FAST Trial reports no cardiovascular risk of a treatment for gout

A treatment for gout presents no increased risk of cardiovascular events for patients compared to an older alternative, a major new study published in the Lancet has found. Nov 20.

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In a study lead by investigators at the University of Dundee, in collaboration with the Universities of Edinburgh and Glasgow compared the cardiovascular safety of allopurinol to the more modern febuxostat in over 6,000 patients between 2011 and 2019.  Prof Stuart Ralston, the University of Edinburgh lead for the project, and Emeritus Prof George Nuki, working with the University’s in-house nursing team from the Edinburgh Clinical Trials Unit, coordinated the second largest recruitment of UK patients to the important study.  The Febuxostat versus Allopurinol Streamlined Trial (FAST) found no significant difference in the number of events such as heart attacks, strokes and cardiovascular causes of death between the two treatments.

Gout is a form of arthritis that causes sudden and severe pain in a person’s joints. It is the most common type of chronic inflammatory arthritis, affecting 2.5% of adults in the United Kingdom. The number of people affected is rising worldwide, with men more frequently affected than women.  Allopurinol has been the first line urate-lowering drug used for the treatment of gout for more than 50 years, however, febuxostat is a more recently developed, potent, and more selective non-purine xanthine oxidase inhibitor which is effective and cost-effective as a second line urate-lowering drug. Because it is metabolised in the liver it is often preferred for treating patients with gout who have impaired kidney function.  However, because of lingering concerns about the possibility of increased cardiovascular risk with febuxostat, the European Union Risk Management Plan indicated that a post-authorisation safety study be carried out in Europe in patients with gout and hyperuricemia, resulting in approval of FAST in 2011.

The trial represents a major collaboration between the Universities of Dundee, Glasgow and Edinburgh, also in collaboration with the Universities of Aberdeen and Nottigham, NHS Highland as well as benefitting from input from researchers at the University of Southern Denmark.  Building on the ability to track patient outcomes using national electronic records of hospitalizations and deaths. This process, known as record-linkage, is possible in some European countries and greatly increases confidence that all events are captured.

We hope that the FAST trial results will help to reassure patients with gout and doctors who treat them that febuxostat is as safe as allopurinol in patients with increased risks of cardiovascular disease.

Prof Stuart Ralston and emeritus Prof George Nuki

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2020
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