Why GPs now dread revalidation
There are 'very few, if any' situations where GPs should be prescribing cox-2 inhibitors, according to an independent review of the available evidence.
The influential Drug and Therapeutics Bulletin concluded supposed gastrointestinal benefits were 'at best marginal' and were outweighed by safety concerns.
The bulletin, which evaluated treatments on behalf of the Consumers Association, said many of the claims on gastrointestinal safety were based on extrapolations from short-term studies.
It found evidence that cox-2s were associated with a lower risk of ulcers than conventional NSAIDs, but not of a lower risk of serious complications such as bleeding or perforation.
'Unqualified assertions that cox-2 selective inhibitors are, as a class, ''safer'' NSAIDs
are untenable on current evidence. We can see very few,
if any, situations in which a coxib should be prescribed in preference to traditional NSAIDs,' the review concluded.
Sharon Hart, head of publications at the bulletin, said the belief cox-2s were safer had been based on 'theoretical grounds'. Emerging evidence on gastrointestinal and cardiovascular safety meant the role of cox-2s was 'likely to be increasingly quite small'.
The bulletin found the only cox-2 proven to have gastrointestinal benefits was lumiracoxib not yet launched in the UK. But it said no cox-2 had been adequately evaluated for cardiovascular safety.
Dr Richard Stevens, chair of the Primary Care Society for Gastroenterology and a GP in Oxford, said: 'Cox-2s did not fulfil their early promise of being less gastrotoxic. The risk-benefit equation is now better informed. Clearly there are individual circumstances, but my view would be to use gastric protection with a traditional NSAID.'
RCGP prescribing lead Dr Jim Kennedy said: 'I always welcome the bulletin's contribution but I think most clinicians find cox-2s can be very useful for a small group of patients who are difficult to treat with other medications.'
Pfizer, manufacturer of cele- coxib (Celebrex) and valdecoxib (Bextra), said both drugs offered a 'favourable GI tolerability profile' compared with traditional NSAIDs.
The Medicines and Healthcare Products Regulatory Agen-cy recently warned GPs to avoid cox-2 inhibitors in patients with cardiovascular disease.
Cox-2s: how the doubts have grown
doubts have grown
Rofecoxib withdrawn by manufacturer after long-term study found increased risk of heart attack and stroke beyond 18 months of use
European Commission orders safety review of cox-2 inhibitors after preliminary EMEA review could not rule out class effect
National Prescribing Centre advises GPs not to switch patients who were taking rofecoxib on to another cox-2
·MHRA advises patients taking cox-2s to see GP and for patients with cardiovascular disease to be switched to alternative treatment
DTB warns there are 'very few, if any' situations when cox-2s should be prescribed ahead of traditional NSAIDs
By Nerys Hairon