0
Q
What was the primary efficacy outcome in APEX
A
%pts with sUA less than 6 mg/dl at last 3 monthly measures
1
Q
Apex trial
Schumacher 2004 arthritis & rheumatism
28wk phase3 dbl blind placebo controlled randomised trial
Effects of Febuxostat versus allopurinol &placebo in reducing serum urate in pts with gout and hyperuricemia
N=1072
Urate levels 8or higher
A
Subset renal pts 100mg allo or 80,120 Febuxostat
Others 300mg allo or placebo or Febuxostat 80,120
Results %pts last 3sua below 360
80 48% 120 65% allop 300 22%
Renal ad80 44% ad120 45% allo 100 0%
2
Q
How many pts in APEX
A
1072
3
Q
FACT phase 3 Efficacy and safety v allopurinol Double blind,parallel group, randomised controlled N=760 52 wk trial
A
F80mg,F120mg Al300mg
SUA
4
Q
CONFIRMS (FDA request) Efficacy&safety N=2269 Dblind,randomised F 40mg F 80mg All300/200mg 26wk trial
A
5
Q
FOCUS open label extension of 004 Schumacher Rheumatology 2009 Long term safety&efficacy N=153 Open label
A
5 years
6
Q
EXCEL open label extension of Apex and Fact
Becker
Long term safety and efficacy vs Allopurinol
N=1086
A
Febuxostat
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