Adjunctive everolimus therapy for treatment-resistant focal-onset seizures associated with tuberous sclerosis (EXIST-3): a phase 3, randomised, double-blind, placebo-controlled study.
Identifieur interne : 002406 ( Main/Exploration ); précédent : 002405; suivant : 002407Adjunctive everolimus therapy for treatment-resistant focal-onset seizures associated with tuberous sclerosis (EXIST-3): a phase 3, randomised, double-blind, placebo-controlled study.
Auteurs : Jacqueline A. French [États-Unis] ; John A. Lawson [Australie] ; Zuhal Yapici [Turquie] ; Hiroko Ikeda [Japon] ; Tilman Polster [Allemagne] ; Rima Nabbout [France] ; Paolo Curatolo [Italie] ; Petrus J. De Vries [Afrique du Sud] ; Dennis J. Dlugos [États-Unis] ; Noah Berkowitz [États-Unis] ; Maurizio Voi [États-Unis] ; Severine Peyrard [France] ; Diana Pelov [États-Unis] ; David N. Franz [États-Unis]Source :
- Lancet (London, England) [ 1474-547X ] ; 2016.
Descripteurs français
- KwdFr :
- Adolescent, Adulte, Adulte d'âge moyen, Anticonvulsivants (usage thérapeutique), Antinéoplasiques (usage thérapeutique), Association thérapeutique, Crises épileptiques (traitement médicamenteux), Enfant, Enfant d'âge préscolaire, Femelle, Humains, Mâle, Méthode en double aveugle, Relation dose-effet des médicaments, Sclérose tubéreuse du cerveau (), Sujet âgé, Évérolimus (effets indésirables), Évérolimus (usage thérapeutique).
- MESH :
- effets indésirables : Évérolimus.
- traitement médicamenteux : Crises épileptiques.
- usage thérapeutique : Anticonvulsivants, Antinéoplasiques, Évérolimus.
- Adolescent, Adulte, Adulte d'âge moyen, Association thérapeutique, Enfant, Enfant d'âge préscolaire, Femelle, Humains, Mâle, Méthode en double aveugle, Relation dose-effet des médicaments, Sclérose tubéreuse du cerveau, Sujet âgé.
English descriptors
- KwdEn :
- Adolescent, Adult, Aged, Anticonvulsants (therapeutic use), Antineoplastic Agents (therapeutic use), Child, Child, Preschool, Combined Modality Therapy, Dose-Response Relationship, Drug, Double-Blind Method, Everolimus (adverse effects), Everolimus (therapeutic use), Female, Humans, Male, Middle Aged, Seizures (drug therapy), Tuberous Sclerosis (complications).
- MESH :
- chemical , adverse effects : Everolimus.
- chemical , therapeutic use : Anticonvulsants, Antineoplastic Agents, Everolimus.
- complications : Tuberous Sclerosis.
- drug therapy : Seizures.
- Adolescent, Adult, Aged, Child, Child, Preschool, Combined Modality Therapy, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Middle Aged.
Abstract
Everolimus, a mammalian target of rapamycin (mTOR) inhibitor, has been used for various benign tumours associated with tuberous sclerosis complex. We assessed the efficacy and safety of two trough exposure concentrations of everolimus, 3-7 ng/mL (low exposure) and 9-15 ng/mL (high exposure), compared with placebo as adjunctive therapy for treatment-resistant focal-onset seizures in tuberous sclerosis complex.
DOI: 10.1016/S0140-6736(16)31419-2
PubMed: 27613521
Affiliations:
- Afrique du Sud, Allemagne, Australie, France, Italie, Japon, Turquie, États-Unis
- Latium, New Jersey, Ohio, Pennsylvanie, État de New York, Île-de-France
- Paris, Rome
Links toward previous steps (curation, corpus...)
