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Table 3 Adverse events

From: The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia of gout: the CONFIRMS trial

 

Febuxostat 40 mg daily

N = 757

Febuxostat 80 mg daily

N = 756

n (%)

Allopurinol 200/300 mg daily

N = 756

Total Subjects with ≥ 1 AE

429 (56.7)

410 (54.2)

433 (57.3)

Total Subjects With at ≥ 1 Serious AE

19 (2.5)

28 (3.7)

31 (4.1)

Most Frequently (≥ 5%) Reported AEs

   

   Upper Respiratory Tract Infections

71 (9.4)

53 (7.0)

57 (7.5)

   Liver Function Analysis

63 (8.3)

52 (6.9)

50 (6.6)

   Rash

44 (5.8)

42 (5.6)

55 (7.3)

   Diarrhea

45 (5.9)

47 (6.2)

57 (7.5)

   Musculoskeletal and Connective Tissue Signs and Symptoms NEC

43 (5.7)

38 (5.0)

32 (4.2)

All APTC CV Events

   Number of Subjects with Events

0

3

3

   Rate (%)

0.00

0.40

0.40

   95% CI (%)

(0.000, 0.486)

(0.082, 1.155)

(0.082, 1.155)

APTC Events Summarized by Category

   CV Death

0

0

2 (0.26)

   Nonfatal Myocardial Infarction

0

1 (0.13)

1 (0.13)

   Nonfatal Stroke

0

2 (0.26)

0

All Non-APTC Events

   Number of Subjects with Events

10

9

7

   Rate (%)

1.32

1.19

0.93

   95% CI (%)

(0.635, 2.416)

(0.546, 2.248)

(0.373, 1.898)

Non-APTC Events Summarized by Category

   Angina

2 (0.26)

0

0

   Coronary Revascularization

1 (0.13)

0

1 (0.13)

   Transient Ischemic Attack

1 (0.13)

0

1 (0.13)

   Cerebral Revascularization

0

0

0

   Venous and Peripheral Arterial Vascular Thrombotic Event

0

2 (0.26)

0

   Congestive Heart Failure

2 (0.26)

0

1 (0.13)

   Arrhythmia, No Evidence of Ischemia

3 (0.40)

4 (0.53)

1 (0.13)

   Other Non-APTC CV Events

1 (0.13)

3 (0.40)

3 (0.40)

  1. AE: adverse events; APTC: antiplatelet trialists collaboration; CI: confidence interval; CV: cardiovascular; NEC: not elsewhere characterized