Summary: In this study, researchers assessed the safety of levodopa-carbidopa intestinal gel treatment (LCIG, carbidopa-levodopa enteral suspension in the US) in advanced Parkinson’s disease (PD) patients who received ≥ 2000 mg/day dose of levodopa during clinical studies. They concluded that patients who needed ≥ 2000 mg/day had higher baseline oral levodopa doses and higher rates for some adverse events (AEs) compared with patients who received < 2000mg/day levodopa.
- Researchers summarized adverse events (AEs) from patients in the phase 3 program who received open-label LCIG through October 1, 2016.
- Post-hoc, they divided patients into two dose groups: 340 patients treated with < 2000 mg and 72 treated with ≥ 2000 mg mean total levodopa per day.
- They excluded all device/procedure AEs from their analysis, and summarized real world safety data from the GLORIA observational study.
- Researchers found that roughly 17% (72/412) of advanced PD patients in the phase 3 program required ≥ 2000 mg/day of levodopa for symptom control.
- Real world data from the GLORIA observational study reflects a similar percentage of patients receiving ≥ 2000 mg (100 ml LCIG) levodopa per day (47/356 [13%]).
- Mean baseline (BL) patient characteristics were comparable between dose groups.
- Mean (SD) BL oral levodopa daily dose was higher for the ≥ 2000 mg/day group than patients receiving < 2000mg/day ( < 2000 mg:1000.3[499.6]mg; ≥ 2000 mg:1464.8[693.3]mg).
- In all, 93% of patients in the < 2000 mg/day group reported AEs, and 97% of patients in the ≥ 2000 mg/day group.
- AEs reported in ≥ 15% of patients in the ≥ 2000 mg dose group with incidence rates ≥ twice that of the < 2000 mg dose group included PD (return/worsening of PD symptoms) ( < 2000 mg: 14%,
≥ 2000 mg: 31%) and vomiting (< 2000 mg:9%, ≥ 2000 mg: 22%).
- Serious AEs were reported by 44% of patients in the < 2000 mg/day group and 64% of patients receiving ≥2000 mg/day.
This study was supported by AbbVie Inc.