48 research outputs found
Tolerability of adjunctive eslicarbazepine acetate according to concomitant lamotrigine or carbamazepine use: A subgroup analysis of three phase III trials in adults with focal (partial-onset) seizures.
To evaluate and compare the effects of concomitant lamotrigine (LTG) or carbamazepine (CBZ) on the incidence of treatment-emergent adverse events (TEAEs) in patients taking adjunctive eslicarbazepine acetate (ESL) for focal (partial-onset) seizures (FS).
These post-hoc analyses of data pooled from three randomized, double-blind, placebo-controlled studies of adjunctive ESL (BIA-2093-301, -302 and -304) included adults (≥16 years) with FS refractory to 1-3 antiepileptic drugs (AEDs). Patients were randomized equally to placebo, ESL 400 mg (Studies 301 and 302 only), 800 mg, or 1200 mg once daily (8-week baseline, 2-week titration, and 12-week maintenance periods). TEAEs, TEAEs leading to discontinuation, and serious AEs (SAEs) were evaluated in patients taking, or not taking, LTG (excluding those taking CBZ or phenytoin [PHT]; i.e., the +LTG and -LTG/-CBZ subgroups), or CBZ (excluding those taking LTG or PHT; i.e., the +CBZ and -LTG/-CBZ subgroups) at baseline.
LTG was used concomitantly by 248 patients (+LTG; placebo, n = 81; ESL, n = 167) and CBZ by 613 patients (+CBZ; placebo, n = 172; ESL, n = 441); 361 patients were taking neither LTG nor CBZ (-LTG/-CBZ; placebo, n = 109; ESL, n = 252). The overall incidence of TEAEs with ESL (any dose) was numerically higher for +CBZ (77%) than for +LTG (73%) or -LTG/-CBZ (68%; statistical significance not tested). Among patients taking ESL, dizziness, diplopia, and vomiting were reported more frequently in the +CBZ subgroup (30%, 14%, and 10%, respectively) than in the +LTG (16%, 8%, 5%) or -LTG/-CBZ (11%, 3%, 5%) subgroups. The overall incidence of TEAEs leading to discontinuation with ESL was higher for +CBZ (21%) than for +LTG (13%) or -LTG/-CBZ (15%). Dizziness leading to discontinuation with ESL was reported more frequently in the +CBZ subgroup than in the +LTG or -LTG/-CBZ subgroups (9%, 3%, and 3%, respectively). The overall incidence of SAEs in patients taking ESL was comparable across subgroups (+LTG, 5%; +CBZ, 6%; -LTG/-CBZ, 5%). The results were similar when evaluating placebo-adjusted incidences.
There was a potential pharmacodynamic interaction between AEDs with a putatively similar mechanism of action, with a seemingly lesser interaction between ESL and LTG versus ESL and CBZ. If combining ESL with LTG or CBZ, clinicians should be aware of the potential risk for an increased incidence of TEAEs typically associated with voltage-gated sodium channel inhibitors (e.g., dizziness, blurred vision, vertigo, diplopia, headache, or vomiting)
Movimenti oculari di "smooth pursuit" in un gruppo di adulti giovani normali.
