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    ABSTRACT: To describe the pharmacology, efficacy, and safety of ziconotide for treatment of severe chronic pain in patients who are candidates for intrathecal therapy. A PubMed/MEDLINE search (1966-June 2006) was conducted using the terms ziconotide, Prialt, and SNX-111. Manufacturer-provided data, the Food and Drug Administration medical review of ziconotide, and abstracts presented at American Pain Society meetings (2001-2006) were also reviewed. Human studies evaluating the efficacy and safety of ziconotide for the treatment of chronic pain were considered. Animal data were excluded. Ziconotide is the first and only neuronal-type (N-type) calcium-channel blocker. Ziconotide must be administered intrathecally via continuous infusion. A programmable implanted variable-rate microinfusion device, or an external microinfusion device and catheter must be utilized. In double-blind, placebo-controlled studies, ziconotide significantly improved patient perception of pain from baseline to the end of the study periods, which ranged from 11 to 21 days. Patients enrolled in clinical trials were intolerant of or refractory to other treatment modalities. There have been no studies that directly compared ziconotide with other intrathecal or systemic analgesics. Key ziconotide-related adverse events are neuropsychiatric, including depression, cognitive impairment, and hallucinations; depressed levels of consciousness; and elevation of creatine kinase levels. Ziconotide is also associated with a risk of meningitis due to possible contamination of the microinfusion device. Ziconotide is a therapeutic option for treatment of severe chronic pain in patients who have exhausted all other agents, including intrathecal morphine, and for whom the potential benefit outweighs the risks of serious neuropsychiatric adverse effects and of having an implanted device. Further studies are needed to determine the comparative efficacy of ziconotide and other pain therapies.
    Annals of Pharmacotherapy 07/2006; 40(7-8):1293-300. DOI:10.1345/aph.1G584 · 2.92 Impact Factor
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    ABSTRACT: Ziconotide is a nonopioid analgesic currently indicated as monotherapy, but frequently used in combination with opioids, for the management of severe chronic pain in patients for whom intrathecal (IT) therapy is warranted and who are intolerant of, or whose pain is, refractory to other treatments. There is a paucity of information regarding ziconotide use in patients with complex regional pain syndrome (CRPS). Seven cases in which IT ziconotide was used in patients with CRPS were analyzed. All patients (4 male, 3 female; age range, 14 to 52 years) had experienced inadequate pain relief with multiple conventional and interventional treatments. Three patients received ziconotide monotherapy exclusively; 4 patients received ziconotide monotherapy initially, then combination IT therapy. The mean ziconotide dose was 5.2 mcg/d (range, 0.5 to 13 mcg/d) at initiation and 24.7 mcg/d (range, 0.06 to 146 mcg/d) at the last available assessment. The mean duration of ziconotide therapy was 3.1 years (range, 26 days to 8 years). At ziconotide initiation, the mean visual analog scale (VAS) score was 89.3 mm (range, 75 to 100 mm); VAS scores decreased by a mean of 47.5% (range, 5% to 100%) at last assessment. Of the 5 patients who experienced substantial improvement in pain, edema, skin abnormalities, and/or mobility with ziconotide therapy, 2 have discontinued ziconotide and are pain free. Another patient experienced marked reversal of both edema and advanced skin trophic changes. Adverse events included urinary retention, depression, anxiety, and hallucinations. Adverse events generally resolved spontaneously, with treatment, or with ziconotide discontinuation/dose reduction. Although further studies are required, ziconotide holds promise as an effective treatment for CRPS.
    Pain Practice 06/2009; 9(4):296 - 303. DOI:10.1111/j.1533-2500.2009.00289.x · 2.18 Impact Factor
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    ABSTRACT: The use, safety, and efficacy of intrathecal medication administration with implantable pumps for cancer and chronic pain management are reviewed. Implanted intrathecal drug-delivery systems (IDDSs) are used for long-term management of persistent, severe pain despite a multimodal approach with conventional pain treatment options. Currently, consensus papers published in the literature are used as guidelines for determining patient selection and medication administration, because there is a lack of supporting evidence from randomized, controlled, clinical trials. Pharmacists have a critical role in the safe use of intrathecal medication. Most of the medication concentrations and combinations administered through IDDSs are not commercially available and therefore must be compounded in a pharmacy. Medications commonly administered through IDDSs include opioids, local anesthetics, clonidine, baclofen, and ziconotide. It is important for pharmacists who prepare products for IDDSs to understand the pharmacology, adverse effects, and concentration limitations of each medication in order to prevent adverse events related to postoperative subarachnoid hemorrhage, infection, catheter-tip inflammatory masses, withdrawal, and overdose. Pharmacists play an important role in maintaining quality assurance of intrathecal drug use, including the use of standard procedures for ordering and compounding medications, documentation of patient education, and monitoring of patient outcomes. The use of long-term intrathecal drug delivery for the treatment of intractable pain or intolerable medication adverse effects has expanded to include the treatment of patients with chronic or cancer-related pain. Important considerations for the use of intrathecal drug therapy include the appropriate selection of patients, delivery systems, and medications, as well as potential complications of therapy and quality-assurance measures necessary to ensure patient safety.
    American journal of health-system pharmacy: AJHP: official journal of the American Society of Health-System Pharmacists 01/2008; 64(23):2447-61. DOI:10.2146/ajhp060204 · 2.21 Impact Factor