Nasim Tabrizi1, Ashraf Zarvani2, Parisa Rezaei2, Hamed Cheraghmakani2, Reza Alizadeh-Navaei3. 1. Neurology department, Mazandaran University of medical sciences, Sari, Iran. Electronic address: nasimtabrizi@gmail.com. 2. Neurology department, Mazandaran University of medical sciences, Sari, Iran. 3. Gastrointestinal Cancer Research Center, Mazandaran University of Medical Sciences, Sari, Iran.
Abstract
PURPOSE: To compare the efficacy and tolerability of levetiracetam (LEV) versus valproate (VPA) monotherapy in adults with genetic generalized tonic-clonic seizures alone (GTCS) and juvenile myoclonic epilepsy (JME). METHODS: This study was an open-label, active-controlled trial with a two-parallel-group design. Outcome measures including withdrawal rate and seizure freedom rate at 26th weeks and time to withdrawal, and time to first seizure were compared between LEV and VPA groups. Furthermore, tolerability and development of adverse events (AEs) were investigated and analyzed. RESULTS:One hundred and three patients enrolled the study. 71.1% of patients in LEV group and 29.3% in VPA group were female. By the end of 26th week, seizure freedom rate and withdrawal rate were 88.9% and 8.9% in LEV group and 86.2% and 10.3% in VPA group with no significant difference. Time to first seizure was longer in VPA group (p = 0.32) and time to withdrawal favored LEV (p = 0.51). At least one AE was reported in 37.7% of patients in LEV group and 55.1% in VPA group. The most common AEs were psychiatric symptoms and dizziness in those on LEV and weight gain and dyspepsia in VPA group. CONCLUSION:LEV has similar efficacy and acceptable safety in comparison to VPA in short-term treatment of patients with genetic GTCS and JME, and it could be considered as an alternative to VPA particularly in women of reproductive age.
RCT Entities:
PURPOSE: To compare the efficacy and tolerability of levetiracetam (LEV) versus valproate (VPA) monotherapy in adults with genetic generalized tonic-clonic seizures alone (GTCS) and juvenile myoclonic epilepsy (JME). METHODS: This study was an open-label, active-controlled trial with a two-parallel-group design. Outcome measures including withdrawal rate and seizure freedom rate at 26th weeks and time to withdrawal, and time to first seizure were compared between LEV and VPA groups. Furthermore, tolerability and development of adverse events (AEs) were investigated and analyzed. RESULTS: One hundred and three patients enrolled the study. 71.1% of patients in LEV group and 29.3% in VPA group were female. By the end of 26th week, seizure freedom rate and withdrawal rate were 88.9% and 8.9% in LEV group and 86.2% and 10.3% in VPA group with no significant difference. Time to first seizure was longer in VPA group (p = 0.32) and time to withdrawal favored LEV (p = 0.51). At least one AE was reported in 37.7% of patients in LEV group and 55.1% in VPA group. The most common AEs were psychiatric symptoms and dizziness in those on LEV and weight gain and dyspepsia in VPA group. CONCLUSION:LEV has similar efficacy and acceptable safety in comparison to VPA in short-term treatment of patients with genetic GTCS and JME, and it could be considered as an alternative to VPA particularly in women of reproductive age.