PMID- 21257324 OWN - NLM STAT- MEDLINE DCOM- 20110803 LR - 20181201 IS - 1532-2688 (Electronic) IS - 1059-1311 (Linking) VI - 20 IP - 4 DP - 2011 May TI - The safety and efficacy of add-on levetiracetam in elderly patients with focal epilepsy: a one-year observational study. PG - 305-11 LID - 10.1016/j.seizure.2010.12.015 [doi] AB - PURPOSE: The long-term safety and efficacy of levetiracetam (LEV) was evaluated as add-on therapy in focal epilepsy patients (n=491) aged at least 65 years who failed at least one monotherapy. METHODS: Patients (n=491) with focal epilepsy treated with at least one antiepileptic drug in monotherapy with insufficient seizure control were included in this prospective open-label study. The recommended LEV dose range was 1000-3000 mg per day. Follow-up visits were done approximately after 3, 6 and 12 months. Safety and efficacy was analysed based on all patients who received LEV (safety population, n=491) and all patients who were seen at all visits and completed the trial (per protocol population, n=364). RESULTS: Patients (53% men, median age 71 years) had a total of 97 adverse events (AEs) reported in 53 patients. The most common AEs were fatigue and restlessness (9.7% each of all AEs). A total of 35 serious AEs occurred in 19 patients (3.9% of the safety population), all but one unrelated to the study medication. Mean monthly seizure frequency dropped significantly from 7.0 (SD 8.7, range 1-85, median 4) at baseline to 1.7 (SD 2.9, range 0-29, median 1) at 3 month, 1.2 (SD 2.6, range 0-30, median 0) at 6, and 1.4 (SD 6.6, range 0-99, median 0) at 12 months, corresponding to a reduction of 75.7%, 82.9%, and 80.0% relative to baseline. Seizure freedom was reported by 42%, 57.7%, and 58% of patients during the previous period at 3, 6 and 12 months follow-up, respectively. CONCLUSIONS: Add-on treatment with LEV in elderly patients with focal epilepsy was safe and efficient. Levetiracetam might be considered as a suitable drug in the elderly. CI - Copyright (c) 2011 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved. FAU - Werhahn, Konrad J AU - Werhahn KJ AD - Department of Neurology, University Medical Center of the Johannes Gutenberg, University Mainz, Langenbeckstr. 1, 55131 Mainz, Germany. werhahn@uni-mainz.de FAU - Klimpe, Sven AU - Klimpe S FAU - Balkaya, Sonja AU - Balkaya S FAU - Trinka, Eugen AU - Trinka E FAU - Kramer, Gunter AU - Kramer G LA - eng PT - Clinical Trial PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20110122 PL - England TA - Seizure JT - Seizure JID - 9306979 RN - 0 (Anticonvulsants) RN - 44YRR34555 (Levetiracetam) RN - ZH516LNZ10 (Piracetam) SB - IM MH - Aged MH - Aged, 80 and over MH - Anticonvulsants/administration & dosage/adverse effects/*therapeutic use MH - Drug Therapy, Combination MH - Epilepsies, Partial/*drug therapy MH - Female MH - Humans MH - Levetiracetam MH - Male MH - Piracetam/administration & dosage/adverse effects/*analogs & derivatives/therapeutic use EDAT- 2011/01/25 06:00 MHDA- 2011/08/04 06:00 CRDT- 2011/01/25 06:00 PHST- 2010/08/10 00:00 [received] PHST- 2010/11/05 00:00 [revised] PHST- 2010/12/27 00:00 [accepted] PHST- 2011/01/25 06:00 [entrez] PHST- 2011/01/25 06:00 [pubmed] PHST- 2011/08/04 06:00 [medline] AID - S1059-1311(11)00005-7 [pii] AID - 10.1016/j.seizure.2010.12.015 [doi] PST - ppublish SO - Seizure. 2011 May;20(4):305-11. doi: 10.1016/j.seizure.2010.12.015. Epub 2011 Jan 22.