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

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

Determinants of depression among patients with epilepsy in Athens, Greece

Objective: Depression is common among patients with epilepsy. The aim of our study was twofold: to estimate the prevalence of a major depressive episode and to identify its determinants among patients with epilepsy treated in the largest Greek hospital in Athens. Methods: All consecutive patients with epilepsy that visited the epilepsy outpatient clinic of Evangelismos General Hospital were invited to participate in the study. Ninety-four patients met our inclusion criteria. Results: A diagnosis of a current major depressive episode was established in 21 out of 94 eligible to participate (22.3%) patients. Being a female was associated with a 19.68-fold increase in the odds of having a major depressive episode (95% CI 3.39-114.14, p = 0.001); being unemployed was associated with a 6.46-fold increase in the odds of having a major depressive episode (95% CI 1.23-34.07, p = 0.028), and each extra seizure experienced per month was associated with a 1.38-fold increase in the odds of having a major depressive episode (95% CI 1.03-1.85, p = 0.031). Conclusion: Unemployment, female gender, and seizure control are important determinants of a major depression episode among patients with epilepsy. © 2014 Elsevier Inc

Potential implications of Luria's work for the neuropsychology of epilepsy and epilepsy surgery: A perspective for re-examination

The pioneeristic work of Alexander Romanovic Luria into the field of human neuropsychology offered eminent contributions to clinical praxis by providing theory guided methods and instruments for the study of higher cortical functions. However, lots of this knowledge corpus either remains untranslated and thus inaccessible, or in some cases selectively overlooked by academic authorities and consequently not passed to the future generations of experts. Although Luria was not exclusively devoted to the study of epilepsy, his theories and clinical approaches actually penetrate the whole neuropathology spectrum. His holistic and systemic approach to the brain sounds nowadays more than opportune and consistent with the network approach of the modern neuroimaging era. As to epilepsy, the logic underlying the Lurian approach (cognitive functions organized into complex functional systems with intra- and/or inter-hemispheric distribution, as opposed to the modularistic view of the brain) seems consistent with our current knowledge in epileptology with respect to epileptic networks, as well as the modern construct of the functional deficit zone. These contributions seem to be highly promising for the neuropsychology of epilepsy and epilepsy surgery, since they provide clinicians with valuable methods and theories to assist them in the localization -and lateralization- of cognitive deficits. Consequently they are of great applicability in the context of the preoperative neuropsychological monitoring of patients candidates for epilepsy surgery, where neuropsychologist are called upon to provide surgeons with anatomical data. © 2017 Elsevier Inc

Validation of the Greek version of the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E)

The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) was developed as a screening tool for symptoms of major depressive episodes in people with epilepsy. Our study describes the development, validation, and psychometric properties of the Greek version of the NDDI-E. A consecutive sample of 101 patients with epilepsy, eligible to participate in the study, has been assessed using the Mini International Neuropsychiatric Interview version 5.0.0 and the NDDI-E. All patients had no major difficulties in understanding or answering the questions of the Greek version. Cronbach's alpha coefficient was 0.74. Receiver operating characteristic analysis showed an area under the curve of 91% (95% CI. = 83%-99%; SE: 0.040, p. <. 0.001). At a cutoff score of greater than 15, the NDDI-E showed a sensitivity of 91%, a specificity of 81%, and a negative predictive value of 97%. •We have developed and validated the Greek version of the NDDI-E.•At a cutoff score of greater than 15, the NDDI-E showed a sensitivity of 91%.•At a cutoff score of greater than 15, the NDDI-E showed a specificity of 81%.•At a cutoff score of greater than 15, the NDDI-E showed a negative predictive value of 97%. © 2013 Elsevier Inc

Cerebrospinal fluid analysis after unprovoked first seizure

The aim of this study was to determine cerebrospinal fluid (CSF) characteristics after an unprovoked first seizure (UFS). We reviewed the medical records of 71 patients with UFS who underwent lumbar puncture, and examined the CSF parameters. Each CSF parameter was evaluated separately for potential correlations with the other study variables. We observed an overall frequency of CSF abnormalities of 35.2%. CSF protein was the most common abnormal parameter (31%) and showed significant positive correlations with male gender (p=0.037) and older age (p=0.007). Only seven patients (9.9%) had an abnormal cell count (5-40 cells/μl). Higher CSF cell counts were found to predict a longer hospitalization period (p=0.005). No relationship with abnormal EEG findings could be established (p=0.169). This study is one of the few to evaluate postictal CSF parameters in a clinical setting, and to our knowledge the first to investigate these parameters specifically in the emergency department. The development of a rapid, easy-to-use test that does not require extensive laboratory equipment to differentiate UFS from other conditions could be of great value in everyday clinical practice. © 2016 CIC Edizioni Internazionali Unauthorized reproduction of this article is prohibited

Simulating memory outcome before right selective amygdalohippocampectomy

In this paper we present the case of a left-sided speech dominant patient with right medial temporal sclerosis (RMTS) and pharmacoresistant epilepsy who showed improved verbal memory during intracarotid amobarbital test (IAT) at his right hemisphere as compared with his own performance before the drug injection (baseline), as well as after right selective amygdalohippocampectomy. We suggest that the defective verbal memory shown by this patient is due to abnormal activity of his right hippocampus that interfered with the function of his left hippocampus. This hypothesis was demonstrated by the fact that disconnection of the two hippocampi, either by anesthetisation or by resection of the right hippocampus, disengaged the left hippocampus and, consequently improved its function. This paper main objective is twofold: first to contribute to the field of neuropsychology of epilepsy surgery by emphasising on postoperative memory outcomes in right medial temporal lobe epilepsy (RMTLE) patients, particularly those undergoing amygdalohippocampectomy, as the pattern of memory changes after resection of the right temporal lobe is less clear; second, by focusing on memory performance asymmetries during IAT, and comparatively considering them with neuropsychological memory performance, because of their possible prognostic-simulating value. © 2013 Copyright Taylor and Francis Group, LLC

Intrathecal baclofen improves psychiatric symptoms in spasticity patients

Symptoms of psychological distress are relatively common in spasticity patients as a result either of the primary central nervous system insult or as a reaction to the ensuing impairment. Intrathecal baclofen (ITB) is an established treatment for the spasticity with an unknown effect on the psychiatric symptoms. In this study, we evaluate the role of ITB in the amelioration of psychological distress symptoms in 15 patients who were not mentally disabled or psychotic. The patients were assessed with the Symptom Check List 90-Revised before and a mean of 12 months after ITB treatment. A significant improvement was noted at the subscales of positive symptoms total and anxiety. The anxiety subscale improvement was correlated with the ITB dose, but not with the reduction in the spasticity. An interesting trend was also noted in the subscales of general severity index, depression, and obsession-compulsion. The results show an additional beneficial effect of ITB and highlight the need of further clarification of the causative mechanism. Copyright © 2014 Lippincott Williams & Wilkins

Brain abscess following intracerebral haemorrhage

A 79-year old male patient developed a brain abscess as infective transformation of a preceding intracerebral haemorrhage after urinary tract infection. The awareness of brain abscess formation at the site of intracerebral haemorrhage is crucial for early diagnosis and treatment of this rare but potentially fatal complication. (c) 2006 Elsevier Ltd. All rights reserved