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Le document en format XML
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French</name><affiliation wicri:level="2"><nlm:affiliation>NYU Comprehensive Epilepsy Center, New York, NY, USA. Electronic address: jacqueline.french@nyumc.org.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>NYU Comprehensive Epilepsy Center, New York, NY</wicri:regionArea><placeName><region type="state">État de New York</region></placeName></affiliation></author><author><name sortKey="Lawson, John A" sort="Lawson, John A" uniqKey="Lawson J" first="John A" last="Lawson">John A. Lawson</name><affiliation wicri:level="1"><nlm:affiliation>Tuberous Sclerosis Multidisciplinary Management Clinic, Sydney Children's Hospital, Randwick, NSW, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Tuberous Sclerosis Multidisciplinary Management Clinic, Sydney Children's Hospital, Randwick, NSW</wicri:regionArea><wicri:noRegion>NSW</wicri:noRegion></affiliation></author><author><name sortKey="Yapici, Zuhal" sort="Yapici, Zuhal" uniqKey="Yapici Z" first="Zuhal" last="Yapici">Zuhal Yapici</name><affiliation wicri:level="1"><nlm:affiliation>Division of Child Neurology, Department of Neurology, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey.</nlm:affiliation><country xml:lang="fr">Turquie</country><wicri:regionArea>Division of Child Neurology, Department of Neurology, Istanbul Faculty of Medicine, Istanbul University, Istanbul</wicri:regionArea><wicri:noRegion>Istanbul</wicri:noRegion></affiliation></author><author><name sortKey="Ikeda, Hiroko" sort="Ikeda, Hiroko" uniqKey="Ikeda H" first="Hiroko" last="Ikeda">Hiroko Ikeda</name><affiliation wicri:level="1"><nlm:affiliation>NHO Epilepsy Center, Shizuoka Institute of Epilepsy and Neurological Disorders, Shizuoka, Japan.</nlm:affiliation><country xml:lang="fr">Japon</country><wicri:regionArea>NHO Epilepsy Center, Shizuoka Institute of Epilepsy and Neurological Disorders, Shizuoka</wicri:regionArea><wicri:noRegion>Shizuoka</wicri:noRegion></affiliation></author><author><name sortKey="Polster, Tilman" sort="Polster, Tilman" uniqKey="Polster T" first="Tilman" last="Polster">Tilman Polster</name><affiliation wicri:level="1"><nlm:affiliation>Paediatric Epileptology, Mara Hospital, Bethel Epilepsy Center, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Paediatric Epileptology, Mara Hospital, Bethel Epilepsy Center</wicri:regionArea><wicri:noRegion>Bethel Epilepsy Center</wicri:noRegion><wicri:noRegion>Bethel Epilepsy Center</wicri:noRegion><wicri:noRegion>Bethel Epilepsy Center</wicri:noRegion></affiliation></author><author><name sortKey="Nabbout, Rima" sort="Nabbout, Rima" uniqKey="Nabbout R" first="Rima" last="Nabbout">Rima Nabbout</name><affiliation wicri:level="3"><nlm:affiliation>Hospital Necker-Enfants Malades, Paris Descartes University, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Hospital Necker-Enfants Malades, Paris Descartes University, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Curatolo, Paolo" sort="Curatolo, Paolo" uniqKey="Curatolo P" first="Paolo" last="Curatolo">Paolo Curatolo</name><affiliation wicri:level="3"><nlm:affiliation>Tor Vergata University Hospital, Rome, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Tor Vergata University Hospital, Rome</wicri:regionArea><placeName><settlement type="city">Rome</settlement><region nuts="2">Latium</region></placeName></affiliation></author><author><name sortKey="De Vries, Petrus J" sort="De Vries, Petrus J" uniqKey="De Vries P" first="Petrus J" last="De Vries">Petrus J. De Vries</name><affiliation wicri:level="1"><nlm:affiliation>Division of Child and Adolescent Psychiatry, University of Cape Town, Cape Town, South Africa.