Ziconotide adverse events in patients with cancer pain: A multicenter observational study of a slow titration, multidrug protocol

Pain Physician

Volumn 15, Issue 5, 2012, Pages 395-403

  Dupoiron, Denis ^a   Bore, François ^a   Lefebvre Kuntz, Danièle ^b   Brenet, Olivier ^a   de Bourmont, Sabine ^a   Dixmerias, Florence ^c   Buisset, Nadia ^d   Lebrec, Nathalie ^a   Monnin, Dominique ^c  

^a Institut de Cancérologie de l'Ouest ^*  (France)

^b CENTRE OSCAR LAMBRET   (France)

^c INSTITUT BERGONIÉ   (France)

^d LILLE UNIVERSITY HOSPITAL   (France)

Author keywords

Adverse events; Cancer pain; Clonidine; Intrathecal therapy; Morphine; Ropivacaine; Ziconotide

Indexed keywords

CLONIDINE; MORPHINE; NARCOTIC ANALGESIC AGENT; OMEGA CONOTOXIN MVIIA; ROPIVACAINE;

ADOLESCENT; ADULT; AGED; ARTICLE; CANCER PAIN; CANCER SURVIVAL; CHRONIC PAIN; CLINICAL PROTOCOL; COHORT ANALYSIS; CONFUSION; DEPRESSION; DIAPHORESIS; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; FOLLOW UP; HUMAN; HYPOTENSION; MAJOR CLINICAL STUDY; MALE; MEMORY; MOOD DISORDER; MULTICENTER STUDY; NAUSEA; NEUROLOGIC DISEASE; OBSERVATIONAL STUDY; PAIN ASSESSMENT; SIDE EFFECT; SPEECH DISORDER; SURVIVAL TIME; UNSPECIFIED SIDE EFFECT; URINE RETENTION; VERTIGO; VISUAL DISORDER;

AGED; ANALGESICS, NON-NARCOTIC; CHRONIC PAIN; COHORT STUDIES; FEMALE; HUMANS; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; NEOPLASMS; OBSERVATION; OMEGA-CONOTOXINS; PAIN MEASUREMENT;

EID: 84867002720     PISSN: 15333159     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (43)

