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Boehringer claims its COX-2 inhibitor meloxicam has low overall and gastrointestinal side-effect profile
Stockholm, Sweden | Saturday, June 15, 2002, 08:00 Hrs  [IST]

New data from two studies presented at the 17th EULAR (European League Against Rheumatism) Congress showed for the selective COX-2 inhibitor meloxicam (Mobic/Mobec/Mobicox) a low overall, gastrointestinal (GI) and cardiovascular risk of adverse events. These data provide reassurance to patients and prescribing physicians concerning the safety profile of meloxicam in a time of growing concern in the medical community over the cardiovascular side-effects of other COX-2 selective anti-rheumatic drugs, rofecoxib and celecoxib.

Mobic is a selective COX-2 inhibitor developed by Boehringer Ingelheim and indicated for the symptomatic treatment of painful osteoarthritis, rheumatoid arthritis and ankylosing spondylitis (indications may vary from country to country). Mobic has been used by more than 70 million patients in 100 countries worldwide. Mobic, classified pharmacologically as a selective COX-2 inhibitor, offers a balance between reliable efficacy and overall safety, including a favourable gastrointestinal tolerability profile.

There is growing concern in the medical community that the COX-2 selectivity of popular anti-rheumatic drugs, such as rofecoxib and celecoxib, could raise the risk of cardiovascular adverse events over traditional non-COX-2 selective non-steroid anti-inflammatory drugs (NSAIDs). In contrast the new data on the selective COX-2 inhibitor meloxicam, which is chemically different from rofecoxib and celecoxib, offer prescribing physicians and patients with concomitant cardiovascular disease reassurance of keeping the GI safety advantages of selective COX-2 inhibition without compromising this benefit by an increased risk of cardiovascular adverse events.

Professor Daniel Furst, University of California, Los Angeles presented a meta-analysis of 48 clinical and observational studies from the meloxicam database on 117,755 patients treated with meloxicam and traditional painkillers. His findings demonstrate a favourable GI risk profile for meloxicam with no indication of excess risk in overall, cardiovascular, renal and hepatic toxicity compared to non-COX-2 selective NSAIDs.

Professor Henning Zeidler, Medical School Hannover, Germany reported on a 3-month large-scale prospective observational cohort study in 4,000 medical practices, with 13,307 patients receiving meloxicam prescriptions. A substantial portion of high risk patients were enrolled: 12 % had a previous history of serious gastrointestinal disease, 24 % had at least one concomitant cardiovascular disorder and 26 % received concomitant anti-hypertensive medication.

Results showed that 85% of patients were treated successfully under normal medical practice conditions, even though a substantial number (21%) of patients for whom previous use of non-COX-2 selective NSAIDs had been insufficiently effective had been included in the study. Despite inclusion of GI high-risk patients in this study, overall, GI, cardiovascular and renal tolerability was favourable.

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