Dr Bhupesh Dhananjayan

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• Dr Bhupesh Dhananjayan
• MD MPH

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Study design

• Randomised, phase 3, double- blind, 52 wk
  multicenter non inferiority trial.
• Exclusion criteria 1)s. creat gt1.5
  /CrCllt50ml/min/1.73m2
• 2)pregnancy/lactation
• 3)BMI gt 50
• 4)Active liver dz/hepatic dysfunction
• 5)Prednisone gt10mg/d
• 6)Change in OCP Rx within last 3mths
• 7) h/o ETOH abuse(gt14 drinks/wk)
• 8) h/o xanthinuria
• 9) Meds urate lowering
  agents/thiazides/ASA
• 6MP/azathioprine
  

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Study Design (contd)

• Study conducted at a 112 centers in US and Canada
• 2 week washout period in people receiving urate
  lowering therapy.
• 3 study groups 80 mg of Febuxostat, 120 mg of
  Febuxostat
• 300 mg of Allopurinol.
• Permuted block randomization used.

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Study Design (contd)

• Prophylaxis with Naproxen 250 mg BID / Colchicine
  0.6 mg for 8 weeks of double blind treatment 2
  wks of washout period.
• Unconventional treatment schedule.
• PE/VS, serum urate concentration, renal
  function, compliance with study drugs was
  assessed, laboratory tests were performed, and
  concomitant medication use, gout flares, and
  adverse events were recorded at 2wks, 4 wks and
  monthly thereafter.
• Elaborate explanation for tophus measurement.
  (PHEW!!)

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Study Design (contd)

• Primary end pts
• serum urate concentration of less than 6.0 mg per
  deciliter at
• each of the last three monthly measurements.
• Secondary end pts
• Proportion of subjects with serum urate levels of
  less than 6.0 mg per deciliter at each visit
• Percentage reduction from baseline in the serum
  urate concentration at each visit.
• Clinical end points were the percentage reduction
  from baseline in tophus area, the change in the
  number of tophi at each visit, and the prop. of
  subjects requiring treatment for acute gout
  flares from wks 9-52.

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