- Email: [email protected]
Safety and efficacy of eslicarbazepine acetate (zebinix) in everyday clinical practice using a retrospective multicentre audit
e64
Abstracts / Journal of the Neurological Sciences 333 (2013) e1–e64
epilepsy live in developing regions and the majority of them do not receive appropriate treatment. This treatment gap is partly attributable to the lack of availability of antiepileptic drugs (AEDs). The WHO has developed a Model List of Essential Medicines (WMLEM) designed to prioritize health care needs, improve the drug supply and lower the costs in health care to assist countries in procurement and supply of medicines prioritization. Aim: To assess to what extent essential AEDs, as recommended in the WMLEM, are present in countries' Essential Medicine Lists (EML) and review their accessibility at the health system level to develop a comprehensive view of treatment gaps. A comparative analysis was performed on 109 EMLs of member countries and the corresponding chapter 5 WMLEM to assess quantitative and qualitative differences concerning the essential AEDs. Phenobarbital was included in the EML of 96% of the responding countries, carbamazepine in 95%, phenytoin in 83%, and valproic acid in 92%. The medications were provided as recommended by the WMLEM in a fraction of these cases: phenobarbital in 12%, carbamazepine in 5%, phenytoin in 3%, and valproic acid in 11%. Firstline AEDs were least likely to be included in low-income countries. All medications were more likely to be available in the hospital compared to the health center. Consistent use and application of WMLEM in guiding national EML development can help improve availability of AEDs. doi:10.1016/j.jns.2013.07.224
Abstract — WCN 2013 No: 3207 Topic: 1 — Epilepsy Psychiatric comorbidity and social aspects in men with epilepsy — The Norwegian mother and child cohort study S.F. Reitera, G. Veibya,b, M.H. Bjørka,b, A.K. Daltveitc,d, B.A. Engelsena,b, N.E. Gilhusa,b. aDepartment of Clinical Medicine, University of Bergen, Norway; bDepartment of Neurology, Haukeland University Hospital, Norway; cDepartment of Global Health and Primary Care, University of Bergen, Norway; dDivision of Epidemiology, Norwegian Institute of Public Health, Bergen, Norway Objectives: To investigate psychiatric disease and social aspects in men with epilepsy. Method: This study was based on the Norwegian Mother and Child Cohort Study (MoBa). Information included self-reported diagnoses and validated diagnostic instruments from 71,700 men, who were fathers of children registered in MoBa. Questionnaires were answered around week 18 of pregnancy. Results: 658 men (mean age 31.8 years) reported epilepsy, 36.9% using antiepileptic drugs (AEDs). Compared to the rest of the MoBa cohort, untreated men with epilepsy more often screened positive for present depression (15.3% vs. 10.3%, p = 0.001), while AED treated men more often had a history of Lifetime Major Depression (15.1% vs. 10.1, p = 0.011). Self-reported ADHD was associated with untreated epilepsy (3.4% vs. 0.4%, p b 0.001), as was bipolar disorder (2.2% vs. 0.3%, p = 0.003), and unspecified psychiatric disorders (5.6% vs. 2.3%, p = 0.008). Unemployment due to disability was linked to both AED treated (9.1% vs. 1.4%, p b 0.001) and untreated
epilepsy (2.9% vs. 1.4%, p = 0.009), as were low income (10.3% vs. 5.4, p = 0.031 and 9.7% vs. 5.4%, p = 0.011). Smoking was associated with untreated epilepsy (60.2% vs. 51.8, p = 0.001). No difference was found for lower education level, alcohol use or narcotic use. Conclusion: Epilepsy in young men is associated with a higher frequency of psychiatric disorders and adverse social aspects, including both AED treated and untreated epilepsy. Our findings indicate that untreated men with epilepsy are a more vulnerable group that may be in need of patient follow up even if they are not using AED. doi:10.1016/j.jns.2013.07.225
