Safety of Levodopa-Carbidopa Intestinal Gel Treatment in Patients with Advanced Parkinson’s Disease Receiving ≥2000 mg Daily Dose of Levodopa
Table 1
Phase III program baseline patient demographics and clinical characteristics.
Characteristics
Mean (SD)a
Levodopa <2000 mg/day (n = 340)
Levodopa ≥2000 mg/day (n = 72)
Overall (N = 412)
Age, years
64.1 (9.1)
64.0 (8.4)
64.1 (8.9)
Sex, n (%)
Female
151 (44)
18 (25)
169 (41)
Male
189 (56)
54 (75)
243 (59)
Race, n (%)
White
312 (92)
69 (96)
381 (93)
Asian
23 (7)
3 (4)
26 (6)
Black/African American
4 (1)
—
4 (1)
American Indian or Alaska Native
1 (0.3)
—
1 (0.2)
BMI, kg/m2
24.7 (4.5)b
25.5 (5.3)c
24.8 (4.7)d
Weight, kg
70.2 (15.6)e
75.9 (18.7)
71.2 (16.3)f
PD duration, years
12.3 (5.6)
12.0 (5.1)
12.3 (5.5)
Baseline oral levodopa dosage, mg/d
1000.3 (499.6)
1464.8 (693.3)
1080.7 (565.3)
UPDRS part II score
16.4 (7.1)g
16.7 (7.5)h
16.4 (7.2)i
UPDRS part III score
27.5 (13.7)j
27.5 (14.5)h
27.5 (13.9)k
Normalized “Off” time, hours
6.7 (2.3)l
6.7 (2.2)
6.7 (2.3)m
Normalized “On” time without TSD, hours
7.7 (2.5)l
8.1 (2.0)
7.8 (2.4)m
Normalized “On” time with TSD, hours
1.6 (2.0)l
1.2 (1.8)
1.5 (2.0)m
Previous PD treatment, n (%)
Oral levodopa
340 (100)
71 (99)n
411 (100)n
Dopamine agonists
207 (61)
49 (68)
256 (62)
COMT inhibitors
101 (30)
30 (42)
131 (32)
MAO-B inhibitors
68 (20)
11 (15)
79 (19)
Amantadine
120 (35)
17 (24)
137 (33)
“On”/“Off” time was normalized to a 16-hour waking day and averaged for the three days prior to each study visit. aData are shown as mean (SD) except where indicated as n (%). bn: 336; cn: 71; dn: 407; en: 338; fn: 410; gn: 315; hn: 64; in: 379; jn: 313; kn: 377; ln: 334; mn: 406; ndata collection issue for one patient. BMI: body mass index; COMT: catechol-O-methyl transferase; MAO-B: monoamine oxidase B; PD: Parkinson’s disease; SD: standard deviation; TSD: troublesome dyskinesia; UPDRS: Unified Parkinson’s Disease Rating Scale.
