Abstract Objective 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.
LIANG Ming-Juan,QIU Wei-Feng,ZHANG Jing-Wen et al. Efficacy and safety of switching from brand-name to domestic generic levetiracetam in children with epilepsy[J]. CJCP, 2022, 24(3): 285-289.
LIANG Ming-Juan,QIU Wei-Feng,ZHANG Jing-Wen et al. Efficacy and safety of switching from brand-name to domestic generic levetiracetam in children with epilepsy[J]. CJCP, 2022, 24(3): 285-289.
Perucca E, Albani F, Capovilla G, et al. Recommendations of the Italian League against Epilepsy working group on generic products of antiepileptic drugs[J]. Epilepsia, 2006, 47 Suppl 5: 16-20. PMID: 17239100. DOI: 10.1111/j.1528-1167.2006.00871.x.
Hensler K, Uhlmann C, Porschen T, et al. Generic substitution of antiepileptic drugs—a survey of patients' perspectives in Germany and other German-speaking countries[J]. Epilepsy Behav, 2013, 27(1): 135-139. PMID: 23416284. DOI: 10.1016/j.yebeh.2012.12.029.
Fitzgerald CL, Jacobson MP. Generic substitution of levetiracetam resulting in increased incidence of breakthrough seizures[J]. Ann Pharmacother, 2011, 45(5): e27. PMID: 21521860. DOI: 10.1345/aph.1P765.
Lang JD, Kostev K, Onugoren MD, et al. Switching the manufacturer of antiepileptic drugs is associated with higher risk of seizures: a nationwide study of prescription data in Germany[J]. Ann Neurol, 2018, 84(6): 918-925. PMID: 30298621. DOI: 10.1002/ana.25353.
Privitera MD, Welty TE, Gidal BE, et al. Generic-to-generic lamotrigine switches in people with epilepsy: the randomised controlled EQUIGEN trial[J]. Lancet Neurol, 2016, 15(4): 365-372. PMID: 26875743. DOI: 10.1016/S1474-4422(16)00014-4.
16 Medicines and Healthcare products Regulatory Agency. Antiepileptic drugs: new advice on switching between different manufacturers' products for a particular drug[EB/OL]. (2014-12-11)[2020-10-07]. https://www.gov.uk/drug-safety-update/antiepileptic-drugs-new-advice-on-switching-between-different-manufacturers-products-for-a-particular-drug.
Reimers A, Olsson P, Nilsson J, et al. Impact of generic substitution on levetiracetam serum concentration—a prospective study in an outpatient setting[J]. Epilepsy Res, 2017, 134: 54-61. PMID: 28595756. DOI: 10.1016/j.eplepsyres.2017.04.017.
Trimboli M, Russo E, Mumoli L, et al. Brand-to-generic levetiracetam switching: a 4-year prospective observational real-life study[J]. Eur J Neurol, 2018, 25(4): 666-671. PMID: 29322654. DOI: 10.1111/ene.13568.
Vari MS, Pinto F, Mencaroni E, et al. Safety of overnight switch from brand-name to generic levetiracetam[J]. Clin Drug Investig, 2016, 36(1): 87-91. PMID: 26507620. DOI: 10.1007/s40261-015-0351-1.
Fanella M, Morano A, Fattouch J, et al. Switch from originator to equivalent drug in the era of generic antiepileptic drugs: study of Keppra versus Epitiram clinical equivalence[J]. Clin Neuropharmacol, 2017, 40(6): 239-242. PMID: 28976412. DOI: 10.1097/WNF.0000000000000250.
Shaanxi Provincial Diagnosis and Treatment Center of Kawasaki Disease/Children's
Hospital of Shaanxi Provincial People's Hospital; Beijing Children's Hospital, Capital Medical University; Shanghai
Children's Medical Center; Children's Hospital of Shanghai Jiao Tong University; Xianyang Children's Hospital of
Shaanxi Province; Suzhou Children's Hospital, Suzhou University; Children's Hospital of Chongqing Medical University;
Expert Committee of Advanced Training for Pediatrician, China Maternal and Children's Health Association; Editorial Board of
Chinese Journal of Contemporary Pediatrics. Pediatric expert consensus on the application of glucocorticoids in Kawasaki disease[J]. CJCP, 2022, 24(3): 225-231.
