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  1. Article ; Online: Restricting valproate prescribing in men: wisdom or folly?

    Berkovic, Samuel F / Perucca, Emilio

    Practical neurology

    2024  

    Language English
    Publishing date 2024-03-18
    Publishing country England
    Document type Editorial
    ZDB-ID 2170881-2
    ISSN 1474-7766 ; 1474-7758
    ISSN (online) 1474-7766
    ISSN 1474-7758
    DOI 10.1136/pn-2024-004097
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    Zs.A 6001: Show issues Location:
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  2. Article ; Online: Antiepileptic drugs: evolution of our knowledge and changes in drug trials.

    Perucca, Emilio

    Epileptic disorders : international epilepsy journal with videotape

    2019  Volume 21, Issue 4, Page(s) 319–329

    Abstract: Clinical trials provide the evidence needed for rational use of medicines. The evolution of drug trials follows largely the evolution of regulatory requirements. This article summarizes methodological changes in antiepileptic drug trials and associated ... ...

    Abstract Clinical trials provide the evidence needed for rational use of medicines. The evolution of drug trials follows largely the evolution of regulatory requirements. This article summarizes methodological changes in antiepileptic drug trials and associated advances in knowledge starting from 1938, the year phenytoin was introduced and also the year when evidence of safety was made a requirement for the marketing of medicines in the United States. The first period (1938-1969) saw the introduction of over 20 new drugs for epilepsy, many of which did not withstand the test of time. Only few well controlled trials were completed in that period and trial designs were generally suboptimal due to methodological constraints. The intermediate period (1970-1988) did not see the introduction of any major new medication, but important therapeutic advances took place due to improved understanding of the properties of available drugs. The value of therapeutic drug monitoring and monotherapy were recognized during the intermediate period, which also saw major improvements in trial methodology. The last period (1989-2019) was dominated by the introduction of second-generation drugs, and further evolution in the design of monotherapy and adjunctive-therapy trials. The expansion of the pharmacological armamentarium has improved opportunities for tailoring drug treatment to the characteristics of the individual. However, there is still inadequate evidence from controlled trials to guide treatment selection for most epilepsy syndromes, particularly in children. Second-generation drugs had a very modest impact on drug resistance, and a change in paradigm for drug discovery and development is needed, focusing on treatments that target the causes and mechanisms of epilepsy rather than its symptoms. Testing potential disease modifying agents will require innovative trial designs and novel endpoints, and will hopefully lead to introduction of safer and more effective therapies.
    MeSH term(s) Anticonvulsants/history ; Anticonvulsants/therapeutic use ; Carbamazepine/therapeutic use ; Drug Monitoring/history ; Drug Monitoring/methods ; Epilepsy/drug therapy ; Epilepsy, Generalized/drug therapy ; Epileptic Syndromes/drug therapy ; History, 20th Century ; History, 21st Century ; Humans
    Chemical Substances Anticonvulsants ; Carbamazepine (33CM23913M)
    Language English
    Publishing date 2019-08-12
    Publishing country France
    Document type Historical Article ; Journal Article ; Review
    ZDB-ID 2086797-9
    ISSN 1950-6945 ; 1294-9361
    ISSN (online) 1950-6945
    ISSN 1294-9361
    DOI 10.1684/epd.2019.1083
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    Zs.A 5740: Show issues Location:
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    Zs.MO 252: Show issues
    Zs.MN 11: Show issues

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  3. Article ; Online: Lorcaserin for Dravet Syndrome: A Potential Advance Over Fenfluramine?

    Bialer, Meir / Perucca, Emilio

    CNS drugs

    2022  Volume 36, Issue 2, Page(s) 113–122

    Abstract: Lorcaserin, a selective serotonin 5- ... ...

    Abstract Lorcaserin, a selective serotonin 5-HT
    MeSH term(s) Animals ; Anticonvulsants/pharmacokinetics ; Anticonvulsants/therapeutic use ; Benzazepines/pharmacokinetics ; Benzazepines/therapeutic use ; Disease Models, Animal ; Drug Development/methods ; Epilepsies, Myoclonic/drug therapy ; Humans ; Risk Assessment ; Serotonin 5-HT2 Receptor Agonists/pharmacokinetics ; Serotonin 5-HT2 Receptor Agonists/therapeutic use
    Chemical Substances Anticonvulsants ; Benzazepines ; Serotonin 5-HT2 Receptor Agonists ; lorcaserin (637E494O0Z)
    Language English
    Publishing date 2022-01-30
    Publishing country New Zealand
    Document type Journal Article ; Review
    ZDB-ID 1203800-3
    ISSN 1179-1934 ; 1172-7047
    ISSN (online) 1179-1934
    ISSN 1172-7047
    DOI 10.1007/s40263-022-00896-3
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  4. Article ; Online: Drug resistance in epilepsy.

    Perucca, Emilio / Perucca, Piero / White, H Steve / Wirrell, Elaine C

    The Lancet. Neurology

    2023  Volume 22, Issue 8, Page(s) 723–734

    Abstract: Drug resistance is estimated to affect about a third of individuals with epilepsy, but its prevalence differs in relation to the epilepsy syndrome, the cause of epilepsy, and other factors such as age of seizure onset and presence of associated ... ...

