Comparison of Efficacy and Safety of Generic and Original Levetiracetam in the Treatment of Epilepsy in Children
OBJECTIVE:To investigate the clinical outcomes of generic and original Levetiracetam tablets and the switching in children with epilepsy during hospitalization,so as to explore the switching and switching-back of generic and original Levetiracetam tablets in outpatient setting.METHODS:Retrospective cohort study was performed on 125 children with epilepsy admitted into the hospital and received 250 mg of Levetiracetam tablets from Jan.2020 to Jun.2022.The reduction rates of seizure frequency of children using generic and originator drugs were calculated,the characteristics of children who switched generic and original Levetiracetam tablets were summarized and analyzed,further follow-up was conducted on the switching and switching-back of original drugs in outpatient.RESULTS:Among the 125 children with epilepsy,the epilepsy control rate was 87.50％(63/72)in the original drug group and 83.02％(44/53)in the generic drug group,the difference was not statistically significant(P＞0.05),while the increase of number of drug combination would decrease the epilepsy control rate(OR=0.333,95％CI=0.114-0.969,P=0.044).Four reports of adverse drug reactions were all from patients received monotherapy in the original drug group,which were respectively emotional lability(2 cases)and rash(2 cases).Fourteen cases of the enrolled children had variety switching between original and generic drugs,the number of hospital admissions(OR=2.7,95％CI=1.506-4.791,P=0.001)and epilepsy control(OR=0.07,95％CI=0.009-0.555,P=0.012)were correlated with the drug variety switching when controlling gender,age and treatment characteristics.During outpatient follow-up,the cumulative switching rate was 50.05％and the corrected cumulative switching-back rate was 20.29％of the original drugs.CONCLUSIONS:There are no differences in efficacy and safety between original and generic Levetiracetam tablets in children with epilepsy in this study cohort,the drug variety switching occurs more frequently under increased hospital admissions and uncontrolled epilepsy.Despite the popularization of generic drugs in outpatient setting,there is still a fixed population using original drugs.
Original drugsGeneric drugsLevetiracetam tabletsChildren with epilepsyEfficacySafety
万方数据
维普
