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EDITORIALS:
Roger Jones
Efficacy and safety of COX 2 inhibitors
BMJ 2002; 325: 607-608 [Full text]
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[Read Rapid Response] COX 2 inhibitors in older people
Helen T Wilson, Ian Hastie   (6 October 2002)
[Read Rapid Response] More data are needed
Christopher Anton, Anthony R Cox   (8 October 2002)

COX 2 inhibitors in older people 6 October 2002
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Helen T Wilson,
specialist registrar in geriatric medicine
St george's hospital, London, SW17 OQT,
Ian Hastie

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Re: COX 2 inhibitors in older people

We were pleased to read that Professor Roger Jones in his editorial on the efficacy and safety of COX 2 inhibitors felt that there were still many unanswered questions, particularly when considering these agents in older people.(1)

The National Institute for Clinical Excellence (NICE) guidance(2)on prescription of COX 2 inhibitors is particularly relevant in Geriatric medicine with age greater than 65 being an indication for their use over traditional non-selective non-steroidal anti-inflammatory drugs (NSAID). Older people are also more likely to fulfil other criteria for being at high risk with a higher incidence of serious co-morbidity and co- prescription of drugs with gastro-intestinal side-effects.

We reviewed the hospital notes of 106 patients on the acute and rehabilitation Geriatric medical wards to examine our current use of NSAIDs and to determine how many would be suitable for COX 2 inhibitors. The average age was 83 (range 67-98). Only 2 patients were prescribed a COX 2 inhibitor. This was appropriate in one but had to be withdrawn in the other due to deteriorating renal function. Five patients were prescribed non-selective NSAIDs for arthritis.

From the hospital notes, following the current NICE guidance and excluding those with specific contraindications it was concluded that only 11 of the 106 patients would be suitable for a COX 2 inhibitor if they developed significant arthritis not responding to simple analgesics.

Low dose aspirin prescription was the commonest reason for not considering a COX 2 inhibitor (n=51). The NICE guidance states that prescription of COX 2 inhibitors in this situation is not justified on current evidence.(2) Anti-platelet therapy is recommended in those with a history of myocardial infarction, angina, stroke, cerebral ischaemia, peripheral artery disease and atrial fibrillation (where warfarin not appropriate) (3) and is probably being under-prescribed. The possible reduction in efficacy of COX 2 inhibitors by aspirin has not been adequately investigated.

Proton pump inhibitors were also commonly prescribed in this population (n=51). In these patients addition of a traditional NSAID would be fist choice as there is no evidence that COX 2 inhibitors have any benefit over this more standard combination.

Non-steroidal anti-inflammatory drugs are probably under used in older patients but until these questions are adequately addressed, prescibing practice is unlikely to change.

Helen Wilson
specialist registrar in geriatric medicine

Ian Hastie
consultant and senior lecturer in geriatric medicine

St George's Hospital, London, SW17 OQT

1. Jones R. Efficacy and safety of COX 2 inhibitors. BMJ 2002;325:607-8

2. National Institute of Clinical Excellence. Guidance on the use of cyclo-oxygenase (COX) 2 selective inhibitors, celecoxib, rofecoxib, meloxicam and etodolac for osteoarthritis and rheumatiod arthritis. London: NHS Executuive, July 2001.

3. Antithrombotic trialists collaboration. Collaborative meta- analysis of randomised trials of anti-platelet therapy for prevention of death, myocardial infarction and stroke in high risk patients. BMJ 2002;234:71-86

More data are needed 8 October 2002
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Christopher Anton,
Administrative Co-ordinator
West Midlands Centre for Adverse Drug Reaction Reporting, City Hospital, Birmingham B18 7QH,
Anthony R Cox

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Re: More data are needed

Dear Editor

We welcome Dr Jones timely editorial on the problems of upper GI toxicity of NSAIDs, (1) and echo his call for more information for prescribers. One solution lies in the hands of prescribers themselves, the simple and relatively cheap Yellow Card scheme. Dr Jones notes that 2000 patients in the UK die each year, yet the entire Medicines Control Agency database lists only 1306 deaths [CSM, personal communication] from gastrointestinal causes associated with NSAID-use; an average of 35 per year since the Yellow Card scheme was introduced. This illustrates the extent of under-reporting to the Yellow Card Scheme – studies have estimated that 6-13% of serious reactions are reported to the Scheme (2,3), although the level of under-reporting is variable and influenced by a number of factors.

Reports to the Yellow Card scheme have already been used by the MCA to stratify the risks associated with NSAID-use, (4) but with more data they could do more. Each Yellow Card adds a further piece of clinical information, particularly with regards to risk factors such as age, disease state or concomitant drug use. Some may think that such cases are not worth reporting because of the known risks, but when prescribers encounter a patient with serious upper GI problems suspected to be associated with an NSAID, or a COX 2 inhibitor, we suggest they reach for a Yellow Card.

References

1. Jones R. Efficacy and safety of COX 2 inhibitors. BMJ 2002; 325: 607-08.

2. Lumley CE, Walker SR, Hall CG, Staunton N, Grob PR. The under- reporting of adverse reactions seen in general practice. Pharmaceutical Medicine 1986; 1: 205-12.

3. Smith CC, Bennett PM, Pearce HM, et al. Adverse drug reactions in a hospital general medical unit meriting notification to the Committee on Safety of Medicines. Br. J. Clin. Pharmacol. 1996; 42: 423-9.

4. Anonymous. Relative safety of oral non-aspirin NSAIDs. Current Problems in Pharmacovigilance 1994; 20: 9-11.