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Comparative Effectiveness of Carbidopa/Levodopa Enteral Suspension and Deep Brain Stimulation on Pill Burden Reduction in Medicare Fee-for-Service Patients with Advanced Parkinson’s Disease

INTRODUCTION: Complex polypharmacy regimens to manage persistent motor fluctuations result in significant pill burden for patients with advanced Parkinson’s disease (APD). This study evaluated the effectiveness of carbidopa/levodopa enteral suspension (CLES) and deep brain stimulation (DBS) on reduc...

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Autores principales: Soileau, Michael J., Pagan, Fernando L., Fasano, Alfonso, Rodriguez-Cruz, Ramon, Yan, Connie H., Gupta, Niodita R., Teigland, Christie L., Pulungan, Zulkarnain, Schinkel, Jill K., Kandukuri, Prasanna L., Ladhani, Omar A., Siddiqui, Mustafa S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10043089/
https://www.ncbi.nlm.nih.gov/pubmed/36652111
http://dx.doi.org/10.1007/s40120-022-00433-w
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author Soileau, Michael J.
Pagan, Fernando L.
Fasano, Alfonso
Rodriguez-Cruz, Ramon
Yan, Connie H.
Gupta, Niodita R.
Teigland, Christie L.
Pulungan, Zulkarnain
Schinkel, Jill K.
Kandukuri, Prasanna L.
Ladhani, Omar A.
Siddiqui, Mustafa S.
author_facet Soileau, Michael J.
Pagan, Fernando L.
Fasano, Alfonso
Rodriguez-Cruz, Ramon
Yan, Connie H.
Gupta, Niodita R.
Teigland, Christie L.
Pulungan, Zulkarnain
Schinkel, Jill K.
Kandukuri, Prasanna L.
Ladhani, Omar A.
Siddiqui, Mustafa S.
author_sort Soileau, Michael J.
collection PubMed
description INTRODUCTION: Complex polypharmacy regimens to manage persistent motor fluctuations result in significant pill burden for patients with advanced Parkinson’s disease (APD). This study evaluated the effectiveness of carbidopa/levodopa enteral suspension (CLES) and deep brain stimulation (DBS) on reducing pill burden in APD patients. METHODS: We utilized 100% Medicare fee-for-service claims from 2014 to 2018 linked to CLES Patient Support Program (PSP) data. CLES initiators (CLES-I) were propensity matched 1:1 with patients enrolled in PSP who did not initiate treatment (CLES-NI) (N = 188) or undergo DBS, and 1:3 with patients who received DBS (N = 204, N = 612). Average daily pill burden and levodopa equivalent daily dosage (LEDD) were measured at baseline, 0–6 months and 7–12 months follow-up. RESULTS: CLES-I and CLES-NI had higher pill burden than DBS patients at baseline. However, at 6 months post-treatment, CLES-I had significantly fewer pills/day than CLES-NI (4.7 versus 11.4, p < 0.05) and DBS (4.8 versus 7.4, p < 0.05). A significant reduction in pill burden was observed at 0–6 months (46.3%) and 7–12 months (68.3%) follow-up for CLES-I (p < 0.001) versus increased burden for CLES-NI (+10.5%, p < 0.05 and +8.2%, p > 0.05) and insignificant reductions for DBS (−3.9% and −6.1%, p > 0.05). Mean adjusted pill burden showed 57.3% fewer pills at 0–6 months and 74.1% at 7–12 months among CLES-I compared with CLES-NI, and 49.6% and 70.1% reduction compared with DBS. CLES-I showed a decrease in LEDD at 7–12 months compared with baseline (935 to 237 mg) and to CLES-NI (237 mg versus 1112 mg) and DBS patients (236 mg versus 594 mg). CONCLUSION: CLES led to a significant reduction in pill burden and oral LEDD compared with CLES-NI and DBS patients. Pill burden reduction could be considered a treatment goal for patients with APD challenged by complex polypharmacy regimens that interfere with activities of daily living and quality of life. GRAPHICAL ABSTRACT: [Image: see text]
