Objective: To evaluate the effectiveness of carbidopa/levodopa enteral suspension (CLES) on patients with advanced Parkinson’s disease who had previously undergone deep brain stimulation (DBS).

Background: Advanced therapies (such as DBS, CLES) may be considered when oral therapies cannot achieve adequate control of motor complications. Patients previously treated with DBS may still require dopaminergic therapy, and motor fluctuations may progress over time.(1) CLES has been shown to be effective as levodopa monotherapy, eliminating the need for other adjunctive dopaminergic medications.(2) The use of CLES in patients previously treated with DBS has been reported to be effective.(1,3-5)

Method: A sub-group of patients (n=13) from the PROviDE study who self-reported having DBS prior to initiation of CLES therapy were included in this analysis. PROviDE is a US-based real-world evidence study in patients initiating CLES.(6) Effectiveness was measured based on a standardized patient-reported outcomes for PD-related symptoms were collected via telephone-call or web-survey at baseline and regular intervals. In this interim analysis, effectiveness was measured as change from baseline at 3 months after initiating CLES therapy.

Results: The baseline demographic characteristics are presented [Table 1]. Patients with prior DBS tended to have longer disease duration (Mean±SD: 17.07±6.76 years) compared to the patient population of PROviDE study. About 85% of the patients required some assistance with walking. Compared to baseline, patients reported to have a significant reduction in off-time (Mean±SD: -2.08±2.81 hours/day; p<0.05) at 3-months. The patients also had a significant numerical improvement in the effectiveness domain of treatment satisfaction (Mean±SD: -14.23±16.21; p<0.05). Patients showed improvement (not significant) in other domains like dyskinesia, quality of life, sleep, fatigue, freezing of gait and overall treatment satisfaction (p>0.05) [Table 2].

Conclusion: Results from this sub-group analysis suggest that CLES may be a viable option for improving PD-symptoms in patients previously treated with DBS. Small sample sizes may challenge statistical comparisons. Additional research is needed to further understand patient characteristics and treatment modalities of using CLES in patients previously treated with DBS.

References: 1. El Kouzi, A. et al., 2018. Levodopa-Carbidopa Intestinal Gel (LCIG) in Deep Brain Stimulation (DBS) Parkinson’s Patients.(P6. 027). Neurology : Clinical practice., 90(15 Supplement), p.P6. 2. Buhmann, C. et al., 2017. Levodopa/carbidopa intestinal gel (LCIG) infusion as mono- or combination therapy. Journal of Neural Transmission, 124(8), pp.1005–1013. 3. Kumar, N. et al., 2018. Levodopa‐carbidopa intestinal gel therapy after deep brain stimulation. Movement Disorders, 33(2), pp.334–335. 4. Klostermann, F., Jugel, C. & Marzinzik, F., 2011. Jejunal levodopa infusion in long‐term DBS patients with Parkinson’s disease. Movement Disorders, 26(12), pp.2298–2299. 5. Regidor, I.C. et al., 2017. Duodenal Levodopa Infusion for Long-Term Deep Brain Stimulation–Refractory Symptoms in Advanced Parkinson Disease. Clinical Neuropharmacology, 40(3), pp.103–107. 6. Pahwa, R., 2018. Evaluating long-term effectiveness of carbidopa/levodopa enteral suspension in advanced Parkinson’s Disease patients: PROviDE study design and baseline characteristics. Movement disorders, 33, p.S93.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/efficacy-of-carbidopa-levodopa-enteral-suspension-cles-in-advanced-parkinsons-disease-patients-previously-treated-with-deep-brain-stimulation-dbs-a-subgroup-analysis-from-provid/