The efficacy and tolerability of aceclofenac in the treatment of patients with ankylosing spondylitis: a multicenter controlled clinical trial. Aceclofenac Indomethacin Study Group.

OBJECTIVE

To evaluate the efficacy and tolerability of aceclofenac, a new nonsteroidal antiinflammatory drug, in patients with active ankylosing spondylitis (AS).

METHODS

310 outpatients with active AS were enrolled in a 3 month, multicenter, parallel, double blind trial and were randomly assigned to receive aceclofenac (200 mg daily) or indomethacin (100 mg daily). They were evaluated after a washout period of 7 days, at baseline, 15, 30, 60, and 90 days.

RESULTS

No significant differences were found between aceclofenac and indomethacin in the number of withdrawals due to lack of efficacy or adverse events. A repeated measures analysis (ANOVA) of patients who completed the trial showed no significant differences between either treatment. Within-group comparisons in an intention-to-treat analysis showed improvement (p < 0.05) in all the primary efficacy variables: pain visual analog scale (VAS) (37 vs 41%), morning stiffness (51 vs 46%), modified Schober's test (21 vs 16%), C7-iliac crest line distraction (11 vs 14%), lateral spinal flexion (6 vs 10%), in aceclofenac and indomethacin treated patients, respectively. Other variables including chest expansion, occiput-to-wall, Likert pain score, use of analgesic rescue, and patient and physician global assessment, also showed significant improvement from baseline values. No significant differences between treatments were noted for any efficacy variable. Good to excellent improvement in pain (52 vs 64%) and morning stiffness (70 vs 68%) was observed in aceclofenac and indomethacin treated patients, respectively. Patients taking aceclofenac had significantly fewer central nervous system related adverse events than patients treated with indomethacin (p < 0.001).

CONCLUSION

Aceclofenac and indomethacin did not differ with respect to efficacy in the treatment of active AS, although aceclofenac was slightly better tolerated.