Levodopa-Carbidopa Intestinal Gel Well Tolerated in East Asians with Advanced PD
VANCOUVER, BC—Levodopa-carbidopa intestinal gel is safe and effective in Japanese, Taiwanese, and Korean patients with advanced Parkinson's disease, a study presented at the 68th AAN Annual Meeting has found.
“Patients had a significant improvement in 'off' time without an increase in 'on' time with troublesome dyskinesia,” stated Miho Murata, MD, PhD, of the National Center of Neurology and Psychiatry, Tokyo, Japan, and coauthors.
Oral levodopa is associated with motor complications “that can often be problematic in some advanced Parkinson's disease patients,” the authors noted. Previous research1 in the U.S. and Europe has shown that levodopa-carbidopa intestinal gel improves "off"-time symptoms better than oral levodopa-carbidopa therapy.
The study investigators enrolled 31 patients (23 Japanese, 4 Taiwanese, and 4 Korean), of whom 28 (90%) completed the Phase 3 open-label study (NCT01960842/JapicCTI-142431). The primary efficacy measure was change from baseline to final in mean daily "off" time, as measured by the Parkinson's Disease Symptom Diary.
Participants were administered levodopa-carbidopa intestinal gel monotherapy via percutaneous endoscopic gastronomy-jejunum (PEG-J) for 12 weeks and mean change from baseline was calculated for "off"-time symptoms and adverse events (AEs).
Results showed a significant mean change (SD) of -4.6 (3.0) daily hours of "off" time from baseline to Week 12 (n=29; P<0.001). This change was also significant for the Japanese patients (n=21) and the Korean patients (n=4), but not the Taiwanese patients (n=4).
These significant improvements in "off" and "on" time with and without troublesome dyskinesias "were observed as early as Week 2 and persisted for the remainder of the study," Dr. Murata noted. A significant improvement in quality of life, based on mean change from baseline of the Parkinson's Disease Questionnaire-39, was also observed at the final visit (P<0.001).
All 31 patients experienced an AE and 1 discontinued due to aspiration pneumonia. The most common AEs were incision site pain (41.9%), excessive granulation tissue (32.3%), procedural pain (16.1%), and incision site erythema (12.9%). One patient died of sepsis unrelated to levodopa-carbidopa intestinal gel treatment.
The study was funded by AbbVie Inc. Dr. Murata was a study investigator and received research support from AbbVie Inc.
1. Olanow CW, et al. Lancet Neurol. 2014;13:141-149.