A study of medicines to treat the pain of arthritis, which reinforces Scotland’s place as a leader in the delivery of major clinical trials, was launched today.
The SCOT Trial, (Standard Care versus Celecoxib Outcome Trial), will compare different types of treatment for arthritis – a series of conditions which affect around nine million people in the UK.
The trial compares traditional non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and diclofenac, with a newer NSAID called Celecoxib. Both types of NSAID are prescribed for the treatment of arthritis, but doctors want to know how the newer NSAID Celecoxib compares with the older NSAID in patients with arthritis in terms of long-term safety.
Professor Tom MacDonald, lead investigator and Professor of Clinical Pharmacology at Dundee University, said: "This trial is of international significance because it will compare the various NSAID treatments prescribed for arthritis sufferers in usual care. There has been a long running debate as to the most effective pain relief with fewest side effects. This study will help us draw some solid conclusions to benefit arthritis sufferers".
Scotland will spearhead the trial, which is made possible by the country's sophisticated patient electronic registration and tracking systems. Professor Ian Ford from the Robertson Centre for Biostatistics at Glasgow University explains: "Scotland now has one of the best electronic patient record systems in the world. We can harness the power of the information this gives us to examine medicines in the real life setting of care within the NHS."
The University of Dundee will lead the trial in partnership with the Universities of Glasgow, Edinburgh, and Aberdeen. There is also collaboration with Professor Chris Hawkey, a world opinion leader in the effects of these drugs on the stomach, based at Nottingham University, and Professor Jesper Hallas at the University of Southern Denmark. Denmark has a similar patient record system to Scotland and the results from Denmark will serve as a check that the Scottish results can be generalised to other countries.
Professor Chris Hawkey said: "Traditional NSAID drugs can cause bleeding from the lining of the stomach. Celecoxib is thought to minimise these stomach problems, but we are unclear what treatment is best overall. The record system in Scotland offers a great opportunity to resolve this. "
Professor Roger Sturrock from Glasgow University said: "This trial is of major significance because it harnesses the strengths of academia and the NHS in Scotland to deliver a world-leading study."
Professor Stuart Ralston from Edinburgh University said: "NSAIDs play an important role in the treatment of arthritis but we know that side effects, such as stomach upset, can occur in some patients. This study will provide important new information on the risks and benefits of older versus newer NSAID and will help us to decide what the best treatment is for the individual patient".
Professor David Reid at the University of Aberdeen said "This trial coming to Scotland demonstrates how Universities and the NHS can work in partnership to answer some of the big questions in the treatment of arthritis".
Four hundred GP practices and 16,000 patients will participate in the three-year trial.
The study, funded by Pfizer, means a £26m cash injection for research which will be based in hundreds of GP practices across Scotland.
Dundee GP Alex Watson says "It is important that this study is done in the "real world" of Scottish general practice and not just with the highly selected patients attending a specialist research centre."
To participate in the SCOT study patients must be aged 60 or over, and should already be taking an NSAID such as ibuprofen or diclofenac which has been prescribed by their GP for arthritis.
According to ISD Scotland, the national organisation for health information, statistics and IT services, a total of 2.55 million prescriptions were issued in Scotland for the treatment of various forms of arthritis during 2005/6.
Arthritis is common and NHS Quality Improvement Scotland estimates that between 152,000 and 217,000 people in Scotland have rheumatoid arthritis or osteoarthritis.