The British Journal of Rheumatology, Vol 37, 946-951, Copyright © 1998 by British Society for Rheumatology
J Dequeker, C Hawkey, A Kahan, K Steinbruck, C Alegre, E Baumelou, B Begaud, H Isomaki, G Littlejohn, J Mau and S Papazoglou
SELECT is a large-scale, prospective, international, multicentre,
double-blind, double-dummy, randomized, parallel-group trial. Patients with
exacerbation of osteoarthritis were treated with the recommended dose of
meloxicam (7.5 mg) or piroxicam (20 mg) once daily for 28 days; 4320
patients were administered meloxicam and 4336 piroxicam. The incidence of
adverse events was significantly lower in the meloxicam group (22.5%)
compared with the piroxicam group (27.9%; P < 0.001), mainly due to the
significantly lower incidence of gastrointestinal (GI) adverse events in
the meloxicam than in the piroxicam group (10.3% vs 15.4%,; P < 0.001),
while the efficacy of both drugs was equivalent. Individual GI events
occurred significantly less often with meloxicam than piroxicam: dyspepsia
(3.4% vs 5.8%; P < 0.001), nausea/vomiting (2.5% vs 3.4%; P < 0.05)
and abdominal pain (2.1% vs 3.6%; P < 0.001). There were 16 patients
with perforations, ulcerations or bleeding (PUBs) of the upper GI tract in
the piroxicam group compared with seven in the meloxicam group (relative
risk piroxicam:meloxicam = 1.4). Four PUBs were complicated (perforations
or bleedings); none of these occurred in the meloxicam group (relative risk
piroxicam:meloxicam = 1.9). The outcome of SELECT is consistent with that
of the large-scale clinical trial of similar design and size which compared
7.5 mg meloxicam with 100 mg diclofenac in patients with osteoarthritis,
and with a previous global analysis of the safety of meloxicam. It adds
further data to the proposed relationship between selective inhibition of
cyclooxygenase-2 and improved GI tolerability of non-steroidal anti-
inflammatory drugs.
ORIGINAL PAPERS
Improvement in gastrointestinal tolerability of the selective cyclooxygenase (COX)-2 inhibitor, meloxicam, compared with piroxicam: results of the Safety and Efficacy Large-scale Evaluation of COX- inhibiting Therapies (SELECT) trial in osteoarthritis
Division of Rheumatology, University Hospitals, K.U. Leuven, Belgium.
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