ABSTRACT
OBJECTIVE: The aim of this study was to evaluate long-term safety, efficacy, and quality of life (QOL) of ≤400-mg/day USL255, Qudexy® XR (topiramate) extended-release capsules, as adjunctive therapy for partial-onset seizures (POS) in adults. METHODS: Patients who completed the 11-week double-blind treatment phase of the phase 3 PREVAIL study were eligible to enroll in this 1-year open-label extension (OLE) study (PREVAIL OLE). The primary objective was to evaluate the safety and tolerability of USL255 (including treatment-emergent adverse events [TEAEs]). The secondary objective was to assess seizure frequency in patients (e.g., median percent reduction from baseline in weekly POS frequency, responder rate [proportion of patients with ≥25%, ≥50%, ≥75%, or 100% reduction from baseline in POS frequency], and seizure-free intervals [proportion of patients who were seizure-free for 4, 12, 24, 36, or 48weeks]). Exploratory clinical-status endpoints included the Global Impression of Change (CGI-C) and Quality of Life in Epilepsy-Problems (QOLIE-31-P) questionnaires. Post hoc analyses evaluated neurocognitive TEAE incidences during the first 11 and entire 55weeks of treatment and efficacy by patient age and drug-resistant status. RESULTS: Of the 217 patients who completed PREVAIL (USL255, n=103; placebo, n=114), 210 (97%) enrolled in PREVAIL OLE and were included in the ITT population. Across the entire 55-week treatment period, USL255 was generally safe and well tolerated, with low individual neurocognitive TEAE incidences. Seizure reduction was sustained across the year-long study and observed in patient subgroups, including those with highly drug-resistant seizures and those ≥50years of age. Improvements in CGI-C and QOLIE-31-P were also observed. SIGNIFICANCE: The results of PREVAIL OLE are consistent with those from PREVAIL and demonstrate that adjunctive treatment with up to 400mg/day of USL255 may be a safe and effective treatment option for a variety of adult patients with refractory POS.
Subject(s)
Anticonvulsants/adverse effects , Anticonvulsants/therapeutic use , Drug Resistant Epilepsy/drug therapy , Epilepsies, Partial/drug therapy , Fructose/analogs & derivatives , Seizures/drug therapy , Adult , Aging , Anticonvulsants/administration & dosage , Cognition Disorders/chemically induced , Cognition Disorders/psychology , Delayed-Action Preparations , Double-Blind Method , Drug Resistant Epilepsy/psychology , Female , Fructose/administration & dosage , Fructose/adverse effects , Fructose/therapeutic use , Humans , Male , Quality of Life , Seizures/psychology , Surveys and Questionnaires , Topiramate , Treatment OutcomeABSTRACT
There is a controversy wheter central pontine myelinolysis can complicate either hyponatremia or its rapid correction. We report a 69 years old woman with a history of one month of vertigo, nausea, vomiting and diarrhea. She was admitted dehydrated ad stuporous, and initial laboratory values showed a serum sodium of 96 mEq/L She was treated with dextrose 5 percent and 3 percent NaCI. Serum sodium raised to 120 mEq/L at the next day and the level of consciousness improved. At the 4th day of admission, the patient was again stuporous and with spastic quadriplegia. A magnetic resonance imaging showed a central and symmetrical pontine lesion on T1 and T2 weighed images. Thereafter, the patient experienced a progressive improvement of her neurological condition and was discharged three months later, moving her lower limbs. Nine month later she was able to walk
Subject(s)
Humans , Female , Aged , Hyponatremia/complications , Myelinolysis, Central Pontine/etiology , Sodium/administration & dosageABSTRACT
We report a 69 years old male with a parkinsonian syndrome and a 50 years old female without neurological problems who showed violent behavior during REM sleep. Polysomnography showed that both had tonic or phasic muscular activity during REM sleep and a REM sleep behavior disorder was diagnosed. Clonazepam was used in both, with good clinical response. This condition is frequently unrecognized and confused with nightmares, nocturnal delirium or other parasomnias
Subject(s)
Humans , Male , Female , Middle Aged , Behavioral Symptoms/etiology , Sleep, REM , Sleep Wake Disorders/diagnosis , Parkinson Disease/complications , Clonazepam/pharmacology , Polysomnography , Sleep Wake Disorders/physiopathology , Sleep Wake Disorders/drug therapyABSTRACT
El status convulsivo secundariamente generalizado (SCSG) es la más común de las formas de status epiléptico (SE), a la vez que el más peligroso ya que con mayor frecuencia es causa de secuelas neurológicas y muerte, si no se trata adecuadamente. SCSG es un estado dinámico, las manifestaciones clínicas y electroencefalográficas varían en el tiempo si las convulsiones persisten al fracasar el tratamiento. Existe una progresión de status manifiesto a status sutil en el SCSG, y de acuerdo a reportes previos tambien existe una progresión o secuencia en la actividad eléctrica en los casos de evolución prolongada. Para verificar lo anterior analizamos las variaciones clínicas y electromagnéticas de cinco pacientes que cumplían criterios de SCSG. En ellos efectivamente pudimos confirmar la mayoría de los cambios o patrones descritos en otras publicaciones. Sin embargo no identificamos ninguna progresión o secuencia definida en estos patrones
