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Randomized trial of lacosamide versus fosphenytoin for nonconvulsive seizures.

Publication ,  Journal Article
Husain, AM; Lee, JW; Kolls, BJ; Hirsch, LJ; Halford, JJ; Gupta, PK; Minazad, Y; Jones, JM; LaRoche, SM; Herman, ST; Swisher, CB; Sinha, SR ...
Published in: Ann Neurol
June 2018

OBJECTIVE: The optimal treatment of nonconvulsive seizures in critically ill patients is uncertain. We evaluated the comparative effectiveness of the antiseizure drugs lacosamide (LCM) and fosphenytoin (fPHT) in this population. METHODS: The TRENdS (Treatment of Recurrent Electrographic Nonconvulsive Seizures) study was a noninferiority, prospective, multicenter, randomized treatment trial of patients diagnosed with nonconvulsive seizures (NCSs) by continuous electroencephalography (cEEG). Treatment was randomized to intravenous (IV) LCM 400mg or IV fPHT 20mg phenytoin equivalents/kg. The primary endpoint was absence of electrographic seizures for 24 hours as determined by 1 blinded EEG reviewer. The frequency with which NCS control was achieved in each arm was compared, and the 90% confidence interval (CI) was determined. Noninferiority of LCM to fPHT was to be concluded if the lower bound of the CI for relative risk was >0.8. RESULTS: Seventy-four subjects were enrolled (37 LCM, 37 fPHT) between August 21, 2012 and December 20, 2013. The mean age was 63.6 years; 38 were women. Seizures were controlled in 19 of 30 (63.3%) subjects in the LCM arm and 16 of 32 (50%) subjects in the fPHT arm. LCM was noninferior to fPHT (p = 0.02), with a risk ratio of 1.27 (90% CI = 0.88-1.83). Treatment emergent adverse events (TEAEs) were similar in both arms, occurring in 9 of 35 (25.7%) LCM and 9 of 37 (24.3%) fPHT subjects (p = 1.0). INTERPRETATION: LCM was noninferior to fPHT in controlling NCS, and TEAEs were comparable. LCM can be considered an alternative to fPHT in the treatment of NCSs detected on cEEG. Ann Neurol 2018;83:1174-1185.

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Published In

Ann Neurol

DOI

EISSN

1531-8249

Publication Date

June 2018

Volume

83

Issue

6

Start / End Page

1174 / 1185

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Single-Blind Method
  • Prospective Studies
  • Phenytoin
  • Neurology & Neurosurgery
  • Middle Aged
  • Male
  • Lacosamide
  • Humans
  • Glasgow Coma Scale
 

Citation

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Husain, A. M., Lee, J. W., Kolls, B. J., Hirsch, L. J., Halford, J. J., Gupta, P. K., … Critical Care EEG Monitoring Research Consortium, . (2018). Randomized trial of lacosamide versus fosphenytoin for nonconvulsive seizures. Ann Neurol, 83(6), 1174–1185. https://doi.org/10.1002/ana.25249
Husain, Aatif M., Jong W. Lee, Bradley J. Kolls, Lawrence J. Hirsch, Jonathan J. Halford, Puneet K. Gupta, Yafa Minazad, et al. “Randomized trial of lacosamide versus fosphenytoin for nonconvulsive seizures.Ann Neurol 83, no. 6 (June 2018): 1174–85. https://doi.org/10.1002/ana.25249.
Husain AM, Lee JW, Kolls BJ, Hirsch LJ, Halford JJ, Gupta PK, et al. Randomized trial of lacosamide versus fosphenytoin for nonconvulsive seizures. Ann Neurol. 2018 Jun;83(6):1174–85.
Husain, Aatif M., et al. “Randomized trial of lacosamide versus fosphenytoin for nonconvulsive seizures.Ann Neurol, vol. 83, no. 6, June 2018, pp. 1174–85. Pubmed, doi:10.1002/ana.25249.
Husain AM, Lee JW, Kolls BJ, Hirsch LJ, Halford JJ, Gupta PK, Minazad Y, Jones JM, LaRoche SM, Herman ST, Swisher CB, Sinha SR, Palade A, Dombrowski KE, Gallentine WB, Hahn CD, Gerard EE, Bhapkar M, Lokhnygina Y, Westover MB, Critical Care EEG Monitoring Research Consortium. Randomized trial of lacosamide versus fosphenytoin for nonconvulsive seizures. Ann Neurol. 2018 Jun;83(6):1174–1185.
Journal cover image

Published In

Ann Neurol

DOI

EISSN

1531-8249

Publication Date

June 2018

Volume

83

Issue

6

Start / End Page

1174 / 1185

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Single-Blind Method
  • Prospective Studies
  • Phenytoin
  • Neurology & Neurosurgery
  • Middle Aged
  • Male
  • Lacosamide
  • Humans
  • Glasgow Coma Scale