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For many years, a medicine called allopurinol has been the mainstay of gout treatment. A newer medicine, called febuxostat, was introduced to Europe in 2008. The initial clinical trials of febuxostat confirmed that it was very effective at controlling gout. However, there was an unexpected finding: some of the results suggested that the drug might be slightly less safe than allopurinol in terms of risk of heart attack and stroke. It was essential to investigate this further. The FAST study (Febuxostat vs Allopurinol Streamlined Trial) was designed to compare the risk of heart disease and stroke in people with gout treated with either febuxostat or allopurinol.
The study was run by MEMO Research, University of Dundee, and led by Professor Tom MacDonald.
The first FAST participants joined the study in 2011. Recruitment continued until the end of January 2018. The study team followed up participants until the end of 2019. The study team analysed the final data over the Summer of 2020.
6,128 people with gout, aged 60 and over, took part in the FAST study. The average age of participants at study entry was 71 years, and 85% were men. We recruited participants in the UK, Denmark, and Sweden. Everyone who took part was taking allopurinol before joining the trial. A third of the participants had been diagnosed with cardiovascular diseases such as angina, heart attack, or stroke before entering the trial. On average, participants took their study medication (either allopurinol or febuxostat) for 3.6 years.
All study participants were randomly assigned to take: Febuxostat (either 80mg or 120mg per day) OR Allopurinol (between 100mg & 900mg per day)
What did the study find?
Febuxostat was not associated with a higher risk of heart attack, stroke, or death from a cardiovascular cause. Importantly, this study did not find any evidence of a higher risk of death with febuxostat.
The lead investigator, Professor Tom MacDonald (MEMO Research, University of Dundee), has recorded a summary of the findings which can be viewed here –
The results of the FAST study are very reassuring. Doctors and patients benefit when there is more than one treatment to choose from because allopurinol does not suit everyone. The FAST study results suggest that febuxostat remains a safe and effective option for treating gout.
Professor MacDonald presented the FAST study results at a meeting of the American College of Rheumatology (ACR) in November 2020.
The results were also published in The Lancet medical journal – https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(20)32234-0.pdf
There have also been several press releases and interviews with the FAST study investigators:
· University of Dundee press release
· Professor MacDonald discussing the results of FAST with TOUCH Immunology
· Professor MacDonald explaining to TOUCH Immunology how the FAST results compare to the results of a previous study, called CARES
We are inviting FAST participants to help us learn more by taking part in a simple questionnaire study. This long-term follow-up study is called FASTER (FAST Extended Review).
You can find out more about FASTER by clicking on the following link:
We are still planning the FASTER study, which should start in 4-5 years. You can register your interest above
Thank you again for your ongoing support for FAST and In advance for our new FASTER study.