LOW-DOSE ETODOLAC IN RHEUMATOID-ARTHRITIS - A REVIEW OF EARLY STUDIES

Short and longterm safety and efficacy of etodolac in a wide range of dosages in patients with rheumatoid arthritis (RA) are summarized. Dat a from 8 studies, one longterm (1 year) and 7 short term (< 10 weeks) were analyzed. All studies were double blind and randomized; 6 had a p lacebo control group and 7 had an active comparator (aspirin, piroxica m, or sulindac) group. In the 1 year study, doses of etodolac were tit rated up from 50 mg bid until clinical efficacy was achieved and maint ained; the highest dose for > 80% of patients was 150 mg bid. In 6 of the 7 short term studies, dosages were fixed and ranged from 50 to 300 mg bid. Continuation rates and 4 efficacy measures (patients' and phy sicians' global assessments and numbers of painful and swollen joints) were assessed. The 1 year study enrolled 475 patients. Overall contin uation rates for etodolac and aspirin were comparable, but more patien ts taking aspirin discontinued the study because of adverse events. Mo st patients given etodolac who discontinued treatment for lack of effi cacy did so during the titration phase. Four of 236 patients received aspirin and none received etodolac developed ulcers. For patients cont inuing to take the study medication, improvement in efficacy variables in the etodolac group was comparable to that in the aspirin group. In the 7 short term studies, dose related improvement in patients' and p hysicians' global assessments and number of swollen joints was noted i n the etodolac group compared with the placebo group; this improvement was statistically significant at dosages of greater than or equal to 200 mg bid. Pooled analysis showed the efficacy of etodolac at dosages of 300 mg bid to be similar to that of comparator drugs. These short and longterm studies show that etodolac in a wide range of dosages, st arting at 200 mg bid, has clinical efficacy in the treatment of RA. It is significantly better tolerated than aspirin, and at doses of 300 m g bid, it is as effective as sulindac, aspirin, and piroxicam.