PMID- 31098888 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20210109 IS - 2193-8253 (Print) IS - 2193-6536 (Electronic) IS - 2193-6536 (Linking) VI - 8 IP - 2 DP - 2019 Dec TI - Effectiveness and Safety/Tolerability of Eslicarbazepine Acetate in Epilepsy Patients Aged >/= 60 Versus < 60 Years: A Subanalysis from the Euro-Esli Study. PG - 491-504 LID - 10.1007/s40120-019-0137-0 [doi] AB - INTRODUCTION: Clinical practice studies help guide antiepileptic drug (AED) therapy in patient groups routinely excluded from clinical trials, such as the elderly. The Euro-Esli study investigated the effectiveness and safety/tolerability of eslicarbazepine acetate (ESL) when used in everyday clinical practice in Europe. A subanalysis of data from elderly patients (>/= 60 years) included in the Euro-Esli study was conducted to assess these aspects of ESL use in this population. METHODS: Euro-Esli was a pooled analysis of 14 European clinical practice studies. Effectiveness parameters included responder (>/= 50% seizure frequency reduction) and seizure freedom rates after 3, 6 and 12 months of treatment and at last visit. Safety and tolerability were assessed throughout the follow-up by evaluating adverse events (AEs) and ESL discontinuation due to AEs, respectively. Data were compared for patients aged >/= 60 versus those aged < 60 years at study entry. RESULTS: Euro-Esli included 2058 patients (mean age 44.0 years). Age at study entry was known for 2057 patients, of whom 358 (17.4%) and 1699 (82.6%) were aged >/= 60 and < 60 years, respectively. Mean maximum ESL dose was 882.0 and 1008.2 mg/day in patients aged >/= 60 and < 60 years, respectively (p < 0.001). At all timepoints, responder and seizure freedom rates were significantly higher in patients aged >/= 60 versus < 60 years; for example, at 12 months, responder rates were 83.9 and 73.7%, respectively (p = 0.002), and seizure freedom rates were 58.5 and 37.1%, respectively (p < 0.001). The incidence of AEs was significantly higher in patients aged >/= 60 versus < 60 years (41.4 vs. 32.5%; p = 0.001), but the rate of discontinuation due to AEs was comparable between age groups (16.2 vs 13.1%; p = not significant). The safety/tolerability of ESL in patients aged >/= 60 years was consistent with its known profile. CONCLUSION: Eslicarbazepine acetate was efficacious and generally well tolerated when used to treat elderly patients with focal epilepsy in clinical practice, with no new or unexpected safety signals emerging in this setting. FUNDING: Eisai Ltd. FAU - Lawthom, Charlotte AU - Lawthom C AUID- ORCID: 0000-0003-1774-6506 AD - Aneurin Bevan University Health Board, Royal Gwent Hospital, Newport, UK. charlotte.lawthom2@wales.nhs.uk. FAU - Bermejo, Pedro AU - Bermejo P AD - Hospital Universitario Puerta de Hierro, Madrid, Spain. FAU - Campos, Dulce AU - Campos D AD - Hospital Clinico Universitario, Valladolid, Spain. FAU - McMurray, Rob AU - McMurray R AD - Eisai Europe Ltd, Hatfield, Hertfordshire, UK. FAU - Villanueva, Vicente AU - Villanueva V AD - Hospital Universitario y Politecnico La Fe, Valencia, Spain. LA - eng PT - Journal Article DEP - 20190516 PL - New Zealand TA - Neurol Ther JT - Neurology and therapy JID - 101637818 PMC - PMC6858887 OTO - NOTNLM OT - Clinical practice OT - Elderly OT - Epilepsy OT - Eslicarbazepine acetate OT - Euro-Esli OT - Focal epilepsy OT - Focal seizures OT - Partial epilepsy OT - Partial seizures COIS- Charlotte Lawthom has participated in clinical trials for Eisai; received speaker fees and participated in advisory boards for Eisai, UCB Pharma, Pfizer, GSK and Bial; and received consultancy fees from Eisai and UCB Pharma. Pedro Bermejo has participated in advisory boards and pharmaceutical industry-sponsored symposia for Eisai, UCB Pharma, Sandoz, Bial, Pfizer, GSK, Esteve and Novartis. Dulce Campos has participated in advisory boards and industry-sponsored symposia for Eisai, UCB Pharma, Bial, and Esteve. Rob McMurray is a current employee of Eisai Europe Ltd. Vicente Villanueva has participated in advisory boards and pharmaceutical industry-sponsored symposia for Eisai, UCB Pharma, Merck Sharp and Dohme, Bial, Pfizer, GSK, Esteve, Novartis, Medtronic, and Cyberonics. EDAT- 2019/05/18 06:00 MHDA- 2019/05/18 06:01 PMCR- 2019/05/16 CRDT- 2019/05/18 06:00 PHST- 2019/03/29 00:00 [received] PHST- 2019/05/18 06:00 [pubmed] PHST- 2019/05/18 06:01 [medline] PHST- 2019/05/18 06:00 [entrez] PHST- 2019/05/16 00:00 [pmc-release] AID - 10.1007/s40120-019-0137-0 [pii] AID - 137 [pii] AID - 10.1007/s40120-019-0137-0 [doi] PST - ppublish SO - Neurol Ther. 2019 Dec;8(2):491-504. doi: 10.1007/s40120-019-0137-0. Epub 2019 May 16.