Intrathecal pain management with ziconotide: Time for consensus?
Abstract This article summarizes recommendations made by six pain specialists who discussed the rationale for ziconotide intrathecal analgesia (ITA) and the requirement for evidence‐based guidance on its use, from a European perspective. Riemser Pharma GmbH (Greifswald, Germany), which holds the Eur...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2021-03-01
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| Series: | Brain and Behavior |
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| Online Access: | https://doi.org/10.1002/brb3.2055 |
| _version_ | 1818846850139029504 |
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| author | Georgios Matis Pasquale De Negri Denis Dupoiron Rudolf Likar Xander Zuidema Dirk Rasche |
| author_facet | Georgios Matis Pasquale De Negri Denis Dupoiron Rudolf Likar Xander Zuidema Dirk Rasche |
| author_sort | Georgios Matis |
| collection | DOAJ |
| description | Abstract This article summarizes recommendations made by six pain specialists who discussed the rationale for ziconotide intrathecal analgesia (ITA) and the requirement for evidence‐based guidance on its use, from a European perspective. Riemser Pharma GmbH (Greifswald, Germany), which holds the European marketing authorization for ziconotide, hosted the meeting. The group agreed that ITA is under‐used in Europe, adding that ziconotide ITA has potential to be a first‐line alternative to morphine; both are already first‐line options in the USA. Ziconotide ITA (initiated using a low‐dose, slow‐titration approach) is suitable for many patients with noncancer‐ or cancer‐related chronic refractory pain and no history of psychosis. Adopting ziconotide as first‐line ITA could reduce opioid usage in these patient populations. The group advocated a risk‐reduction strategy for all candidate patients, including compulsory prescreening for neuropsychosis, and requested US–European alignment of the licensed starting dose for ziconotide: the low‐and‐slow approach practiced in the USA has a better tolerability profile than the fixed high starting dose licensed in Europe. Of note, an update to the European Summary of Product Characteristics is anticipated in early 2021. The group acknowledged that the Polyanalgesic Consensus Conference (PACC) treatment algorithms for ziconotide ITA provide useful guidance, but recommendations tailored specifically for European settings are required. Before a consensus process can formally begin, the group called for additional European prospective studies to investigate ziconotide in low‐and‐slow dosing strategies, in different patient settings. Such data would enable European guidance to have the most appropriate evidence at its core. |
| first_indexed | 2024-12-19T05:52:06Z |
| format | Article |
| id | doaj.art-0d4c733fc59d410bbbc8030d7e6d16ac |
| institution | Directory Open Access Journal |
| issn | 2162-3279 |
| language | English |
| last_indexed | 2024-12-19T05:52:06Z |
| publishDate | 2021-03-01 |
| publisher | Wiley |
| record_format | Article |
| series | Brain and Behavior |
| spelling | doaj.art-0d4c733fc59d410bbbc8030d7e6d16ac2022-12-21T20:33:33ZengWileyBrain and Behavior2162-32792021-03-0111S1n/an/a10.1002/brb3.2055Intrathecal pain management with ziconotide: Time for consensus?Georgios Matis0Pasquale De Negri1Denis Dupoiron2Rudolf Likar3Xander Zuidema4Dirk Rasche5Department of Stereotactic and Functional Neurosurgery Faculty of Medicine and University Hospital Cologne University of Cologne Cologne GermanyDepartment of Anaesthesia, Intensive Care and Pain Medicine San Giuliano Hospital Giugliano, Naples ItalyAnesthesiology and Pain Department Institut de Cancérologie de l’Ouest ICO Paul Papin Angers FranceDepartment of Anaesthesiology and Intensive Care Klagenfurt Clinic Klagenfurt AustriaDepartment of Anaesthesiology and Pain Medicine Diakonessenhuis Utrecht/Zeist Zeist The NetherlandsFunctional Neurosurgery and Neurosurgical Pain Therapy University Hospital Schleswig‐Holstein Lübeck GermanyAbstract This article summarizes recommendations made by six pain specialists who discussed the rationale for ziconotide intrathecal analgesia (ITA) and the requirement for evidence‐based guidance on its use, from a European perspective. Riemser Pharma GmbH (Greifswald, Germany), which holds the European marketing authorization for ziconotide, hosted the meeting. The group agreed that ITA is under‐used in Europe, adding that ziconotide ITA has potential to be a first‐line alternative to morphine; both are already first‐line options in the USA. Ziconotide ITA (initiated using a low‐dose, slow‐titration approach) is suitable for many patients with noncancer‐ or cancer‐related chronic refractory pain and no history of psychosis. Adopting ziconotide as first‐line ITA could reduce opioid usage in these patient populations. The group advocated a risk‐reduction strategy for all candidate patients, including compulsory prescreening for neuropsychosis, and requested US–European alignment of the licensed starting dose for ziconotide: the low‐and‐slow approach practiced in the USA has a better tolerability profile than the fixed high starting dose licensed in Europe. Of note, an update to the European Summary of Product Characteristics is anticipated in early 2021. The group acknowledged that the Polyanalgesic Consensus Conference (PACC) treatment algorithms for ziconotide ITA provide useful guidance, but recommendations tailored specifically for European settings are required. Before a consensus process can formally begin, the group called for additional European prospective studies to investigate ziconotide in low‐and‐slow dosing strategies, in different patient settings. Such data would enable European guidance to have the most appropriate evidence at its core.https://doi.org/10.1002/brb3.2055cancer painchronic painconsensusintrathecal therapypain managementziconotide |
| spellingShingle | Georgios Matis Pasquale De Negri Denis Dupoiron Rudolf Likar Xander Zuidema Dirk Rasche Intrathecal pain management with ziconotide: Time for consensus? Brain and Behavior cancer pain chronic pain consensus intrathecal therapy pain management ziconotide |
| title | Intrathecal pain management with ziconotide: Time for consensus? |
| title_full | Intrathecal pain management with ziconotide: Time for consensus? |
| title_fullStr | Intrathecal pain management with ziconotide: Time for consensus? |
| title_full_unstemmed | Intrathecal pain management with ziconotide: Time for consensus? |
| title_short | Intrathecal pain management with ziconotide: Time for consensus? |
| title_sort | intrathecal pain management with ziconotide time for consensus |
| topic | cancer pain chronic pain consensus intrathecal therapy pain management ziconotide |
| url | https://doi.org/10.1002/brb3.2055 |
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