RESUMEN
PURPOSE: To determine the effectiveness and safety outcomes of cenobamate in a cohort of patients with highly refractory focal epilepsy in routine clinical practice. METHODS: Observational, retrospective, phase 4 study on subjects receiving cenobamate in three Spanish centers. The primary endpoint was the retention rate at the last follow-up. The main secondary endpoints were the 50%-responder and seizure-free rates at three months and the last follow-up. Other secondary endpoints were Global Clinical Impressions-Improvement (CGI-I) scores and treatment-emergent adverse events (TEAEs). RESULTS: Fifty-one patients with highly refractory focal epilepsy with 24.7 years of disease evolution, ten previously tried ASM, and a 23.5% of previous epilepsy surgery were included. The retention rate at the last follow-up was 80.4%. The 50% responder rate in focal seizures at three months was 56.5% (median reduction per month 51%, 0-74.6; p < 0.0001) and in focal to bilateral tonic-clonic seizures was 63.6% (median reduction per month 89%, 0-100; p = 0.022). A total of 54.3% of subjects reported a reduction in the intensity of focal seizures, and 66% manifested clinically significant satisfaction. Cenobamate allowed a significant decrease in concomitant ASM, especially sodium channel blockers. TEAEs were reported in 43.1% of individuals, 85% of whom resolved or improved, with no new safety findings. CONCLUSION: In this analysis of patients with highly refractory focal epilepsy treated with cenobamate according to standard clinical practice, there was evidence of a high reduction in both seizure frequency and intensity, with a manageable safety profile.
Asunto(s)
Anticonvulsivantes , Epilepsia Refractaria , Epilepsias Parciales , Humanos , Anticonvulsivantes/efectos adversos , Epilepsia Refractaria/tratamiento farmacológico , Quimioterapia Combinada , Epilepsias Parciales/tratamiento farmacológico , Estudios Retrospectivos , Convulsiones/tratamiento farmacológico , Resultado del TratamientoRESUMEN
INTRODUCTION: Acute ischemic stroke is the most common neurological complication of infective endocarditis. Intravenous thrombolysis is contraindicated in these patients due to a higher risk of hemorrhagic complications. Whether mechanical thrombectomy has some benefit in these patients remains unanswered although some favorable results can be found in literature. METHODS: We report twelve cases of acute ischemic stroke due to septic emboli treated with mechanical thrombectomy in two comprehensive stroke centers. RESULTS: Median age was 63 years (IQR 58.8-77.5 years). Diagnosis of infective endocarditis was previous to the diagnosis of stroke in three of the patients. There were five cases of prosthetic-valve endocarditis and eight cases of native-valve endocarditis. Two patients were treated with intravenous thrombolysis with an extensive subarachnoid hemorrhage in 24 h follow-up CT in one of them. Another patient suffered an arterial perforation during the endovascular procedure without successful recanalization. 6 of the patients (50%) developed some type of hemorrhagic complications with three cases of symptomatic intracerebral hemorrhage. Early neurological recovery was achieved in 3 (25%) patients. Functional independence at 3 months in patients with successful revascularization was reached in 50% of the cases. CONCLUSIONS: In patients with large vessel acute ischemic stroke related to infective endocarditis, mechanical thrombectomy might be considered with some potential benefit reported. There may be a high risk of hemorrhagic complications, as known for intravenous thrombolysis in this condition, suggesting that this procedure should be carefully evaluated in these patients.