Abstract — WCN 2013 No: 3219 Topic: 1 — Epilepsy Safety and efficacy of eslicarbazepine acetate (zebinix) in everyday clinical practice using a retrospective multicentre audit S. Keogha, P. McDonalda, C. Lawthomb, M.J. Brodiec, B. McLeand, R. Mohanraje, J. Morrowf, P. Tittensorg, M. Bagarya. aThe Barberry, BSMHFT, Birmingham, UK; bRoyal Gwent Hospital, Gwent, UK; cWestern Infirmary Glasgow, Glasgow, UK; dRoyal Cornwall Hospitals NHS Trust, Cornwall, UK; eSalford Royal Hospital, Salford, UK; fRoyal Victoria Hospital Belfast, Belfast. UK; gStafford Hospital, Stafford, UK Background/Objective: We report on the safety and efficacy of Eslicarbazepine acetate (ESL) in routine clinical practice. Method: A retrospective multicentre audit of outcomes following treatment with ESL for localisation-related epilepsy across 7 UK sites (2009–2013). Results: 202 patients with median values for age 42.5 (17–83) years; duration of epilepsy 16.5 (0–65) years; 2 (0–4) concomitant AEDs, 12 month (2 days–53 months) duration of ESL treatment and 0–12 (64% ≥ 2) previous AED exposures. ESL dosage ranged from 600 to 1600 mg/day. Baseline seizure types comprised secondarily generalised tonic–clonic seizures (78.2%), complex partial seizures (74.3%) and simple partial seizures (23.8%). Psychiatric comorbidity was reported in 30% of patients, mainly depression and anxiety.105 patients (52%) experienced ≥50% seizure frequency reduction. 40 subjects (19.8%) became seizure free, of whom 26 (65%) had 0–1 previous AED exposures. ESL was discontinued in 70 patients (34.7%) for reasons related to tolerability (n = 43), efficacy (n = 7), both (n = 4) or other (n = 15). Adverse events (AEs) were fatigue (18.8%), dizziness (10%) and disturbance in attention/concentration (9%); all were observed with AED polytherapy. Psychiatric and behavioural AEs (n = 6, 3.0%), included suicidal ideation (n = 1), and led to ESL withdrawal in 2 patients (1.0%). Hyponatraemia was reported (n = 14, 6.9%) and led to discontinuation in 4 patients (2.0%). Conclusions: ESL has comparable efficacy to other AEDs for partialonset seizures with or without secondary generalisation. Discontinuation due to tolerability was related to AED polytherapy. Reported AEs were consistent with ESL's known safety profile. The benign neuropsychiatric profile with once-daily dosing may convey some advantage in AED selection. doi:10.1016/j.jns.2013.07.226
Abstracts / Journal of the Neurological Sciences 333 (2013) e1–e64
epilepsy live in developing regions and the majority of them do not receive appropriate treatment. This treatment gap is partly attributable to the lack of availability of antiepileptic drugs (AEDs). The WHO has developed a Model List of Essential Medicines (WMLEM) designed to prioritize health care needs, improve the drug supply and lower the costs in health care to assist countries in procurement and supply of medicines prioritization. Aim: To assess to what extent essential AEDs, as recommended in the WMLEM, are present in countries' Essential Medicine Lists (EML) and review their accessibility at the health system level to develop a comprehensive view of treatment gaps. A comparative analysis was performed on 109 EMLs of member countries and the corresponding chapter 5 WMLEM to assess quantitative and qualitative differences concerning the essential AEDs. Phenobarbital was included in the EML of 96% of the responding countries, carbamazepine in 95%, phenytoin in 83%, and valproic acid in 92%. The medications were provided as recommended by the WMLEM in a fraction of these cases: phenobarbital in 12%, carbamazepine in 5%, phenytoin in 3%, and valproic acid in 11%. Firstline AEDs were least likely to be included in low-income countries. All medications were more likely to be available in the hospital compared to the health center. Consistent use and application of WMLEM in guiding national EML development can help improve availability of AEDs. doi:10.1016/j.jns.2013.07.224
