RESUMEN
OBJECTIVE: To compare the effectiveness of controlled-released carbamazepine (CR-CBZ) to levetiracetam (LEV) and to lamotrigine (LTG) in elderly patients with newly diagnosed focal epilepsy. METHODS: Randomized, double-blind, parallel-group trial conducted between January 2007 and August 2011, in 47 ambulatory or hospital sites in Germany, Austria, or Switzerland. Eligible participants were aged ≥ 60, had new-onset epilepsy, had no acute illness as the cause of their seizures, and had no contraindication to the drugs in the trial. Patients were randomized 1:1:1 to CR-CBZ, LTG, or LEV. Doses were up-titrated for 6 weeks and could be maintained or adjusted depending on seizure relapse or tolerability over an additional period of 52 weeks. Primary outcome was the retention to treatment at week 58; secondary measures related to seizure and adverse event frequency. RESULTS: Of 361 randomized patients, 359 were included (CR-CBZ n = 121, LTG n = 117, LEV n = 122) in the modified intent-to-treat population (mean age [range] 71.4 [60-95] years). At week 58, the retention rate for LEV was significantly higher than for CR-CBZ (61.5% vs. 45.8%, p = 0.02), and similar to LTG (55.6%). Seizure freedom rates at weeks 30 and 58 were not different across the groups. Twice as many patients receiving CR-CBZ discontinued due to adverse events or death compared to those in the LEV group (32.2% vs. 17.2%; odds ratio 2.28, 95% confidence interval [CI] 1.25-4.19, p = 0.007), whereas discontinuation was intermediate for LTG (26.3%). Median daily doses of completers (n = 195) were CR-CBZ 380.0 mg/day (333.0-384.0), LTG 95 mg/day (94.0-97.0), and LEV 950 mg/day (940.0-985.0). SIGNIFICANCE: In the initial monotherapy of focal epilepsy in the elderly, 1-year retention to LEV was higher compared to CR-CBZ due to better tolerability. Retention of LTG was intermediate and close to LEV, but did not differ significantly from either comparators. NCT00438451, www.clinicaltrials.gov.
Asunto(s)
Anticonvulsivantes/uso terapéutico , Epilepsias Parciales/tratamiento farmacológico , Anciano , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Europa (Continente) , Femenino , Humanos , Estimación de Kaplan-Meier , Modelos Logísticos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Acute non-traumatic focal subarachnoid haemorrhage (fSAH) is a rare transient ischaemic attack (TIA)-mimic. MRI is considered to be indispensable by some authors in order to avoid misdiagnosis, and subsequent improper therapy. We therefore evaluated the role of CT and MRI in the diagnosis of fSAH patients by comparing our cases to those from the literature. METHODS: From 01/2010 to 12/2012 we retrospectively identified seven patients with transient neurological episodes due to fSAH, who had received unenhanced thin-sliced multiplanar CT and subsequent MRI within 3 days on a 1.5 T scanner. MRI protocol included at least fast-field-echo (FFE), diffusion-weighted imaging (DWI), T2-weighted fluid-attenuated inversion recovery (FLAIR) and time-of-flight (TOF) MRA sequences. By using MRI as gold-standard, we re-evaluated images and data from recent publications regarding the sensitivity to detect fSAH in unenhanced CT. RESULTS: fSAH was detected by CT and by FFE and FLAIR on MRI in all of our own cases. However, DWI and T2w-spin-echo sequences revealed fSAH in 3 of 7 and 4 of 6 cases respectively. Vascular imaging was negative in all cases. FFE-MRI revealed additional multiple microbleeds and superficial siderosis in 4 of 7 patients and 5 of 7 patients respectively. Including data from recently published literature CT scans delivered positive results for fSAH in 95 of 100 cases (95%), whereas MRI was positive for fSAH in 69 of 69 cases (100%). CONCLUSIONS: Thin-sliced unenhanced CT is a valuable emergency diagnostic tool to rule out intracranial haemorrhage including fSAH in patients with acute transient neurological episodes if immediate MRI is not available. However, MRI work-up is crucial and mandatorily has to be completed within the next 24-72 hours.