate, randomized, double-blind, multicenter, 6-week trials. This report presents an interim analysis of the data from these studies. One study included 174 patients with
rheumatoid arthritis (RA): 58 received
etodolac SR 400 mg once daily (q.d.), 59 received
etodolac SR 600 mg q.d., and 57 received
etodolac 200 mg twice daily (b.i.d.). The second study included 230 patients with
osteoarthritis (OA): 80 patients received
etodolac SR 400 mg q.d., 76 received
etodolac SR 600 mg q.d., and 74 received
etodolac 300 mg b.i.d. Efficacy was evaluated by physician's global and patient's global assessment (both studies), number of painful joints (RA study), number of swollen joints (RA study),
pain intensity (OA study), and weight-bearing
pain (OA study). The interim analyses of the data from the studies indicates that all three regimens produced significant improvements from baseline in all mean efficacy values at each assessment; there were no significant differences between the treatment groups. The incidence of study events, except for
dyspepsia, was comparable among the treatment groups in each study;
dyspepsia occurred at a significantly lower rate in patients treated with
etodolac SR than in patients treated with the conventional formulation of
etodolac. We conclude that
etodolac SR is as effective and safe as conventional
etodolac for the treatment of patients with RA or OA.