PMID- 25488477
OWN - NLM
STAT- MEDLINE
DCOM- 20150925
LR  - 20220410
IS  - 1179-1918 (Electronic)
IS  - 1173-2563 (Linking)
VI  - 35
IP  - 2
DP  - 2015 Feb
TI  - Early add-on lacosamide in a real-life setting: results of the REALLY study.
PG  - 121-31
LID - 10.1007/s40261-014-0255-5 [doi]
AB  - BACKGROUND AND OBJECTIVES: Many patients with epilepsy are treated with 
      antiepileptic drug (AED) polytherapy. Several factors influence the choice of 
      early add-on therapy, and deciding on the most appropriate drug can be difficult. 
      This study aimed to assess the efficacy and tolerability of lacosamide as early 
      add-on therapy in patients with partial-onset seizures. METHODS: REALLY 
      (REtrospective study of lAcosamide as earLy add-on aLong one Year) was a 
      multicenter, retrospective, 1-year, real-life study. Patients included were aged 
      older than 16 years, had partial-onset seizures, and were treated with lacosamide 
      as add-on therapy after one or two prior AEDs. Data were collected 
      retrospectively from clinical records. The primary study objective was to assess 
      the efficacy of lacosamide over 12 months (seizure-free and responder rates), and 
      the secondary objective was to assess the tolerability of lacosamide at 3, 6, and 
      12 months [adverse events (AEs) and discontinuation]. RESULTS: One hundred and 
      ninety-nine patients were enrolled in the study; 89 patients (44.7 %) had tried 
      one AED and 110 patients (55.3 %) had tried two AEDs before lacosamide. At 
      12 months, the proportion of patients who were seizure free was 44.9 %, and 76 % 
      of patients were responders. The seizure-free rate at 12 months for patients who 
      had previously received one or two AEDs was 58 and 34.3 %, and the responder rate 
      at 12 months was 83.0 and 70.4 %, respectively. The AE rate was 21.5 % at 
      3 months, 27.1 % at 6 months, and 31.2 % at 12 months, with 7.0 % of patients 
      discontinuing treatment because of an AE. The most common AE reported was 
      dizziness (11.6 %). Cryptogenic epilepsy, a higher number of prior AEDs, and the 
      use of a sodium channel blocker at onset were associated with a worse outcome. 
      The number of concomitant AEDs decreased over 1 year (Z = 5.89; p < 0.001). 
      Twenty-two patients were converted to lacosamide monotherapy with at least one 
      evaluation >/=6 months from the beginning of monotherapy conversion. CONCLUSIONS: 
      Lacosamide was effective and well tolerated as early add-on treatment in patients 
      who had received one or two previous AEDs.
FAU - Villanueva, Vicente
AU  - Villanueva V
AD  - Hospital Universitario y Politecnico La Fe, Bulevard Sur, s/n, Carretera de 
      Malilla, 46026, Valencia, Spain, vevillanuevah@yahoo.es.
FAU - Garces, Mercedes
AU  - Garces M
FAU - Lopez-Gomariz, Elena
AU  - Lopez-Gomariz E
FAU - Serratosa, Jose Maria
AU  - Serratosa JM
FAU - Gonzalez-Giraldez, Beatriz
AU  - Gonzalez-Giraldez B
FAU - Parra, Jaime
AU  - Parra J
FAU - Rodriguez-Uranga, Juan
AU  - Rodriguez-Uranga J
FAU - Toledo, Manuel
AU  - Toledo M
FAU - Lopez Gonzalez, Francisco Javier
AU  - Lopez Gonzalez FJ
FAU - Bermejo, Pedro
AU  - Bermejo P
FAU - Giner, Pau
AU  - Giner P
FAU - Castillo, Ascension
AU  - Castillo A
FAU - Molins, Albert
AU  - Molins A
FAU - Campos, Dulce
AU  - Campos D
FAU - Mauri, Jose Angel
AU  - Mauri JA
FAU - Munoz, Rosario
AU  - Munoz R
FAU - Bonet, Macarena
AU  - Bonet M
FAU - Serrano-Castro, Pedro
AU  - Serrano-Castro P
FAU - del Villar, Ana
AU  - del Villar A
FAU - Saiz-Diaz, Rosa Ana
AU  - Saiz-Diaz RA
CN  - REALLY Study Group
LA  - eng
PT  - Journal Article
PL  - New Zealand
TA  - Clin Drug Investig
JT  - Clinical drug investigation
JID - 9504817
RN  - 0 (Acetamides)
RN  - 0 (Anticonvulsants)
RN  - 563KS2PQY5 (Lacosamide)
SB  - IM
MH  - Acetamides/*administration & dosage/therapeutic use
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anticonvulsants/*administration & dosage/therapeutic use
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Lacosamide
MH  - Male
MH  - Middle Aged
MH  - Retrospective Studies
MH  - Seizures/*drug therapy
MH  - Young Adult
EDAT- 2014/12/10 06:00
MHDA- 2015/09/26 06:00
CRDT- 2014/12/10 06:00
PHST- 2014/12/10 06:00 [entrez]
PHST- 2014/12/10 06:00 [pubmed]
PHST- 2015/09/26 06:00 [medline]
AID - 10.1007/s40261-014-0255-5 [doi]
PST - ppublish
SO  - Clin Drug Investig. 2015 Feb;35(2):121-31. doi: 10.1007/s40261-014-0255-5.