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Previous Urate-Lowering Therapy Plus Febuxostat Lowers Urate Levels, Number of Flares in Patients With Gout: Presented at ACR/ARHP

By Liz Meszaros

PHILADELPHIA -- October 25, 2009 -- Upon further treatment with febuxostat, patients previously treated with urate-lowering therapy achieved serum urate levels (sUA) <6.0 mg/dL more often than patients who had no previous treatment, and reported fewer gout flares.

The conclusions were reported here on October 20 at the 2009 Annual Scientific Meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP).

"One of the hallmarks of gout is the painful and disabling acute flare of arthritis that patients experience," said lead author Michael A. Becker, MD, University of Chicago School of Medicine, Chicago, Illinois. "The results of the CONFIRMS [Confirmation of Febuxostat in Reducing and Maintaining Serum Urate] trial suggest that by achieving and maintaining sUA <6.0 mg/dL over time, the risk of future gout flares can be diminished."

In the 6-month trial, Dr. Becker and colleagues randomised 2,269 patients to receive daily treatment with febuxostat 40 or 80 mg or allopurinol 300 or 200 mg (based on creatinine clearance).

A subset of 276 patients had previously participated in the Open-Label Clinical Trial of Urate-Lowering Efficacy and Safety (FOCUS) or Febuxostat/Allopurinol Comparative Extension Long-Term (EXCEL) trials and had maintained sUA <6 mg/dL for up to 5 years while receiving febuxostat (40, 80, or 120 mg) or allopurinol 300 mg.

All patients who had received prior urate-lowering therapy were washed out for 30 days, with baseline sUA levels of 8 mg/dL or more before participating in the CONFIRMS trial.

In those who had previously participated in either the FOCUS or EXCEL trials, 57% of the febuxostat 40-mg group, 77% of the febuxostat 80-mg group, and 52% of those in the allopurinol group achieved sUA <6.0 mg/dL.

For patients who had not previously participated in these trials, this rate was lower, at 43% in the febuxostat 40-mg group, 66% in the febuxostat 80-mg group, and 41% in the allopurinol group (P <= .05 for comparison of patients with and without prior participation for each treatment group).

Overall, patients with prior participation in each of the treatment groups had lower rates of flares (P <= .001) compared with patients without prior participation.

The rate of adverse events was similar in all groups, regardless of prior participation. The most frequent of these were upper respiratory infection, abnormal liver function tests, musculoskeletal pain, and diarrhoea.

"Overall, study results from the CONFIRMS trial demonstrated that febuxostat 80 mg was superior in lowering sUA levels compared with febuxostat 40 mg, and allopurinol," concluded Dr. Becker.

[Presentation title: Documentation of Fewer Gout Flares After Long-Term Urate-Lowering Treatment. Abstract 1501]

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