OBJECTIVES: To study the efficacy and safety of domestic generic levetiracetam in replacement of brand-name levetiracetam in the treatment of children with epilepsy. METHODS: A retrospective analysis was performed on the medical data of 154 children with epilepsy who received domestic generic levetiracetam in the inpatient or outpatient service of Guangdong Provincial People's Hospital from May 2019 to December 2020. Domestic generic levetiracetam and brand-name levetiracetam were compared in terms of efficacy and safety. RESULTS: For these 154 children, the epilepsy control rate was 77.3% (119/154) at baseline. At 6 months after switching to domestic generic levetiracetam, the epilepsy control rate reached 83.8% (129/154), which showed a significant increase (P<0.05). There was no significant change in the frequency of seizures from baseline to 6 months after switching (P>0.05). The incidence of refractory epilepsy in children with no response after switching treatment was significantly higher than that in children with response (P<0.05). Before switching, only 1 child (0.6%) experienced somnolence, while after switching, 3 children (1.9%) experienced mild adverse drug reactions, including dizziness, somnolence, irritability, and bad temper. CONCLUSIONS: Switching from brand-name to generic levetiracetam is safe and effective and holds promise for clinical application, but more prospective randomized controlled trials are required in future.
OBJECTIVES: To study the efficacy and safety of domestic generic levetiracetam in replacement of brand-name levetiracetam in the treatment of children with epilepsy. METHODS: A retrospective analysis was performed on the medical data of 154 children with epilepsy who received domestic generic levetiracetam in the inpatient or outpatient service of Guangdong Provincial People's Hospital from May 2019 to December 2020. Domestic generic levetiracetam and brand-name levetiracetam were compared in terms of efficacy and safety. RESULTS: For these 154 children, the epilepsy control rate was 77.3% (119/154) at baseline. At 6 months after switching to domestic generic levetiracetam, the epilepsy control rate reached 83.8% (129/154), which showed a significant increase (P<0.05). There was no significant change in the frequency of seizures from baseline to 6 months after switching (P>0.05). The incidence of refractory epilepsy in children with no response after switching treatment was significantly higher than that in children with response (P<0.05). Before switching, only 1 child (0.6%) experienced somnolence, while after switching, 3 children (1.9%) experienced mild adverse drug reactions, including dizziness, somnolence, irritability, and bad temper. CONCLUSIONS: Switching from brand-name to generic levetiracetam is safe and effective and holds promise for clinical application, but more prospective randomized controlled trials are required in future.
Authors: Michael D Privitera; Timothy E Welty; Barry E Gidal; Francisco J Diaz; Ron Krebill; Jerzy P Szaflarski; Barbara A Dworetzky; John R Pollard; Edmund J Elder; Wenlei Jiang; Xiaohui Jiang; Michel Berg Journal: Lancet Neurol Date: 2016-02-12 Impact factor: 44.182
Authors: Katrin Hensler; Carmen Uhlmann; Thomas Porschen; Reiner Benecke; Johannes Rösche Journal: Epilepsy Behav Date: 2013-02-14 Impact factor: 2.937
Authors: M Trimboli; E Russo; L Mumoli; G Tripepi; F Fortunato; G Mastroianni; F Abate; G De Sarro; A Gambardella; A Labate Journal: Eur J Neurol Date: 2018-02-01 Impact factor: 6.089
Authors: Martina Fanella; Alessandra Morano; Jinane Fattouch; Mariarita Albini; Luca M Basili; Sara Casciato; Mario Manfredi; Anna T Giallonardo; Carlo Di Bonaventura Journal: Clin Neuropharmacol Date: 2017 Nov/Dec Impact factor: 1.592