Rheumatology, Vol 38, 235-244, Copyright © 1999 by British Society for Rheumatology
M Dougados, A Gueguen, JP Nakache, P Velicitat, EM Veys, H Zeidler and A Calin
OBJECTIVE: To consider the relevance of the duration of a clinical trial in
ankylosing spondylitis: long-term (i.e. 1 yr) vs short-term (i.e. 6 weeks)
assessment of a non-steroidal anti-inflammatory drug (NSAID)-placebo
controlled study. METHODS: The design was a prospective, multicentre,
double-blind, placebo-controlled study of 6 weeks duration with a 12 months
double-blind extension. Study drugs were placebo (n = 121) or active NSAID
(n = 352). A decrease of at least 50% in pain and/or global assessment
and/or functional impairment during the study defined the response to
treatment. The percentage of patients discontinuing the study drug over
time (life table analysis) permitted the evaluation of both the efficacy
and toxicity. RESULTS: Among the 473 recruited patients, the percentage of
responders was similar at 1 yr and week 6 with a highly statistically
significant difference in favour of the active NSAID groups when compared
to placebo (at 1 yr, 17% in the placebo group vs 37, 50 and 43% in the
piroxicam 20 mg, meloxicam 15 mg and meloxicam 22.5 mg, respectively, for
the patient's overall assessment) without any statistically significant
difference between the three active groups. However, evaluation of the
patients discontinuing the study drug during the 1 yr of the study
permitted the detection of a statistically significant difference between
the active NSAID groups. A lower percentage of patients taking meloxicam
22.5 mg had to discontinue the study drug when compared to either meloxicam
15 mg or piroxicam 20 mg (37% vs 53% and 53%, respectively, P < 0.05).
By 52 weeks, drug-related upper gastrointestinal adverse events occurred in
13, 32, 20 and 18% in the placebo, piroxicam 20 mg, meloxicam 15 mg and
meloxicam 22.5 mg groups, respectively. Some of the adverse events occurred
only after week 6. CONCLUSION: This study suggests that a 1 yr trial might
be of optimum value compared to a 6 week assessment in order to define
better the efficacy and tolerability of NSAIDs in ankylosing spondylitis.
ORIGINAL PAPERS
Ankylosing spondylitis: what is the optimum duration of a clinical study? A one year versus a 6 weeks non-steroidal anti-inflammatory drug trial
Universite Rene Descartes, Assistance Publique-Hopitaux de Paris, Hopital Cochin, Paris, France.
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