PMID- 18227325
OWN - NLM
STAT- MEDLINE
DCOM- 20080219
LR  - 20220408
IS  - 1526-7598 (Electronic)
IS  - 0003-2999 (Linking)
VI  - 106
IP  - 2
DP  - 2008 Feb
TI  - Intrathecal ziconotide for severe chronic pain: safety and tolerability results 
      of an open-label, long-term trial.
PG  - 628-37, table of contents
LID - 10.1213/ane.0b013e3181606fad [doi]
AB  - 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 > or = 
      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 microg/d (range, 0.048-240.0 microg/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 > or = 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 (> or = 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.
FAU - Wallace, Mark S
AU  - Wallace MS
AD  - Center for Pain Medicine, University of California, San Diego, La Jolla, 
      California 92093, USA. mswallace@ucsd.edu
FAU - Rauck, Richard
AU  - Rauck R
FAU - Fisher, Robert
AU  - Fisher R
FAU - Charapata, Steven G
AU  - Charapata SG
FAU - Ellis, David
AU  - Ellis D
FAU - Dissanayake, Sanjeeva
AU  - Dissanayake S
CN  - Ziconotide 98-022 Study Group
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Anesth Analg
JT  - Anesthesia and analgesia
JID - 1310650
RN  - 0 (omega-Conotoxins)
RN  - 7I64C51O16 (ziconotide)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Ambulatory Care/methods
MH  - Chronic Disease
MH  - Female
MH  - Gastrointestinal Diseases/chemically induced/epidemiology
MH  - Humans
MH  - Infusion Pumps
MH  - Male
MH  - Middle Aged
MH  - Pain/*drug therapy/epidemiology
MH  - Time
MH  - omega-Conotoxins/*administration & dosage/*adverse effects
EDAT- 2008/01/30 09:00
MHDA- 2008/02/20 09:00
CRDT- 2008/01/30 09:00
PHST- 2008/01/30 09:00 [pubmed]
PHST- 2008/02/20 09:00 [medline]
PHST- 2008/01/30 09:00 [entrez]
AID - 106/2/628 [pii]
AID - 10.1213/ane.0b013e3181606fad [doi]
PST - ppublish
SO  - Anesth Analg. 2008 Feb;106(2):628-37, table of contents. doi: 
      10.1213/ane.0b013e3181606fad.