Objective: To describe the real-world characteristics of advanced Parkinson’s disease (APD) patients initiating carbidopa/levodopa enteral suspension (CLES) therapy in USA
Background: CLES is an FDA approved treatment for motor fluctuations in APD patients. Various clinical trials and observational studies have reported the characteristics of patients initiating CLES, but these patient characteristics may not be reflective of real-world patients initiating CLES owing to study selection criteria, smaller study sample size, and lack of guidelines on identification of real-world patients who may be candidates for CLES.
Method: This is a retrospective, cross-sectional, medical chart review study using data from eligible APD patients initiating CLES and enrolled in a patient services program between 2015 to 2018. The medical charts used in this study are from the visit when CLES was prescribed to the patients. Patients were also categorized based on their prior use of deep brain stimulation (DBS). Descriptive statistics, chi-square test and t-tests are used to summarize the data.
Results: Of the 693 eligible patients initiating CLES, 102 patients (14.7%) had prior DBS during CLES initiation. The mean age of patients initiating CLES was 68.6 years and 63.6% of the patients were males. Among these patients, the top 3 motor symptoms were motor fluctuations, bradykinesia, and dyskinesia [Table 1] and the top 3 non-motor symptoms were night-time sleep disturbances, anxiety, and depression [Table 2]. Most of the motor and non-motor symptoms were comparable between those initiating CLES with and without prior DBS. Higher percent of patients with prior DBS had dystonia, postural instability, and dysarthria. Higher percent of patients without prior DBS had cognitive impairment, hallucinations, delusions, psychosis, and dementia, which may have been contraindications for DBS. Most of the patients (55.2%) initiating CLES were on medications from 2-3 drug classes [Table 3]. Higher percentage of patients with prior DBS were on more than 3 drug classes (56.86%) as compared to those without prior DBS (23.69%).
Conclusion: This is the first study describing the real-world patient and treatment profiles for APD patients initiating CLES; findings suggest that CLES may be suitable for a wide range of patients including those with prior DBS.
To cite this abstract in AMA style:M. Soileau, I. Malaty, J. Aldred, A. Merola, R. Rodriguez, N. Gupta, I. Sultan, P. Kandukuri, Y. Jalundhwala, O. Ladhani, I. Pan, R. Pahwa. Real-world characteristics of advanced Parkinson’s disease patients initiating carbidopa/levodopa enteral suspension [abstract]. Mov Disord. 2021; 36 (suppl 1). https://www.mdsabstracts.org/abstract/real-world-characteristics-of-advanced-parkinsons-disease-patients-initiating-carbidopa-levodopa-enteral-suspension/. Accessed December 7, 2023.
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