    Abstract Drug resistance is estimated to affect about a third of individuals with epilepsy, but its prevalence differs in relation to the epilepsy syndrome, the cause of epilepsy, and other factors such as age of seizure onset and presence of associated neurological deficits. Although drug-resistant epilepsy is not synonymous with unresponsiveness to any drug treatment, the probability of achieving seizure freedom on a newly tried medication decreases with increasing number of previously failed treatments. After two appropriately used antiseizure medications have failed to control seizures, individuals should be referred whenever possible to a comprehensive epilepsy centre for diagnostic re-evaluation and targeted management. The feasibility of epilepsy surgery and other treatments, including those targeting the cause of epilepsy, should be considered early after diagnosis. Substantial evidence indicates that a delay in identifying an effective treatment can adversely affect ultimate outcome and carry an increased risk of cognitive disability, other comorbidities, and premature mortality. Research on mechanisms of drug resistance and novel therapeutics is progressing rapidly, and potentially improved treatments, including those targeting disease modification, are on the horizon.
    MeSH term(s) Humans ; Anticonvulsants/therapeutic use ; Epilepsy/drug therapy ; Epilepsy/diagnosis ; Seizures/drug therapy ; Treatment Outcome ; Drug Resistant Epilepsy/drug therapy ; Drug Resistance
    Chemical Substances Anticonvulsants
    Language English
    Publishing date 2023-06-20
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2081241-3
    ISSN 1474-4465 ; 1474-4422
    ISSN (online) 1474-4465
    ISSN 1474-4422
    DOI 10.1016/S1474-4422(23)00151-5
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    Zs.A 5955: Show issues Location:
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  5. Article ; Online: Drug interactions with carbamazepine: An ever expanding list?

    Perucca, Emilio

    Epilepsy research

    2018  Volume 147, Page(s) 119–120

    Abstract: In a study that applied a nonlinear mixed effect model to evaluate factors affecting steady-state serum carbamazepine concentrations in elderly nursing home residents, co-administration of iron supplements was reported to reduce serum carbamazepine ... ...

    Abstract In a study that applied a nonlinear mixed effect model to evaluate factors affecting steady-state serum carbamazepine concentrations in elderly nursing home residents, co-administration of iron supplements was reported to reduce serum carbamazepine concentrations by approximately one third. Although these findings suggest that iron ions reduce the oral bioavailability of carbamazepine, the influence of confounders cannot be excluded. Further studies are required to confirm this interaction.
    MeSH term(s) Aged ; Carbamazepine ; Dietary Supplements ; Drug Interactions ; Humans ; Iron ; Nursing Homes
    Chemical Substances Carbamazepine (33CM23913M) ; Iron (E1UOL152H7)
    Language English
    Publishing date 2018-08-06
    Publishing country Netherlands
    Document type Letter ; Comment
    ZDB-ID 632939-1
    ISSN 1872-6844 ; 0920-1211
    ISSN (online) 1872-6844
    ISSN 0920-1211
    DOI 10.1016/j.eplepsyres.2018.08.001
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    Zs.A 2193: Show issues Location:
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  6. Article: From clinical trials of antiepileptic drugs to treatment.

    Perucca, Emilio

    Epilepsia open

    2018  Volume 3, Issue Suppl Suppl 2, Page(s) 220–230

    Abstract: Rational prescribing should be based on the assessment of high-quality evidence about the benefits and risks of available treatment options. Because clinical trials, particularly randomized controlled trials (RCTs), provide the best source of evidence, ... ...

    Abstract Rational prescribing should be based on the assessment of high-quality evidence about the benefits and risks of available treatment options. Because clinical trials, particularly randomized controlled trials (RCTs), provide the best source of evidence, their design and results need to be carefully scrutinized. The majority of RCTs of antiepileptic drugs (AEDs) have been designed to address regulatory requirements, and generally they involve restrictive eligibility criteria, rigid dosing schemes, short duration of follow-up, and comparison with placebo rather than standard treatments. Although these studies have high internal validity, they are conducted in a setting that is distant from routine clinical practice and therefore their usefulness in guiding treatment decisions is limited. Information more directly applicable to clinical practice can be derived from a relatively small number of comparative effectiveness monotherapy RCTs, although the design of some of these studies was probably biased in favor of the sponsor's product. Alarmingly, there is a paucity of well-designed trials in epilepsy syndromes other than focal epilepsies, and no RCTs at all in most of the less common epileptic syndromes of infancy and childhood. In the light of these shortcomings, there is scope for re-assessing regulatory requirements to facilitate generation of data more directly applicable to the routine clinical setting. Likewise, research-funding organizations should be sensitized about the lack of adequate evidence to guide therapeutic practice in epilepsy, and the need to promote high-quality comparative effectiveness trials. Future prospective pragmatic trials may benefit from the increasingly widespread availability of electronic health records.
    Language English
    Publishing date 2018-07-10
    Publishing country United States
    Document type Journal Article
    ISSN 2470-9239
    ISSN 2470-9239
    DOI 10.1002/epi4.12239
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  7. Article ; Online: New GABA-Targeting Therapies for the Treatment of Seizures and Epilepsy: I. Role of GABA as a Modulator of Seizure Activity and Recently Approved Medications Acting on the GABA System.

