Safety and tolerability of lacosamide monotherapy in elderly: A subgroup analysis from lacosamide trials in diabetic neuropathic pain (P1.239)

OBJECTIVE: To analyze the safety and tolerability of lacosamide (LCM) monotherapy in elderly patients. BACKGROUND: Adjunctive LCM epilepsy trials enrolled few elderly (蠅65 years). The safety profile of LCM monotherapy in elderly was analyzed from diabetic neuropathic pain trials (DNP; discontinued program). DESIGN/METHODS: Of 1500 patients with DNP enrolled in double-blind, placebo-controlled trials of LCM monotherapy up to 400mg/day (NCT00861445, NCT00235469, NCT00238524, NCT00135109, NCT00350103), 411 were elderly. Safety data of elderly and younger patients (<65 years) were compared within these trials and with pivotal epilepsy trials in adjunctive treatment in adult patients (n=1105; 17 (1.5[percnt]) 蠅65 years). The DNP population was older and at higher cardiovascular risk. RESULTS: In the DNP population, the most frequently reported adverse events (AEs) for LCM monotherapy (200 and 400mg/day combined) in elderly vs younger patients were dizziness (11.7[percnt] vs 9.4[percnt]), nausea (9.1[percnt] vs 7.1[percnt]) and headache (7.0[percnt] vs 8.1[percnt]). Incidences of Cardiac Disorders AEs were higher in elderly vs younger patients in placebo (6.2[percnt] vs 3.9[percnt]), LCM 200mg/day (4.8[percnt] vs 3.3[percnt]) and 400mg/day groups (7.0[percnt] vs 4.1[percnt]). Discontinuations due to any AE in elderly vs younger patients were similar for placebo (3.5[percnt] vs 3.1[percnt]) and LCM 200mg/day (7.2[percnt] vs 7.9[percnt]) and higher for LCM 400mg/day (17.2[percnt] vs 6.5[percnt]). Within the epilepsy trials (n=1105), common AEs for adjunctive LCM (200 and 400mg/day combined) were dizziness (24.6[percnt]), headache (12.8[percnt]) and nausea (9.9[percnt]). Incidences of Cardiac Disorders AEs were 1.4[percnt] (placebo), 2.2[percnt] (LCM 200mg/day) and 2.8[percnt] (400mg/day). Discontinuations for placebo, LCM 200 and 400 mg/day groups, respectively, were 4.9[percnt], 8.1[percnt] and 17.2[percnt] for any AE and 0.5[percnt], 0.4[percnt] and 4.2[percnt] for dizziness. CONCLUSIONS: LCM monotherapy up to 400mg/day was well tolerated in elderly with DNP, with an overall AE profile comparable to observations from epilepsy trials. Study Supported by: UCB Pharma Disclosure: Dr. Faugh has received personal compensation for activities with Lundbeck Research USA, Inc., Esai Inc., SK Life Science, Inc., Acordia Therapeutics, Inc., Supernus Pharmaceuticals, Upsher-Smith, and UCB Pharma. Dr. De Backer has received personal compensation for activities with UCB Pharma as an employee. Dr. Eckhardt has received personal compensation for activities with UCB Pharma as employee. Dr. Tennigkeit has received personal compensation for activities with UCB Pharma as an employee. Dr. Bongardt has received personal compensation for activities with UCB Pharma as employee. Dr. Rudd has received personal compensation for activities with UCB Pharma as a consultant. Dr. Rudd holds stock and/or stock options in UCB Pharma. Dr. Sen has received stock and/or stock options in UCB Pharma. Dr. Werhahn holds stock and/or stock options in UCB Pharma.