PMID- 26861566
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20160624
LR  - 20200930
IS  - 2193-8253 (Print)
IS  - 2193-6536 (Electronic)
IS  - 2193-6536 (Linking)
VI  - 5
IP  - 1
DP  - 2016 Jun
TI  - Treatment of Adults with Lennox-Gastaut Syndrome: Further Analysis of Efficacy 
      and Safety/Tolerability of Rufinamide.
PG  - 35-43
LID - 10.1007/s40120-016-0041-9 [doi]
AB  - INTRODUCTION: Management of Lennox-Gastaut syndrome (LGS) in adulthood can be 
      particularly challenging. Published reports describing the use of rufinamide 
      specifically in adult patients with LGS are scarce. A post hoc subgroup analysis 
      of data from a phase III trial was conducted to investigate the efficacy and 
      safety/tolerability of rufinamide in adults with LGS. METHODS: A randomized, 
      double-blind, placebo-controlled trial was conducted in patients with LGS, aged 
      4 years and above. During an 84-day, double-blind treatment period, patients 
      received either adjunctive rufinamide therapy or placebo. Efficacy and 
      safety/tolerability were assessed in a post hoc subgroup analysis of adult 
      patients (>/=18 years). Efficacy was assessed as change from baseline in 28-day 
      seizure frequency, 50% responder rate, and seizure freedom rate; each calculated 
      for total seizures and drop attacks. Safety/tolerability assessments included the 
      evaluation of adverse events (AEs). RESULTS: Thirty-one adults aged 18-37 years 
      with LGS received treatment with either rufinamide (n = 21) or placebo (n = 10). 
      Three patients in the rufinamide group did not complete the trial. The median 
      change from baseline in seizure frequency was -31.5% for rufinamide versus +22.1% 
      for placebo (P = 0.008) for all seizures and -54.9% versus +21.7% (P = 0.002) for 
      drop attacks. Responder rates were 33.3% for rufinamide versus 0% for placebo 
      (P = 0.066) for all seizures and 57.1% versus 10.0% (P = 0.020) for drop attacks. 
      No patient achieved freedom from all seizures but two rufinamide-treated patients 
      (9.5%) became free of drop attacks. Overall, 71.4% of patients treated with 
      rufinamide and 60.0% of patients treated with placebo experienced AEs; most 
      commonly, somnolence (33.3% vs. 20.0%) and vomiting (19.0% vs. 0%). Most AEs were 
      of mild or moderate intensity. CONCLUSION: Rufinamide demonstrated favorable 
      efficacy and was generally well tolerated when used as adjunctive treatment for 
      adults with LGS. FUNDING: Eisai.
FAU - McMurray, Rob
AU  - McMurray R
AD  - European Knowledge Centre, Eisai Europe Ltd, Mosquito Way, Hatfield, 
      Hertfordshire, AL10 9SN, UK. Rob_McMurray@eisai.net.
FAU - Striano, Pasquale
AU  - Striano P
AD  - Department of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal 
      and Child Health, G. Gaslini Institute, University of Genoa, Genoa, Italy.
LA  - eng
PT  - Journal Article
DEP - 20160210
PL  - New Zealand
TA  - Neurol Ther
JT  - Neurology and therapy
JID - 101637818
PMC - PMC4919131
OTO - NOTNLM
OT  - Adult
OT  - Antiepileptic drug
OT  - Epilepsy
OT  - Lennox-Gastaut syndrome
OT  - Rufinamide
EDAT- 2016/02/11 06:00
MHDA- 2016/02/11 06:01
PMCR- 2016/02/10
CRDT- 2016/02/11 06:00
PHST- 2015/12/18 00:00 [received]
PHST- 2016/02/11 06:00 [entrez]
PHST- 2016/02/11 06:00 [pubmed]
PHST- 2016/02/11 06:01 [medline]
PHST- 2016/02/10 00:00 [pmc-release]
AID - 10.1007/s40120-016-0041-9 [pii]
AID - 41 [pii]
AID - 10.1007/s40120-016-0041-9 [doi]
PST - ppublish
SO  - Neurol Ther. 2016 Jun;5(1):35-43. doi: 10.1007/s40120-016-0041-9. Epub 2016 Feb 
      10.