Safety and tolerance of rapidly infused Depacon® - A randomized trial in subjects with epilepsy

R. E. Ramsay, D. Cantrell, S. D. Collins, J. K. Walch, D. K. Naritoku, J. C. Cloyd, K. Sommerville

Research output: Contribution to journalArticlepeer-review

36 Scopus citations

Abstract

Background: Valproate sodium injection (Depacon®) is an intravenous form of valproate for use in absence and complex partial seizures when circumstances preclude oral administration. Certain situations may warrant larger and more rapid infusions than permitted by the original labeling. This study evaluated the safety of more rapid infusions. Methods: Subjects with epilepsy were randomized in a 2:1 ratio to receive up to 15 mg/kg of valproate sodium infused at 3.0 or 1.5 mg/kg/min. Up to four infusions were allowed within 24 h to achieve target plasma valproate concentrations of 50-100 mcg/ml. Primary safety endpoints were the changes in the 5-min and minimum post-first infusion blood pressures (BPs). Results: One hundred twelve subjects were treated, (3.0 mg/kg/min group: n=72, 1.5 mg/kg/min group: n=40). No significant treatment differences were detected for changes in the primary BP endpoints. Two subjects in the 3.0 mg/kg/min group had potentially clinically significant low systolic BP values during the study. Similar proportions of subjects in the two groups reported adverse events during or within 6 h following the first infusion. Conclusions: Valproate sodium injection dosages up to 15 mg/kg and rates of 1.5 and 3.0 mg/kg/min were well tolerated in this population.

Original languageEnglish (US)
Pages (from-to)189-201
Number of pages13
JournalEpilepsy Research
Volume52
Issue number3
DOIs
StatePublished - Jan 2003

Bibliographical note

Funding Information:
This research was supported by Abbott Laboratories. The authors would like to thank Guoliang Cao, Roger Deaton, Sandeep Dutta, PhD, Yihua Giu, and David Morris, PhD, for their technical expertise in the development and analysis of this study.

Copyright:
Copyright 2008 Elsevier B.V., All rights reserved.

Keywords

  • Epilepsy
  • Intravenous infusion
  • Safety
  • Seizures
  • Valproate

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