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ANALGESIA

Intrathecal Ziconotide for Severe Chronic Pain: Safety and Tolerability Results of an Open-Label, Long-Term Trial

Mark S. Wallace, MD^*, Richard Rauck, MD, Robert Fisher, MD, Steven G. Charapata, MD, David Ellis, MD, PhD^||, Sanjeeva Dissanayake, MBBS, MRCP^¶ For the Ziconotide 98-022 Study Group

From the *Center for Pain Medicine, University of California, San Diego, La Jolla, California; Center for Clinical Research, Winston-Salem, North Carolina; RC Goodman Institute for Pain Management, Sparks Regional Medical Center, Fort Smith, Arkansas; Pain Management Associates, Kansas City, Missouri; ||Elan Pharmaceuticals, Inc., San Diego, California; and ¶Elan Pharma, Ltd., Stevenage, UK.

Address correspondence and reprint requests to Mark S. Wallace, MD, University of CA, San Diego, Medical Center, 9500 Gilman Dr., Ste. 0924, La Jolla, CA 92093. Address e-mail to mswallace{at}ucsd.edu.

Abstract

BACKGROUND: Ziconotide is a non-opioid drug indicated for management of severe chronic pain in patients for whom intrathecal (IT) therapy is warranted and who are intolerant of or refractory to other treatments.

METHODS: Six-hundred and forty-four patients with severe chronic pain participated in this open-label, multicenter study. Ziconotide titration was followed by long-term infusion. Efficacy assessments included the Visual Analog Scale of Pain Intensity. Safety was assessed via adverse events (AEs), vital signs, and routine laboratory values.

RESULTS: One-hundred and nineteen patients received ziconotide for 360 days; total exposure was 350.9 patient years. Median duration of ziconotide therapy was 67.5 days (range, 1.2–1215.5 days); mean dose at last infusion was 8.4 µg/d (range, 0.048–240.0 µg/d). Median Visual Analog Scale of Pain Intensity scores at baseline, month 1, and the last available observation up to month 2 were 76 mm (range, 4–100 mm), 68 mm (range, 0–100 mm), and 73 mm (range, 0–100 mm), respectively. Most patients (99.7%) experienced 1 AE. Most AEs were of mild (43.5%) or moderate (42.3%) severity; 58.6% of AEs were considered unrelated to ziconotide. The most commonly reported AEs (25% of patients) included nausea, dizziness, headache, confusion, pain, somnolence, and memory impairment. Clinically significant abnormalities (>3 times the upper limit of normal) in creatine kinase levels were reported in 0.9% of patients at baseline, 5.7% at month 1, and 3.4% at ziconotide discontinuation. No drug-related deaths, IT granulomas, or permanent adverse sequelae occurred with ziconotide therapy.

CONCLUSION: We conclude that long-term IT ziconotide is an option for patients with severe, refractory chronic pain.

Anesthesia & Analgesia® is published for the International Anesthesia Research Society® by Lippincott Williams & Wilkins with the assistance of Stanford University Libraries' HighWire Press®. Copyright 2006 by the International Anesthesia Research Society. Online ISSN: 1526-7598   Print ISSN: 0003-2999