R C Mundlamuri1, S Sinha2, D K Subbakrishna3, P V Prathyusha3, M Nagappa1, P S Bindu1, A B Taly1, G S Umamaheswara Rao4, P Satishchandra1. 1. Department of Neurology, National Institute of Mental Health and NeuroSciences (NIMHANS), Bangalore, India. 2. Department of Neurology, National Institute of Mental Health and NeuroSciences (NIMHANS), Bangalore, India. Electronic address: sanjib_sinha2004@yahoo.co.in. 3. Department of Biostatistics, National Institute of Mental Health and NeuroSciences (NIMHANS), Bangalore, India. 4. Department of Neuroanesthesia, National Institute of Mental Health and NeuroSciences (NIMHANS), Bangalore, India.
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. SIGNIFICANCE: 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.
RCT Entities:
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. SIGNIFICANCE: 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: Aatif M Husain; Jong W Lee; Bradley J Kolls; Lawrence J Hirsch; Jonathan J Halford; Puneet K Gupta; Yafa Minazad; Jennifer M Jones; Suzette M LaRoche; Susan T Herman; Christa B Swisher; Saurabh R Sinha; Adriana Palade; Keith E Dombrowski; William B Gallentine; Cecil D Hahn; Elizabeth E Gerard; Manjushri Bhapkar; Yuliya Lokhnygina; M Brandon Westover Journal: Ann Neurol Date: 2018-06 Impact factor: 10.422
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