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Long-term intrathecal ziconotide for chronic pain: an open-label study.
J Pain Symptom Manage. 2009 Mar; 37(3):363-72.JP

Abstract

This open-label multicenter study evaluated the long-term safety and efficacy of intrathecal ziconotide and included 78 patients with chronic pain who had completed one of two previous ziconotide clinical trials. Each patient's initial ziconotide dose was based on his or her dose from the study of origin and was adjusted as necessary on the basis of adverse events and analgesic effect. The median ziconotide dose was 6.48 mcg/day (range, 0.00-120.00 mcg/day) at the Initial Visit and ranged from 5.52 to 7.20 mcg/day across all study visits. The most commonly reported new adverse events that were considered ziconotide related were memory impairment (11.3%); dizziness, nystagmus, and speech disorder (8.5% each); nervousness and somnolence (7.0% each); and abnormal gait (5.6%). There was no evidence of increased adverse event incidence at higher cumulative ziconotide doses. Elevations in creatine kinase were noted, but the proportion of patients with creatine kinase elevations did not change from the Initial Visit to the Termination Visit (4.1% each). Stable mean Visual Analog Scale of Pain Intensity scores during the three years of the study suggested no evidence of increased pain intensity with increased duration of ziconotide exposure. Long-term treatment with ziconotide appeared to be well tolerated and effective in patients whose response to ziconotide and ability to tolerate the drug had been previously demonstrated.

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Authors+Show Affiliations

Webster LR
Lifetree Clinical Research and Pain Clinic, Salt Lake City, Utah, USA. lynnw@lifetreepain.com
Fisher R
No affiliation info available
Charapata S
No affiliation info available
Wallace MS
No affiliation info available

MeSH

Analgesics, Non-NarcoticChronic DiseaseFemaleHumansInjections, SpinalLong-Term CareMaleMiddle AgedPainPain Measurementomega-Conotoxins

Pub Type(s)

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

Language

eng

PubMed ID

18715748

Citation

Webster, Lynn R., et al. "Long-term Intrathecal Ziconotide for Chronic Pain: an Open-label Study." Journal of Pain and Symptom Management, vol. 37, no. 3, 2009, pp. 363-72.
Webster LR, Fisher R, Charapata S, et al. Long-term intrathecal ziconotide for chronic pain: an open-label study. J Pain Symptom Manage. 2009;37(3):363-72.
Webster, L. R., Fisher, R., Charapata, S., & Wallace, M. S. (2009). Long-term intrathecal ziconotide for chronic pain: an open-label study. Journal of Pain and Symptom Management, 37(3), 363-72. https://doi.org/10.1016/j.jpainsymman.2008.02.016
Webster LR, et al. Long-term Intrathecal Ziconotide for Chronic Pain: an Open-label Study. J Pain Symptom Manage. 2009;37(3):363-72. PubMed PMID: 18715748.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term intrathecal ziconotide for chronic pain: an open-label study. AU - Webster,Lynn R, AU - Fisher,Robert, AU - Charapata,Steven, AU - Wallace,Mark S, Y1 - 2008/08/19/ PY - 2007/12/03/received PY - 2008/02/19/revised PY - 2008/02/20/accepted PY - 2008/8/22/pubmed PY - 2009/5/22/medline PY - 2008/8/22/entrez SP - 363 EP - 72 JF - Journal of pain and symptom management JO - J Pain Symptom Manage VL - 37 IS - 3 N2 - This open-label multicenter study evaluated the long-term safety and efficacy of intrathecal ziconotide and included 78 patients with chronic pain who had completed one of two previous ziconotide clinical trials. Each patient's initial ziconotide dose was based on his or her dose from the study of origin and was adjusted as necessary on the basis of adverse events and analgesic effect. The median ziconotide dose was 6.48 mcg/day (range, 0.00-120.00 mcg/day) at the Initial Visit and ranged from 5.52 to 7.20 mcg/day across all study visits. The most commonly reported new adverse events that were considered ziconotide related were memory impairment (11.3%); dizziness, nystagmus, and speech disorder (8.5% each); nervousness and somnolence (7.0% each); and abnormal gait (5.6%). There was no evidence of increased adverse event incidence at higher cumulative ziconotide doses. Elevations in creatine kinase were noted, but the proportion of patients with creatine kinase elevations did not change from the Initial Visit to the Termination Visit (4.1% each). Stable mean Visual Analog Scale of Pain Intensity scores during the three years of the study suggested no evidence of increased pain intensity with increased duration of ziconotide exposure. Long-term treatment with ziconotide appeared to be well tolerated and effective in patients whose response to ziconotide and ability to tolerate the drug had been previously demonstrated. SN - 1873-6513 UR - https://www.unboundmedicine.com/medline/citation/18715748/Long_term_intrathecal_ziconotide_for_chronic_pain:_an_open_label_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0885-3924(08)00376-X DB - PRIME DP - Unbound Medicine ER -