NICE guidance - use of COX2 selective inhibitors

Summary points:

• COX2 selective inhibitors - not recommended for routine use in patients with rheumatoid arthritis (RA) or osteoarthritis (OA)
• COX2 inhibitors should be used, in preference to standard NSAIDs, in the management of RA or OA in patients at 'high risk' of developing gastrointestinal side effects (1):
  • patients aged over 65 years
  • in patients using concomitant medications known to increased the likelihood of upper gastrointestinal side effects
  • patients with serious co-morbidity
  • patients requiring use of maximum recommended doses of standard NSAIDs
• the use of COX2 inhibitors should particularly be considered where there is an increased risk of NSAID - induced complications e.g. previous clinical history of peptic ulcer, gastroduodenal perforation, or gastrointestinal bleeding
• in patients with cardiovascular disease the use of COX2 inhibitors should not be prescribed routinely in preference to standard NSAIDs

Note that since the NICE guidance was issued that there has been a voluntary worldwide withdrawal of the 'COX-2 selective NSAID' rofecoxib (Vioxx/VioxxAcute) by the manufacturer. This follows new clinical trial results showing an increased risk of confirmed serious thrombotic events (including myocardial infarction and stroke) compared to placebo, following long-term use.

There has been advice for Prescribers in light of concerns about cardiovascular safety of COX-2 inhibitors (2)

• patients treated with any COX-2 inhibitor who have established ischaemic heart disease or cerebrovascular disease should be switched to alternative (non-COX-2 selective) treatments as soon as is convenient
• for all patients, alternative treatments should be considered in light of an individual assessment of risks and benefits of COX-2 inhibitors, in particular cardiovascular, gastrointestinal and other risk factors
• prescribers are reminded that for all NSAIDs (including COX-2 inhibitors), the lowest effective dose should be used, for the shortest duration necessary
• for patients switched to chronic non-selective NSAIDs, consideration should be given to the possible need for gastro-protective treatments

NICE have stated (15 December 2004) that the review concerning the guidance on the use of COX-2 inhibitors has been suspended pending the outcome of the European Medicines Agency (EMEA) review on COX-2 inhibitors.

Reference:

1. NICE (July 2001). Guidance on the use of cyclo - oxygenase (Cox) II selective inhibitors, celecoxib, rofecoxib, meloxicam and etodolac for osteoarthritis and rheumatoiod arthritis. Committee on Safety of Medicines (2001), Current Problems in Pharmacovigilance, 27, 1-8.
2. Medicines and Healthcare products Regulatory Agency (December 2004). Advice on the use of celecoxib and other selective cox-2 inhibitors in light of concerns about cardiovascular safety.