I movimenti oculari di lento inseguimento sono stati studiati in 50 soggetti normali. I risultati hanno evidenziato un comportamento non univoco dei soggetti giovani adulti normali. E' stato possibile evidenziare tre tipi fondamentali di movimento riflesso. In due di questi il movimento oculare non era corrispondente al movimento pendolare della mira fino ad essere completamente avulso da questo. Lo studio psicologico dei soggetti ha evidenziato che nei gruppi con irregolare o alterato movimento di inseguimento oculare era correlabile di alterazioni psicologiche al test di Rorschach e con la positività delle scale di ipocondria e depressione al MMPI. Oltre all'alterazione delle capacità attentiva e percettivo-motoria nello svolgimento della prova
Social aspects of epilepsy in the adult in seven european countries
The social implications of epilepsy are ill-defined, and there are no comparative findings from different countries. A multicenter cohort study has recontly been completed on the risk of morbidity and accidents. Seven hundred six adult patients with idiopathic or remote symptomatic epilepsy and 662 matched controls without epilepsy were enrolled by secondary and tertiary centers in seven European coutries. The study support the concept that epilepsy has a considerable impact on driving and-to a lesser extent-on education, occupation, leisure activities, and insurance.The social implications of epilepsy in this sample are partly related to its severity and clinical features
Morbidity and accidents in patients with epilepsy. Results of a European cohort study
To assess the risk of illnesses and accidents in patients with eppilepsy and to evaluate the proportion of those risks attributable to epilepsy. Nine hundred fifty-one referrral patients with idiopathic, cryptogenic, or remote symptomatic epilepsy and 909 matched controls were followed up prospectively for 1-2 years in eight European countries. Patients have a moderately higher risk of illnesses and accidents than do the general population. With few exceptions, the event are trivial. When seizure-related events are excluded, patients with epilepsy are not at any significantly higher risk of ilnesses and accidents
Psychologic effects of taurine in epileptics having partial seizures with complex symptomatology
Psychological variations after taurine treatment (150 mg/kg/die i.v.) in ten partial seizures with complex symptomatology epileptics have been valued by means of Wechsler-Bellevue Intelligence Scale, Wechsler Memory Scale, Cattel's Retentivity Test, Raven's Progressive Matrices 1947, Mira Stambak's Test and Oseretzky's Test. The findings of the group of patients treated with taurine have been compared to results of another group of ten similar patients treated with placebo. At the base conditions, mean values of mental tests were similar in both groups. After treatments, improvement of mean scores has been observed in only the group treated with taurine, concerning intellectual performances in toto, and in detail intellectual vivacity and quickness, interest of surrounding environment, motivation, attention, memory and psychomotor capacities. These data indicate the employment of taurine in epileptics also to improve intellective functions
Accidents in patients with epilepsy: types, circumstancies and complications. A European cohort study.
PURPOSE: To investigate the risk of accidents in a cohort of patients with epilepsy and in matched nonepilepsy controls, by type, circumstances, and complications.
METHODS: A total of 951 children and adults with idiopathic, cryptogenic, or remote symptomatic epilepsy and 904 matched controls seen in secondary and tertiary centers in eight European countries (England, Estonia, Germany, Italy,
the Netherlands, Portugal, Russia, and Slovenia) were followed up prospectively for 17,484 and 17,206 person-months and asked to report any accident requiring medical attention, its site, and complications. Risk assessment was done by using
actuarial methods, relative risks (RRs), and 95% confidence intervals (CIs). RESULTS: During the study period, 199 (21%) patients and 123 (14%) controls reported an accident (p < 0.0001); 24% were seizure related. The cumulative probability of accidents at 12 and 24 months was 17 and 27% in the cases and 12 and 17% in the controls. The risk was highest for concussions (RR, 2.6; 95% CI, 1.2-5.8), abrasions (RR, 2.1; 95% CI, 1.1-4.0), and wounds (RR, 1.9; CI, 1.2-3.1). Domestic accidents prevailed in both groups, followed by street and work accidents, and were more common among cases. Compared with controls, patients with epilepsy reported more hospitalization, complications, and medical action. Disease characteristics associated with an increased risk of accidents included generalized epilepsy (concussions), active epilepsy, and at least monthly seizures (abrasions). Most risks decreased, becoming nonsignificant after excluding seizure-related events.