Abstract — WCN 2013 No: 3207 Topic: 1 — Epilepsy Psychiatric comorbidity and social aspects in men with epilepsy — The Norwegian mother and child cohort study S.F. Reitera, G. Veibya,b, M.H. Bjørka,b, A.K. Daltveitc,d, B.A. Engelsena,b, N.E. Gilhusa,b. aDepartment of Clinical Medicine, University of Bergen, Norway; bDepartment of Neurology, Haukeland University Hospital, Norway; cDepartment of Global Health and Primary Care, University of Bergen, Norway; dDivision of Epidemiology, Norwegian Institute of Public Health, Bergen, Norway Objectives: To investigate psychiatric disease and social aspects in men with epilepsy. Method: This study was based on the Norwegian Mother and Child Cohort Study (MoBa). Information included self-reported diagnoses and validated diagnostic instruments from 71,700 men, who were fathers of children registered in MoBa. Questionnaires were answered around week 18 of pregnancy. Results: 658 men (mean age 31.8 years) reported epilepsy, 36.9% using antiepileptic drugs (AEDs). Compared to the rest of the MoBa cohort, untreated men with epilepsy more often screened positive for present depression (15.3% vs. 10.3%, p = 0.001), while AED treated men more often had a history of Lifetime Major Depression (15.1% vs. 10.1, p = 0.011). Self-reported ADHD was associated with untreated epilepsy (3.4% vs. 0.4%, p b 0.001), as was bipolar disorder (2.2% vs. 0.3%, p = 0.003), and unspecified psychiatric disorders (5.6% vs. 2.3%, p = 0.008). Unemployment due to disability was linked to both AED treated (9.1% vs. 1.4%, p b 0.001) and untreated
epilepsy (2.9% vs. 1.4%, p = 0.009), as were low income (10.3% vs. 5.4, p = 0.031 and 9.7% vs. 5.4%, p = 0.011). Smoking was associated with untreated epilepsy (60.2% vs. 51.8, p = 0.001). No difference was found for lower education level, alcohol use or narcotic use. Conclusion: Epilepsy in young men is associated with a higher frequency of psychiatric disorders and adverse social aspects, including both AED treated and untreated epilepsy. Our findings indicate that untreated men with epilepsy are a more vulnerable group that may be in need of patient follow up even if they are not using AED. doi:10.1016/j.jns.2013.07.225
Abstract — WCN 2013 No: 3219 Topic: 1 — Epilepsy Safety and efficacy of eslicarbazepine acetate (zebinix) in everyday clinical practice using a retrospective multicentre audit S. Keogha, P. McDonalda, C. Lawthomb, M.J. Brodiec, B. McLeand, R. Mohanraje, J. Morrowf, P. Tittensorg, M. Bagarya. aThe Barberry, BSMHFT, Birmingham, UK; bRoyal Gwent Hospital, Gwent, UK; cWestern Infirmary Glasgow, Glasgow, UK; dRoyal Cornwall Hospitals NHS Trust, Cornwall, UK; eSalford Royal Hospital, Salford, UK; fRoyal Victoria Hospital Belfast, Belfast. UK; gStafford Hospital, Stafford, UK Background/Objective: We report on the safety and efficacy of Eslicarbazepine acetate (ESL) in routine clinical practice. Method: A retrospective multicentre audit of outcomes following treatment with ESL for localisation-related epilepsy across 7 UK sites (2009–2013). Results: 202 patients with median values for age 42.5 (17–83) years; duration of epilepsy 16.5 (0–65) years; 2 (0–4) concomitant AEDs, 12 month (2 days–53 months) duration of ESL treatment and 0–12 (64% ≥ 2) previous AED exposures. ESL dosage ranged from 600 to 1600 mg/day. Baseline seizure types comprised secondarily generalised tonic–clonic seizures (78.2%), complex partial seizures (74.3%) and simple partial seizures (23.8%). Psychiatric comorbidity was reported in 30% of patients, mainly depression and anxiety.105 patients (52%) experienced ≥50% seizure frequency reduction. 40 subjects (19.8%) became seizure free, of whom 26 (65%) had 0–1 previous AED exposures. ESL was discontinued in 70 patients (34.7%) for reasons related to tolerability (n = 43), efficacy (n = 7), both (n = 4) or other (n = 15). Adverse events (AEs) were fatigue (18.8%), dizziness (10%) and disturbance in attention/concentration (9%); all were observed with AED polytherapy. Psychiatric and behavioural AEs (n = 6, 3.0%), included suicidal ideation (n = 1), and led to ESL withdrawal in 2 patients (1.0%). Hyponatraemia was reported (n = 14, 6.9%) and led to discontinuation in 4 patients (2.0%). Conclusions: ESL has comparable efficacy to other AEDs for partialonset seizures with or without secondary generalisation. Discontinuation due to tolerability was related to AED polytherapy. Reported AEs were consistent with ESL's known safety profile. The benign neuropsychiatric profile with once-daily dosing may convey some advantage in AED selection. doi:10.1016/j.jns.2013.07.226