</nlm:affiliation><country xml:lang="fr">Afrique du Sud</country><wicri:regionArea>Division of Child and Adolescent Psychiatry, University of Cape Town, Cape Town</wicri:regionArea><wicri:noRegion>Cape Town</wicri:noRegion></affiliation></author><author><name sortKey="Dlugos, Dennis J" sort="Dlugos, Dennis J" uniqKey="Dlugos D" first="Dennis J" last="Dlugos">Dennis J. Dlugos</name><affiliation wicri:level="2"><nlm:affiliation>Departments of Neurology and Pediatrics, The Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Departments of Neurology and Pediatrics, The Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Berkowitz, Noah" sort="Berkowitz, Noah" uniqKey="Berkowitz N" first="Noah" last="Berkowitz">Noah Berkowitz</name><affiliation wicri:level="2"><nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Novartis Pharmaceuticals Corporation, East Hanover, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Voi, Maurizio" sort="Voi, Maurizio" uniqKey="Voi M" first="Maurizio" last="Voi">Maurizio Voi</name><affiliation wicri:level="2"><nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Novartis Pharmaceuticals Corporation, East Hanover, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Peyrard, Severine" sort="Peyrard, Severine" uniqKey="Peyrard S" first="Severine" last="Peyrard">Severine Peyrard</name><affiliation wicri:level="1"><nlm:affiliation>Novartis Pharmaceuticals SAS, Rueil-Malmaison, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Novartis Pharmaceuticals SAS, Rueil-Malmaison</wicri:regionArea><wicri:noRegion>Rueil-Malmaison</wicri:noRegion><wicri:noRegion>Rueil-Malmaison</wicri:noRegion></affiliation></author><author><name sortKey="Pelov, Diana" sort="Pelov, Diana" uniqKey="Pelov D" first="Diana" last="Pelov">Diana Pelov</name><affiliation wicri:level="2"><nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Novartis Pharmaceuticals Corporation, East Hanover, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Franz, David N" sort="Franz, David N" uniqKey="Franz D" first="David N" last="Franz">David N. Franz</name><affiliation wicri:level="2"><nlm:affiliation>Departments of Pediatrics and Neurology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Departments of Pediatrics and Neurology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH</wicri:regionArea><placeName><region type="state">Ohio</region></placeName></affiliation></author></analytic><series><title level="j">Lancet (London, England)</title><idno type="eISSN">1474-547X</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Aged</term><term>Anticonvulsants (therapeutic use)</term><term>Antineoplastic Agents (therapeutic use)</term><term>Child</term><term>Child, Preschool</term><term>Combined Modality Therapy</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Everolimus (adverse effects)</term><term>Everolimus (therapeutic use)</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Seizures (drug therapy)</term><term>Tuberous Sclerosis (complications)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adolescent</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Anticonvulsivants (usage thérapeutique)</term><term>Antinéoplasiques (usage thérapeutique)</term><term>Association thérapeutique</term><term>Crises épileptiques (traitement médicamenteux)</term><term>Enfant</term><term>Enfant d'âge préscolaire</term><term>Femelle</term><term>Humains</term><term>Mâle</term><term>Méthode en double aveugle</term><term>Relation dose-effet des médicaments</term><term>Sclérose tubéreuse du cerveau ()</term><term>Sujet âgé</term><term>Évérolimus (effets indésirables)</term><term>Évérolimus (usage thérapeutique)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Everolimus</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Anticonvulsants</term><term>Antineoplastic Agents</term><term>Everolimus</term></keywords><keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Tuberous Sclerosis</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Seizures</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Évérolimus</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Crises