1. Belot A, Grosclaude P, Bossard N, Jougla E, Benhamou E, Delafosse P, Guizard A V, Molinie F, Danzon A, Bara S, Bouvier A M, Tretarre B, Binder-Foucard F, Colonna M, Daubisse L, Hedelin G,Launoy G, Le Stang N, Maynadie M, Monnereau A, Troussard X, Faivre J, Collignon A, Janoray I, Arveux P, Buemi A, Raverdy N, Schvartz C, Bovet M, Cherie-Challine L, Esteve J.Remontet L, Velten M. Cancer incidence and mortality in France over the period 1980-2005. Rev Epidemiol Sante Publique 2008; 56: 159-175.
2. Breivik H, Cherny N, Collett B, de Conno F, Filbet M, Foubert AJ, Cohen R, Dow L. Cancer-related pain: a pan-European survey of prevalence, treatment, and patient attitudes. Ann Oncol 2009; 20: 1420-1433.
3. World Health Organization, Cancer Pain Relief. WHO Publications Center. http://whqlibdoc.who.int/publications/9241544821.pdf.
4. Zech DF, Grond S, Lynch J, Hertel D, Lehmann KA. Validation of World Health Organization Guidelines for cancer pain relief: a 10-year prospective study. Pain 1995; 63: 65-76.
5. Meuser T, Pietruck C, Radbruch L, Stute P, Lehmann KA, Grond S. Symptoms during cancer pain treatment following WHO-guidelines: a longitudinal followup study of symptom prevalence, severity and etiology. Pain 2001; 93: 247-257.
6. Miguel R. Interventional treatment of cancer pain: the fourth step in the World Health Organization analgesic ladder? Cancer Control 2000; 7: 149-156.
7. Rauck RL, Cherry D, Boyer MF, Kosek P, Dunn J, Alo K. Long-term intrathecal opioid therapy with a patient-activated, implanted delivery system for the treatment of refractory cancer pain. J Pain. 2003; 4: 441-447.
8. Smith TJ, Staats PS, Deer T, Stearns LJ, Rauck RL, Boortz-Marx RL, Buchser E, Catala E, Bryce DA, Coyne PJ, Pool GE. Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain: impact on pain, drug-related toxicity, and survival. J Clin Oncol. 2002; 20: 4040-4049.
9. Wang JK, Nauss LA, Thomas JE. Pain relief by intrathecally applied morphine in man. Anesthesiology. 1979; 50: 149-151.
10. Smith TJ and Coyne PJ. How to use implantable intrathecal drug delivery systems for refractory cancer pain. J Support Oncol 2003;1: 73-76.
11. van Dongen RT, Crul BJ, van Egmond J. Intrathecal coadministration of bupivacaine diminishes morphine dose progression during long-term intrathecal infusion in cancer patients. Clin J Pain 1999; 15: 166-172.
12. Kawamata, Omote K, Yamamoto H, Toriyabe M, Wada K, Namiki A, Antihyperalgesic and side effects of intrathecal clonidine and tizanidine in a rat model of neuropathic pain. Anesthesiology 2003; 98:1480-1483.
13. Ackerman LL, Follett KA, Rosenquist RW. Long-term outcomes during treatment of chronic pain with intrathecal clonidine or clonidine/opioid combinations. J Pain Symptom Manage, 2003; 26: 668-677.
14. Kozek SA, Sator-Katzenschlager S, Kress HG, Intrathecal S(+)-ketamine in refractory neuropathic cancer pain. Pain 2006; 121: 283-284.
15. Sator-Katzenschlager S, Deusch E, Maier P, Spacek A, Kress HG., The long-term antinociceptive effect of intrathecal S(+)ketamine in a patient with established morphine tolerance. Anesth Analg 2001; 93: 1032-1034.
16. Atanassoff PG, Hartmannsgruber MW, Thrasher J, Wermeling D, Longton W, Gaeta R, Singh T, Mayo M, McGuire D, Luther RR, Ziconotide, a new N-type calcium channel blocker, administered intrathecally for acute postoperative pain. Reg Anesth Pain Med 2000; 25: 274278.
17. Rauck RL, Wallace MS, Leong MS, Minehart M, Webster LR, Charapata SG, Abraham JE, Buffington DE, Ellis D, Kartzinel R. A randomized, double-blind, placebo-controlled study of intrathecal ziconotide in adults with severe chronic pain. J Pain Symptom Manage 2006; 31: 393-406.
18. 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. Intrathecal ziconotide in the treatment of refractory pain in patients with cancer or AIDS: a randomized controlled trial. JAMA 2004; 291: 63-70.
19. Deer TR, Hassenbusch SJ, Burton AW, Dupen S, Eisenach J, Erdek M, Kim P, Levy R, Mekhail N, Panchal S, Prager J, Saulino M, Sitzman, Stanton-Hicks M, Stearns L, Willis KD, Follett K Huntoon M, Rathmell J, Wallace MS, Buchser E, Ver Donck A, Polyanalgesic Consensus Conference2007: Recommendations for the Management of Pain by Intrathecal (Intraspinal) Drug Delivery: Report of an Interdisciplinary Expert Panel. 2007; 10: 300-328.
