A new Cox-II selective non-steroidal anti-inflammatory (Cox-II NSAID) has been launched by Novartis. Lumiracoxib (Prexige) is available in 100mg and 400mg tablets and is licensed for symptomatic relief of osteo-arthritis and short term relief of moderate to severe acute pain associated with primary dysmenorrhea, dental surgery or orthopaedic surgery.
The Summary of Product Characteristics draws attention to the cardiovascular effects of Cox-II NSAIDs by warning that the risk of thrombotic events is raised in comparison to placebo and other NSAIDs.
Clinicians are advised to use lumiracoxib for the shortest duration and at the lowest effective dose in order to minimise these risks.
The SPC wording is as follows:
Clinical trials suggest that the selective COX-2 inhibitor class of drugs may be associated with a risk of thrombotic events (especially MI and stroke), relative to placebo and some NSAID's. As the cardiovascular risks of lumiracoxib may increase with dose and duration of exposure, the shortest duration and the lowest effective daily dose should be used. The patients need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis.
The SPC also states:
The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks.
Overall risk includes assessment of cardiovascular, gastrointestinal and renal risk.
A stepped approach to analgesia has already been reported that recommends paracetamol based analgesics first with NSAIDs used where risk is low or use of additional pain killers is necessary. Use of the NSAID of lowest risk is recommended, usually Ibuprofen. Gastrointestinal risks can be lowered by concurrent use of omeprazole.
Action: At this time it is therefore difficult to foresee a place in therapy for lumiracoxib.