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Lesson 9 of 13
In Progress

Clinical Trials for the Use of Anti-Epileptic Drugs in SE


Clinical Trials for the Use of Anti-Epileptic Drugs in SE

AuthorDesign/SampleIntervention and ComparisonOutcome
Chakravathi et al, 2015
Prospective, Randomized, Open-LabelN=44

IV Leviteracetam 20 mg/kg infused at 100 mg/mgVsIV Phenytoin 20 mg/kg infused over 30 minutes; max rate 50 mg/min
No difference in seizure termination or seizure recurrence
More adverse effects in Phenytoin
Guijjar et al, 2017
Prospective, Randomized, Open-LabelN= 52

IV Leviteracetam 20 mg/kg infused over 30 minutesVsIV Phenytoin 20 mg/kg infused over 30 minutes
No difference in seizure termination or outcome at discharge
Less severe adverse effects in IV Leviteracetam group
Nakamura et al, 2017ObservativeN=63IV Leviteracetam 1000mg infused over 30 minutesVsFosphenytoin 22.5 mg/kgNo difference in seizure cessation, adverse effects
Dalziel et al, 2019
Prospective, Randomized, Open-LabelN= 52

IV or IO Leviteracetam 40 mg/kg over 5 minutesVsIV or IO Phenytoin 20 mg/kg over 20 minutes
No difference in seizure termination or seizure recurrence
Lyttle et al, 2019
Prospective, Randomized, Open-LabelN= 286

IV Leviteracetam 40 mg/kg over 5 minutesVsIV Phenytoin 20 mg/kg over 20 minutes
No difference in time to seizure cessation
Shaner et al, 1998Prospective, Randomized, Non-blindedN=36IV Diazepam 2 mg/min up to 20 mg + IV Phenytoin, up to 18 mg/kgVsPhenobarbital 10 mg/kgPhenobarbital is as effective as IV Diazepam + IV Phenytoin
Misra et al, 2006
Prospective, Randomized Pilot Study, used as first-lie and second-line AEDN=68
IV Pheytoin 18 mg/kgVsIV Valproic Acid30 mg/kgIV Valproic  Acid is more effective than IV Phenytoin
Agarwal et al, 2007
Prospective, Randomized, Non-blinded, Refractory to IV DiazepamN=100
IV Pheytoin 20 mg/kgVsIV Valproic Acid20 mg/kgIV Valproic Acid is equivalent to IV Phenytoin


Gilad et al, 2008


Prospective, Randomized, Without prior Benzodiazepine AdministrationN=74


IV Pheytoin 18 mg/kgVsIV Valproic Acid30 mg/kg


IV Valproic Acid is equivalent to IV Phenytoin
Alvarez et al, 2011
Retrospective, Non-randomized, Refractory to BenzodiazepinesN=187

IV Pheytoin 20 mg/kgVsIV Leviteracetam20 mg/kg

IV Leviteracetam is less effective than IV Valproic Acid
No significant difference between IV Valproic Acid and IV Phenytoin
Misra et al, 2012
Prospective, Randomized, Open-Label Pilot StudyN=79

IV Leviteracetam20 mg/kgVsIV Lorazepammg/kg
IV Leviteracetam is equivalent to IV Lorazepam
Mundlamuri, 2015RCTN=150
IV Valproic Acid30 mg/kgVsIV Leviteracetam25 mg/kgVsIV Phenytoin20 mg/kg
No statistically significant difference for control of SE
Kapur et al, 2019Randomized, Double-blind, Adaptive Comparative Effectiveness TrialN=400
IV Leviteracetam 60 mg/kg, max dose 4500mgVsIV Fosphenytoin 20 mgPE/kg, max dose 1500 mgPEVsIV Valproate 40 mg/kg, max dose 3000mg
No significant difference in seizure cessation among the AED group
Hypotension and Endotracheal intubation were more frequent with IV Leviteracetam

Conclusions

  1. IV Phenytoin and IV Leviteracetam show no significant difference in terms of seizure cessation but IV Phenytoin showed more adverse effects
  2. Some studies show IV Valproic Acid to be better than IV Phenytoin but some conclude both drugs to have no significant difference as an AED drug for SE
  3. IV Leviteracetam shows more adverse effects but is equally effective with IV Valproic Acid and IV Fosphenytoin
  4. Despite the less frequent usage due to its long half-life, Phenobarbital is as effective as IV Diazepam + IV Phenytoin