Study into safety of common over-the-counter drugs reaches milestone

March 21, 2012, University of Nottingham

An international study into the safety of some of the most widely used medicines has reached a significant milestone by recruiting its 6,000th patient.

The SCOT study, involving researchers at The University of Nottingham, 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 6,000 patients and 685 GP practices to the study, across Scotland, England, Denmark and The Netherlands.

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

Local principal investigator Professor Chris Hawkey of The University of Nottingham is running the SCOT study across Nottinghamshire, Derbyshire, Lincolnshire, Leicestershire and South Yorkshire, and is keen to continue recruitment to the SCOT study locally. So far, 70 GP practices and 650 patients are helping with this study in this region.

"This study is designed to answer an important scientific question, which has the potential to improve the care of the thousands of arthritis sufferers across the UK. It is the first large-scale safety study of its kind, and really will make a difference to future prescribing within primary care," said Professor Hawkey.

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 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.

The study is being led by The University of Dundee, which is aiming 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 project 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.

Professor Tom MacDonald, chief investigator on the study and Director of the Medicines Monitoring Unit at the University of Dundee, said: "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."

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.

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