PMID- 31812902
OWN - NLM
STAT- MEDLINE
DCOM- 20201109
LR  - 20211204
IS  - 1525-5069 (Electronic)
IS  - 1525-5050 (Linking)
VI  - 102
DP  - 2020 Jan
TI  - Effectiveness and safety of perampanel as early add-on treatment in patients with 
      epilepsy and focal seizures in the routine clinical practice: Spain prospective 
      study (PERADON).
PG  - 106655
LID - S1525-5050(19)30715-2 [pii]
LID - 10.1016/j.yebeh.2019.106655 [doi]
AB  - OBJECTIVE: Perampanel (PER) has been shown to be effective as an adjunctive 
      therapy for controlling refractory focal-onset seizures (FOS). However, the 
      information as early add-on for the treatment of FOS in the clinical practice is 
      still scarce and must be further assessed. METHODS: An observational prospective 
      study was conducted to evaluate the effectiveness of early add-on PER, assessed 
      as 50% responders (seizure frequency reduced by at least 50% during the last 
      3 months as compared with baseline) rate at 6 and 12 months, in patients with FOS 
      in the routine clinical practice of Spain. RESULTS: One hundred and thirteen 
      patients (mean age: 40.3 years, 51.3% male) with FOS received PER as early add-on 
      (1st add-on: 37.2% and 2nd: 62.8%) for a mean exposure of 11 months (mean PER 
      dose: 6.3 mg/day at month 12). At 6 months, 50.4% and 20.4% of the patients were 
      responders and seizure-free (respectively) relative to baseline (3 months prior 
      to PER initiation), and at 12 months, 68.1% and 26.5% of the patients were 
      responders and seizure-free (respectively), relative to baseline (3 months prior 
      to PER initiation). The retention rate at 6 and 12 months was 83.2% and 80.5%, 
      respectively. The percentage of seizure-free patients at 12 months was 
      significantly (p = 0.033) higher when PER was added as first vs. second add-on. 
      The number of concomitant antiepileptic drugs (AEDs) was significantly reduced 
      from baseline to 6 and 12 months (p = 0.001). Treatment was simplified in 23.9% 
      of patients at the end of the observation period. Drug-related adverse events 
      (AEs), most mild or moderate, were reported in 30.1% of patients, with 
      irritability (8%) and dizziness (7.1%) as the most frequent ones. CONCLUSIONS: 
      This is the first observational, prospective study to evaluate efficacy and 
      safety of early adjunctive treatment with PER in patients with focal epilepsy at 
      12 months. Perampanel demonstrated a good efficacy and safety profile when used 
      at a median dose of 6 mg/day, regardless of the combination with other AEDs. 
      Adverse events were mild or moderate, with dizziness being the most frequent one.
CI  - Copyright (c) 2019 Elsevier Inc. All rights reserved.
FAU - Abril Jaramillo, Javier
AU  - Abril Jaramillo J
AD  - Centro de Neurologia Avanzada, Sevilla, Spain. Electronic address: 
      javierabriljaramillo@hotmail.com.
FAU - Estevez Maria, Jose Carlos
AU  - Estevez Maria JC
AD  - Hospital Reina Sofia, Cordoba, Spain.
FAU - Giron Ubeda, Juan Miguel
AU  - Giron Ubeda JM
AD  - Hospital de Jerez de la Frontera, Jerez, Spain.
FAU - Vega Lopez, Oscar
AU  - Vega Lopez O
AD  - Hospital Cruz Roja, Cordoba, Spain.
FAU - Calzado Rivas, Maria Elena
AU  - Calzado Rivas ME
AD  - Hospital de Jerez de la Frontera, Jerez, Spain.
FAU - Perez Diaz, Hernando
AU  - Perez Diaz H
AD  - Centro de Neurologia Avanzada, Sevilla, Spain.
FAU - Garcia Martin, Guillermina
AU  - Garcia Martin G
AD  - Hospital Virgen de la Victoria, Malaga, Spain.
FAU - Vila Herrero, Elena
AU  - Vila Herrero E
AD  - Hospital de Quiron Malaga, Spain.
FAU - Chamorro-Munoz, M
AU  - Chamorro-Munoz M
AD  - Hospital Virgen de la Victoria, Malaga, Spain.
FAU - Vazquez, F
AU  - Vazquez F
AD  - Hospital de Torrecardenas, Almeria, Spain.
FAU - De la Fuente, C
AU  - De la Fuente C
AD  - Hospital Vithas Xanit, Malaga, Spain.
FAU - Redondo, L
AU  - Redondo L
AD  - Hospital Virgen Macarena, Spain.
FAU - Pelaez, N
AU  - Pelaez N
AD  - Hospital Reina Sofia, Cordoba, Spain.
FAU - Santagueda, Patricia
AU  - Santagueda P
AD  - Biodatos S.A., Madrid, Spain.
FAU - Rodriguez Uranga, Juan Jesus
AU  - Rodriguez Uranga JJ
AD  - Centro de Neurologia Avanzada, Sevilla, Spain.
LA  - eng
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20191206
PL  - United States
TA  - Epilepsy Behav
JT  - Epilepsy & behavior : E&B
JID - 100892858
RN  - 0 (Anticonvulsants)
RN  - 0 (Nitriles)
RN  - 0 (Pyridones)
RN  - H821664NPK (perampanel)
SB  - IM
EIN - Epilepsy Behav. 2020 Mar;104(Pt A):106917. PMID: 32005527
MH  - Adult
MH  - Anticonvulsants/*administration & dosage/adverse effects
MH  - Dizziness/chemically induced
MH  - Drug Therapy, Combination
MH  - Epilepsy/*drug therapy/*epidemiology
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Nitriles
MH  - Prospective Studies
MH  - Pyridones/*administration & dosage/adverse effects
MH  - Seizures/*drug therapy/*epidemiology
MH  - Spain/epidemiology
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - Antiepileptic drug
OT  - Early add-on
OT  - Epilepsy
OT  - Focal-onset seizures
OT  - Perampanel
EDAT- 2019/12/10 06:00
MHDA- 2020/11/11 06:00
CRDT- 2019/12/09 06:00
PHST- 2019/08/02 00:00 [received]
PHST- 2019/10/02 00:00 [revised]
PHST- 2019/10/04 00:00 [accepted]
PHST- 2019/12/10 06:00 [pubmed]
PHST- 2020/11/11 06:00 [medline]
PHST- 2019/12/09 06:00 [entrez]
AID - S1525-5050(19)30715-2 [pii]
AID - 10.1016/j.yebeh.2019.106655 [doi]
PST - ppublish
SO  - Epilepsy Behav. 2020 Jan;102:106655. doi: 10.1016/j.yebeh.2019.106655. Epub 2019 
      Dec 6.