19 March 2012

Arthritis pain killer study recruits 6000th Patient

A Scottish-led large-scale safety study into some of the most widely used medicines has reached a significant milestone by recruiting its 6000th patient volunteer.

The SCOT study is comparing the safety of commonly prescribed, non-steroidal anti-inflammatory drugs (NSAIDs) which include ibuprofen (Brufen®) and diclofenac (Voltarol®). The study has now managed to recruit 6000 patients and 685 GP practices to the study, across Scotland, England, Denmark and The Netherlands.

Health Secretary Nicola Sturgeon said the SCOT project showed the country's capability to host and co-ordinate large-scale, multi-national, medical studies.

"The success of the SCOT study highlights Scotland's ability to generate and host major clinical trials which will deliver considerable benefits to patients of major diseases," said Ms Sturgeon.

It is hoped the findings of the study could benefit millions of arthritis sufferers around the world.

"This is a major achievement and marks a milestone in the success of the project," said Professor Tom MacDonald, chief investigator on the study and Director of the Medicines Monitoring Unit at the University of Dundee.

NSAIDS are the group of drugs most commonly prescribed to relieve the joint pains associated with arthritis. Often they do that job well, which is why they are so popular, with millions of prescriptions written across the UK every year for NSAIDs, not counting all those sold 'over-the-counter' in pharmacies and shops. However, like all drugs, NSAIDs can have side effects. These include irritation of the digestive system and effects on blood pressure and the heart.

A more recent group of NSAIDs called 'Cox-2 inhibitors' was developed, which have been shown to be less harsh on the digestive system than the most popular existing NSAIDs, leading to fewer stomach ulcers and bleeding.

The question to be answered by the SCOT study is whether one of these new drugs, Celecoxib (Celebrex) has similar or dissimilar effects on the cardiovascular system as the older drugs. The study formally tests the hypothesis that celecoxib is no different from the older NSAIDs.

The current patent for Celecoxib expires in 2014, allowing the drug to be produced generically and sold at a significantly lower price, slashing the price the NHS has to pay. This is about the time that the SCOT study is due to publish its results.

"This information will be of great value to everyone who needs to take these drugs on a regular basis, which is millions of people around the world. The findings will allow doctors and people with arthritis to make the best choice, not just for their joint pains but also for their general health," said Professor MacDonald.

"The fact that we can run a study of this size and complexity from Scotland reflects the world class scientists and research facilities that Scotland, England, Denmark and The Netherlands have to offer, and the collaborative effort of all involved is something that we should all be immensely proud of."

The University of Dundee, which leads the study, is looking to secure continued funding to finish the study and publish the findings, allowing doctors and people with arthritis to make the best choice, not just for their joint pains but also for their general health.

The SCOT study is supported by nine other Universities across Scotland, England, Denmark and The Netherlands, having recently expanded to include The University of Oxford, and Kings College London, making it one of the biggest ever studies run by a Scottish university.

Professor MacDonald and the SCOT study steering committee, which is made up of leading international experts, hope further funding may be granted to the project to extend recruitment into 2014, allowing the generation of significant extra data.

Patients and GP practices are still welcome to join the study. Anyone interested in taking part in the SCOT study can telephone: +44 (0) 1382 632575, check the website for details (www.scottrial.co.uk or info@scottrial.co.uk) or speak to their GP directly to ask if they can take part.

NOTES TO EDITORS

• Arthritis affects around 10% of adults in the UK at some time in their life.
• The NHS spent over £100m on NSAIDs in 2011, handing out over 18 million prescriptions.
• The vast majority of these prescriptions (60%) are for diclofenac, Ibuprofen and naproxen, costing the NHS £43 million.
• Celecoxib currently accounts for around 4% of all prescriptions.
• The SCOT study has over 6,000 patients taking part, and is being run locally at over 650 GP practices across Scotland, England, Denmark and the Netherlands.
• The SCOT study is sponsored by The University of Dundee, and run in collaboration with the Universities of Edinburgh, Glasgow, Aberdeen, Birmingham, Nottingham, Oxford and Kings College London in the UK, and also the University of Southern Denmark and Julius Clinical Research (The Netherlands).
• The Scot study is funded by an investigator initiated grant awarded to the University of Dundee by Pfizer USA.
• The protocol, all data and results are owned by the SCOT study steering committee and the study is entirely run independently with no input from Pfizer

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