Switching the manufacturer of antiepileptic drugs is associated with higher risk of seizures: A nationwide study of prescription data in Germany

Autor: Tamara Müller, Stephanie Gollwitzer, Karel Kostev, Johannes Lang, David G. Olmes, Wolfgang Graf, Hajo M. Hamer, Müjgan Dogan Onugoren
Rok vydání: 2018
Předmět:
Zdroj: Annals of Neurology. 84:918-925
ISSN: 0364-5134
Popis: OBJECTIVE Despite bioequivalence, the exchangeability of antiepileptic drugs in clinical settings is disputed. Therefore, we investigated the risk for recurrent seizures after switching the manufacturer of the same drug in a large German cohort. METHODS Anonymous patient data from practice neurologists throughout Germany between 2011 and 2016 were collected using the IMS Disease Analyzer database (QuintilesIMS, Frankfurt, Germany). People 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 physician. The risk for breakthrough seizures after a manufacturer switch of the same antiepileptic drug was analyzed using multivariate regression models. RESULTS A total of 3,530 people with epilepsy were included (each group, n = 1,765; age = 53.7 ± 19.8 years). Patients with seizures had switched the drug manufacturer more often than controls (26.8% vs 14.2%; odds ratio [OR] = 1.35, 95% confidence interval [CI] = 1.08-1.69, p = 0.009), both from branded to generic (5.5% vs 2.4%; OR = 1.85, 95% CI = 1.30-2.64, p
Databáze: OpenAIRE
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