Efficacy and safety of febuxostat extended release and immediate release in patients with gout and moderate renal impairment: phase II placebo-controlled study

Table 1 Demographic and patient characteristics at baseline

Variable	Placebo (n = 38)	FBX IR 40 mg (n = 37)	FBX XR 40 mg (n = 39)	FBX IR 80 mg (n = 37)	FBX XR 80 mg (n = 38)
Age (years), mean (SD)	64.6 (12.8)	61.3 (10.1)	64.4 (11.2)	63.5 (10.3)	61.4 (12.2)
Sex, n (%)
Male	26 (68.4)	25 (67.6)	26 (66.7)	28 (75.7)	29 (76.3)
Female	12 (31.6)	12 (32.4)	13 (33.3)	9 (24.3)	9 (23.7)
Race, n (%)^a
White	33 (86.8)	24 (64.9)	26 (66.7)	21 (56.8)	22 (57.9)
Black or African American	4 (10.5)	10 (27.0)	10 (25.6)	12 (32.4)	10 (26.3)
BMI (kg/m²), mean (SD)	34.1 (7.0)	36.5 (9.0)	35.2 (8.7)	33.1 (7.2)	32.6 (6.6)
Baseline sUA (mg/dl), mean (SD)^b	9.7 (1.2)	9.8 (1.4)	9.6 (1.3)	9.6 (1.1)	9.8 (1.4)
Approximate gout flares during past year, n (%)^b
1–3	24 (63.2)	22 (59.5)	27 (69.2)	23 (62.2)	22 (57.9)
4–6	10 (26.3)	6 (16.2)	9 (23.1)	9 (24.3)	9 (23.7)
> 6	4 (10.5)	9 (24.3)	3 (7.7)	5 (13.5)	7 (18.4)
Baseline eGFR (ml/min), mean (SD)^c	47.3 (9.4)	46.0 (8.3)	43.3 (6.7)	48.2 (7.5)	48.3 (8.8)

Data from the full analysis set unless indicated otherwise
BMI body mass index, eGFR estimated glomerular filtration rate, FBX febuxostat, IR immediate release, SD standard deviation, sUA serum uric acid, XR extended release
^aTotal numbers (%) of patients classified as ‘Asian’, ‘Native Hawaiian or Other Pacific Islander’, and ‘Other’ were 9 (4.8), 4 (2.1), and 4 (2.1), respectively
^bData from the safety analysis set (n same as full analysis set)
^cAll patients had moderately impaired renal function at baseline, defined as between ≥ 30 ml/min and < 60 ml/min, in line with study inclusion criteria

ISSN: 1478-6362