The ketogenic diet can be used safely in the adult and adolescent population, with a response rate similar to those seen in children. Patient with symptomatic generalized epilepsy may be particularly good candidates for this type of dietary treatment.
Aims: Recombinant PEGylated human granulocyte colony-stimulating factor (pegfilgrastim) is indicated for the reduction of chemotherapy-induced neutropenia and prevention of febrile neutropenia. Biosimilar pegfilgrastim is expected to reduce the financial burden of this complication of chemotherapy. The aim of this study was to demonstrate biosimilarity between Sandoz biosimilar pegfilgrastim and its US-and EU-approved reference biologics.Methods: Phase I, randomized, double-blind, single-dose, 3-period, 6-sequence cross-over, multicentre study to evaluate the pharmacokinetics, pharmacodynamics, safety and immunogenicity of Sandoz biosimilar pegfilgrastim with US-and EUreferences in healthy adults.Results: Pharmacokinetic and pharmacodynamic similarity was demonstrated between the 3 biologics, as the 90% confidence interval for all primary pharmacokinetic and pharmacodynamic endpoint comparisons were contained within the predefined similarity margins of 0.80-1.25. Safety, immunogenicity and tolerability were also similar.Conclusions: Sandoz biosimilar pegfilgrastim demonstrated pharmacokinetic and pharmacodynamic similarity to both US-and EU-reference biologics. No meaningful differences in safety, local tolerability and immunogenicity were identified.
Summary:A 40-year-old man with a left frontotemporal grade II oligodendroglioma developed seizures that were refractory to 14 antiepileptic medications, the ketogenic diet, and epilepsy surgery. With temozolomide therapy, his seizure frequency gradually changed from 30 partial seizures per day to a single simple partial seizure in 6 months. No additional therapeutic measures were introduced during this time. This reduction in seizure frequency appears attributable solely to temozolomide therapy. Key Words: Seizure-Refractory epilepsy-TemozolomideOligodendroglioma-Brain tumor.Low-grade oligodendrogliomas represent 3% to 5% of primary brain tumors (1). The frequency of seizures in patients with oligodendroglioma ranges from 35 to 91% (2). Temozolomide chemotherapy has been shown to provide clinical benefit in patients with epilepsy. In a study of 31 adults, complete seizure control was obtained in six patients and partial seizure control in nine patients treated with temozolomide (3). Similarly, improvement in seizure frequency was seen in 15 of 28 patients, with six patients becoming seizure free after temozolomide treatment (4). However, we are not aware of any reports of seizure control occurring in patients with well-documented refractory epilepsy and a primary brain tumor in response to temozolomide treatment. We report a patient who was refractory to 14 antiepileptic drugs (AEDs), epilepsy surgery, and the ketogenic diet but showed a dramatic decrease in seizure frequency in response to temozolomide.
CASE REPORTA 40-year-old man was diagnosed with a left frontotemporal World Health Organization (WHO) grade II oligodendroglioma 2 years before presentation to the Jefferson Comprehensive Epilepsy Center. He initially had 1 month of simple partial seizures with speech arrest occurring twice a week. He then underwent a subtotal left frontal resection. He was seizure free for 2 months after surgery but then had recurrent complex partial and simple partial seizures at a frequency of two to four per week, as well as intermittent generalized tonic-clonic seizures. Over a period of 6 months, he began experiencing daily simple partial and complex partial seizures. The seizures were refractory to multiple AEDs (maximum daily dosage in parentheses), including phenobarbital (210 mg), phenytoin (600 mg), zonisamide (600 mg), oxcarbazepine (1,200 mg), and levetiracetam (3,000 mg), and he was admitted for video-EEG monitoring. This revealed continuous left frontotemporal focal slowing in the theta and delta frequencies, T3 spikes, and F7 and F3 sharp waves. Seizures were not well localized on scalp EEG; however, two of four complex partial seizures were lateralized to the left hemisphere with a left frontal onset. Neuropsychological evaluation revealed a verbal IQ of 91, performance IQ of 105, and impaired verbal function. Subsequent intracranial EEG monitoring revealed multiple subclinical seizures arising from the left frontal lobe and several complex partial and secondarily generalized tonic-clonic seizures arising from t...
This study suggests that absolute spike frequency does not predict seizure outcome after anterior temporal lobectomy unlike in selective procedures, and should not be used as a prognostic factor in this population.
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