Parkinson’s Disease / 2020 / Article / Tab 6

Research Article

Safety of Levodopa-Carbidopa Intestinal Gel Treatment in Patients with Advanced Parkinson’s Disease Receiving ≥2000 mg Daily Dose of Levodopa

Table 6

AEs and ADRs that led to discontinuation.

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

Incidence of AEs leading to discontinuation59 (17.4)18 (25.0)77 (18.7)
AEs leading to discontinuation in >2 patients overall
 Death9 (2.6)1 (1.4)10 (2.4)
 Pneumonia4 (1.2)1 (1.4)5 (1.2)
 Myocardial infarction3 (0.9)1 (1.4)4 (1.0)
 Cardiac arrest1 (0.3)2 (2.8)3 (0.7)
 Fall2 (0.6)1 (1.4)3 (0.7)
 Parkinson’s diseasea3 (0.9)3 (0.7)

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

Patients with ≥1 ADRb leading to discontinuation24 (7.8)24 (6.7)
ADRs leading to discontinuation in 2 patientsc overallNo ADRs met this criterion

aRefers to the reemergence of Parkinson’s disease symptoms, often due to a problem with drug delivery. bADRs were AEs deemed by the investigator to have at least a reasonable possibility of a causal relationship to the treatment drug/device. cExcluding those associated with the procedure/device. ADR: adverse drug reaction; AE: adverse event.

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