Table 3 Most frequently reported adverse eventsa and elevated serum liver function tests, by treatment group
From: The efficacy and safety of febuxostat for urate lowering in gout patients ≥65 years of age
Febuxostat 40 mg N = 115 | Febuxostat 80 mg N = 128 | Allopurinol 200/300 mg N = 131 | |
|---|---|---|---|
Total subjects reporting ≥1 AE, n (%) | n (%)70 (60.9) | 75 (58.6) | 81 (61.8) |
Most frequently reported b AEs, n (%) | |||
Diarrhea (non infectious) | 14 (12.2) | 12 (9.4) | 10 (7.6) |
Musculoskeletal and connective tissue signs and symptoms | 10 (8.7) | 7 (5.5) | 6 (4.6) |
Upper respiratory tract infections | 9 (7.8) | 11 (8.6) | 9 (6.9) |
Neurological signs and symptoms | 8 (7.0) | 1 (0.8) | 1 (0.8) |
(Dizziness) | 7 (6.1) | 1 (0.8) | 1 (0.8) |
(Presyncope) | 1 (0.9) | 0 | 0 |
Joint related signs and symptoms | 2 (1.7) | 8 (6.3) | 3 (2.3) |
Lower respiratory tract and lung infections | 2 (1.7) | 3 (2.3) | 7 (5.3) |
Headaches | 6 (5.2) | 2 (1.6) | 3 (2.3) |
Nausea and vomiting | 6 (5.2) | 1 (0.8) | 4 (3.1) |
Elevated liver function tests, n/N (%) | |||
ALT | |||
≥2X ULN | 4/106 (4) | 4/117 (3) | 3/115 (3) |
≥3X ULN | 2/106 (2) | 0/117 | 1/115 (<1) |
AST | |||
≥2X ULN | 3/106 (3) | 1/117 (<1) | 0/115 |
≥3X ULN | 2/106 (2) | 0/117 | 0/115 |
ALT and AST concurrently | |||
≥3X ULN | 2/106 (2) | 0/117 | 0/115 |