Aceclofenac is as safe and effective as tenoxicam in the treatment of ankylosing spondylitis: a 3 month multicenter comparative trial. Spanish Study Group on Aceclofenac in Ankylosing Spondylitis.

To compare in a 3 month, multicenter, double blind, parallel study the efficacy and safety of a nonsteroidal antiinflammatory drug, aceclofenac, 100 mg bid orally, with that of tenoxicam, 20 mg orally at bedtime, in the treatment of adult patients with active ankylosing spondylitis (AS).
A total of 273 patients (135 in the aceclofenac group and 138 in the tenoxicam group) entered the study. Eight efficacy variables were assessed: morning stiffness, visual analog pain scale, control of additional paracetamol, modified Schöber's test, C7 line-iliac crest distance, lateral flexion of the spine, thoracic expansion, and occiput-wall distance.
Seven of the 8 variables improved significantly in both groups, with no differences between the 2 groups in any variable at the end of the study. Six percent of patients taking aceclofenac and 5% of patients taking tenoxicam withdrew because of unsatisfactory therapeutic action. Forty-two adverse events possibly or probably related to treatment were observed in the aceclofenac group and 37 in the tenoxicam group. However, only 2.2% of patients in the aceclofenac group and 1.4% in the tenoxicam group withdrew for this reason.
Aceclofenac and tenoxicam are similar in terms of safety and effectiveness; and aceclofenac, 100 mg orally twice daily, is a safe, effective, and convenient treatment for active AS.
AuthorsL F Villa Alcázar, M de Buergo, H Rico Lenza, E Montull Fruitós
JournalThe Journal of rheumatology (J Rheumatol) Vol. 23 Issue 7 Pg. 1194-9 (Jul 1996) ISSN: 0315-162X [Print] CANADA
PMID8823692 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Anti-Inflammatory Agents, Non-Steroidal
  • Placebos
  • Piroxicam
  • Diclofenac
  • tenoxicam
  • aceclofenac
  • Administration, Oral
  • Adolescent
  • Adult
  • Anti-Inflammatory Agents, Non-Steroidal (administration & dosage, adverse effects)
  • Diclofenac (administration & dosage, adverse effects, analogs & derivatives)
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Patient Participation
  • Piroxicam (administration & dosage, adverse effects, analogs & derivatives)
  • Placebos
  • Spondylitis, Ankylosing (drug therapy)
  • Surveys and Questionnaires

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