20. Deer TR, Smith HS, Burton AW, Pope JE, Doleys DM, Levy RM, Staats PS, Wallace MS, Webster LR, Rauck RL, Cousins M. Comprehensive consensus based guidelines on intrathecal drug delivery systems in the treatment of pain caused by cancer pain. Pain Physician 2011; 14; 283-312.
21. Wallace MS, Rauck R, Fisher R, Charapata SG, Ellis D, Dissanayake S. Intrathecal ziconotide for severe chronic pain: safety and tolerability results of an open-label, long-term trial. Anesth Analg 2008; 106: 628-637.
22. Wallace M.S. Ziconotide: a new nonopioid intrathecal analgesic for the treatment of chronic pain. Expert Rev Neurother 2006; 6: 1423-1428.
23. Wallace MS, Rauck RL, and Deer TR. Ziconotide combination intrathecal therapy: rationale and evidence. Clin J Pain 2010; 26: 635-644.
24. Deer TR, Kim C, Bowman R, Tolentino D, Stewart C, Tolentino W. Intrathecal ziconotide and opioid combination therapy for noncancer pain: an observational study. Pain Physician 2009; 12: E291-296.
25. Webster LR, Fakata KL, Charapata S, Fisher R, MineHart M. Open-label, multicenter study of combined intrathecal morphine and ziconotide: addition of morphine in patients receiving ziconotide for severe chronic pain. Pain Med 2008;. 9: 282-290.
26. Smith HS, Deer TR. Safety and efficacy of intrathecal ziconotide in the management of severe chronic pain. Ther Clin Risk Manag 2009; 5: 521-534.
27. Kress, HG, Simpson KH, Marchettini P, Ver Donck A, Varrassi G. Intrathecal therapy: what has changed with the introduction of ziconotide. Pain Pract 2009; 9: 338-347.
28. Williams JA, Day M, Heavner JE, Ziconotide: an update and review. Expert Opin Pharmacother 2008; 9: 1575-1583.
29. Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 1982; 5: 649-655.
30. Schmidtko A., Lotsch J, Freynhagen R, Geisslinger G. Ziconotide for treatment of severe chronic pain. Lancet 2010; 375: 1569-1577.
31. Payne R, Gradert TL, Inturrisi CE. Cerebrospinal fluid distribution of opioids after intraventricular & lumbar subarachnoid administration in sheep. Life Sci 1996; 59:1307-1321.
32. Bailey PL, Rhondeau S, Schafer PG, Lu JK, Timmins BS, Foster W, Pace NL, Stanley TH. Dose-response pharmacology of intrathecal morphine in human volunteers. Anesthesiology 1993; 79: 4959
33. Lawson EF, Wallace MS. Current developments in intraspinal agents for cancer and noncancer pain. Curr Pain Headache Rep 2010; 14: 8-16.
34. Uhle EI, Becker R, Gatscher S, Bertalanffy H. Continuous intrathecal clonidine administration for the treatment of neuropathic pain. Stereotact Funct Neurosurg 2000; 75:167-175.
35. Simpson KH, Jones I. Intrathecal drug delivery for management of cancer and noncancer pain. J Opioid Manag 2008; 4: 293-304.
36. Stearns L, Boortz-Marx R, Du Pen S, Friehs G, Gordon M, Halyard M, Herbst L, Kiser J. Intrathecal drug delivery for the management of cancer pain: a multidisciplinary consensus of best clinical practices. J Support Oncol 2005; 3: 399408.
37. Raffaeli W, Sarti D, Demartini L, Sotgiu A, Bonezzi C. Italian registry on longterm intrathecal ziconotide treatment. Pain Physician 2011; 14: 15-24.
38. Wallace MS, Kosek PS, Staats P, Fisher R, Schultz DM, Leong M. Phase II, openlabel, multicenter study of combined intrathecal morphine and ziconotide: addition of ziconotide in patients receiving intrathecal morphine for severe chronic pain. Pain Med 2008; 9: 271-281.
39. Alicino I, Giglio M, Manca F, Bruno F, Puntillo F. Intrathecal combination of ziconotide and morphine for refractory malignant pain: A rapidly acting and effective choice. Pain 2011; 153: 245-249
40. Shields D, Montenegro R, Aclan J. Chemical stability of an admixture combining Ziconotide and Bupivacaine during simulated intrathecal administration. Neuromudulation 2007; 10: 1-5.
41. Wallace M S, Charapata SG, Fisher R, Byas-Smith M,Staats PS, Mayo M, McGuire D, Ellis D. Intrathecal Ziconotide in the Treatment of Chronic Nonmalignant Pain: A Randomized, DoubleBlind, Placebo-Controlled Clinical Trial. Neuromodulation 2006; 9:75 -86.
42. Wang YX, Gao D, Pettus M, Phillips C, Bowersox SS. Interactions of intrathecally administered ziconotide, a selective blocker of neuronal N-type voltagesensitive calcium channels, with morphine on nociception in rats. Pain 2000; 84: 271-281.
43. Wang, YX, Pettus M, Gao D, Phillips C, Scott Bowersox S. Effects of intrathecal administration of ziconotide, a selective neuronal N-type calcium channel blocker, on mechanical allodynia and heat hyperalgesia in a rat model of postoperative pain. Pain 2000; 84: 151-158.