Background: Intrathecal ziconotide is used to manage severe chronic pain. Although ziconotide
is approved by the US Food and Drug Administration for monotherapy, it is sometimes used in
combination with other intrathecal drugs for the management of intractable pain conditions in
clinical 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 inadequate
analgesia with intrathecal opioid therapy (with or without intrathecal adjuvants) and who had
ziconotide added to their intrathecal regimens were included. Patient characteristics, intrathecal
ziconotide doses, concomitant intrathecal and systemic drug use, visual analog scale pain scores,
Oswestry Disability Index scores, mini-mental status examination scores, neurological examination
results, clinical observations (including adverse event reports), and equipment complications were
reviewed for 12 weeks after ziconotide initiation.
Results: Sixteen patients were identified. Ziconotide was initiated at a dose of 0.5 mcg/d and
titrated 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 treatment
was 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%) and
increased 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 ziconotide
and opioid therapy may be a safe and potentially effective treatment option for patients with
refractory chronic pain. Controlled, prospective clinical trials to evaluate ziconotide combination
therapy are needed.
Key words: Ziconotide, intrathecal, chronic pain, opioids, combination therapy, nonopioid
analgesic
Developments in managing severe chronic pain: role of oxycodone–naloxone extended release
