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Author Notes:

Edward Faught, Emory University, Brain Health Center 292, 12 Executive Park Drive NE, Atlanta, GA 30329, U.S.A. E‐mail: rfaught@emory.edu

The authors acknowledge the contributions of David Rudd to this analysis.

The authors thank the subjects and their caregivers in addition to the investigators and their teams who contributed to this study.

The authors acknowledge Jesse Fishman, PharmD, of UCB Pharma (Atlanta, Georgia, U.S.A.) for publication coordination.

Editorial support was provided by Richard Fay and Lynne Isbell of Evidence Scientific Solutions (Philadelphia, Pennsylvania, U.S.A.) and was funded by UCB Pharma.

Jacquelyn Bainbridge has received honoraria for service on advisory boards from Sunovion and UCB Pharma, investigator‐initiated grant funding from Supernus and UCB Pharma, and grant support from NINDS.

Marc De Backer, Klaus Eckhardt, Frank Tennigkeit, Sabine Bongardt, and Konrad J. Werhahn are all employees of UCB Pharma.

David Sen was an employee of UCB Pharma at the time of the study.

Aziz Shaibani has no conflict of interest to disclose.

Edward Faught has received consulting fees from Eisai, SAGE, Sunovion, UCB, and Upsher‐Smith and for service on Data Safety Monitoring Boards from Eisai, Lundbeck, and SK Life Science.

Edward Faught has received research support from Brain Sentinel and UCB.

We confirm that we have read the Journal's position on issues involved in ethical publication and affirm that this report is consistent with those guideline.

Subjects:

Research Funding:

This study was a UCB Pharma–sponsored study.

Keywords:

  • Lacosamide
  • Elderly
  • Epilepsy
  • Tolerability
  • Safety

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

Tools:

Journal Title:

Epilepsia Open

Volume:

Volume 2, Number 4

Publisher:

, Pages 415-423

Type of Work:

Article | Final Publisher PDF

Abstract:

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 (AEs) 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 AEs 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.

Copyright information:

© 2017 The Authors. Epilepsia Open published by Wiley Periodicals Inc. on behalf of International League Against Epilepsy.

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