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.
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.


CONCLUSIONS
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.
Villa Alcázar
L F
LF
Rheumatology Unit, Hospital Universitario Príncipe de Asturias, Alcalá de Henares, Madrid, Spain.
de Buergo
M
M
Rico Lenza
H
H
Montull Fruitós
E
E
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D004008:Diclofenac / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010358:Patient Participation; D010894:Piroxicam / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D010919:Placebos; D013167:Spondylitis, Ankylosing / Q000188:drug therapy*; D011795:Surveys and Questionnaires
D000894:Anti-Inflammatory Agents, Non-Steroidal; D010919:Placebos; D010894:Piroxicam; D004008:Diclofenac; C056498:aceclofenac; C032801:tenoxicam