Objective: To compare the real-world impact of initiating carbidopa/levodopa enteral suspension (CLES) or deep brain stimulation (DBS) on reducing pill burden (i.e. total number of daily PD-related pills) in advanced Parkinson’s disease (PD) patients initiating CLES or DBS.

Background: Oral medications may not adequately control the PD-related symptoms in advanced PD patients due to erratic gastric emptying and narrowing therapeutic window. The compliance with a complex polypharmacy-based oral regimen is likely to be poor with negative health and economic outcomes.[1] CLES and DBS have both been shown to be effective in managing PD symptoms in advanced PD patients [2,3] even when used as monotherapy.[4]

Method: A retrospective cohort analysis of IBM® MarketScan® Databases (medical and prescription claims) was conducted. PD patients (taking oral PD medications only) newly initiating CLES or DBS between Jan 1, 2015 and Jun 30, 2018 were identified. CLES patients were matched to DBS patients (1:3) based on a propensity-score to account for potential confounding factors in initiating treatment. Pill burden was measured as a 30-day average number of PD-related pills/day. Wilcoxon-Rank Sum test was used to compare  mean reduction in daily pill count at 6-months between CLES and DBS. Generalized Linear Model was used to estimate the difference between the pill-burden reduction in patients on CLES compares to DBS. Proportion of patients on monotherapy was compared between both groups.

Results: The study sample included 41 CLES patients matched to 118 DBS patients in real-world US settings. At baseline, patients in both cohorts had similar daily pill counts (CLES: 11.1 ± 7.0; DBS: 10.3 ± 5.7; p>0.05). At 6 months follow up, patients initiating both therapies were observed to have a significant reduction in pill burden (CLES: 3.1 ± 3.1; DBS: 7.6 ± 5.2; p<0.0001). The p164+ill burden reduction in CLES patients was significantly higher than matched DBS patients (∆: -5.4 ± 1.1; p<0.0001). At 6 months, almost 3x higher proportion of CLES patients were pill-free (26.8% vs 7.6%, p<0.05).

Conclusion: Device-aided therapies like CLES and DBS are effective in reducing pill-burden as measured by prescriptions in the insurance claims data base over a three-year time period, with trend toward greater reduction from CLES.

References: 1. Malek N and Grosset DG. (2015) Medication Adherence in Patients with Parkinson’s Disease. CNS Drugs 29, 47–53 2. Olanow CW, Kieburtz K, Odin P et al. “LCIG Horizon Study Group”. (2014) Continuous intrajejunal infusion of levodopa-carbidopa intestinal gel for patients with advanced Parkinson’s disease: a randomised, controlled, double-blind, double-dummy study.” Lancet Neurol 13, no. 2: 141-149. 3. Dafsari HS, Martinez‐Martin P, Rizos A et al. (2019) EuroInf 2: Subthalamic stimulation, apomorphine, and levodopa infusion in Parkinson’s disease. Movement disorders, 34(3): 353-365. 4. Poewe W, Bergmann L, Kukreja P, Robieson WZ, and Antonini A. (2019) Levodopa-carbidopa intestinal gel monotherapy: GLORIA registry demographics, efficacy, and safety. J Parkinsons Dis; 9(3): 531-541 5. Austin PC (2011). Optimal caliper widths for propensity-score matching when estimating differences in means and differences in proportions in observational studies. Pharm Stat. 10(2): 150-161.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/pill-burden-reduction-in-patients-with-advanced-parkinsons-disease-comparative-effectiveness-of-carbidopa-levodopa-enteral-suspension-and-deep-brain-stimulation/