A stepwise dose increase of febuxostat was comparable to prophylactic low-dose colchicine for reducing flares in an open-label, randomized study of 241 patients with gout. Flares occurred in 20.8% of patients taking stepped-up (10 mg to 40 mg daily) febuxostat and in 18.9% of patients taking 40 mg daily febuxostat with low-dose colchicine, incidences that were significantly lower than those seen in patients taking 40 mg daily febuxostat alone (P = 0.047 and P = 0.024, respectively).