Safety, efficacy and outcome-related factors of perampanel over 12 months in a real-world setting: The FYDATA study.

BACKGROUND: Real-world data of current antiepileptic drugs (AEDs) used to treat focal seizures is of importance to understand the efficacy and safety outside of the clinical trial setting. Here we report real-world data from a large series of patients treated with perampanel for 1year. METHODS: FYDATA was a multicentre, retrospective, 1-year observational study assessing the efficacy and safety of adjuvant perampanel in patients ≥12 years of age with focal epilepsy in a real-world setting. At 12 months, the proportion of patients who were seizure free, median percentage seizure reduction, proportion of responders, retention rate and proportion of patients with adverse events (AEs) were assessed. Analyses were also performed to identify any patient-, medication- and disease-related factors associated with a large clinical response or carry a risk for AEs. RESULTS: A total of 464 patients were included in the study with a retention rate of 60.6% at 1year. The mean number of prior AEDs was 7.8. The median percentage reduction in overall seizures was 33.3% (75% for secondary generalised seizures) after 1year, with 7.2% of patients achieving seizure freedom. Furthermore, patients on non-enzyme-inducing AEDs were more likely to achieve seizure freedom, and logistic regression revealed that patients aged ≥65 years, those with epilepsy due to a vascular aetiology and those who had received fewer prior AEDs showed a better clinical response to perampanel. A total of 62.9% of the patients experienced AEs at 12 months; dizziness, somnolence and irritability were the most frequent AEs. Patients with prior psychiatric comorbidities (hyperactivity and personality disorder) were more likely to experience psychiatric AEs with perampanel, and slower titration schedules were associated with less AEs overall. CONCLUSION: Perampanel, for the treatment of focal epilepsy in a real-world setting in a refractory population, over 1year, demonstrates a similar efficacy and safety profile to that observed in clinical trials. Our results have implications for the optimisation of perampanel use in a clinical setting.

Brucellar spinal epidural abscess of cervical location: report of four cases.

Spinal epidural abscesses account for 1 or 2 of every 10,000 hospital admissions, Staphylococcus aureus being the bacterium most frequently involved. Brucellosis is a disorder of worldwide distribution, relatively frequent in South America and in Mediterranean countries in Europe and Africa. Whilst in the USA only 200 cases are reported every year, in Spain it is the most frequent zoonosis. This systemic disease seldom produces spondylodiscitis which in a minority of cases may be complicated by spinal epidural abscesses, in general of lumbar location. The purpose of this article is to analyse 4 cases of brucellar spinal epidural abscess of cervical location and diagnosed in the Province of Teruel, Spain, an endemic area for the disease, through 10 consecutive years (1990-1999). We consider noteworthy the following facts: the first case was a technical employee who acquired the infection in our laboratory of microbiology, the second presented with an extensive purulent collection invading prevertebral and retropharyngeal regions, the third case was cured only with antibiotics without residual deficits. In the fourth case we were not able to demonstrate spondylodiscitis accompanying the epidural abscess at the C2-C6 levels. We discuss especially the epidemiological aspects of brucellosis, the existence of epidural abscess without spondylodiscitis, the clinical manifestations, the diagnosis by means of magnetic resonance imaging, specific serological tests for Brucella, antibiotic treatment and the prognosis of our cases.

[Complications of Gaucher's disease]. / Complicaciones de la enfermedad de Gaucher.

We discuss two cases of Gaucher's disease of the adult with neurological complications. First of the patients came to Hospital due to sudden pain in dorso-lumbar region and motor weakness of lower extremities. In the neurological exploration there were no concluding objective deficit signs except an unstable deambulation. After several hours of rest, symptoms disappeared progressively. In the radiology of the raquis a crushed in the last three dorsal vertebral was seen; this finding together with the clinic the patient showed, suggested a mild and transitory medullar compression. Second patient suffered an intraparenchymatous brain hemorrhage on the course of a platelet depletion and with other mild coagulation disorders. This type of complication have never been described in Gaucher's disease.

[Primary empty sella turcica: clinical aspects and hormonal study of 15 cases]. / Silla turca vacía primaria: aspectos clínicos y estudio hormonal de 15 casos.

The goal pursued has been to analyze clinical observations and hormonal studies of patients with empty sella turcica (EST), in order to review this disorder and determine if it can be considered a real syndrome. Fifteen patients with EST (3 men and 12 women) and mean age of 45.6 +/- 17.9 years have been prospectively studied. In the hypothalamus-hypophysis study, reserves of thyrotropin (TSH), prolactin (PRL), gonadotropins (FSH and LH), growth hormone (GH), adrenocorticotropin (ACTH) and cortisol were assessed. In addition, thyroid hormones and, for men, testosterone, were determined. The pathogenic mechanism was explained in two cases (13.3%). We registered headache in 10 patients, obesity in 8, arterial hypertension in 2 and diabetes mellitus in 2. Multiparity antecedent was found in 2 cases. The hormonal study was abnormal in two cases (40%). Most common abnormalities were hyperprolactinemia (3 cases), deficit of gonadotropins (3 cases), without coexisting both of them in any case, and deficit of GH (2 cases). EST is frequently associated with endocrine disfunction, although clinical implications are rare. The absence of common clinical manifestations in most cases questions the EST as a real syndrome.