The efficacy and safety of
aceclofenac (100 mg bid), a new nonsteroidal anti-inflammatory/
anti-rheumatic agent, were compared with those of
naproxen (500 mg bid) in a multi-centre, twelve-week, randomized, double-blind, parallel-group clinical trial in outpatients with active
osteoarthritis of the knee. 190 patients received
aceclofenac, 184
naproxen. The two treatments were compared on the basis of several characteristic clinical features of
osteoarthritis of the knee, including various
pain measurements. In both groups, the treatment resulted in a significant reduction of the
pain at rest,
pain on movement and the
pain from pressure on the joint, 76-86% of
aceclofenac patients reporting reduction in
pain after 12 weeks. Three-quarters of the
aceclofenac-treated patients had an accompanying reduction in joint swelling and 81.4% in knee function capacity, up to complete freedom of movement. Joint stiffness, which at baseline lasted 20 minutes, was reduced in the
aceclofenac group to 10 minutes. A statistically significant difference in the efficacy of the two drugs was not found. The 34 adverse
drug effects documented in 24 (12.6%) of the
aceclofenac patients were fewer than the 43 events in 30 patients (16.3%) reported for
naproxen. The trend towards better tolerability of
aceclofenac manifested itself above all in a lower total incidence of gastrointestinal side-effects.
Aceclofenac is as effective as
naproxen in the symptomatic treatment of
osteoarthritis of the knee and is well tolerated in general.