NICE Says COX-2 Inhibitors Should Be Reserved for High-Risk Patients
Gosh, I’ll but Pharmacia and Merck weren’t terribly happy about this announcement!! Overall, despite much, much hype, the evidence supporting greatly safety with the new selective COX-2 inhibitors for pain is just not that strong. Remember that most NSAIDs inhibit both cyclooxygenase 1 and 2 and that COX-1 has a protective effect on many tissues in the body and that COX-2 is needed for certain pain producing pathways. Block COX-1 and you block the body’s ability to protect itself and create injury. However, we still do not fully understand the picture of what COX-2 does. Block it and we are not yet sure what the long term consequences may be. The arrogance of man over nature never ceases to amaze me. Remember that nature already makes some selective COX-2 inhibitors with centuries of safety.
(article) Britain’s National Institute for Clinical Excellence (NICE) said on Thursday that Merck and Pharmacia’s blockbuster cyclooxygenase 2 inhibitors, Vioxx (rofecoxib) and Celebrex (celecoxib), should not be used routinely. In guidance to the National Health Service, NICE said that selective inhibitors of COX-2 should be used instead of standard nonsteroid anti-inflammatory drugs (NSAIDs) only by people with rheumatoid arthritis or osteoarthritis who are at high risk of developing serious gastrointestinal adverse events. NICE defined high-risk patients to include those over 65 years, those already using medications known to increase the likelihood of upper gastrointestinal adverse events, those with serious co-morbidity, and those requiring prolonged use of maximum recommended doses of standard NSAIDs. NICE also announced that its appeals’ committee has rejected all appeals by Pharmacia and Merck. Both companies had complained that the Institute’s guidance was perverse in the light of the evidence submitted. The guidance says that all NSAIDs, including the COX-2 selective agents, can cause gastrointestinal adverse events, including life-threatening perforations, ulcers or bleeds. “The risk of NSAID-induced complications is particularly increased in patients with a previous clinical history of gastroduodenal ulcer, gastrointestinal bleeding or gastroduodenal perforation. The use of even a COX-2 selective agent should therefore be considered especially carefully in this situation.” The guidance adds that concerns have been raised over the cardiovascular effects of COX-2 drugs. One study comparing Vioxx and naproxen detected an increase in the rate of myocardial infarction in the Vioxx group. Further research is needed to resolve this issue but in the meantime the potential increased risk should be taken into account when prescribing COX-2 agents for patients with cardiovascular disease, according to the guidance.