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Autor: Jacobson, Mercedes P

2 záznamů v Medvik Filtry

Článek

Conversion to eslicarbazepine acetate monotherapy: A pooled analysis of 2 phase III studies

Sperling, Michael R
Autor Sperling, Michael R From Thomas Jefferson University (M.R.S.), Philadelphia, PA New York University Comprehensive Epilepsy Center (J.F.), New York, NY Department of Neurology (M.P.J.), Temple University School of Medicine, Philadelphia, PA Vestra Clinics s.r.o. (L.P.), Rychnov nad Kneznou, Czech Republic FireKite (M.G.), Macclesfield, UK and Sunovion Pharmaceuticals Inc. (H.C., T.G., D.B), Marlborough, MA. michael.sperling@jefferson.edu
French, Jacqueline
Autor French, Jacqueline From Thomas Jefferson University (M.R.S.), Philadelphia, PA New York University Comprehensive Epilepsy Center (J.F.), New York, NY Department of Neurology (M.P.J.), Temple University School of Medicine, Philadelphia, PA Vestra Clinics s.r.o. (L.P.), Rychnov nad Kneznou, Czech Republic FireKite (M.G.), Macclesfield, UK and Sunovion Pharmaceuticals Inc. (H.C., T.G., D.B), Marlborough, MA
Jacobson, Mercedes P
Autor Jacobson, Mercedes P From Thomas Jefferson University (M.R.S.), Philadelphia, PA New York University Comprehensive Epilepsy Center (J.F.), New York, NY Department of Neurology (M.P.J.), Temple University School of Medicine, Philadelphia, PA Vestra Clinics s.r.o. (L.P.), Rychnov nad Kneznou, Czech Republic FireKite (M.G.), Macclesfield, UK and Sunovion Pharmaceuticals Inc. (H.C., T.G., D.B), Marlborough, MA
Pazdera, Ladislav
Autor Pazdera, Ladislav From Thomas Jefferson University (M.R.S.), Philadelphia, PA New York University Comprehensive Epilepsy Center (J.F.), New York, NY Department of Neurology (M.P.J.), Temple University School of Medicine, Philadelphia, PA Vestra Clinics s.r.o. (L.P.), Rychnov nad Kneznou, Czech Republic FireKite (M.G.), Macclesfield, UK and Sunovion Pharmaceuticals Inc. (H.C., T.G., D.B), Marlborough, MA
Gough, Mallory
Autor Gough, Mallory From Thomas Jefferson University (M.R.S.), Philadelphia, PA New York University Comprehensive Epilepsy Center (J.F.), New York, NY Department of Neurology (M.P.J.), Temple University School of Medicine, Philadelphia, PA Vestra Clinics s.r.o. (L.P.), Rychnov nad Kneznou, Czech Republic FireKite (M.G.), Macclesfield, UK and Sunovion Pharmaceuticals Inc. (H.C., T.G., D.B), Marlborough, MA
Cheng, Hailong
Autor Cheng, Hailong From Thomas Jefferson University (M.R.S.), Philadelphia, PA New York University Comprehensive Epilepsy Center (J.F.), New York, NY Department of Neurology (M.P.J.), Temple University School of Medicine, Philadelphia, PA Vestra Clinics s.r.o. (L.P.), Rychnov nad Kneznou, Czech Republic FireKite (M.G.), Macclesfield, UK and Sunovion Pharmaceuticals Inc. (H.C., T.G., D.B), Marlborough, MA
Grinnell, Todd
Autor Grinnell, Todd From Thomas Jefferson University (M.R.S.), Philadelphia, PA New York University Comprehensive Epilepsy Center (J.F.), New York, NY Department of Neurology (M.P.J.), Temple University School of Medicine, Philadelphia, PA Vestra Clinics s.r.o. (L.P.), Rychnov nad Kneznou, Czech Republic FireKite (M.G.), Macclesfield, UK and Sunovion Pharmaceuticals Inc. (H.C., T.G., D.B), Marlborough, MA
Blum, David
Autor Blum, David

