A large-scale international study of thousands of arthritis patients has found the risks arising from prescribed use of some of the most common painkillers are relatively low, offering reassurance to doctors and patients.
The SCOT study (Standard Care versus Celecoxib Outcome Trial), published recently in the European Heart Journal and involved academics from The University of Nottingham’s School of Medicine.
It set out to examine the comparative safety of treating arthritis either with commonly used non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, diclofenac and naproxen, or a newer class of more targeted drugs called COX2 inhibitors, which include celecoxib.
Chris Hawkey, Professor of Gastroenterology at the Nottingham Digestive Diseases Centre, said: “Although the trial was set up to investigate whether there are striking differences in the risk of cardiovascular or gastrointestinal problems, the striking feature is how low the incidence of such problems was. This is consistent with other observations suggesting a decline in heart attacks and ulcer complications.”
Adverse affects 'rare'
The trial, led by the University of Dundee, involved more than 7,000 patients and found the use of either NSAIDs or celecoxib was associated with only a low rate of the cardiovascular problems studied. In addition, gastrointestinal adverse effects studied were very rare indeed.
The potential gastrointestinal adverse effects, such as stomach ulcers and gut bleeding, arising from the use of NSAIDs have led to concerns from both doctors and patients about using these treatments for the long-term relief of arthritis symptoms.
It was hoped that the new group of more targeted COX2 drugs would reduce some of these possible problems, but prescribing of these reduced when concerns arose that they may be associated with increased cardiovascular diseases.
Despite ongoing scientific debate, a reliable comparison of celecoxib and older non-selective NSAIDs which specifically examined cardiovascular consequences was lacking. The SCOT trial was carried out to help answer the question of whether it is similarly safe to treat arthritis with the selective COX2 NSAID celecoxib or other older non-selective NSAIDs.
About 7,300 patients, average age 68, with arthritis managed in family doctor practices in the UK, Denmark and the Netherlands took part in the study. Patients taking chronic non-selective NSAID treatments for arthritis and who had no history of established CV disease were written to by their family doctor asking if they would like to participate.
Subjects who agreed were screened for suitability then were randomly allocated to continue their usual NSAID painkiller or switch to celecoxib. Patients were then tracked looking for hospitalisations for heart attacks, strokes or CV deaths.
Whilst no subject in SCOT had established CV disease at entry to the study, this population of people had the usual risk factors for CV disease such as high blood pressure (44 per cent), high cholesterol (34 per cent), smoking (15 per cent) and diabetes (8 per cent). Despite these risk factors the rate of CV events that occurred during the study was low, at less than half of that expected at about 9 events per 100 patients over a 10-year period.
An additional finding from the study was that when the prescribing of the NSAID that the patient had been taking for a long time was switched to celecoxib, then quite a high proportion of people switched back to their previous NSAID.
Professor Hawkey, added: “Although celecoxib is a good choice for safe prescribing, there is little value in switching patients from existing medication that they have acclimatised to as some patients will develop side effects from any new drug they are not used to.
“We don’t know why there were so few ulcer complications. One possibility is that it is at least partly attributed to co-prescription of anti-ulcer drugs, seen in 38 per cent of patients as they entered the trial. This strategy, which was developed from Nottingham, is recommended by most guidelines for use in all users of NSAIDs.”
Nottingham was a major contributor to the trial as the fastest recruiting centre, developing a primary care network with around 1,000 practices that have enrolled more than 25,000 patients in an ongoing follow on study.
The SCOT trial worked in collaboration with a wide range of universities in Scotland (Aberdeen, Glasgow and Edinburgh), England (Nottingham, Oxford, Birmingham, University College London), Denmark (University of Southern Denmark) and the Netherlands (Julius Centre, University of Utrecht). The study data centre was the Robertson Centre for Biostatistics at the University of Glasgow.
The study was sponsored by the University of Dundee with an unrestricted Investigator Initiated Research Grant from Pfizer USA.
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Notes to editors: The University of Nottingham has 43,000 students and is ‘the nearest Britain has to a truly global university, with a “distinct” approach to internationalisation, which rests on those full-scale campuses in China and Malaysia, as well as a large presence in its home city.’ (Times Good University Guide 2016). It is also one of the most popular universities in the UK among graduate employers and was named University of the Year for Graduate Employment in the 2017 The Times and The Sunday Times Good University Guide. It is ranked in the world’s top 75 by the QS World University Rankings 2015/16, and 8th in the UK for research power according to the Research Excellence Framework 2014. It has been voted the world’s greenest campus for four years running, according to Greenmetrics Ranking of World Universities.
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