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.

• Abstract: OBJECTIVE: 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). METHODS: 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. RESULTS: 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. CONCLUSION: 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.
• Authors: L F Villa Alcázar, M de Buergo, H Rico Lenza, E Montull Fruitós (Affiliation: Rheumatology Unit, Hospital Universitario Príncipe de Asturias, Alcalá de Henares, Madrid, Spain.)
• Journal: The Journal of rheumatology (J Rheumatol) Vol. 23 Issue 7 Pg. 1194-9 (Jul 1996) ISSN: 0315-162X [Print] CANADA
• PMID: 8823692 (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
• Diclofenac
• Piroxicam
• tenoxicam
• aceclofenac

Topics

• 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
• Questionnaires
• Spondylitis, Ankylosing (drug therapy)