CONCLUSIONS: Patients with epilepsy are at higher risk of accidents and their complications. However, the risk was substantially lower after exclusion of seizure-related events
Morbidity in patients with epilepsy: type and complications. A European cohort study
PURPOSE: To investigate the risk of illnesses in a cohort of patients with epilepsy and in matched nonepilepsy controls, by type and complications. METHODS: A total of 951 children and adults with idiopathic, cryptogenic, or remote symptomatic epilepsy and 904 matched controls seen in secondary and
tertiary centers in eight European countries (England, Estonia, Germany, Italy, the Netherlands, Portugal, Russia, Slovenia) were followed prospectively for 17,484 and 17,206 person-months and asked to report any spontaneous complaint
requiring medical attention (illness), its type and complications
(hospitalization, absence from work or school, medical action). Risk assessment was done by actuarial methods, relative risks (RR), and 95% confidence intervals (CIs).
RESULTS: During the study period 644 patients (68%) and 504 controls (56%) reported an illness (p < 0.0001); 30% were seizure related. The cumulative probability of illness at 12 and 24 months was 49 and 86% in the cases and 39 and 75% in the controls (p < 0.0001). The largest differences regarded disorders affecting the nervous system (NS) (RR, 3.3; 95% CI, 2.3-4.2) and ear, nose, and throat (ENT) (RR, 1.3; 95% CI, 1.0-1.6). In patients with epilepsy, an NS illness was more likely to be followed by hospital admission, work absence, or medical intervention. All risks were significantly reduced after excluding seizure-related events.
CONCLUSIONS: Patients with epilepsy are at higher risk of NS and ENT illnesses and complications than the general population. However, the risk of illness is significantly reduced when seizure-related events are excluded
Prognosis of epilepsy in newly referred patients: a multicenter prospective study of the effects of monotherapy on the long-term course of epilepsy.
A cohort of 280 previously untreated epilepsy subjects recruited in 14 Italian centers were treated with antiepileptic drug monotherapy and followed for a median period of 48 months to investigate the rates of seizure remission, in general and with reference to various prognostic factors. The cumulative probability of achieving 1-year remission was 62% by 1 year after onset of treatment, 81% by 2 years, 92% by 3 years, and 98% by 5 years. The corresponding figures for 2- and 3-year remission at 5 years were 92 and 78%, respectively. Sixty-two patients (22.1%) had no remission period with monotherapy. Remission rate were significantly lower among patients with two or more seizure types and were inversely correlated to the number of seizures before treatment. The rate of seizure relapses during the first year of follow-up appear to correlate to the risk of developing refractory epileps
Early modifications of auditory event-related potentials in carriers of the Huntington's disease gene
The P3 wave is one cognitive component of event-related potentials (ERP) used to investigate various types of dementia. The aim of this study was to use the odd-ball paradigm to evaluate the P3 in Huntington's Disease (HD) gene carriers
who showed no symptoms of chorea, compared to a group of mildly affected HD patients. We selected 14 HD patients and six individuals who, despite testing positive for the HD gene, did not show any clinical evidence of the disease. Thirty-six normal subjects were also selected as controls. Statistical evaluation of N1, P2, N2 and P3 latencies and amplitudes was performed in each group. Both the N2 latency and the P3 latency corrected for age (cP3) were significantly correlated with the duration of illness in pooled symptomatic and presymptomatic gene carriers. However, these latencies did not correlate with any clinical scale or psychometric test, including WAIS subtests. As the individual P3 latency of
the majority of HD patients and all presymptomatic gene carriers was distributed within normal confidence intervals, and no correlation existed between ERP parameters and the signs of illness progression, the data appear to provide preliminary evidence against the valence of P3 in detecting the early cognitive impairment of HD
Prognosi dell'epilessia in 283 soggetti alla prima diagnosi. Studio prospettico multicentrico
283 pazienti con epilessia sono stati reclutati in 14 centri italiana nel periodo 1982-1985. IN tale popolazione è stata valutata la prognosi dell'epilessia espressa in termini di controllo delle crisi nel follow-up e sono stati ricercati i fattori in grado di influenzarla. I risultati hanno evidenziato che la metà circa dei pazienti presenta un completo controllo delle crisi dall'inizio del trattamento. Inoltre una correlazione negativa è stata osservata tra numero di crisi prima del trattamento e richio di ricorrenze nel follow-up