PMID- 29588972
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200930
IS  - 2470-9239 (Print)
IS  - 2470-9239 (Electronic)
IS  - 2470-9239 (Linking)
VI  - 2
IP  - 4
DP  - 2017 Dec
TI  - Safety and tolerability of lacosamide monotherapy in the elderly: A subgroup 
      analysis from lacosamide trials in diabetic neuropathic pain.
PG  - 415-423
LID - 10.1002/epi4.12079 [doi]
AB  - 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.
FAU - Bainbridge, Jacquelyn
AU  - Bainbridge J
AUID- ORCID: 0000-0001-5649-1564
AD  - University of Colorado Anschutz Medical Campus Skaggs School of Pharmacy and 
      Pharmaceutical Sciences Aurora Colorado U.S.A.
FAU - De Backer, Marc
AU  - De Backer M
AD  - UCB Pharma Brussels Belgium.
FAU - Eckhardt, Klaus
AU  - Eckhardt K
AD  - UCB Pharma Monheim am Rhein Germany.
FAU - Tennigkeit, Frank
AU  - Tennigkeit F
AD  - UCB Pharma Monheim am Rhein Germany.
FAU - Bongardt, Sabine
AU  - Bongardt S
AD  - UCB Pharma Monheim am Rhein Germany.
FAU - Sen, David
AU  - Sen D
AD  - UCB Pharma Raleigh North Carolina U.S.A.
FAU - Werhahn, Konrad J
AU  - Werhahn KJ
AD  - UCB Pharma Monheim am Rhein Germany.
FAU - Shaibani, Aziz
AU  - Shaibani A
AD  - Nerve and Muscle Center of Texas Houston Texas U.S.A.
FAU - Faught, Edward
AU  - Faught E
AD  - Emory University School of Medicine Atlanta Georgia U.S.A.
LA  - eng
PT  - Journal Article
DEP - 20170911
PL  - United States
TA  - Epilepsia Open
JT  - Epilepsia open
JID - 101692036
PMC - PMC5862116
OTO - NOTNLM
OT  - Elderly
OT  - Epilepsy
OT  - Lacosamide
OT  - Safety
OT  - Tolerability
EDAT- 2018/03/29 06:00
MHDA- 2018/03/29 06:01
PMCR- 2017/09/11
CRDT- 2018/03/29 06:00
PHST- 2017/07/16 00:00 [accepted]
PHST- 2018/03/29 06:00 [entrez]
PHST- 2018/03/29 06:00 [pubmed]
PHST- 2018/03/29 06:01 [medline]
PHST- 2017/09/11 00:00 [pmc-release]
AID - EPI412079 [pii]
AID - 10.1002/epi4.12079 [doi]
PST - epublish
SO  - Epilepsia Open. 2017 Sep 11;2(4):415-423. doi: 10.1002/epi4.12079. eCollection 
      2017 Dec.