PMID- 34476770
OWN - NLM
STAT- MEDLINE
DCOM- 20220317
LR  - 20220317
IS  - 1179-1934 (Electronic)
IS  - 1172-7047 (Print)
IS  - 1172-7047 (Linking)
VI  - 35
IP  - 12
DP  - 2021 Dec
TI  - Adjunctive Brivaracetam in Focal Epilepsy: Real-World Evidence from the 
      BRIVAracetam add-on First Italian netwoRk STudy (BRIVAFIRST).
PG  - 1289-1301
LID - 10.1007/s40263-021-00856-3 [doi]
AB  - BACKGROUND: In randomized controlled trials, add-on brivaracetam (BRV) reduced 
      seizure frequency in patients with drug-resistant focal epilepsy. Studies 
      performed in a naturalistic setting are a useful complement to characterize the 
      drug profile. OBJECTIVE: This multicentre study assessed the effectiveness and 
      tolerability of adjunctive BRV in a large population of patients with focal 
      epilepsy in the context of real-world clinical practice. METHODS: The BRIVAFIRST 
      (BRIVAracetam add-on First Italian netwoRk STudy) was a retrospective, 
      multicentre study including adult patients prescribed adjunctive BRV. Patients 
      with focal epilepsy and 12-month follow-up were considered. Main outcomes 
      included the rates of seizure-freedom, seizure response (>/= 50% reduction in 
      baseline seizure frequency), and treatment discontinuation. The incidence of 
      adverse events (AEs) was also considered. Analyses by levetiracetam (LEV) status 
      and concomitant use of strong enzyme-inducing antiseizure medications (EiASMs) 
      and sodium channel blockers (SCBs) were performed. RESULTS: A total of 1029 
      patients with a median age of 45 years (33-56) was included. At 12 months, 169 
      (16.4%) patients were seizure-free and 383 (37.2%) were seizure responders. The 
      rate of seizure freedom was 22.3% in LEV-naive patients, 7.1% in patients with 
      prior LEV use and discontinuation due to insufficient efficacy, and 31.2% in 
      patients with prior LEV use and discontinuation due to AEs (p < 0.001); the 
      corresponding values for >/= 50% seizure frequency reduction were 47.9%, 29.7%, and 
      42.8% (p < 0.001). There were no statistically significant differences in seizure 
      freedom and seizure response rates by use of strong EiASMs. The rates of seizure 
      freedom (20.0% vs. 16.6%;  p = 0.341) and seizure response (39.7% vs. 26.9%; 
      p = 0.006) were higher in patients receiving SCBs than those not receiving SCBs; 
      265 (25.8%) patients discontinued BRV. AEs were reported by 30.1% of patients, 
      and were less common in patients treated with BRV and concomitant SCBs than those 
      not treated with SCBs (28.9% vs. 39.8%; p = 0.017). CONCLUSION: The BRIVAFIRST 
      provided real-world evidence on the effectiveness of BRV in patients with focal 
      epilepsy irrespective of LEV history and concomitant ASMs, and suggested 
      favourable therapeutic combinations.
CI  - (c) 2021. The Author(s).
FAU - Lattanzi, Simona
AU  - Lattanzi S
AUID- ORCID: 0000-0001-8748-0083
AD  - Neurological Clinic, Department of Experimental and Clinical Medicine, Marche 
      Polytechnic University, Via Conca 71, 60020, Ancona, Italy. 
      alfierelattanzisimona@gmail.com.
FAU - Canafoglia, Laura
AU  - Canafoglia L
AD  - Department of Epileptology, Fondazione IRCCS Istituto Neurologico Carlo Besta, 
      Milan, Italy.
FAU - Canevini, Maria Paola
AU  - Canevini MP
AD  - Epilepsy Center, Child Neuropsychiatry Unit, AAST Santi Paolo Carlo, Milan, 
      Italy.
AD  - Department of Health Sciences, Universita degli Studi, Milan, Italy.
FAU - Casciato, Sara
AU  - Casciato S
AD  - IRCCS Neuromed, Pozzilli, Italy.
FAU - Chiesa, Valentina
AU  - Chiesa V
AD  - Epilepsy Center, Child Neuropsychiatry Unit, AAST Santi Paolo Carlo, Milan, 
      Italy.
FAU - Dainese, Filippo
AU  - Dainese F
AD  - Epilepsy Centre, Neurology Unit, Venice, Italy.
FAU - De Maria, Giovanni
AU  - De Maria G
AD  - Clinical Neurophysiology Unit, Epilepsy Center, Spedali Civili, Brescia, Italy.
