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

Abstract

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.

A comparison of the cost-effectiveness of five strategies for the prevention of non-steroidal anti-inflammatory drug-induced gastrointestinal toxicity: a systematic review with economic modelling

“…Extra outcome data were provided for only eight of these studies. [37][38][39][40][41][42][43][44] Five offered data on outcomes not previously recorded for that study, five offered information that no events had occurred in some outcomes and four offered data differing from those already collected from the study publication(s). Replies about the same eight studies and one further study 45 provided extra information on study quality (method of randomisation, allocation concealment, etc.…”

“…107,116,122 Authors of five studies provided additional information on outcomes when contacted. 37,38,40,42,44 Participants Thirty-eight studies included only adults with OA and nine studies included only adults with RA. Two studies included participants with 'degenerative joint disease', one study included participants with both OA and RA and one study only recruited participants with AS.…”

In vivo microfocal computed tomography and micro–magnetic resonance imaging evaluation of antiresorptive and antiinflammatory drugs as preventive treatments of osteoarthritis in the rat

“…The NSAID meloxicam is a selective cyclooxygenase 2 (COX-2) inhibitor (10), with known antiinflammatory and antiangiogenic effects (11)(12)(13). NSAIDs are prescribed primarily for the management of OA pain (14,15); however, they have also been found to have positive effects on cartilage health in OA by increasing proteoglycan and hyaluronan synthesis (16). Thus, we hypothesized that the addition of an NSAID to the bisphosphonate drug regimen may further mediate the reduction of the inflammatory stimulus and prove beneficial in preventing or slowing osteophytes and cartilage degradation.…”

Reasonable Therapy of Pain Syndromes of Diseases of T H E Musculoskeletal System

“…Серьезные ЖКТ-осложнения в группе мелоксикама возникли у 7, в группе пироксикама у 16 (р < 0,05). Также чаще отмечались эпизоды отмены тера-пии из-за диспепсии у больных на пироксикаме -15,4% по сравнению с мелоксикамом -10,3% (р < 0,001) [12].…”