COMPARISON OF ACECLOFENAC WITH PIROXICAM IN THE TREATMENT OF OSTEOARTHRITIS

A multicentre, double-blind, randomised, parallel group study was unde rtaken to investigate the efficacy and safety of aceclofenac (123 pati ents, 100 mg twice daily) in comparison to piroxicam (117 patients, 20 mg once daily and placebo once daily) in patients with osteoarthritis of the knee. The treatment period of two months was preceded by a was hout period of one week duration. On completion of the study, patients in both aceclofenac and piroxicam-treated groups exhibited significan t improvement in pain intensity and functional capacity of the affecte d knee, as represented by the Osteoarthritis Severity Index (OSI) (p<0 .0001 and p<0.001 respectively). This was further substantiated follow ing the patient's assessment of pain intensity using the Visual Analog ue Scale (VAS), in which significant improvements were demonstrated at all time points for each treatment group (p<0.001). Although both tre atment groups showed a significant improvement in all investigator's c linical assessments (functional exploration of the knee, knee flexion and extension (EXT)), there were no significant differences between th e groups. There was, however, a more rapid improvement in knee flexion in the aceclofenac group after 15 days of treatment. Both aceclofenac and piroxicam were well tolerated by patients, the most commonly repo rted adverse events being gastrointestinal, although their incidence w as low. Only 24 patients on aceclofenac, as opposed to 33 on piroxicam complained of dyspepsia, epigastralgia and pyrosis. While 7 patients in each group were withdrawn because of adverse events, only one patie nt with piroxicam was withdrawn because of severe upper gastrointestin al bleeding. Twice as many reports of fecal blood loss were made in th e piroxicam group in comparison to the aceclofenac group. In summary, this study confirms the therapeutic efficacy of aceclofenac and sugges ts that it is a well-tolerated alternative NSAID to piroxicam in the t reatment of osteoarthritis.