African American patients with gout: efficacy and safety of febuxostat vs allopurinol

Table 2 Most Frequently Reported Adverse Events and Elevated Serum Liver Function Tests in African American and Caucasian Subjects

	African American N = 228	Caucasian N = 1863	p value^a
Total subjects reporting ≥ 1 AE, n (%)	115 (50.4)	1052 (56.5)	0.090
Most frequently reported AEs, n (%)
Liver function analyses	8 (3.5)	141 (7.6)	0.020
Upper respiratory tract infections	15 (6.6)	141 (7.6)	0.689
Diarrhea	10 (4.4)	128 (6.9)	0.202
Musculoskeletal and connective tissue signs and symptoms	9 (3.9)	89 (4.8)	0.739
Joint related signs and symptoms	7 (3.1)	69 (3.7)	0.851
Elevated liver function tests, n/N (%)
ALT
≥ 2X ULN	5/206 (2)	172/1737 (10)	< 0.001
≥ 3X ULN	1/206 (< 1)	50/1737 (3)	0.037
AST
≥ 2X ULN	8/206 (4)	93/1736 (5)	0.505
≥ 3X ULN	3/206 (1)	24/1736 (1)	0.760

AE = adverse event; ALT = alanine aminotransferase; AST = aspartate aminotransferase; ULN = upper limit of normal
^a p values are from Fisher's exact test
AEs are reported by MedDRA High Level Term. Most frequent events are those occurring in at least 3 percent of African American subjects.

ISSN: 1471-2474