Continuous intrathecal infusion of ziconotide for treatment of chronic malignant and nonmalignant pain over 12 months: A prospective, open-label study

David J. Ellis, Sanjeeva Dissanayake, Dawn McGuire, Steven G. Charapata, Peter S. Staats, Mark S. Wallace, Gene W. Grove, Piet Vercruysse

Research output: Contribution to journalArticle

Abstract

Objectives. This study aims to assess the safety and efficacy of long-term intrathecal (IT) ziconotide infusion. Materials and Methods. In this prospective study, 155 patients with severe chronic pain (48 with malignant pain, 107 with nonmalignant pain) who had been responsive to short-term IT ziconotide in a double-blind, placebo-controlled study received long-term, open-label IT ziconotide monotherapy. Efficacy assessments included the mean percentage change on the visual analog scale of pain intensity from baseline in the study of origin; safety was monitored by adverse event (AE) reports, periodic laboratory tests, and vital sign measurements. Results. At the last available observation, the visual analog scale of pain intensity scores had decreased by a mean of 36.9% from baseline in the short-term trial (N = 144; 95% CI: 30.1-43.7%; p <0.0001). The mean IT ziconotide dose remained stable over 12 months in the 31 patients who participated in the study for ≥ one year. Ziconotide-related AEs were reported in 147 out of 155 patients (94.8%); 39.4% of patients discontinued treatment because of AEs, the majority of which were considered ziconotide related. Conclusions. Ziconotide IT monotherapy provided patients with analgesia for 12 months in this open-label study, with an acceptable benefit/risk profile and no evidence of tolerance.

Original languageEnglish (US)
Pages (from-to)40-49
Number of pages10
JournalNeuromodulation
Volume11
Issue number1
DOIs
StatePublished - Jan 2008

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Pain
Pain Measurement
Therapeutics
Safety
Vital Signs
ziconotide
Chronic Pain
Analgesia
Placebos
Observation
Prospective Studies

Keywords

  • Chronic malignant pain
  • Chronic nonmalignant pain
  • Intrathecal
  • Ziconotide

ASJC Scopus subject areas

  • Anesthesiology and Pain Medicine
  • Neuroscience(all)

Cite this

Continuous intrathecal infusion of ziconotide for treatment of chronic malignant and nonmalignant pain over 12 months : A prospective, open-label study. / Ellis, David J.; Dissanayake, Sanjeeva; McGuire, Dawn; Charapata, Steven G.; Staats, Peter S.; Wallace, Mark S.; Grove, Gene W.; Vercruysse, Piet.

In: Neuromodulation, Vol. 11, No. 1, 01.2008, p. 40-49.

Research output: Contribution to journalArticle

Ellis, DJ, Dissanayake, S, McGuire, D, Charapata, SG, Staats, PS, Wallace, MS, Grove, GW & Vercruysse, P 2008, 'Continuous intrathecal infusion of ziconotide for treatment of chronic malignant and nonmalignant pain over 12 months: A prospective, open-label study', Neuromodulation, vol. 11, no. 1, pp. 40-49. https://doi.org/10.1111/j.1525-1403.2007.00141.x
Ellis, David J. ; Dissanayake, Sanjeeva ; McGuire, Dawn ; Charapata, Steven G. ; Staats, Peter S. ; Wallace, Mark S. ; Grove, Gene W. ; Vercruysse, Piet. / Continuous intrathecal infusion of ziconotide for treatment of chronic malignant and nonmalignant pain over 12 months : A prospective, open-label study. In: Neuromodulation. 2008 ; Vol. 11, No. 1. pp. 40-49.
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AB - Objectives. This study aims to assess the safety and efficacy of long-term intrathecal (IT) ziconotide infusion. Materials and Methods. In this prospective study, 155 patients with severe chronic pain (48 with malignant pain, 107 with nonmalignant pain) who had been responsive to short-term IT ziconotide in a double-blind, placebo-controlled study received long-term, open-label IT ziconotide monotherapy. Efficacy assessments included the mean percentage change on the visual analog scale of pain intensity from baseline in the study of origin; safety was monitored by adverse event (AE) reports, periodic laboratory tests, and vital sign measurements. Results. At the last available observation, the visual analog scale of pain intensity scores had decreased by a mean of 36.9% from baseline in the short-term trial (N = 144; 95% CI: 30.1-43.7%; p <0.0001). The mean IT ziconotide dose remained stable over 12 months in the 31 patients who participated in the study for ≥ one year. Ziconotide-related AEs were reported in 147 out of 155 patients (94.8%); 39.4% of patients discontinued treatment because of AEs, the majority of which were considered ziconotide related. Conclusions. Ziconotide IT monotherapy provided patients with analgesia for 12 months in this open-label study, with an acceptable benefit/risk profile and no evidence of tolerance.

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