Open AccessIntrathecal Ziconotide and Opioid Combination Therapy for Noncancer Pain: An Observational Study
Author(s) -
Timothy R. Deer
Publication year - 2009
Publication title -
pain physician
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.31
H-Index - 99
eISSN - 2150-1149
pISSN - 1533-3159
DOI - 10.36076/ppj.2009/12/e291
Subject(s) - medicine , adverse effect , tolerability , visual analogue scale , anesthesia , opioid , hydromorphone , morphine , chronic pain , fentanyl , physical therapy , receptor
Background: Intrathecal ziconotide is used to manage severe chronic pain. Although ziconotideis approved by the US Food and Drug Administration for monotherapy, it is sometimes used incombination with other intrathecal drugs for the management of intractable pain conditions inclinical practice.Objectives: Evaluate the safety and tolerability of ziconotide combination therapy.Study Design: A retrospective, observational study.Setting: A single center.Methods: Patients with severe chronic pain of noncancer origin who were receiving inadequateanalgesia with intrathecal opioid therapy (with or without intrathecal adjuvants) and who hadziconotide added to their intrathecal regimens were included. Patient characteristics, intrathecalziconotide doses, concomitant intrathecal and systemic drug use, visual analog scale pain scores,Oswestry Disability Index scores, mini-mental status examination scores, neurological examinationresults, clinical observations (including adverse event reports), and equipment complications werereviewed for 12 weeks after ziconotide initiation.Results: Sixteen patients were identified. Ziconotide was initiated at a dose of 0.5 mcg/d andtitrated to a mean dose of 2.64 mcg/d at week 12. Intrathecal opioids were hydromorphone (n=7),morphine (n=5), fentanyl (n=3), and sufentanil (n=1). Adverse events were noted in one patient,who reported increased depression and pain during combination therapy; ziconotide treatmentwas discontinued, and all adverse events resolved over a 4-week period. Substantial pain relief(≥4-point decrease in visual analog scale score) was reported in 3 of 15 patients (20.0%) andincreased functional capacity was evident in 3 of 15 patients (20.0%).Limitations: A retrospective study with a limited number of patients from a single center.Conclusion: Results from this observational study suggest that combination intrathecal ziconotideand opioid therapy may be a safe and potentially effective treatment option for patients withrefractory chronic pain. Controlled, prospective clinical trials to evaluate ziconotide combinationtherapy are needed.Key words: Ziconotide, intrathecal, chronic pain, opioids, combination therapy, nonopioidanalgesic