Neurology. 2016 ; 86 (12) : 1095-102. [pub] 20160224

ISSN 1526-632X
Medvik
Zdroj

OBJECTIVE: To assess the efficacy and safety of eslicarbazepine acetate (ESL) monotherapy. METHODS: This post hoc pooled analysis of 2 randomized double-blind studies (093-045 and -046) included adults with partial-onset seizures medically uncontrolled by 1 or 2 antiepileptic drugs (AEDs). Following the baseline period (8 weeks), eligible patients were randomized 2:1 to receive ESL 1,600 mg or 1,200 mg once daily for 18 weeks; the primary endpoint was study exit by meeting predefined exit criteria (signifying worsening seizure control). In each study, treatment was considered effective if the upper 95% confidence limit for exit rate was lower than the historical control threshold (65.3%). RESULTS: Pooled exit rates were as follows: ESL 1,600 mg = 20.6% (95% confidence interval: 15.6%-26.8%); ESL 1,200 mg = 30.8% (23.0%-40.5%). Use of 2 baseline AEDs or rescue medication, US location, epilepsy duration ≥20 years, and higher maximum baseline seizure frequency were associated with higher exit risks. Median percent reductions in standardized seizure frequency between baseline and the 18-week double-blind period were as follows: ESL 1,600 mg = 43.2%; ESL 1,200 mg = 35.7%; baseline carbamazepine use was associated with smaller reductions. Safety profiles were similar between ESL doses. CONCLUSIONS: Exit rates for ESL monotherapy (1,600 mg and 1,200 mg once daily) were lower than the historical control threshold, irrespective of baseline AED use and region, with no additional safety concerns identified. Clinical factors and location clearly influence treatment responses in conversion-to-monotherapy trials. CLASSIFICATION OF EVIDENCE: This pooled analysis provides Class IV evidence that for adults with medically uncontrolled partial-onset seizures, ESL monotherapy is well tolerated and effective.

Článek

Efficacy and safety of conversion to monotherapy with eslicarbazepine acetate in adults with uncontrolled partial-onset seizures: a historical-control phase III study

BMC neurology. 2015 ; 15 (-) : 46. [pub] 20150328

BMC Neurol
ISSN 1471-2377
Medvik
Zdroj

BACKGROUND: Eslicarbazepine acetate (ESL, Aptiom®) is a once-daily (QD) anticonvulsant, approved as adjunctive treatment of partial-onset seizures (POS). It is extensively converted after oral administration to eslicarbazepine, and is believed to exert its effect through inhibition of voltage-gated sodium channels. The possible role of ESL as monotherapy to treat POS has not yet been established. METHODS: This study was an 18-week, multicenter, randomized double-blind trial of gradual conversion to ESL monotherapy in adults with POS not well controlled by 1-2 antiepileptic drugs (AEDs), using historical data as the control. The study comprised an 8-week baseline period, a 2-week titration period, a 6-week AED conversion period, a 10-week monotherapy period, and either a 1-week taper period or optional entry to an open-label extension study. The primary endpoint compared the Kaplan-Meier (KM)-estimated 112-day exit rate with a threshold value calculated from the historical controls. RESULTS: There were 172 randomized patients; 154 (90%) entered the AED conversion period and 121 (70%) completed the study. The KM-estimated exit rates [confidence interval (CI)] were 15.6% [8.1-28.7%] for ESL 1200 mg, and 12.8% [7.5-21.5%] for ESL 1600 mg. The upper limits of the 95% CI KM-estimates were below the pre-specified threshold for historical control of 65.3%, indicating that ESL was efficacious in reducing seizure-related exits, compared with historical control. During the 18-week double-blind treatment period, median reductions in standardized seizure frequency occurred with ESL 1200 mg (36.1%) and ESL 1600 mg (47.5%). The responder rates (a 50% or greater reduction in seizure frequency from baseline) during the 18-week double-blind period and the monotherapy period, respectively, were 35.2% and 38.9% for ESL 1200 mg, and 46.0% and 46.0% for ESL 1600 mg. The overall adverse event profile was consistent with the known safety profile of ESL. CONCLUSIONS: These findings indicate that ESL monotherapy (1200 and 1600 mg QD) was efficacious and well tolerated in this study. TRIAL REGISTRATION: NCT01091662 ; EudraCT No. 2010-018684-42.

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