Manufacturer switch of anti-seizure drugs may not increase the risk of seizure recurrence in Children: A nationwide study of prescription data in Germany.

Several publications on the exchangeability of antiepileptic drugs in clinical settings revealed an increased risk for seizure recurrence after changing the manufacturer of anti-seizure drugs (ASD) in adults, possibly due to a decline of adherence. It is unclear whether this holds true in children and adolescents. Patient data of children and adolescents (<18 years) were collected anonymously from 236 German pediatricians and pediatric neurologists between January 2011 and December 2018 using the IMS® Disease Analyzer database (IQVIA, Frankfurt, Germany). Patients with epilepsy were included if at least 2 prescriptions within 360 days and 1 within 180 days prior to the index date were available. The cohort was separated into a seizure group and seizure-free controls. Both groups were matched 1:1 according to age, gender, insurance status, and treating pediatrician. The risk for seizure recurrence after a manufacturer switch of the same ASD at the last prescription before the index date was analyzed using a multivariate regression model. A total of 678 children and adolescents with epilepsy were included (each group: n = 339; age: 9.6 ± 4.4 years). Comparing both groups, the risk for seizures recurrence was not increased after a manufacturer switch had occurred. Albeit changes during the last prescription before the index date had occurred more often in the seizure-free group, neither change of branded and generic products nor substances reached significance. Only change of ASD strength showed a significantly reduced odds ratio for seizures (OR 0.40, 95% CI 0.24-0.65, p < 0.001). In contrast to the available evidence in adults, changing the manufacturer did not appear to increase the risk for seizure recurrence in previously seizure-free children and adolescents with epilepsy.

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Déclaration de conflit d'intérêts

Declaration of Competing Interest Lang JD served on the Speakers’ Bureau of Eisai. Kostev K is an employee of IQVIA, a company that focuses on analyses of pharmacy records and runs the database used in this analysis. This study, however, was not part of any business project. Reindl C, Müller T, Stritzelberger J, and Westermayer V have nothing to declare. Gollwitzer S has served on the Scientific Advisory Board or on the Speakers’ Bureau or received grants from of Desitin, Eisai, and UCB Pharma. Trollmann R has served on the Scientific Advisory Board of Novartis, Desitin, PTC Therapeutics, and Biogen. She served on the Speakers’ Bureau of Novartis and PTC Therapeutics and received an unrestricted grant from Pfizer. Hamer HM has served on the Scientific Advisory Board of Arvelle, Bial, Desitin, Eisai, facetoface, GW, Novartis, Sandoz, and UCB Pharma. He served on the Speakers’ Bureau of or received unrestricted grants from Amgen, Ad-Tech, Bial, Bracco, Desitin, Eisai, GW, Nihon Kohden, Novartis, Pfizer, and UCB Pharma.