Abstract ID: A35
Abstract Title: Incidence of AEs in the Time Period Surrounding Ziconotide Mandatory Pump Refill
Authors: Narayana A1, Marmon T2, Ludington E3, McLennan G4
Elan Pharmaceuticals San Diego CA USA1, Elan Pharmaceuticals San Diego CA USA2, Elan Pharmaceuticals San Diego CA USA3, Elan Pharmaceuticals San Diego CA USA4
Poster Type: Poster
ABSTRACT BODY
Introduction: Ziconotide is a non-opioid analgesic administered intrathecally to treat severe chronic pain. In a double-blind, placebo-controlled clinical trial (Study ELN92045-301) the infusion pump was refilled with ziconotide on Day 14 to compensate for initial dilution, adsorption and degradation of ziconotide in the Synchromed Infusion System. To determine the impact of the pump refill at Day 14, we evaluated the incidence of adverse events (AEs) occurring immediately before and following the initial pump refill.
Methods: At the baseline visit, the pump was rinsed three times with 2 ml of study drug (25 mcg/ml) to reduce the effects of dilution and degradation of the initial dose of ziconotide as well as the effects of adsorption of ziconotide to the pump itself. To evaluate the potential effect of the first mandatory pump refill at Day 14 on the incidence of AEs, patients were contacted approximately 48 hours after the refill and assessed for AEs. The incidence of AEs occurring the day before and the day of refill was compared with the incidence of AEs occurring the first two days after refill, and with the incidence of AEs occurring the third and fourth days after refill.
Results: Within the ziconotide group, the proportions of patients with AEs before and after the refill were comparable. In the 103 ziconotide patients who had a pump refill, 23.3% had an AE on the day before or the day of the pump refill; 22.3% had an AE on the first or second day after the pump refill while 22.3% had an AE on the third or fourth day after the pump refill. Before and after the pump refill, dizziness occurred with the highest frequency in ziconotide patients (5.8% and 3.9%, respectively). The overall pattern of AEs was unchanged across the three time periods. The percentage of patients with a moderate or severe AE was slightly lower after pump refill (11.6% and 12.6%) than before the pump refill (13.6%). Three patients had a serious adverse event during the six days surrounding the pump refill, with one patient during each of the three time periods.
Conclusion: There was no notable difference in the overall incidence, pattern, severity or seriousness of AEs across ziconotide-treated patients within the time periods before and after the 14-day pump refill.
ATTACHED FILES
Reg Anesth Pain Med 2005; 30(3):A35