title: Management of generalised convulsive status epilepticus (SE): A prospective randomised controlled study of combined treatment with intravenous lorazepam with either phenytoin, sodium valproate or levetiracetam--Pilot study.
abstract: OBJECTIVE
  This study was conducted to compare the efficacy of phenytoin, valproate and levetiracetam in patients with GCSE.
  
  
  METHODS
  This randomised controlled prospective study was conducted on 150 patients to compare the efficacy of phenytoin (n = 50), valproate (n = 50) and levetiracetam (n = 50) along with lorazepam in patients with GCSE. All recruited patients received i.v. lorazepam (0.1mg/kg) followed by one of the 3 AEDs viz. phenytoin (20 mg/kg), valproate (30 mg/kg), and levetiracetam (25 mg/kg). Those who remained uncontrolled with 1st AED, received the other two AEDs sequentially. Clinical, imaging, EEG, etiological factors were analysed. Predictors of poor seizure control and outcome at discharge and at one month follow-up were assessed.
  
  
  RESULTS
  In the phenytoin subgroup, the seizures could be controlled in 34 (68%) with lorazepam+phenytoin infusion. In the valproate subgroup (n = 50), seizures could be controlled in 34 (68%) with lorazepam+valproate infusion. In the levetiracetam subgroup (n = 50), seizures could be controlled in 39 (78%) with lorazepam+levetiracetam infusion. There was no statistically significant difference between the subgroups (p = 0.44). Overall, following lorazepam and 1st AED, 107/150 (71.3%) were controlled; with addition of 2nd AED, 130/150 (86.7%) and by adding 3rd AED, 138/150 (92%) were controlled. Fifteen out of 110 (13.6%) expired within 1 month of SE: phenytoin-6; valproate-4; and levetiracetam-5. Interestingly, 3 patients in the levetiracetam had post-ictal psychosis.
  
  
  CONCLUSIONS
  Phenytoin, valproate, and levetiracetam are safe and equally efficacious following lorazepam in GCSE. The choice of AEDs could be individualised based on co-morbidities. SE could be controlled in 92% of patients with AEDs only and anaesthetics were not required in them.
authors.affiliation: Department of Neurology, National Institute of Mental Health and NeuroSciences (NIMHANS), Bangalore, India.
authors.forename: R C
authors.initials: RC
authors.lastname: Mundlamuri
authors.affiliation: Department of Neurology, National Institute of Mental Health and NeuroSciences (NIMHANS), Bangalore, India. Electronic address: sanjib_sinha2004@yahoo.co.in.
authors.forename: S
authors.initials: S
authors.lastname: Sinha
authors.affiliation: Department of Biostatistics, National Institute of Mental Health and NeuroSciences (NIMHANS), Bangalore, India.
authors.forename: D K
authors.initials: DK
authors.lastname: Subbakrishna
authors.affiliation: Department of Biostatistics, National Institute of Mental Health and NeuroSciences (NIMHANS), Bangalore, India.
authors.forename: P V
authors.initials: PV
authors.lastname: Prathyusha
authors.affiliation: Department of Neurology, National Institute of Mental Health and NeuroSciences (NIMHANS), Bangalore, India.
authors.forename: M
authors.initials: M
authors.lastname: Nagappa
authors.affiliation: Department of Neurology, National Institute of Mental Health and NeuroSciences (NIMHANS), Bangalore, India.
authors.forename: P S
authors.initials: PS
authors.lastname: Bindu
authors.affiliation: Department of Neurology, National Institute of Mental Health and NeuroSciences (NIMHANS), Bangalore, India.
authors.forename: A B
authors.initials: AB
authors.lastname: Taly
authors.affiliation: Department of Neuroanesthesia, National Institute of Mental Health and NeuroSciences (NIMHANS), Bangalore, India.
authors.forename: G S
authors.initials: GS
authors.lastname: Umamaheswara Rao
authors.affiliation: Department of Neurology, National Institute of Mental Health and NeuroSciences (NIMHANS), Bangalore, India.
authors.forename: P
authors.initials: P
authors.lastname: Satishchandra
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D004569:Electroencephalography; D004829:Epilepsy, Generalized / Q000188:drug therapy / Q000503:physiopathology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007275:Injections, Intravenous; D000077287:Levetiracetam; D008140:Lorazepam / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010672:Phenytoin / Q000009:adverse effects / Q000627:therapeutic use; D010865:Pilot Projects; D010889:Piracetam / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D011379:Prognosis; D011446:Prospective Studies; D013226:Status Epilepticus / Q000188:drug therapy*; D016896:Treatment Outcome; D014635:Valproic Acid / Q000009:adverse effects / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D000927:Anticonvulsants; D000077287:Levetiracetam; D014635:Valproic Acid; D010672:Phenytoin; D008140:Lorazepam; D010889:Piracetam
keywords: Efficacy of AEDs; GCSE; Levetiracetam; Phenytoin; Status epilepticus; Valproate