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Summary   Objective  To assess the safety profile of lacosamide monotherapy in elderly (≥65 years) subjects with diabetic neuropathic pain ( DNP ).    Methods  Of 1,863  DNP  subjects in double‐blind, randomized, placebo‐controlled trials of lacosamide monotherapy (NCT00861445, NCT00235469, NCT00238524, NCT00135109, NCT00350103), 502 were elderly. Safety data from elderly subjects were compared with that of younger subjects (<65 years) within these  DNP  trials. It should be noted that lacosamide is approved for the treatment of focal (partial‐onset) seizures; it is not approved/recommended for the treatment of  DNP .    Results  Overall, cardiovascular diseases were prevalent in the  DNP  population, as was the use of cardiac, blood pressure, diabetes, and cholesterol‐lowering medications among both young and elderly subjects. The most frequently reported adverse events ( AE s) for lacosamide monotherapy (200, 400, and 600 mg/day combined) in elderly versus younger subjects were dizziness (16.2% vs. 13.2%), nausea (10.0% vs. 9.4%), and headache (8.0% vs. 8.7%). Incidences of cardiac disorder  AE s were higher in elderly versus younger subjects receiving placebo (6.2% vs. 3.9%), lacosamide 200 (4.8% vs. 3.3%), lacosamide 400 (7.0% vs. 4.1%), and lacosamide 600 mg/day (7.7% vs. 4.0%). Discontinuation rates because of any  AE  in the elderly versus younger subjects were similar for placebo (8.8% vs. 7.0%) and lacosamide 200 mg/day (9.6% vs. 11.9%) and higher for lacosamide 400 (25.1% vs. 10.8%) and lacosamide 600 mg/day (52.7% vs. 28.3%).    Significance  Lacosamide monotherapy was well tolerated in elderly subjects with  DNP , with an overall  AE  profile consistent with that reported in epilepsy trials.

Safety and tolerability of lacosamide monotherapy in the elderly: A subgroup analysis from lacosamide trials in diabetic neuropathic pain