Ximoprofen in ankylosing spondylitis. A double blind placebo controlled dose ranging study.
Ximoprofen is a new propionic NSAID which has previously demonstrated its efficacy at a daily dose of 30 mg. The aim of the study was to evaluate the efficacy of different daily dosages of Ximoprofen in patients with active ankylosing spondylitis. For 2 weeks 5 parallel groups were studied: placebo and Ximoprofen at 5, 10, 20 and 30 mg daily. Response to treatment was defined as an improvement in pain (VAS 100 mm) of at least 50% during the study. 285 out of the 332 screened patients were included. At the end of the study, the percentage of responders was higher in the Ximoprofen groups (54%, 41%, 53%, 56% in the 5, 10, 20 and 30 mg groups, respectively) than in the placebo group (21%). The clearest dose related effect of Ximoprofen observed occurred after one week of treatment. This study 1/confirms the efficacy of Ximoprofen at a 30 mg daily dosage, 2/shows the persistence of this efficacy at lower dosages, 3/suggests that ankylosing spondylitis is a sensitive and relevant human model to assess NSAIDs at an early stage of clinical evaluation.
Clinique de Rhumatologie, Hôpital Cochin, Paris, France.
M
M
Dougados
M
M
Nguyen
R
R
Caporal
J
J
Legeais
A
A
Bouxin-Sauzet
B
B
Pellegri-Guegnault
C
C
Gomeni
D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010666:Phenylpropionates / Q000008:administration & dosage / Q000627:therapeutic use*; D013167:Spondylitis, Ankylosing / Q000188:drug therapy*; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D010666:Phenylpropionates; C061944:ximoprofen