A Double-Blind Study Comparing Nimesulide with Naproxen in the Treatment of Osteoarthritis of the Hip.

ABSTRACT

120 patients, aged between 45 and 87 years, with a history of osteoarthritic disease of at least 12 months' duration and unilateral or bilateral hip pain, were randomly allocated to treatment with either nimesulide (100mg twice daily) or naproxen (500mg twice daily) for 4 weeks. Nimesulide was associated with a statistically significant improvement in the primary efficacy variable - pain intensity at rest - compared with baseline (mean improvement 71 % at week 2, 80% at week 4; p & 0.01), and a significant concomitant improvement in the number of night awakenings, pain on active and passive movement, morning stiffness and impairment of articular mobility on active and passive movement. The global clinical efficacy of nimesulide at the end of treatment was rated as good/fair by ≥ 85% of patients and doctor. For all the efficacy variables assessed, there was no statistically significant difference between treatment with nimesulide or naproxen. Four adverse events were reported in each treatment group; they were mild/moderate in intensity and predominantly gastrointestinal in nature. The results of this study confirm that nimesulide is clinically effective and a suitable alternative to naproxen for the short term treatment of patients with osteoarthritis of the hip.