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#83 Febuxostat: Precipitating Crystals of Evidence About Gout Prevention

Does febuxostat (Uloric) offer any advantages over allopurinol in preventing gout?

Febuxostat is not better than allopurinol for preventing gout and has a higher rate of gout flares. It should only be considered in patients who have experienced a serious adverse event with allopurinol.

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Meta-analysis1 of 5 randomized controlled trial (RCT) conducted in Canada,1 US2-4 and Japan5,6 including 4250 mostly-male patients with gout 
  • 3 RCTs gave colchicine or naproxen (8 or 24 weeks2-4), whereas the other 2 trials did not provide any prophylaxis against gout flares5,6  
  • Febuxostat 40-240 mg compared to allopurinol 200-300 mg daily x8-52 weeks 
  • Gout episodes: Significant increase with febuxostat 
    • 43.6% versus 38.1% with allopurinol (number needed to harm [NNH]=19) 
  • Tophi number and size: No difference2,3 
  • Achieved serum uric acid <360 µmol/L: Febuxostat 66.4% versus 43.2% with allopurinol. 
2 RCTs conducted in China7,8 
  • 5167 and 5048 mostly-male patients, given colchicine or NSAID x8 weeks7 or NSAID for trial duration,8 randomized to febuxostat 40 or 80 mg, or allopurinol 300 mg daily for ~6 months 
    • No difference in gout episodes between groups 
    • No difference in number of tophi7 
    • Serum uric acid <360 µmol/L more likely with febuxostat 80 mg versus both febuxostat 40 mg and allopurinol.  
Studies’ methodological weaknesses: Selective reporting of clinical outcomes, emphasizing surrogate outcomes, and under-dosing allopurinol.  Context:  
  • Start urate-lowering therapy at low dose and titrate up every 2-6 weeks, and use colchicine or NSAIDs for ~6 months to prevent initial flares.9-11 
  • Though it lowers serum uric acid, allopurinol has never been shown in RCTs to reduce gout flares.12 
  • Allopurinol adverse events: Mild rash, pruritus (~2%); allopurinol hypersensitivity syndrome (severe rash, fever, hepatitis and renal toxicity) [<1/1000].13,14 
  • Yearly costsFebuxostat 80 mg ~$680 (approved Canadian dose), allopurinol 300 mg ~$100.15 
  • Febuxostat cardiovascular safety has been questioned16 and is being studied (NCT01101035). 
updated aug 6 2016 by ricky

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  • Michael R Kolber BSc MD CCFP MSc
  • Tony Nickonchuk BScPharm CDE APA

1. Faruque LI, Ehteshami-Afshar A, Wiebe N, Tjosvold L, Homik J, Tonelli M. Semin Arthritis Rheum 2013;43:367-75.

2. Becker MA, Schumacher Jr HR, Wortmann RL, et al. N Engl J Med 2005;353:2450-61.

3. Schumacher Jr HR, Becker MA, Wortmann RL, et al. Arthritis Rheum 2008;59:1540–8.

4. Becker MA, Schumacher Jr HR, Espinoza LR, et al. Arthritis Res Ther 2010;2:R63.

5. Kamatani N, Fujimori S, Hada T, et al. J Clin Rheumatol 2011;17:S44-S49.

6. Kamatani N, Fujimori S, Hada T, et al. J Clin Rheumatol 2011;17:S13-S18.

7. Huang X, Du H, Gu J, et al. Int J Rheum Dis 2014;17:679-86.

8. Xu S, Liu X, Ming J, et al. Int J Rheum Dis 2015;18:669-78.

9. Shmerling RH. JAMA 2012;308:2133-41.

10. Neogi T. Ann Intern Med 2016;165:ITC1-ITC16.

11. Borstad GC, Bryant LR, Abel MP. J Rheumatol 2004;31:2429–32.

12. Seth R, Kydd ASR, Buchbinder R, Bombardier C, Edwards CJ. Cochrane Database Syst Rev 2014;10:CD006077.

13. Chao J, Terkeltaub R. Curr Rheumatol Rep 2009;11:135-40.

14. Dalbeth N, Stamp L. Semin Dial 2007;20:391–5.

15. [Accessed 3 Aug 2016]

16. Schumacher Jr HR, Becker MA, Lloyd E, et al. Rheumatology 2009;48:188–94.

Authors do not have any conflicts of interest to declare.

Les auteurs n’ont aucun conflit d’intérêts à déclarer.

Most recent review: 03/08/2016

By: Ricky Turgeon BSc(Pharm) ACPR PharmD


Evidence Updated: Updated; Bottom Line: No change.

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