01.12.2012 | Research article | Ausgabe 1/2012 Open Access

The efficacy and safety of febuxostat for urate lowering in gout patients ≥65 years of age
- Zeitschrift:
- BMC Geriatrics > Ausgabe 1/2012
Electronic supplementary material
Competing interests
Authors' contributions
Background
Methods
Results
Variable
|
Febuxostat 40 mg
N = 115
|
Febuxostat 80 mg
N = 128
|
Allopurinol 200/300 mg
N = 131
|
---|---|---|---|
Gender, n (%)
|
|||
Male
|
104 (90.4)
|
109 (85.2)
|
108 (82.4)
|
Female
|
11 (9.6)
|
19 (14.8)
|
23 (17.6)
|
Race, n (%)
|
|||
American Indian or Alaska Native
|
1 (0.9)
|
1 (0.8)
|
0
|
Asian
|
2 (1.7)
|
4 (3.1)
|
5 (3.8)
|
Black or African American
|
10 (8.7)
|
16 (12.5)
|
8 (6.1)
|
Native Hawaiian or Other Pacific Islander
|
1 (0.9)
|
2 (1.6)
|
0
|
White
|
98 (85.2)
|
103 (80.5)
|
116 (88.5)
|
Other
|
3 (2.6)
|
2 (1.6)
|
2 (1.5)
|
Ethnicity, n (%)
|
|||
Hispanic or Latino
|
2 (1.7)
|
3 (2.3)
|
9 (6.9)
|
Not Hispanic or Latino
|
113 (98.3)
|
125 (97.7)
|
122 (93.1)
|
Age (years)
|
|||
Mean ± SD
|
70.8 ± 5.19
|
71.2 ± 5.22
|
70.1 ± 4.59
|
Range
|
65-85
|
65-85
|
65-85
|
Body mass index (kg/m
2
)
|
|||
Mean ± SD
|
31.0 ± 5.47
|
30.7 ± 5.13
|
31.6 ± 5.60
|
Range
|
20-48
|
16-49
|
22-48
|
Alcohol use, n (%)
|
|||
Non-/Ex-drinker
|
42 (36.5)
|
49 (38.3)
|
53 (40.5)
|
Drinker (1-14 drinks/week)
|
73 (63.5)
|
79 (61.7)
|
78 (59.5)
|
Serum urate (mg/dL)
|
|||
Mean ± SD
|
9.4 ± 1.14
|
9.5 ± 1.17
|
9.3 ± 1.04
|
Range
|
8-14
|
8-13
|
8-13
|
Years with gout
|
|||
Mean ± SD
|
15.0 ± 11.3
|
14.8 ± 12.40
|
14.1 ± 12.44
|
Range
|
0-53
|
0-50
|
0-48
|
Tophi present, n (%)
|
|||
No
|
93 (80.9)
|
104 (81.3)
|
105 (80.2)
|
Yes
|
22 (19.1)
|
24 (18.8)
|
26 (19.8)
|
Participated in a previous febuxostat study
b , n (%)
|
|||
Yes
|
18 (15.7)
|
23 (18.0)
|
21 (16.0)
|
Prior urate lowering therapies, n (%)
|
|||
No
|
31 (27.0)
|
34 (26.6)
|
44 (33.6)
|
Yes (any)
|
84 (73.0)
|
94 (73.4)
|
87 (66.4)
|
Febuxostat
|
17 (14.8)
|
21 (16.4)
|
18 (13.7)
|
Allopurinol
|
76 (66.1)
|
85 (66.4)
|
75 (57.3)
|
Probenecid
|
5 (4.3)
|
6 (4.7)
|
6 (4.6)
|
Other
|
4 (3.5)
|
4 (3.1)
|
3 (2.3)
|
Renal Function
c , n (%)
|
|||
Moderately Impaired
|
67 (58.3)
|
82 (64.1)
|
80 (61.1)
|
Mildly Impaired
|
45 (39.1)
|
44 (34.4)
|
50 (38.2)
|
Normal
|
3 (2.6)
|
2 (1.6)
|
1 (0.8)
|
Medical History, n (%)
|
|||
Any cardiovascular disease
d
|
102 (88.7)
|
108 (84.4)
|
116 (88.5)
|
Hypertension
|
98 (85.2)
|
102 (79.7)
|
108 (82.4)
|
Coronary artery disease
|
26 (22.6)
|
28 (21.9)
|
37 (28.2)
|
Cardiac arrhythmia
|
16 (13.9)
|
28 (21.9)
|
35 (26.7)
|
Diabetes
|
23 (20.0)
|
35 (27.3)
|
34 (26.0)
|
Hypercholesterolemia
|
15 (13.0)
|
10 (7.8)
|
17 (13.0)
|
Hyperlipidemia
|
66 (57.4)
|
73 (57.0)
|
84 (64.1)
|
Use of low-dose aspirin (≤325 mg daily)
|
48 (41.7)
|
52 (40.6)
|
49 (37.4)
|
Febuxostat 40 mg
N = 115
|
Febuxostat 80 mg
N = 128
|
Allopurinol 200/300 mg
N = 131
|
|
---|---|---|---|
n (%)
|
|||
Subjects with one or more concomitant medication
|
|||
Agents acting on the renin-angiotensin system
a
|
65 (57)
|
78 (61)
|
83 (63)
|
Analgesics
|
23 (20)
|
33 (26)
|
27 (21)
|
Antiinflammatory and antirheumatic products
|
26 (23)
|
32 (25)
|
26 (20)
|
Antithrombotic agents
|
58 (50)
|
65 (51)
|
65 (50)
|
Beta blockers
|
45 (39)
|
43 (34)
|
55 (42)
|
Calcium channel blockers
|
19 (17)
|
21 (16)
|
30 (23)
|
Corticosteroids for systemic use
|
12 (10)
|
21 (16)
|
15 (11)
|
Drugs for acid-related gastrointestinal disorders
|
23 (20)
|
32 (25)
|
34 (26)
|
Drugs used in diabetes
|
20 (17)
|
25 (20)
|
29 (22)
|
Diuretics
|
26 (23)
|
32 (25)
|
33 (25)
|
Lipid modifying agents
|
64 (56)
|
69 (54)
|
75 (57)
|
Other antihypertensives
b
|
13 (11)
|
4 (3)
|
10 (8)
|
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
|