Intrathecal Ziconotide in the Treatment of Refractory Pain in Patients with Cancer or AIDS: A Randomized Controlled Trial

Peter S. Staats, Thomas Yearwood, Steven G. Charapata, Robert W. Presley, Mark S. Wallace, Michael Byas-Smith, Robert Fisher, David A. Bryce, Eugene A. Mangieri, Robert R. Luther, Martha Mayo, Dawn McGuire, David Ellis

Research output: Contribution to journalArticle

Abstract

Context: Ziconotide (formerly SNX-111) selectively blocks N-type voltage-sensitive calcium channels and may be effective in patients with pain that is refractory to opioid therapy or those with intolerable opioid-related adverse effects. Objective: To assess the safety and efficacy of intrathecal ziconotide in patients with pain that is refractory to conventional treatment. Design, Setting, and Patients: Double-blind, placebo-controlled, randomized trial conducted from March 12, 1996, to July 11, 1998, at 32 study centers in the United States, Australia, and the Netherlands. Patients were 111 individuals ages 24 to 85 years with cancer or AIDS and a mean Visual Analog Scale of Pain Intensity (VASPI) score of 50 mm or greater. Patients were randomly assigned in a 2:1 ratio to receive ziconotide or placebo treatment. Interventions Intrathecal ziconotide was titrated over 5 to 6 days, followed by a 5-day maintenance phase for responders and crossover of nonresponders to the opposite treatment group. Main Outcome Measure: Mean percentage change in VASPI score from baseline to the end of the initial titration period. Results: Of the evaluable population, 67 (98.5%) of 68 patients receiving ziconotide and 38 (95%) of 40 patients receiving placebo were taking opioids at baseline (median morphine equivalent dosage of 300 mg/d for the ziconotide group and 600 mg/d for the placebo group; P=.63, based on mean values), and 36 had used intrathecal morphine. Mean (SD) VASPI scores were 73.6 (1.8) mm in the ziconotide group and 77.9 (2.3) mm in the placebo group (P=.18). Mean VASPI scores improved 53.1% (95% confidence interval [CI], 44.0%-62.2%) in the ziconotide group and 18.1% (95% CI, 4.8%-31.4%) in the placebo group (P

Original languageEnglish (US)
Pages (from-to)63-70
Number of pages8
JournalJournal of the American Medical Association
Volume291
Issue number1
DOIs
StatePublished - Jan 7 2004

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Intractable Pain
Acquired Immunodeficiency Syndrome
Randomized Controlled Trials
Placebos
Pain Measurement
Neoplasms
Opioid Analgesics
Therapeutics
Morphine
Confidence Intervals
ziconotide
Calcium Channels
Netherlands
Maintenance
Outcome Assessment (Health Care)
Safety

ASJC Scopus subject areas

  • Medicine(all)

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Staats, P. S., Yearwood, T., Charapata, S. G., Presley, R. W., Wallace, M. S., Byas-Smith, M., ... Ellis, D. (2004). Intrathecal Ziconotide in the Treatment of Refractory Pain in Patients with Cancer or AIDS: A Randomized Controlled Trial. Journal of the American Medical Association, 291(1), 63-70. https://doi.org/10.1001/jama.291.1.63

Intrathecal Ziconotide in the Treatment of Refractory Pain in Patients with Cancer or AIDS : A Randomized Controlled Trial. / Staats, Peter S.; Yearwood, Thomas; Charapata, Steven G.; Presley, Robert W.; Wallace, Mark S.; Byas-Smith, Michael; Fisher, Robert; Bryce, David A.; Mangieri, Eugene A.; Luther, Robert R.; Mayo, Martha; McGuire, Dawn; Ellis, David.

In: Journal of the American Medical Association, Vol. 291, No. 1, 07.01.2004, p. 63-70.

Research output: Contribution to journalArticle

Staats, PS, Yearwood, T, Charapata, SG, Presley, RW, Wallace, MS, Byas-Smith, M, Fisher, R, Bryce, DA, Mangieri, EA, Luther, RR, Mayo, M, McGuire, D & Ellis, D 2004, 'Intrathecal Ziconotide in the Treatment of Refractory Pain in Patients with Cancer or AIDS: A Randomized Controlled Trial', Journal of the American Medical Association, vol. 291, no. 1, pp. 63-70. https://doi.org/10.1001/jama.291.1.63
Staats, Peter S. ; Yearwood, Thomas ; Charapata, Steven G. ; Presley, Robert W. ; Wallace, Mark S. ; Byas-Smith, Michael ; Fisher, Robert ; Bryce, David A. ; Mangieri, Eugene A. ; Luther, Robert R. ; Mayo, Martha ; McGuire, Dawn ; Ellis, David. / Intrathecal Ziconotide in the Treatment of Refractory Pain in Patients with Cancer or AIDS : A Randomized Controlled Trial. In: Journal of the American Medical Association. 2004 ; Vol. 291, No. 1. pp. 63-70.
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