Parkinson’s Disease / 2020 / Article / Tab 3

Research Article

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 programPatients, n (%)
Levodopa <2000 mg/day (n = 340)Levodopa ≥2000 mg/day (n = 72)Overall (N = 412)

Patients with any AEa315 (92.6)71 (98.6)386 (93.7)
Select AEs and AEs occurring in ≥10% of patients overall
 Fall76 (22.4)27 (37.5)103 (25.0)
 Insomnia83 (24.4)17 (23.6)100 (24.3)
 Nausea67 (19.7)21 (29.2)88 (21.4)
 Constipation64 (18.8)22 (30.6)86 (20.9)
 Decreased vitamin B671 (20.9)15 (20.8)86 (20.9)
 Urinary tract infection69 (20.3)16 (22.2)85 (20.6)
Parkinson’s diseaseb48 (14.1)22 (30.6)70 (17.0)
Increased blood homocysteine47 (13.8)19 (26.4)66 (16.0)
 Decreased weight48 (14.1)18 (25.0)66 (16.0)
 Anxiety49 (14.4)17 (23.6)66 (16.0)
 Dyskinesia49 (14.4)14 (19.4)63 (15.3)
 Depression52 (15.3)11 (15.3)63 (15.3)
 Back pain42 (12.4)8 (11.1)50 (12.1)
 Orthostatic hypotension39 (11.5)10 (13.9)49 (11.9)
Vomiting29 (8.5)16 (22.2)45 (10.9)
 Diarrhea35 (10.3)9 (12.5)44 (10.7)
 Headache34 (10.0)9 (12.5)43 (10.4)
Arthralgia28 (8.2)13 (18.1)41 (10.0)
 Dizziness18 (5.3)10 (13.9)28 (6.8)
 Sedation1 (0.3)1 (0.2)

GLORIA registryLevodopa <2000 mg/day (n = 309)Levodopa ≥2000 mg/day (n = 47)Overall (N = 356)

Patients with any ADRc153 (49.5)38 (80.9)191 (53.7)
ADRs occurring in ≥3% of patients overalla
Decreased weight16 (5.2)8 (17.0)24 (6.7)
Polyneuropathy12 (3.9)4 (8.5)16 (4.5)
Hallucination9 (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.

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