Universität zu Köln

Matis, Georgios ORCID: 0000-0002-1046-2829, De Negri, Pasquale ORCID: 0000-0002-3464-1506, Dupoiron, Denis, Likar, Rudolf, Zuidema, Xander and Rasche, Dirk (2021). Intrathecal pain management with ziconotide: Time for consensus? Brain Behav., 11. HOBOKEN: WILEY. ISSN 2162-3279

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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 noncanceror 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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Matis, Georgios UNSPECIFIED orcid.org/0000-0002-1046-2829 UNSPECIFIED De Negri, Pasquale UNSPECIFIED orcid.org/0000-0002-3464-1506 UNSPECIFIED Dupoiron, Denis UNSPECIFIED UNSPECIFIED UNSPECIFIED Likar, Rudolf UNSPECIFIED UNSPECIFIED UNSPECIFIED Zuidema, Xander UNSPECIFIED UNSPECIFIED UNSPECIFIED Rasche, Dirk UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-595036
DOI:	10.1002/brb3.2055
Journal or Publication Title:	Brain Behav.
Volume:	11
Date:	2021
Publisher:	WILEY
Place of Publication:	HOBOKEN
ISSN:	2162-3279
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language Behavioral Sciences; Neurosciences Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/59503