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spelling pubmed-100430892023-03-29 Comparative Effectiveness of Carbidopa/Levodopa Enteral Suspension and Deep Brain Stimulation on Pill Burden Reduction in Medicare Fee-for-Service Patients with Advanced Parkinson’s Disease Soileau, Michael J. Pagan, Fernando L. Fasano, Alfonso Rodriguez-Cruz, Ramon Yan, Connie H. Gupta, Niodita R. Teigland, Christie L. Pulungan, Zulkarnain Schinkel, Jill K. Kandukuri, Prasanna L. Ladhani, Omar A. Siddiqui, Mustafa S. Neurol Ther Original Research INTRODUCTION: Complex polypharmacy regimens to manage persistent motor fluctuations result in significant pill burden for patients with advanced Parkinson’s disease (APD). This study evaluated the effectiveness of carbidopa/levodopa enteral suspension (CLES) and deep brain stimulation (DBS) on reducing pill burden in APD patients. METHODS: We utilized 100% Medicare fee-for-service claims from 2014 to 2018 linked to CLES Patient Support Program (PSP) data. CLES initiators (CLES-I) were propensity matched 1:1 with patients enrolled in PSP who did not initiate treatment (CLES-NI) (N = 188) or undergo DBS, and 1:3 with patients who received DBS (N = 204, N = 612). Average daily pill burden and levodopa equivalent daily dosage (LEDD) were measured at baseline, 0–6 months and 7–12 months follow-up. RESULTS: CLES-I and CLES-NI had higher pill burden than DBS patients at baseline. However, at 6 months post-treatment, CLES-I had significantly fewer pills/day than CLES-NI (4.7 versus 11.4, p < 0.05) and DBS (4.8 versus 7.4, p < 0.05). A significant reduction in pill burden was observed at 0–6 months (46.3%) and 7–12 months (68.3%) follow-up for CLES-I (p < 0.001) versus increased burden for CLES-NI (+10.5%, p < 0.05 and +8.2%, p > 0.05) and insignificant reductions for DBS (−3.9% and −6.1%, p > 0.05). Mean adjusted pill burden showed 57.3% fewer pills at 0–6 months and 74.1% at 7–12 months among CLES-I compared with CLES-NI, and 49.6% and 70.1% reduction compared with DBS. CLES-I showed a decrease in LEDD at 7–12 months compared with baseline (935 to 237 mg) and to CLES-NI (237 mg versus 1112 mg) and DBS patients (236 mg versus 594 mg). CONCLUSION: CLES led to a significant reduction in pill burden and oral LEDD compared with CLES-NI and DBS patients. Pill burden reduction could be considered a treatment goal for patients with APD challenged by complex polypharmacy regimens that interfere with activities of daily living and quality of life. GRAPHICAL ABSTRACT: [Image: see text] Springer Healthcare 2023-01-18 /pmc/articles/PMC10043089/ /pubmed/36652111 http://dx.doi.org/10.1007/s40120-022-00433-w Text en © The Author(s) 2023 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original Research
Soileau, Michael J.
Pagan, Fernando L.
Fasano, Alfonso
Rodriguez-Cruz, Ramon
Yan, Connie H.
Gupta, Niodita R.
Teigland, Christie L.
Pulungan, Zulkarnain
Schinkel, Jill K.
Kandukuri, Prasanna L.
Ladhani, Omar A.
Siddiqui, Mustafa S.
Comparative Effectiveness of Carbidopa/Levodopa Enteral Suspension and Deep Brain Stimulation on Pill Burden Reduction in Medicare Fee-for-Service Patients with Advanced Parkinson’s Disease
title Comparative Effectiveness of Carbidopa/Levodopa Enteral Suspension and Deep Brain Stimulation on Pill Burden Reduction in Medicare Fee-for-Service Patients with Advanced Parkinson’s Disease
title_full Comparative Effectiveness of Carbidopa/Levodopa Enteral Suspension and Deep Brain Stimulation on Pill Burden Reduction in Medicare Fee-for-Service Patients with Advanced Parkinson’s Disease
title_fullStr Comparative Effectiveness of Carbidopa/Levodopa Enteral Suspension and Deep Brain Stimulation on Pill Burden Reduction in Medicare Fee-for-Service Patients with Advanced Parkinson’s Disease
title_full_unstemmed Comparative Effectiveness of Carbidopa/Levodopa Enteral Suspension and Deep Brain Stimulation on Pill Burden Reduction in Medicare Fee-for-Service Patients with Advanced Parkinson’s Disease
title_short Comparative Effectiveness of Carbidopa/Levodopa Enteral Suspension and Deep Brain Stimulation on Pill Burden Reduction in Medicare Fee-for-Service Patients with Advanced Parkinson’s Disease
title_sort comparative effectiveness of carbidopa/levodopa enteral suspension and deep brain stimulation on pill burden reduction in medicare fee-for-service patients with advanced parkinson’s disease
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10043089/
https://www.ncbi.nlm.nih.gov/pubmed/36652111
http://dx.doi.org/10.1007/s40120-022-00433-w
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