    Perucca, Emilio / Bialer, Meir / White, H Steve

    CNS drugs

    2023  Volume 37, Issue 9, Page(s) 755–779

    Abstract: γ-Aminobutyric acid (GABA) is the most prevalent inhibitory neurotransmitter in the mammalian brain and has been found to play an important role in the pathogenesis or the expression of many neurological diseases, including epilepsy. Although GABA can ... ...

    Abstract γ-Aminobutyric acid (GABA) is the most prevalent inhibitory neurotransmitter in the mammalian brain and has been found to play an important role in the pathogenesis or the expression of many neurological diseases, including epilepsy. Although GABA can act on different receptor subtypes, the component of the GABA system that is most critical to modulation of seizure activity is the GABA
    MeSH term(s) Animals ; Humans ; Chlorides ; Epilepsy/drug therapy ; Brain ; Anticonvulsants/pharmacology ; Anticonvulsants/therapeutic use ; Seizures/drug therapy ; Mammals
    Chemical Substances Chlorides ; Anticonvulsants
    Language English
    Publishing date 2023-08-21
    Publishing country New Zealand
    Document type Journal Article ; Review ; Research Support, Non-U.S. Gov't
    ZDB-ID 1203800-3
    ISSN 1179-1934 ; 1172-7047
    ISSN (online) 1179-1934
    ISSN 1172-7047
    DOI 10.1007/s40263-023-01027-2
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    Zs.A 4083: Show issues Location:
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  8. Article ; Online: New GABA-Targeting Therapies for the Treatment of Seizures and Epilepsy: II. Treatments in Clinical Development.

    Perucca, Emilio / White, H Steve / Bialer, Meir

    CNS drugs

    2023  Volume 37, Issue 9, Page(s) 781–795

    Abstract: The inhibitory neurotransmitter γ-aminobutyric acid (GABA) plays an important role in the modulation of neuronal excitability, and a disruption of GABAergic transmission contributes to the pathogenesis of some seizure disorders. Although many currently ... ...

    Abstract The inhibitory neurotransmitter γ-aminobutyric acid (GABA) plays an important role in the modulation of neuronal excitability, and a disruption of GABAergic transmission contributes to the pathogenesis of some seizure disorders. Although many currently available antiseizure medications do act at least in part by potentiating GABAergic transmission, there is an opportunity for further research aimed at developing more innovative GABA-targeting therapies. The present article summarises available evidence on a number of such treatments in clinical development. These can be broadly divided into three groups. The first group consists of positive allosteric modulators of GABA
    MeSH term(s) Infant, Newborn ; Humans ; Epilepsy/drug therapy ; gamma-Aminobutyric Acid/therapeutic use ; Epilepsies, Myoclonic ; Epilepsies, Partial ; Lennox Gastaut Syndrome ; Randomized Controlled Trials as Topic
    Chemical Substances gamma-Aminobutyric Acid (56-12-2)
    Language English
    Publishing date 2023-08-21
    Publishing country New Zealand
    Document type Journal Article ; Review ; Research Support, Non-U.S. Gov't
    ZDB-ID 1203800-3
    ISSN 1179-1934 ; 1172-7047
    ISSN (online) 1179-1934
    ISSN 1172-7047
    DOI 10.1007/s40263-023-01025-4
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  9. Article: Commentary: Message from the ILAE president.

    Perucca, Emilio

    Epilepsia open

    2016  Volume 1, Issue 1-2, Page(s) 8

    Language English
    Publishing date 2016-07-21
    Publishing country United States
    Document type Journal Article
    ISSN 2470-9239
    ISSN 2470-9239
    DOI 10.1002/epi4.6
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  10. Article ; Online: Stereoselective Analysis of the Antiseizure Activity of Fenfluramine and Norfenfluramine in Mice: Is

    Erenburg, Natalia / Perucca, Emilio / Bechard, Jeff / Dube, Celine / Weishaupt, Nina / Sherrington, Robin / Bialer, Meir

    International journal of molecular sciences

    2024  Volume 25, Issue 5

    Abstract: The aim of this study was to investigate the comparative antiseizure activity of ... ...

    Abstract The aim of this study was to investigate the comparative antiseizure activity of the
    MeSH term(s) Mice ; Animals ; Fenfluramine ; Norfenfluramine/metabolism ; Anticonvulsants ; Follow-Up Studies ; Mice, Inbred DBA ; Epilepsy, Reflex ; Seizures
    Chemical Substances Fenfluramine (2DS058H2CF) ; Norfenfluramine (1886-26-6) ; Anticonvulsants
    Language English
    Publishing date 2024-02-21
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2019364-6
    ISSN 1422-0067 ; 1422-0067 ; 1661-6596
    ISSN (online) 1422-0067
    ISSN 1422-0067 ; 1661-6596
    DOI 10.3390/ijms25052522
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