FAU - Didato, Giuseppe
AU  - Didato G
AD  - Epilepsy Unit, Fondazione IRCCS Istituto Neurologico "Carlo Besta", Milan, Italy.
FAU - Falcicchio, Giovanni
AU  - Falcicchio G
AD  - Department of Basic Medical Sciences, Neurosciences and Sense Organs, University 
      Hospital of Bari "A. Moro", Bari, Italy.
FAU - Fanella, Martina
AU  - Fanella M
AD  - Department of Human Neurosciences, Policlinico Umberto I, Sapienza University of 
      Rome, Rome, Italy.
FAU - Ferlazzo, Edoardo
AU  - Ferlazzo E
AD  - Department of Medical and Surgical Sciences, Magna Graecia University of 
      Catanzaro, Catanzaro, Italy.
FAU - Fisco, Giacomo
AU  - Fisco G
AD  - Department of Human Neurosciences, Policlinico Umberto I, Sapienza University of 
      Rome, Rome, Italy.
FAU - Gangitano, Massimo
AU  - Gangitano M
AD  - Department of Biomedicine, Neuroscience, and advanced Diagnostic (BIND), 
      University of Palermo, Palermo, Italy.
FAU - Giallonardo, Anna Teresa
AU  - Giallonardo AT
AD  - Department of Human Neurosciences, Policlinico Umberto I, Sapienza University of 
      Rome, Rome, Italy.
FAU - Giorgi, Filippo Sean
AU  - Giorgi FS
AD  - Department of Translational Research on New Technologies in Medicine and Surgery, 
      University of Pisa, Pisa, Italy.
AD  - Neurology Unit, Pisa University Hospital, Pisa, Italy.
FAU - La Neve, Angela
AU  - La Neve A
AD  - Department of Basic Medical Sciences, Neurosciences and Sense Organs, University 
      Hospital of Bari "A. Moro", Bari, Italy.
FAU - Mecarelli, Oriano
AU  - Mecarelli O
AD  - Department of Human Neurosciences, Policlinico Umberto I, Sapienza University of 
      Rome, Rome, Italy.
FAU - Montalenti, Elisa
AU  - Montalenti E
AD  - Epilepsy Center, AOU Citta della Salute e della Scienza di Torino, Turin, Italy.
FAU - Piazza, Federico
AU  - Piazza F
AD  - Department of Neurosciences, Rita Levi Montalcini, University of Turin, Turin, 
      Italy.
FAU - Pulitano, Patrizia
AU  - Pulitano P
AD  - Department of Human Neurosciences, Policlinico Umberto I, Sapienza University of 
      Rome, Rome, Italy.
FAU - Quarato, Pier Paolo
AU  - Quarato PP
AD  - IRCCS Neuromed, Pozzilli, Italy.
FAU - Ranzato, Federica
AU  - Ranzato F
AD  - Epilepsy Center, UOC Neurology, AULSS, 8 Vicenza, Vicenza, Italy.
FAU - Rosati, Eleonora
AU  - Rosati E
AD  - Department Neurology 2, Careggi University Hospital, Florence, Italy.
FAU - Tassi, Laura
AU  - Tassi L
AD  - C. Munari" Epilepsy Surgery Centre, Niguarda Hospital, Milan, Italy.
FAU - Di Bonaventura, Carlo
AU  - Di Bonaventura C
AD  - Department of Human Neurosciences, Policlinico Umberto I, Sapienza University of 
      Rome, Rome, Italy.
CN  - BRIVAFIRST Group Membership
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20210902
PL  - New Zealand
TA  - CNS Drugs
JT  - CNS drugs
JID - 9431220
RN  - 0 (Anticonvulsants)
RN  - 0 (Pyrrolidinones)
RN  - 44YRR34555 (Levetiracetam)
RN  - U863JGG2IA (brivaracetam)
SB  - IM
EIN - CNS Drugs. 2021 Nov 17;:. PMID: 34787838
MH  - Adult
MH  - Anticonvulsants/administration & dosage/*therapeutic use
MH  - Chemotherapy, Adjuvant
MH  - Drug Resistant Epilepsy/*drug therapy
MH  - Epilepsies, Partial/*drug therapy
MH  - Female
MH  - Humans
MH  - Italy
MH  - Levetiracetam/administration & dosage/therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Pyrrolidinones/administration & dosage/*therapeutic use
MH  - Retrospective Studies
MH  - Treatment Outcome
PMC - PMC8642333
COIS- Simona Lattanzi has received speaker's or consultancy fees from Angelini, Eisai, 
      GW Pharmaceuticals, and UCB Pharma, and has served on advisory boards for 
      Angelini, Arvelle Therapeutics, Bial, and GW Pharmaceuticals. Laura Canafoglia 
      has received consultancy fee from Eisai. Maria Paola Canevini has received 
      speaker's or consultancy fees from Bial, Eisai, Italfarmaco, Sanofi, and UCB 
      Pharma. Sara Casciato has participated in pharmaceutical industry-sponsored 
      symposia for Eisai, UCB Pharma and Lusofarmaco. Valentina Chiesa has received 
      speaker's or consultancy fees from Eisai and UCB Pharma. Anna Teresa Giallonardo 
      has received consulting fees or speaker honoraria from Eisai. Angela La Neve has 
      received speaker's or consultancy fees from Eisai, Mylan, Bial, Sanofi, and UCB 
      Pharma. Patrizia Pulitano has received consulting fees or speaker honoraria from 
      UCB Pharma and Eisai. Pier Paolo Quarato has participated in pharmaceutical 
      industry-sponsored clinical trials and symposia for UCB Pharma. Federica Ranzato 
      has received speaker's fees from Eisai, UCB, and Livanova. Eleonora Rosati has 
      received fees for participation in advisory board or scientific consultation from 
      Eisai, GW Pharmaceuticals, Bial, and UCB Pharma. Laura Tassi has received 
      speaker's or consultancy fees from Arvelle Therapeutics, Eisai and UCB Pharma. 
