Clinical Trials for the Use of Anti-Epileptic Drugs in SE
Author | Design/Sample | Intervention and Comparison | Outcome |
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, 2017 | ObservativeN=63 | IV Leviteracetam 1000mg infused over 30 minutesVsFosphenytoin 22.5 mg/kg | No 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, 1998 | Prospective, Randomized, Non-blindedN=36 | IV Diazepam 2 mg/min up to 20 mg + IV Phenytoin, up to 18 mg/kgVsPhenobarbital 10 mg/kg | Phenobarbital 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/kg | IV 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/kg | IV 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, 2015 | RCTN=150 | IV Valproic Acid30 mg/kgVsIV Leviteracetam25 mg/kgVsIV Phenytoin20 mg/kg | No statistically significant difference for control of SE |
Kapur et al, 2019 | Randomized, 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
- IV Phenytoin and IV Leviteracetam show no significant difference in terms of seizure cessation but IV Phenytoin showed more adverse effects
- 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
- IV Leviteracetam shows more adverse effects but is equally effective with IV Valproic Acid and IV Fosphenytoin
- Despite the less frequent usage due to its long half-life, Phenobarbital is as effective as IV Diazepam + IV Phenytoin