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. Data 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 placebo control group and 7 had an active comparator (aspirin, piroxicam, or sulindac) group. In the 1 year study, doses of etodolac were titrated up from 50 mg bid until clinical efficacy was achieved and maintained; 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 physicians' global assessments and numbers of painful and swollen joints) were assessed. The 1 year study enrolled 475 patients. Overall continuation rates for etodolac and aspirin were comparable, but more patients taking aspirin discontinued the study because of adverse events. Most patients given etodolac who discontinued treatment for lack of efficacy did so during the titration phase. Four of 236 patients received aspirin and none received etodolac developed ulcers. For patients continuing 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 physicians' global assessments and number of swollen joints was noted in the etodolac group compared with the placebo group; this improvement was statistically significant at dosages of > or = 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, starting at 200 mg bid, has clinical efficacy in the treatment of RA. It is significantly better tolerated than aspirin, and at doses of 300 mg bid, it is as effective as sulindac, aspirin, and piroxicam.