Brand-to-generic levetiracetam switch in patients with epilepsy in a routine clinical setting.

摘要: Abstract Purpose The therapeutic equivalence of generic and brand antiepileptic drugs, based on studies performed healthy volunteers, has been questioned. We compare, in a routine clinical setting, versus levetiracetam (LEV) bioequivalence patients with epilepsy also the efficacy tolerability substitution. Methods A prospective, open-label, non-randomized, steady-state, multiple-dose, study was conducted 12 (5 females), mean age 38.4±16.2 years. Patients treated LEV (Keppra; UCB Pharma) were closely followed for four-week period subsequently switched to (Pharmaten) another period. Blood samples collected at end each 4-week period, during dose interval formulation, concentration measurements by liquid chromatography mass spectrometry. Steady-state area under curve (AUC) peak plasma (Cmax) data subjected conventional average analysis. Secondary outcomes, including seizure frequency adverse events, recorded. Results had 14.1±10.6years daily 2583.3±763.7mg. AUC±SD Cmax±SD 288.4±86.3(mg/L)h 37.8±10.4mg/L respectively 319.2±104.7(mg/L)h 41.6±12.3mg/L LEV. Statistic analysis showed no statistical significant difference bioequivalence. Also, change seizures and/or events Conclusions In our determined be bioequivalent Furthermore, or/and not affected upon switching from