Open AccessSafety and tolerability of lacosamide monotherapy in the elderly: A subgroup analysis from lacosamide trials in diabetic neuropathic pain
Author(s) -
Bainbridge Jacquelyn,
De Backer Marc,
Eckhardt Klaus,
Tennigkeit Frank,
Bongardt Sabine,
Sen David,
Werhahn Konrad J.,
Shaibani Aziz,
Faught Edward
Publication year - 2017
Publication title -
epilepsia open
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.247
H-Index - 16
ISSN - 2470-9239
DOI - 10.1002/epi4.12079
Subject(s) - lacosamide , medicine , tolerability , placebo , discontinuation , adverse effect , anesthesia , population , subgroup analysis , epilepsy , psychiatry , alternative medicine , environmental health , pathology , confidence interval
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.