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Targeted Drug Delivery for Chronic Nonmalignant Pain: Longitudinal Data From the Product Surveillance Registry

OBJECTIVES: To assist in assessment of therapy risks and benefits of targeted drug delivery (TDD) for chronic nonmalignant pain using registry data on product performance, adverse events, and elective device replacement. MATERIALS AND METHODS: The Product Surveillance Registry (PSR) (NCT01524276) is...

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Autores principales: Schultz, David M., Abd‐Elsayed, Alaa, Calodney, Aaron, Stromberg, Katherine, Weaver, Todd, Spencer, Robert J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons, Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8597001/
https://www.ncbi.nlm.nih.gov/pubmed/33449428
http://dx.doi.org/10.1111/ner.13353
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author Schultz, David M.
Abd‐Elsayed, Alaa
Calodney, Aaron
Stromberg, Katherine
Weaver, Todd
Spencer, Robert J.
author_facet Schultz, David M.
Abd‐Elsayed, Alaa
Calodney, Aaron
Stromberg, Katherine
Weaver, Todd
Spencer, Robert J.
author_sort Schultz, David M.
collection PubMed
description OBJECTIVES: To assist in assessment of therapy risks and benefits of targeted drug delivery (TDD) for chronic nonmalignant pain using registry data on product performance, adverse events, and elective device replacement. MATERIALS AND METHODS: The Product Surveillance Registry (PSR) (NCT01524276) is an ongoing prospective, long‐term, multicenter registry enrolling consented patients implanted with an intrathecal drug delivery system. Patients are followed prospectively with participating investigators providing pump and catheter performance data for events related to the device, procedure, and therapy. Event descriptions include patient symptoms and outcomes. RESULTS: Registry data from the 4646 patients (59.7% female) treated with TDD for chronic, nonmalignant pain at 59 registry sites between August 2003 and October 2019, with over 17,000 patient‐years (4646 patients with 44 months average follow‐up), were analyzed. Registry discontinuation was largely (46.2% of discontinued patients) due to study site closure and patient death; exit due to an adverse or device event was limited to 10.2%. CONCLUSIONS: Treating chronic pain with escalating doses of strong systemic opioids often leads to inconsistent pain control, impaired function, untenable side effects, and reduced quality of life and this practice has contributed to the current opioid crisis in the United States. TDD has been an available therapy for these patients for greater than 30 years, and data from this real‐world registry offer supporting evidence to the long‐term safety of this therapy as an alternative to systemic opioids, as well as insights into patient acceptance and satisfaction.
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spelling pubmed-85970012021-11-22 Targeted Drug Delivery for Chronic Nonmalignant Pain: Longitudinal Data From the Product Surveillance Registry Schultz, David M. Abd‐Elsayed, Alaa Calodney, Aaron Stromberg, Katherine Weaver, Todd Spencer, Robert J. Neuromodulation INTRATHECAL DRUG DELIVERY OBJECTIVES: To assist in assessment of therapy risks and benefits of targeted drug delivery (TDD) for chronic nonmalignant pain using registry data on product performance, adverse events, and elective device replacement. MATERIALS AND METHODS: The Product Surveillance Registry (PSR) (NCT01524276) is an ongoing prospective, long‐term, multicenter registry enrolling consented patients implanted with an intrathecal drug delivery system. Patients are followed prospectively with participating investigators providing pump and catheter performance data for events related to the device, procedure, and therapy. Event descriptions include patient symptoms and outcomes. RESULTS: Registry data from the 4646 patients (59.7% female) treated with TDD for chronic, nonmalignant pain at 59 registry sites between August 2003 and October 2019, with over 17,000 patient‐years (4646 patients with 44 months average follow‐up), were analyzed. Registry discontinuation was largely (46.2% of discontinued patients) due to study site closure and patient death; exit due to an adverse or device event was limited to 10.2%. CONCLUSIONS: Treating chronic pain with escalating doses of strong systemic opioids often leads to inconsistent pain control, impaired function, untenable side effects, and reduced quality of life and this practice has contributed to the current opioid crisis in the United States. TDD has been an available therapy for these patients for greater than 30 years, and data from this real‐world registry offer supporting evidence to the long‐term safety of this therapy as an alternative to systemic opioids, as well as insights into patient acceptance and satisfaction. John Wiley & Sons, Inc. 2021-01-15 2021-10 /pmc/articles/PMC8597001/ /pubmed/33449428 http://dx.doi.org/10.1111/ner.13353 Text en © 2021 Medtronic Inc. Neuromodulation: Technology at the Neural Interface published by Wiley Periodicals LLC on behalf of International Neuromodulation Society. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle INTRATHECAL DRUG DELIVERY
Schultz, David M.
Abd‐Elsayed, Alaa
Calodney, Aaron
Stromberg, Katherine
Weaver, Todd
Spencer, Robert J.
Targeted Drug Delivery for Chronic Nonmalignant Pain: Longitudinal Data From the Product Surveillance Registry
title Targeted Drug Delivery for Chronic Nonmalignant Pain: Longitudinal Data From the Product Surveillance Registry
title_full Targeted Drug Delivery for Chronic Nonmalignant Pain: Longitudinal Data From the Product Surveillance Registry
title_fullStr Targeted Drug Delivery for Chronic Nonmalignant Pain: Longitudinal Data From the Product Surveillance Registry
title_full_unstemmed Targeted Drug Delivery for Chronic Nonmalignant Pain: Longitudinal Data From the Product Surveillance Registry
title_short Targeted Drug Delivery for Chronic Nonmalignant Pain: Longitudinal Data From the Product Surveillance Registry
title_sort targeted drug delivery for chronic nonmalignant pain: longitudinal data from the product surveillance registry
topic INTRATHECAL DRUG DELIVERY
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8597001/
https://www.ncbi.nlm.nih.gov/pubmed/33449428
http://dx.doi.org/10.1111/ner.13353
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