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Bolus intrathecal injection of ziconotide (Prialt®) to evaluate the option of continuous administration via an implanted intrathecal drug delivery (ITDD) system: a pilot study.
Neuromodulation. 2013 Nov-Dec; 16(6):576-81; discussion 582.N

Abstract

OBJECTIVES

This study evaluated efficacy and safety of bolus doses of ziconotide (Prialt®, Eisai Limited, Hertfordshire, UK) to assess the option of continuous administration of this drug via an implanted intrathecal drug delivery system.

MATERIALS AND METHODS

Twenty adults with severe chronic pain who were under consideration for intrathecal (IT) therapy were enrolled in this open label, nonrandomized, pilot study. Informed consent was obtained. Demographics, medical/pain history, pain scores, and concomitant medications were recorded. A physical examination was performed. Creatine kinase was measured. Initial visual analog scale (VAS), blood pressure, heart rate, and respiratory rate were recorded. All patients received an initial bolus dose of 2.5 mcg ziconotide; the dose in the subsequent visits was modified according to response. Subsequent doses were 2.5 mcg, 1.2 mcg, or 3.75 mcg as per protocol. A good response (≥30% reduction in baseline pain VAS) with no side-effects on two occasions was considered a successful trial. Data were analyzed using a generalized estimating equations model, with pain VAS as the outcome and time (seven time points; preinjection and one to six hours postinjection) as the predictor.

RESULTS

Generalized estimating equations analysis of summary measures showed a mean reduction of pain VAS of approximately 25% at the group level; of 11 responders, seven underwent pump implantation procedure, two withdrew because of adverse effects, one refused an implant, and one could not have an implant (lack of funding from the Primary Care Trust).

CONCLUSIONS

Our data demonstrated that mean VAS was reduced by approximately 25% at the group level after IT ziconotide bolus. Treatment efficacy did not vary with sex, center, age, or pain etiology. Ziconotide bolus was generally well tolerated. Larger studies are needed to determine if bolus dosing with ziconotide is a good predictor of response to continuous IT ziconotide via an intrathecal drug delivery system.

Authors+Show Affiliations

James Cook University Hospital, Middlesbrough, UK.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23205907

Citation

Mohammed, Salma I., et al. "Bolus Intrathecal Injection of Ziconotide (Prialt®) to Evaluate the Option of Continuous Administration Via an Implanted Intrathecal Drug Delivery (ITDD) System: a Pilot Study." Neuromodulation : Journal of the International Neuromodulation Society, vol. 16, no. 6, 2013, pp. 576-81; discussion 582.
Mohammed SI, Eldabe S, Simpson KH, et al. Bolus intrathecal injection of ziconotide (Prialt®) to evaluate the option of continuous administration via an implanted intrathecal drug delivery (ITDD) system: a pilot study. Neuromodulation. 2013;16(6):576-81; discussion 582.
Mohammed, S. I., Eldabe, S., Simpson, K. H., Brookes, M., Madzinga, G., Gulve, A., Baranidharan, G., Radford, H., Crowther, T., Buchser, E., Perruchoud, C., & Batterham, A. M. (2013). Bolus intrathecal injection of ziconotide (Prialt®) to evaluate the option of continuous administration via an implanted intrathecal drug delivery (ITDD) system: a pilot study. Neuromodulation : Journal of the International Neuromodulation Society, 16(6), 576-81; discussion 582. https://doi.org/10.1111/ner.12003
Mohammed SI, et al. Bolus Intrathecal Injection of Ziconotide (Prialt®) to Evaluate the Option of Continuous Administration Via an Implanted Intrathecal Drug Delivery (ITDD) System: a Pilot Study. Neuromodulation. 2013 Nov-Dec;16(6):576-81; discussion 582. PubMed PMID: 23205907.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Bolus intrathecal injection of ziconotide (Prialt®) to evaluate the option of continuous administration via an implanted intrathecal drug delivery (ITDD) system: a pilot study. AU - Mohammed,Salma I, AU - Eldabe,Sam, AU - Simpson,Karen H, AU - Brookes,Morag, AU - Madzinga,Grace, AU - Gulve,Ashish, AU - Baranidharan,Ganesan, AU - Radford,Helen, AU - Crowther,Tracey, AU - Buchser,Eric, AU - Perruchoud,Christophe, AU - Batterham,Alan Mark, Y1 - 2012/12/03/ PY - 2012/01/19/received PY - 2012/06/30/revised PY - 2012/10/04/accepted PY - 2012/12/5/entrez PY - 2012/12/5/pubmed PY - 2014/9/25/medline KW - Creatine kinase (CK) KW - intrathecal drug delivery (ITDD) system KW - visual analog score (VAS) KW - ziconotide SP - 576-81; discussion 582 JF - Neuromodulation : journal of the International Neuromodulation Society JO - Neuromodulation VL - 16 IS - 6 N2 - OBJECTIVES: This study evaluated efficacy and safety of bolus doses of ziconotide (Prialt®, Eisai Limited, Hertfordshire, UK) to assess the option of continuous administration of this drug via an implanted intrathecal drug delivery system. MATERIALS AND METHODS: Twenty adults with severe chronic pain who were under consideration for intrathecal (IT) therapy were enrolled in this open label, nonrandomized, pilot study. Informed consent was obtained. Demographics, medical/pain history, pain scores, and concomitant medications were recorded. A physical examination was performed. Creatine kinase was measured. Initial visual analog scale (VAS), blood pressure, heart rate, and respiratory rate were recorded. All patients received an initial bolus dose of 2.5 mcg ziconotide; the dose in the subsequent visits was modified according to response. Subsequent doses were 2.5 mcg, 1.2 mcg, or 3.75 mcg as per protocol. A good response (≥30% reduction in baseline pain VAS) with no side-effects on two occasions was considered a successful trial. Data were analyzed using a generalized estimating equations model, with pain VAS as the outcome and time (seven time points; preinjection and one to six hours postinjection) as the predictor. RESULTS: Generalized estimating equations analysis of summary measures showed a mean reduction of pain VAS of approximately 25% at the group level; of 11 responders, seven underwent pump implantation procedure, two withdrew because of adverse effects, one refused an implant, and one could not have an implant (lack of funding from the Primary Care Trust). CONCLUSIONS: Our data demonstrated that mean VAS was reduced by approximately 25% at the group level after IT ziconotide bolus. Treatment efficacy did not vary with sex, center, age, or pain etiology. Ziconotide bolus was generally well tolerated. Larger studies are needed to determine if bolus dosing with ziconotide is a good predictor of response to continuous IT ziconotide via an intrathecal drug delivery system. SN - 1525-1403 UR - https://www.unboundmedicine.com/medline/citation/23205907/Bolus_intrathecal_injection_of_ziconotide__Prialt®__to_evaluate_the_option_of_continuous_administration_via_an_implanted_intrathecal_drug_delivery__ITDD__system:_a_pilot_study_ L2 - https://doi.org/10.1111/ner.12003 DB - PRIME DP - Unbound Medicine ER -