      Carlo Di Bonaventura has received consulting fees or speaker honoraria from UCB 
      Pharma, Eisai, GW Pharmaceuticals, Bial, and Lusopharma., Filippo Dainese, 
      Giovanni De Maria, Giuseppe Didato, Giovanni Falcicchio, Martina Fanella, Edoardo 
      Ferlazzo, Giacomo Fisco, Massimo Gangitano, Filippo Sean Giorgi, Oriano 
      Mecarelli, Elisa Montalenti and Federico Piazza have no conflicts of interest to 
      declare.
FIR - Alicino, Angela
IR  - Alicino A
FIR - Ascoli, Michele
IR  - Ascoli M
FIR - Assenza, Giovanni
IR  - Assenza G
FIR - Avorio, Federica
IR  - Avorio F
FIR - Badioni, Valeria
IR  - Badioni V
FIR - Banfi, Paola
IR  - Banfi P
FIR - Bartolini, Emanuele
IR  - Bartolini E
FIR - Basili, Luca Manfredi
IR  - Basili LM
FIR - Belcastro, Vincenzo
IR  - Belcastro V
FIR - Beretta, Simone
IR  - Beretta S
FIR - Berto, Irene
IR  - Berto I
FIR - Biggi, Martina
IR  - Biggi M
FIR - Billo, Giuseppe
IR  - Billo G
FIR - Boero, Giovanni
IR  - Boero G
FIR - Bonanni, Paolo
IR  - Bonanni P
FIR - Bongorno, Jole
IR  - Bongorno J
FIR - Brigo, Francesco
IR  - Brigo F
FIR - Caggia, Emanuele
IR  - Caggia E
FIR - Cagnetti, Claudia
IR  - Cagnetti C
FIR - Calvello, Carmen
IR  - Calvello C
FIR - Irelli, Emanuele Cerulli
IR  - Irelli EC
FIR - Cesnik, Edward
IR  - Cesnik E
FIR - Chianale, Gigliola
IR  - Chianale G
FIR - Ciampanelli, Domenico
IR  - Ciampanelli D
FIR - Ciuffini, Roberta
IR  - Ciuffini R
FIR - Cocito, Dario
IR  - Cocito D
FIR - Colella, Donato
IR  - Colella D
FIR - Contento, Margerita
IR  - Contento M
FIR - Costa, Cinzia
IR  - Costa C
FIR - Cumbo, Eduardo
IR  - Cumbo E
FIR - D'Aniello, Alfredo
IR  - D'Aniello A
FIR - Deleo, Francesco
IR  - Deleo F
FIR - DiFrancesco, Jacopo C
IR  - DiFrancesco JC
FIR - Di Gennaro, Giancarlo
IR  - Di Gennaro G
FIR - Di Giacomo, Roberta
IR  - Di Giacomo R
FIR - Di Liberto, Alessandra
IR  - Di Liberto A
FIR - Domina, Elisabetta
IR  - Domina E
FIR - Donato, Francesco
IR  - Donato F
FIR - Dono, Fedele
IR  - Dono F
FIR - Durante, Vania
IR  - Durante V
FIR - Elia, Maurizio
IR  - Elia M
FIR - Estraneo, Anna
IR  - Estraneo A
FIR - Evangelista, Giacomo
IR  - Evangelista G
FIR - Faedda, Maria Teresa
IR  - Faedda MT
FIR - Failli, Ylenia
IR  - Failli Y
FIR - Fallica, Elisa
IR  - Fallica E
FIR - Fattouch, Jinane
IR  - Fattouch J
FIR - Ferrari, Alessandra
IR  - Ferrari A
FIR - Ferreri, Florinda
IR  - Ferreri F
FIR - Fonti, Davide
IR  - Fonti D
FIR - Fortunato, Francesco
IR  - Fortunato F
FIR - Foschi, Nicoletta
IR  - Foschi N
FIR - Francavilla, Teresa
IR  - Francavilla T
FIR - Galli, Rosita
