FAST- Febuxostat versus Allopurinol Streamlined Trial V 11.0

• Research type

  Research Study

• Full title

  FAST- Febuxostat versus Allopurinol Streamlined Trial A prospective, randomised, open-label, blinded endpoint (PROBE) clinical trial evaluating long term cardiovascular safety of febuxostat in comparison with allopurinol in patients with chronic symptomatic hyperuricaemia

• IRAS ID

  31578

• Sponsor organisation

  University of Dundee

• Eudract number

  2011-001883-23

• ISRCTN Number

  Applied For

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Gout affects at least 1% of the population in Western countries and is the most common inflammatory joint disease in men older than 40 years of age. The UK prevalence of gout was reported to be 1.4% in 1999.Urate lowering therapy (ULT) is indicated in patients with recurrent acute flares, arthropathy, tophi or radiographic changes of gout. After their first gout flare, however, most untreated patients will experience a second episode within two years.For patients with severe established gout, ULT should be recommended, but opinion ranges from initiation of ULT after the first gout flare, through to waiting until further gout flares occur. Each clinical decision must be individualised according to specific patient characteristics.A numerical but non-significant increase in cardiovascular events (the Anti-Platelet Trialists?? Collaboration composite endpoint to non-fatal MI, non-fatal stroke and cardiovascular death: APTC) was seen with febuxostat when compared to allopurinol in the pivotal PhaseIII studies and long-term extension (LTE) clinical studies. Nevertheless, the incidence of primary APTC events was well within the range expected for patient populations with gout and a similar cardiovascular risk profile, based on published literature. This study will use a prospective, randomised, open, blinded endpoint evaluation (PROBE) design. An open design allows real-world use of these drugs to be compared and allows for dose adjustments of the drug during the study phase. Whilst the open label design resembles real-life clinical practice, the study is only open to the patients and the treating physicians with respect to the treatment received. Conversely, the primary endpoint evaluation will be blinded.The study primary study objective is to compare the cardiovascular safety profile of febuxostat versus allopurinol when taken for an average of 3 years in patients 60 years or over with chronic hyperuricaemia in conditions where urate deposition has already occurred.

• REC name

  Scotland B REC

• REC reference

  11/AL/0311

• Date of REC Opinion

  3 Aug 2011

• REC opinion

  Further Information Favourable Opinion