Tags

Type your tag names separated by a space and hit enter

Open-label, multicenter study of combined intrathecal morphine and ziconotide: addition of morphine in patients receiving ziconotide for severe chronic pain.
Pain Med. 2008 Apr; 9(3):282-90.PM

Abstract

OBJECTIVE

To assess the safety and efficacy of adding intrathecal morphine to intrathecal ziconotide in patients treated with stable ziconotide doses.

DESIGN

Multicenter, open-label study with a 4-week morphine titration phase during which ziconotide was held constant and an extension phase during which dosing of either drug could vary.

SETTING

Outpatient clinics.

PATIENTS

Patients with suboptimal pain relief receiving stable ziconotide doses (> or = 4.8 microg/day) in one of two ongoing ziconotide trials.

INTERVENTIONS

Ziconotide dosing remained constant during the titration phase; intrathecal morphine titration was based on each patient's daily systemic opioid dose at the study's start. During the extension phase, intrathecal ziconotide and morphine dosing were adjusted per investigator discretion.

OUTCOME MEASURES

Safety was assessed primarily via adverse events. Efficacy was analyzed via percentage change on the visual analog scale of pain intensity and in weekly systemic opioid consumption.

RESULTS

Twenty-five patients enrolled. The most common (> or = 10% of patients in either study phase) study drug-related (i.e., ziconotide/morphine combination [or ziconotide monotherapy in the extension phase only]) treatment-emergent adverse events included dizziness, peripheral edema, pruritus, and nausea. From the initial visit to week 4, visual analog scale of pain intensity scores improved by a mean of 26.3% (95% confidence interval: 15.6%-37.1%) but varied during the extension phase (mean percentage change from the initial visit ranged from -0.4% at week 16 to -35.0% at week 72). Mean percentage decrease in systemic opioid consumption from the initial visit was 49.1% at week 4 and 51.2% at week 56 of the extension phase.

CONCLUSIONS

Intrathecal morphine, combined with stable intrathecal ziconotide doses, reduced pain in patients with previously suboptimal pain relief on ziconotide monotherapy.

Authors+Show Affiliations

Lifetree Clinical Research and Pain Clinic, Salt Lake City, Utah, USA. lynnw@lifetreepain.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

18366508

Citation

Webster, Lynn R., et al. "Open-label, Multicenter Study of Combined Intrathecal Morphine and Ziconotide: Addition of Morphine in Patients Receiving Ziconotide for Severe Chronic Pain." Pain Medicine (Malden, Mass.), vol. 9, no. 3, 2008, pp. 282-90.
Webster LR, Fakata KL, Charapata S, et al. 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(3):282-90.
Webster, L. R., Fakata, K. L., Charapata, S., Fisher, R., & MineHart, M. (2008). Open-label, multicenter study of combined intrathecal morphine and ziconotide: addition of morphine in patients receiving ziconotide for severe chronic pain. Pain Medicine (Malden, Mass.), 9(3), 282-90. https://doi.org/10.1111/j.1526-4637.2007.00356.x
Webster LR, et al. 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(3):282-90. PubMed PMID: 18366508.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Open-label, multicenter study of combined intrathecal morphine and ziconotide: addition of morphine in patients receiving ziconotide for severe chronic pain. AU - Webster,Lynn R, AU - Fakata,Keri L, AU - Charapata,Steven, AU - Fisher,Robert, AU - MineHart,Michael, PY - 2008/3/28/pubmed PY - 2008/6/25/medline PY - 2008/3/28/entrez SP - 282 EP - 90 JF - Pain medicine (Malden, Mass.) JO - Pain Med VL - 9 IS - 3 N2 - OBJECTIVE: To assess the safety and efficacy of adding intrathecal morphine to intrathecal ziconotide in patients treated with stable ziconotide doses. DESIGN: Multicenter, open-label study with a 4-week morphine titration phase during which ziconotide was held constant and an extension phase during which dosing of either drug could vary. SETTING: Outpatient clinics. PATIENTS: Patients with suboptimal pain relief receiving stable ziconotide doses (> or = 4.8 microg/day) in one of two ongoing ziconotide trials. INTERVENTIONS: Ziconotide dosing remained constant during the titration phase; intrathecal morphine titration was based on each patient's daily systemic opioid dose at the study's start. During the extension phase, intrathecal ziconotide and morphine dosing were adjusted per investigator discretion. OUTCOME MEASURES: Safety was assessed primarily via adverse events. Efficacy was analyzed via percentage change on the visual analog scale of pain intensity and in weekly systemic opioid consumption. RESULTS: Twenty-five patients enrolled. The most common (> or = 10% of patients in either study phase) study drug-related (i.e., ziconotide/morphine combination [or ziconotide monotherapy in the extension phase only]) treatment-emergent adverse events included dizziness, peripheral edema, pruritus, and nausea. From the initial visit to week 4, visual analog scale of pain intensity scores improved by a mean of 26.3% (95% confidence interval: 15.6%-37.1%) but varied during the extension phase (mean percentage change from the initial visit ranged from -0.4% at week 16 to -35.0% at week 72). Mean percentage decrease in systemic opioid consumption from the initial visit was 49.1% at week 4 and 51.2% at week 56 of the extension phase. CONCLUSIONS: Intrathecal morphine, combined with stable intrathecal ziconotide doses, reduced pain in patients with previously suboptimal pain relief on ziconotide monotherapy. SN - 1526-4637 UR - https://www.unboundmedicine.com/medline/citation/18366508/Open_label_multicenter_study_of_combined_intrathecal_morphine_and_ziconotide:_addition_of_morphine_in_patients_receiving_ziconotide_for_severe_chronic_pain_ DB - PRIME DP - Unbound Medicine ER -