DOUBLE‐BLIND STUDY COMPARING THE LONG‐TERM EFFICACY OF THE COX‐2 INHIBITOR NIMESULIDE AND NAPROXEN IN PATIENTS WITH OSTEOARTHRITIS

Abstract

SUMMARYThis double‐blind one‐year study compares the long‐term efficacy and safety of nimesulide with naproxen in patients with osteoarthritis (OA) of the knee or hip. Patients were randomised to nimesulide 100 mg twice daily (n=183) or naproxen 250 mg morning, 500 mg evening (n=187). The primary efficacy variable was change in pain intensity (WOMAC A scale) at 6 months. Nimesulide tablets showed at least equivalent efficacy to naproxen tablets in reducing pain intensity at 6 and 12 months (nimesulide ‐22.5% at 6 and 12 months; naproxen ‐22.4% at 6 months, ‐19.9% at 12 months; non‐inferiority proven). At 6 months the investigator assessed efficacy as ‘good’ or ‘excellent’ in 59.3% of nimesulide and 56.4% of naproxen‐treated patients, with corresponding values for patient assessment of 57% and 52.7%. Both treatments were well tolerated, with fewer related gastrointestinal adverse events reported with nimesulide (77 cases, 47.5%) than with naproxen (96 cases, 54.5%). This study shows nimesulide to be as effective as naproxen in the long‐term treatment of OA and to be associated with fewer gastrointestinal side‐effects.