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International Journal of Rheumatology
Volume 2014 (2014), Article ID 123105, 6 pages
Clinical Study

Urate Lowering Therapy with Febuxostat in Daily Practice—A Multicentre, Open-Label, Prospective Observational Study

1Department of Rheumatology, University Clinic “Carl Gustav Carus”, Technical University Dresden, Fetscherstraße 74, 01307 Dresden, Germany
2Rheumatology, Rehaklinik am Kurpark, Kurhausstraße 9, 97688 Bad Kissingen, Germany
3Sybelstraße 42, 10629 Berlin, Germany

Received 7 February 2014; Revised 23 July 2014; Accepted 20 August 2014; Published 3 September 2014

Academic Editor: Ruben Burgos-Vargas

Copyright © 2014 Anne-Kathrin Tausche et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


Introduction. Febuxostat, a novel xanthine oxidase inhibitor for the treatment of symptomatic hyperuricemia, showed superiority over allopurinol in the reduction of serum uric acid levels in pivotal studies. Whether this holds true the FORTE (febuxostat in the oral urate lowering treatment: effectiveness and safety) study was conducted to evaluate treatment with febuxostat under daily practice conditions. Materials/Methods. The multicentre, open-label, and prospective observational study was conducted in 1,690 German medical practices from 9/2010 to 5/2011. Safety and efficacy data were assessed at baseline and week 4. Results. Data from 5,592 gout patients (72.6% male, mean age 63.7 years) were collected. Under urate lowering treatment with febuxostat mean serum uric acid levels decreased significantly from  mg/dL (mol/L) at baseline to  mg/dL (mol/L) at week 4. 67% which reached the mean uric acid target ( mg/dL [mol/L]). Only 43.1% of patients received concomitant flare prophylaxis. A total of 178 adverse events (mostly gout flares) were reported in 152 patients (2.6%). Conclusion. Febuxostat lowers serum uric acid levels effectively in routine clinical practice. Overall, treatment with febuxostat in both available dosages (80 mg/120 mg) was safe and well tolerated.