Background/Purpose:   Gout is a common cause of morbidity in the US population.  Traditionally, allopurinol is not initiated during an acute episode to avoid prolonging the painful gouty attack.  The 2012 ACR guidelines for management of gout suggested that urate-lowering therapy could be started during an acute gout attack, provided that effective acute management was instituted.  These recommendations were based on “consensus opinion of experts, case studies, or standard of care.”  We conducted a 28-day, placebo-controlled, double-blind study of allopurinol initiation in patients receiving treatment for acute gout.   

Methods:   Pre-study power analysis suggested 32 subjects to detect a two-day difference in days to resolution (DTR) of acute gout with a power level of 0.8.  Exclusion criteria included GFR < 50cc/min, AST/ALT or alkaline phosphatase  > 1.25 times normal.  The treating physician determined therapy for the acute gout attack.  Standard prophylaxis, with colchicine or NSAIDs, was prescribed.  Patients were assessed at five visits over 28 days.   The primary endpoint was DTR of acute gout, using separate Likert scales for patient rated involved joint pain and physician exam.  Secondary measures included MHAQ, physician global assessment, side effects of therapy, per protocol (completer) analysis, serum uric acid, CBC, and CMP at two and four weeks.  The intent to treat analysis included any patient who took at least one pill; we assigned 28 days DTR to allopurinol dropouts and actual DTR or last study day to placebo. 

Results:   Thirty-six patients were randomized to 19 placebo and 17 allopurinol. One allopurinol patient dropped out before taking one pill, and was excluded from analysis. Three placebo and two allopurinol patients dropped out before day 28.  The intent to treat analysis showed a statistically insignificant 4.5 days longer DTR in the allopurinol group that was reduced to two days in the per protocol analysis.  Both groups had similar patient rated Likert pain scores at enrollment and at day 28.  The acute gout attack resolved in all patients by the end of the study.