Drugs

, Volume 68, Issue 13, pp 1865–1874 | Cite as

Febuxostat

  • Philip I. Hair
  • Paul L. McCormack
  • Gillian M. Keating
Adis Drug Profile

Abstract

  • ▲ Febuxostat is an orally administered, non-purine, selective inhibitor of xanthine oxidase approved for the management of chronic hyperuricaemia in patients with gout.

  • ▲ In a randomized, double-blind, dose-ranging study in patients with gout and hyperuricaemia, significantly more recipients of febuxostat 40–120 mg/day than placebo had serum urate levels of <6.0 mg/dL after 4 weeks of treatment.

  • ▲ Serum urate levels were reduced below 6.0 mg/dL at the last three monthly observations in a significantly greater proportion of patients with gout and hyperuricaemia receiving febuxostat 80 or 120 mg once daily than in those receiving allopurinol 300 mg once daily in a 52-week, randomized, double-blind trial (FACT).

  • ▲ Similarly, febuxostat 80, 120 or 240 mg once daily showed significantly greater urate-lowering efficacy than allopurinol 100 or 300 mg once daily in a 28-week, randomized, double-blind, placebo-controlled trial (APEX) in patients with gout and hyperuricaemia.

  • ▲ Long-term treatment with febuxostat for up to 4 years or more reduced the incidence of gout flares to (or close to) zero.

  • ▲ Febuxostat was generally well tolerated in clinical trials, including extension studies lasting ≥4 years, with most treatment-related adverse events being mild to moderate in severity.

Keywords

Gout Xanthine Oxidase Allopurinol Febuxostat Gouty Arthritis 

Notes

Acknowledgements and Disclosures

The manuscript was reviewed by: L.X. Chen, University of Pennsylvania and the VA Medical Center, Philadelphia, Pennsylvania, USA; N.L. Edwards, Department of Medicine, University of Florida, Gainesville, Florida, USA; N. Schlesinger, UMDNJ-Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA; H.R. Schumacher Jr, University of Pennsylvania and the VA Medical Center, Philadelphia, Pennsylvania, USA.

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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Copyright information

© Adis Data Information BV 2008

Authors and Affiliations

  • Philip I. Hair
    • 1
    • 2
  • Paul L. McCormack
    • 1
    • 2
  • Gillian M. Keating
    • 1
    • 2
  1. 1.Wolters Kluwer Health ¦ AdisMairangi Bay, North Shore, AucklandNew Zealand
  2. 2.Wolters Kluwer HealthConshohockenUSA

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