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Conversion to eslicarbazepine acetate monotherapy: A pooled analysis of 2 phase III studies
MR. Sperling, J. French, MP. Jacobson, L. Pazdera, M. Gough, H. Cheng, T. Grinnell, D. Blum, . ,
Language English Country United States
Document type Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
- MeSH
- Anticonvulsants therapeutic use MeSH
- Dibenzazepines therapeutic use MeSH
- Adult MeSH
- Epilepsy diagnosis drug therapy MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Aged MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
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.
Department of Neurology Temple University School of Medicine Philadelphia PA
From Thomas Jefferson University Philadelphia PA
New York University Comprehensive Epilepsy Center New York NY
References provided by Crossref.org
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- $a Sperling, Michael R $u 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.
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- $a Conversion to eslicarbazepine acetate monotherapy: A pooled analysis of 2 phase III studies / $c MR. Sperling, J. French, MP. Jacobson, L. Pazdera, M. Gough, H. Cheng, T. Grinnell, D. Blum, . ,
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- $a 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.
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- $a French, Jacqueline $u 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.
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- $a Jacobson, Mercedes P $u 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.
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- $a Pazdera, Ladislav $u 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.
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- $a Gough, Mallory $u 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.
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- $a Cheng, Hailong $u 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.
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- $a Grinnell, Todd $u 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.
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