EFFICACY AND SAFETY OF NABUMETONE IN THE TREATMENT OF KNEE OSTEOARTHRITIS - A COMPARATIVE CLINICAL-TRIAL VERSUS ACECLOFENAC

BACKGROUND: Non-steroidal antiinflammatory drugs are extensively presc ribed for the symptomatic treatment of osteoarthritis (OA). This study compared the efficacy and safety of nabumetone with aceclofenac in pa tients with active knee osteoarthritis. PATIENTS AND METHODS: Phase IV , multicentre, prospective, open-label, parallel-group, randomized, th ree-month treatment, clinical trial, of nabumetone (1-2 g once a day) vs aceclofenac (100 mg two times each day], The main efficacy variable was intensity of pain, evaluated on a Visual Analogic Scale (VAS), In addition: Gonarthrosis Severity index (GSI) -baseline score > 5 and < 17-, patient and physician Global Assessment of OA activity, patient and physician Global Assessment of OA progression were assessed, Adver se events incidence and severity were assessed, Three study visits wer e made on a monthly basis, The main statistical analysis was by intent ion to treat (ITT). RESULTS: In 12 centres 274 patients were recruited (137/group), aged 62.5 +/- 8.4 years, of whom 189 completed the trial (97 nabumetone and 92 aceclofenac). 90% were female, and 83% of the p atients had both knees affected, In both groups the intensity of pain at month 3 improved significantly (p < 0.001) with respect to baseline : VAS of the nabumetone group: 6.1 +/- 1.9 to 4.3 +/- 2.8 cm; VAS of t he aceclofenac group: 6.1 +/- 1.9 to 4.4 +/- 2.7 cm, There were no sig nificant differences in any of the intergroup comparisons made, 15 nab umetone-treated and 23 aceclofenac-treated patients withdrew from the study due to moderate to severe adverse events. Gastrointestinal adver se events were the reason for withdrawal in 7 nabumetone and IL! acecl ofenac-treated patients, CONCLUSIONS: The efficacy and safety of nabum etone are similar to those of aceclofenac in the treatment of knee ost eoarthritis.