Objective: The aim of this observational study for PD patients treated with foslevodopa/foscarbidopa(LDP/CDP) is to evaluate clinical characteristics, therapeutic efficacy and safety, and to determine the appropriate therapeutic threshold by measuring levodopa(LD) blood levels.
Background: LDP/CDP is a novel therapy that provides a steady dose of LD through continuous 24-hour subcutaneous administration. In Japan, LDP/CDP therapy will be available in July 2023. It is necessary to identify the optimal patient population to receive this new therapy.
Method: We collected data retrospectively on 22 patients who started LDP/CDP at our hospital between July 2023 and March 2024. Data were collected on patient characteristics, LDP/CDP treatment efficacy, safety, and continuation, as well as LD pharmacokinetics. The study was approved by the Research Ethics Committee, Faculty of Medicine, Juntendo University(H15-0124).
Results: The 22 (11 female) PD patients treated with LDP/CDP had a mean age of 59.5 (SD 9.9) years, disease duration of 13.6 (9.5) years, LD equivalent daily dose 1053.4 (400.2) mg and MDS-UPDRS part III (on state) of 23.3 (8.4). The 15/22 (68.2%) had visual hallucinations and 3/22 (13.6%) had history of psychosis. The continuous LDP/CDP dose was 0.297 (0.099) mL/hr and the plasma LD concentration was correlated with body weight and continuous LDP/CDP dose. Five patients (23%) discontinued LDP/CDP treatment. Three patients discontinued within 7 days due to unsatisfactory efficacy, one patient discontinued after 2 months due to relocation, and one patient discontinued after 2 months due to difficulty in obtaining therapeutic techniques. One patient required hospitalization due to worsening hallucinations, but continued treatment. Although skin reactions occurred in almost all patients, none of the patients discontinued due to skin reactions or infection. The LDP/CDP doses of the 10 patients who were able to continue treatment for more than 3 months did not increase. Excluding two patients who were hospitalized for hallucinations and recurrent malignant lymphoma, MDS-UPDRS part III decreased by an average of 5.8 points, off time decreased by 4.3 hours, and dyskinesia decreased by 5 hours.
Conclusion: LDP/CDP had the favorable therapeutic response in patients who sustained it for at least 3 months.
To cite this abstract in AMA style:
D. Kamiyama, N. Nishikawa, C. Abe, H. Iwaki, G. Oyama, T. Hatano, N. Hattori. An observational study of the efficacy, safety, and discontinuation rate of foslevodopa/foscarbidopa in 22 patients with advanced Parkinson’s disease [abstract]. Mov Disord. 2024; 39 (suppl 1). https://www.mdsabstracts.org/abstract/an-observational-study-of-the-efficacy-safety-and-discontinuation-rate-of-foslevodopa-foscarbidopa-in-22-patients-with-advanced-parkinsons-disease/. Accessed October 10, 2024.« Back to 2024 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/an-observational-study-of-the-efficacy-safety-and-discontinuation-rate-of-foslevodopa-foscarbidopa-in-22-patients-with-advanced-parkinsons-disease/