épileptiques</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Anticonvulsivants</term><term>Antinéoplasiques</term><term>Évérolimus</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Aged</term><term>Child</term><term>Child, Preschool</term><term>Combined Modality Therapy</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adolescent</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Association thérapeutique</term><term>Enfant</term><term>Enfant d'âge préscolaire</term><term>Femelle</term><term>Humains</term><term>Mâle</term><term>Méthode en double aveugle</term><term>Relation dose-effet des médicaments</term><term>Sclérose tubéreuse du cerveau</term><term>Sujet âgé</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Everolimus, a mammalian target of rapamycin (mTOR) inhibitor, has been used for various benign tumours associated with tuberous sclerosis complex. We assessed the efficacy and safety of two trough exposure concentrations of everolimus, 3-7 ng/mL (low exposure) and 9-15 ng/mL (high exposure), compared with placebo as adjunctive therapy for treatment-resistant focal-onset seizures in tuberous sclerosis complex.</div></front></TEI><affiliations><list><country><li>Afrique du Sud</li><li>Allemagne</li><li>Australie</li><li>France</li><li>Italie</li><li>Japon</li><li>Turquie</li><li>États-Unis</li></country><region><li>Latium</li><li>New Jersey</li><li>Ohio</li><li>Pennsylvanie</li><li>État de New York</li><li>Île-de-France</li></region><settlement><li>Paris</li><li>Rome</li></settlement></list><tree><country name="États-Unis"><region name="État de New York"><name sortKey="French, Jacqueline A" sort="French, Jacqueline A" uniqKey="French J" first="Jacqueline A" last="French">Jacqueline A. French</name></region><name sortKey="Berkowitz, Noah" sort="Berkowitz, Noah" uniqKey="Berkowitz N" first="Noah" last="Berkowitz">Noah Berkowitz</name><name sortKey="Dlugos, Dennis J" sort="Dlugos, Dennis J" uniqKey="Dlugos D" first="Dennis J" last="Dlugos">Dennis J. Dlugos</name><name sortKey="Franz, David N" sort="Franz, David N" uniqKey="Franz D" first="David N" last="Franz">David N. Franz</name><name sortKey="Pelov, Diana" sort="Pelov, Diana" uniqKey="Pelov D" first="Diana" last="Pelov">Diana Pelov</name><name sortKey="Voi, Maurizio" sort="Voi, Maurizio" uniqKey="Voi M" first="Maurizio" last="Voi">Maurizio Voi</name></country><country name="Australie"><noRegion><name sortKey="Lawson, John A" sort="Lawson, John A" uniqKey="Lawson J" first="John A" last="Lawson">John A. Lawson</name></noRegion></country><country name="Turquie"><noRegion><name sortKey="Yapici, Zuhal" sort="Yapici, Zuhal" uniqKey="Yapici Z" first="Zuhal" last="Yapici">Zuhal Yapici</name></noRegion></country><country name="Japon"><noRegion><name sortKey="Ikeda, Hiroko" sort="Ikeda, Hiroko" uniqKey="Ikeda H" first="Hiroko" last="Ikeda">Hiroko Ikeda</name></noRegion></country><country name="Allemagne"><noRegion><name sortKey="Polster, Tilman" sort="Polster, Tilman" uniqKey="Polster T" first="Tilman" last="Polster">Tilman Polster</name></noRegion></country><country name="France"><region name="Île-de-France"><name sortKey="Nabbout, Rima" sort="Nabbout, Rima" uniqKey="Nabbout R" first="Rima" last="Nabbout">Rima Nabbout</name></region><name sortKey="Peyrard, Severine" sort="Peyrard, Severine" uniqKey="Peyrard S" first="Severine" last="Peyrard">Severine Peyrard</name></country><country name="Italie"><region name="Latium"><name sortKey="Curatolo, Paolo" sort="Curatolo, Paolo" uniqKey="Curatolo P" first="Paolo" last="Curatolo">Paolo Curatolo</name></region></country><country name="Afrique du Sud"><noRegion><name sortKey="De Vries, Petrus J" sort="De Vries, Petrus J" uniqKey="De Vries P" first="Petrus J" last="De Vries">Petrus J. De Vries</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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