: a prospective, randomised, double-blind, controlled multicentre study.

The efficacy and safety of etodolac and piroxicam were compared in patients with osteoarthritis of the hip (n = 111) or knee (n = 160). Special emphasis was placed on clinical gastrointestinal adverse effects. 271 patients participated in this 8-week prospective, multicentre, randomised, double-blind trial. Efficacy was measured by patient's and investigator's assessment of key parameters after 4 and 8 weeks of treatment compared with baseline. Tolerability was evaluated by patients' complaints at each visit (adverse events) and laboratory tests performed before and at the end of treatment. After 4 and 8 weeks of treatment and at the end of treatment, patients' and investigators' assessments were significantly improved from baseline in both groups. There were no statistically significant differences between the groups in any efficacy assessment at any observation. In the etodolac group 30% reported adverse events, compared with 46% in the piroxicam group (p < 0.01). In the study, 20% in the etodolac group and 29% in the piroxicam group reported gastrointestinal adverse events (not significant). Clinically significant falls in haemoglobin occurred in 22% of patients with no significant difference between the 2 groups. In conclusion, the study indicated that etodolac 600mg per day was as effective as piroxicam 20mg per day in the treatment of osteoarthritis. Etodolac produced adverse events in a significantly smaller number of patients than piroxicam. No significant differences were found between etodolac and piroxicam with respect to incidence of clinical gastrointestinal adverse events.