IR  - Galli R
FIR - Gazzina, Stefano
IR  - Gazzina S
FIR - Giuliano, Loretta
IR  - Giuliano L
FIR - Habetswallner, Francesco
IR  - Habetswallner F
FIR - Izzi, Francesca
IR  - Izzi F
FIR - Kassabian, Benedetta
IR  - Kassabian B
FIR - Labate, Angelo
IR  - Labate A
FIR - Luisi, Concetta
IR  - Luisi C
FIR - Magliani, Matteo
IR  - Magliani M
FIR - Maira, Giulia
IR  - Maira G
FIR - Mari, Luisa
IR  - Mari L
FIR - Marino, Daniela
IR  - Marino D
FIR - Mascia, Addolorata
IR  - Mascia A
FIR - Mazzeo, Alessandra
IR  - Mazzeo A
FIR - Meletti, Stefano
IR  - Meletti S
FIR - Morano, Alessandra
IR  - Morano A
FIR - Nilo, Annacarmen
IR  - Nilo A
FIR - Orlando, Biagio
IR  - Orlando B
FIR - Paladin, Francesco
IR  - Paladin F
FIR - Pascarella, Maria Grazia
IR  - Pascarella MG
FIR - Pastori, Chiara
IR  - Pastori C
FIR - Pauletto, Giada
IR  - Pauletto G
FIR - Peretti, Alessia
IR  - Peretti A
FIR - Perri, Gabriella
IR  - Perri G
FIR - Pezzella, Marianna
IR  - Pezzella M
FIR - Piccioli, Marta
IR  - Piccioli M
FIR - Pignatta, Pietro
IR  - Pignatta P
FIR - Pilolli, Nicola
IR  - Pilolli N
FIR - Pisani, Francesco
IR  - Pisani F
FIR - Pisani, Laura Rosa
IR  - Pisani LR
FIR - Placidi, Fabio
IR  - Placidi F
FIR - Pollicino, Patrizia
IR  - Pollicino P
FIR - Porcella, Vittoria
IR  - Porcella V
FIR - Pradella, Silvia
IR  - Pradella S
FIR - Puligheddu, Monica
IR  - Puligheddu M
FIR - Quadri, Stefano
IR  - Quadri S
FIR - Quintas, Rui
IR  - Quintas R
FIR - Renna, Rosaria
IR  - Renna R
FIR - Rossi, Jessica
IR  - Rossi J
FIR - Rum, Adriana
IR  - Rum A
FIR - Salamone, Enrico Michele
IR  - Salamone EM
FIR - Savastano, Ersilia
IR  - Savastano E
FIR - Sessa, Maria
IR  - Sessa M
FIR - Stokelj, David
IR  - Stokelj D
FIR - Tartara, Elena
IR  - Tartara E
FIR - Tombini, Mario
IR  - Tombini M
FIR - Tumminelli, Gemma
IR  - Tumminelli G
FIR - Ventura, Maria
IR  - Ventura M
FIR - Vigano, Ilaria
IR  - Vigano I
FIR - Viglietta, Emanuela
IR  - Viglietta E
FIR - Vignoli, Aglaia
IR  - Vignoli A
FIR - Villani, Flavio
IR  - Villani F
FIR - Zambrelli, Elena
IR  - Zambrelli E
FIR - Zummo, Lelia
IR  - Zummo L
EDAT- 2021/09/04 06:00
MHDA- 2022/03/18 06:00
PMCR- 2021/09/02
CRDT- 2021/09/03 07:07
PHST- 2021/08/09 00:00 [accepted]
PHST- 2021/09/04 06:00 [pubmed]
PHST- 2022/03/18 06:00 [medline]
PHST- 2021/09/03 07:07 [entrez]
PHST- 2021/09/02 00:00 [pmc-release]
AID - 10.1007/s40263-021-00856-3 [pii]
AID - 856 [pii]
AID - 10.1007/s40263-021-00856-3 [doi]
PST - ppublish
SO  - CNS Drugs. 2021 Dec;35(12):1289-1301. doi: 10.1007/s40263-021-00856-3. Epub 2021 
      Sep 2.