Safety of Levodopa-Carbidopa Intestinal Gel Treatment in Patients with Advanced Parkinson’s Disease Receiving ≥2000 mg Daily Dose of Levodopa
Table 5
Patients with select AEs and ADRs of special interest.
Phase III program
Patients, n (%)
Levodopa <2000 mg/day (n = 340)
Levodopa ≥2000 mg/day (n = 72)
Overall (N = 412)
Abuse liability AEs
Intentional overdose
1 (0.3)
—
1 (0.2)
Psychomotor hyperactivity
—
1 (1.4)
1 (0.2)
Sleep/sleep attack-related AEs
Sleep attacks
30 (8.8)
9 (12.5)
39 (9.5)
Somnolence
8 (2.4)
4 (5.6)
12 (2.9)
Hallucination/psychosis-related AEs
Hallucination
25 (7.4)
13 (18.1)
38 (9.2)
Hallucination, auditory
4 (1.2)
—
4 (1.0)
Hallucination, tactile
2 (0.6)
—
2 (0.5)
Hallucination, visual
11 (3.2)
1 (1.4)
12 (2.9)
Hallucination, mixed
1 (0.3)
—
1 (0.2)
Psychotic disorder
3 (0.9)
3 (4.2)
6 (1.5)
Polyneuropathy-related AEsa
32 (9.4)
17 (23.6)
49 (11.9)
Polyneuropathy-related AEs reported in >1% of patients overallb
Polyneuropathy
15 (4.4)
10 (13.9)
25 (6.1)
Peripheral neuropathy
5 (1.5)
1 (1.4)
6 (1.5)
Peripheral sensory neuropathy
5 (1.5)
1 (1.4)
6 (1.5)
GLORIA registry
Levodopa <2000 mg/day (n = 309)
Levodopa ≥2000 mg/day (n = 47)
Overall (N = 356)
Somnolence
2 (0.6)
1 (2.1)
3 (0.8)
Hallucination/psychosis-related ADRsb
Hallucination
9 (2.9)
3 (6.4)
12 (3.4)
Hallucination, visual
1 (0.3)
1 (2.1)
2 (0.6)
Psychotic disorder
6 (1.9)
1 (2.1)
7 (2.0)
Polyneuropathy-related ADRsb reported in >1% of patients overall
Polyneuropathy
12 (3.9)
4 (8.5)
16 (4.5)
Peripheral neuropathy
4 (1.3)
1 (2.1)
5 (1.4)
Peripheral sensory neuropathy
1 (0.3)
3 (6.4)
4 (1.1)
aBased on the Standard MedDRA Query narrow search of Guillain–Barré syndrome and peripheral neuropathy. bPolyneuropathy AEs not listed in the table include Guillain–Barré syndrome, which occurred in two patients (n/N = 2/72, 2.8%) who required ≥2000 mg dose for PD symptom control. bADRs 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; PD: Parkinson’s disease.
