Safety of Levodopa-Carbidopa Intestinal Gel Treatment in Patients with Advanced Parkinson’s Disease Receiving ≥2000 mg Daily Dose of Levodopa
Table 3
AE and ADR summary.
Phase III program
Patients, n (%)
Levodopa <2000 mg/day (n = 340)
Levodopa ≥2000 mg/day (n = 72)
Overall (N = 412)
Patients with any AEa
315 (92.6)
71 (98.6)
386 (93.7)
Select AEs and AEs occurring in ≥10% of patients overall
Fall
76 (22.4)
27 (37.5)
103 (25.0)
Insomnia
83 (24.4)
17 (23.6)
100 (24.3)
Nausea
67 (19.7)
21 (29.2)
88 (21.4)
Constipation
64 (18.8)
22 (30.6)
86 (20.9)
Decreased vitamin B6
71 (20.9)
15 (20.8)
86 (20.9)
Urinary tract infection
69 (20.3)
16 (22.2)
85 (20.6)
Parkinson’s diseaseb
48 (14.1)
22 (30.6)
70 (17.0)
Increased blood homocysteine
47 (13.8)
19 (26.4)
66 (16.0)
Decreased weight
48 (14.1)
18 (25.0)
66 (16.0)
Anxiety
49 (14.4)
17 (23.6)
66 (16.0)
Dyskinesia
49 (14.4)
14 (19.4)
63 (15.3)
Depression
52 (15.3)
11 (15.3)
63 (15.3)
Back pain
42 (12.4)
8 (11.1)
50 (12.1)
Orthostatic hypotension
39 (11.5)
10 (13.9)
49 (11.9)
Vomiting
29 (8.5)
16 (22.2)
45 (10.9)
Diarrhea
35 (10.3)
9 (12.5)
44 (10.7)
Headache
34 (10.0)
9 (12.5)
43 (10.4)
Arthralgia
28 (8.2)
13 (18.1)
41 (10.0)
Dizziness
18 (5.3)
10 (13.9)
28 (6.8)
Sedation
1 (0.3)
—
1 (0.2)
GLORIA registry
Levodopa <2000 mg/day (n = 309)
Levodopa ≥2000 mg/day (n = 47)
Overall (N = 356)
Patients with any ADRc
153 (49.5)
38 (80.9)
191 (53.7)
ADRs occurring in ≥3% of patients overalla
Decreased weight
16 (5.2)
8 (17.0)
24 (6.7)
Polyneuropathy
12 (3.9)
4 (8.5)
16 (4.5)
Hallucination
9 (2.9)
3 (6.4)
12 (3.4)
AEs and ADRs in italics represent events reported in the ≥2000 mg dose group at twice the rate of that reported in the low-dose group. aExcluding those associated with the procedure/device. bRefers to the reemergence of Parkinson’s disease symptoms, often due to a problem with drug delivery. cADRs were AEs deemed by the investigator to have at least a reasonable possibility of a causal relationship to the treatment drug/device. ADR: adverse drug reaction; AE: adverse event.
