PMID- 20041945
OWN - NLM
STAT- MEDLINE
DCOM- 20100802
LR  - 20181201
IS  - 1528-1167 (Electronic)
IS  - 0013-9580 (Linking)
VI  - 51
IP  - 6
DP  - 2010 Jun
TI  - Intravenous lacosamide as short-term replacement for oral lacosamide in 
      partial-onset seizures.
PG  - 951-7
LID - 10.1111/j.1528-1167.2009.02463.x [doi]
AB  - PURPOSE: Lacosamide is a new antiepileptic drug effective for adjunctive 
      treatment of partial-onset seizures. We evaluated the safety and tolerability of 
      an intravenous (i.v.) formulation of lacosamide (200-800 mg/day) infused over 10, 
      15, and 30 min as short-term replacement for oral lacosamide in patients with 
      partial-onset seizures. METHODS: This multicenter, open-label, inpatient trial 
      enrolled 160 patients from ongoing open-label, long-term trials who were taking 
      stable doses of oral lacosamide and up to three concomitant antiepileptic drugs 
      (AEDs). Serial cohorts of patients were converted from oral lacosamide treatment 
      to the same intravenous doses infused over progressively shorter infusion 
      durations: 30, 15, and 10 min for 2-5 days. A data monitoring committee (DMC) 
      reviewed safety data for each cohort. The safety of intravenous lacosamide was 
      assessed from adverse events (AEs), laboratory variables, electrocardiography 
      findings, and physical/neurologic examinations. RESULTS: A total of 160 patients 
      received lacosamide 200-800 mg/day, i.v., for 2-5 days, of which 69% received 
      400-800 mg/day doses. The most common AEs (reported by <or=10% of patients) were 
      headache, dizziness, and somnolence. There was no increase in frequency or 
      severity of AEs with shorter durations of infusion or increased days of exposure. 
      AEs were similar, but more frequent, with higher doses (>or=400 mg/day). 
      Injection-site events were rare and did not appear to be linked to infusion doses 
      or rates. Lacosamide plasma concentrations were linearly related to dose across 
      the cohorts. DISCUSSION: This comprehensive evaluation supports the safety of an 
      intravenous lacosamide infusion duration as short as 15 min for short-term (2-5 
      days) replacement for patients temporarily unable to take oral lacosamide.
FAU - Krauss, Gregory
AU  - Krauss G
AD  - Department of Neurology, Johns Hopkins Hospital, Baltimore, Maryland 21287-7247, 
      USA. gkrauss@jhmi.edu
FAU - Ben-Menachem, Elinor
AU  - Ben-Menachem E
FAU - Mameniskiene, Ruta
AU  - Mameniskiene R
FAU - Vaiciene-Magistris, Nerija
AU  - Vaiciene-Magistris N
FAU - Brock, Melissa
AU  - Brock M
FAU - Whitesides, John G
AU  - Whitesides JG
FAU - Johnson, Martin E
AU  - Johnson ME
CN  - SP757 Study Group
LA  - eng
SI  - ClinicalTrials.gov/NCT00151879
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20091222
PL  - United States
TA  - Epilepsia
JT  - Epilepsia
JID - 2983306R
RN  - 0 (Acetamides)
RN  - 563KS2PQY5 (Lacosamide)
SB  - IM
MH  - Acetamides/*administration & dosage/adverse effects
MH  - Administration, Oral
MH  - Adult
MH  - Aged
MH  - Cohort Studies
MH  - Diplopia/chemically induced
MH  - Drug Administration Schedule
MH  - Epilepsies, Partial/*drug therapy/physiopathology
MH  - Female
MH  - Humans
MH  - Infusions, Intravenous
MH  - Internationality
MH  - Lacosamide
MH  - Male
MH  - Middle Aged
MH  - Seizures/*drug therapy/physiopathology
MH  - Young Adult
EDAT- 2010/01/01 06:00
MHDA- 2010/08/03 06:00
CRDT- 2010/01/01 06:00
PHST- 2010/01/01 06:00 [entrez]
PHST- 2010/01/01 06:00 [pubmed]
PHST- 2010/08/03 06:00 [medline]
AID - EPI2463 [pii]
AID - 10.1111/j.1528-1167.2009.02463.x [doi]
PST - ppublish
SO  - Epilepsia. 2010 Jun;51(6):951-7. doi: 10.1111/j.1528-1167.2009.02463.x. Epub 2009 
      Dec 22.