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Current Medical Research and Opinion Volume 33, 2017 - Issue 10
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Neurology

Cardiovascular safety of low-dose fenfluramine in Dravet syndrome: a review of its benefit-risk profile in a new patient population

An-Sofie SchoonjansDepartment of Paediatric Neurology, Antwerp University Hospital, University of Antwerp, Antwerp, Belgium;
,
Fabienne MarchauDepartment of Paediatric Cardiology, Antwerp University Hospital, University of Antwerp, Antwerp, Belgium;
,
Bernard P. PaelinckDepartment of Cardiology, Antwerp University Hospital, University of Antwerp, Antwerp, Belgium;
,
Lieven LagaeDepartment of Development and Regeneration, Section of Paediatric Neurology, University Hospitals Gasthuisberg, Leuven, Belgium;
,
Arnold GammaitoniZogenix, Inc., Emeryville, CA, USA;
,
Milka PringsheimDepartment of Pediatric Cardiology, German Heart Centre Munich, Munich, Germany; ;Pediatric Neurology, Schön Klinik Vogtareuth, Vogtareuth, Germany;
,
Martin G. KeaneTemple University Hospital, Philadelphia, PA, USA
&
Berten CeulemansDepartment of Paediatric Neurology, Antwerp University Hospital, University of Antwerp, Antwerp, Belgium; Correspondence[email protected]
 show all
Pages 1773-1781 | Received 21 Apr 2017, Accepted 10 Jul 2017, Published online: 31 Jul 2017

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An-Sofie Schoonjans & Berten Ceulemans. (2022) A critical evaluation of fenfluramine hydrochloride for the treatment of Dravet syndrome. Expert Review of Neurotherapeutics 22:5, pages 351-364.
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Ana Pejčić, Slobodan M. Janković, Miralem Đešević, Refet Gojak, Snežana Lukić, Nenad Marković & Miloš Milosavljević. (2021) Novel and emerging therapeutics for genetic epilepsies. Expert Review of Neurotherapeutics 21:11, pages 1283-1301.
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Adam Strzelczyk & Susanne Schubert-Bast. (2020) Therapeutic advances in Dravet syndrome: a targeted literature review. Expert Review of Neurotherapeutics 20:10, pages 1065-1079.
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Krista Eschbach & Kelly G Knupp. (2019) Stiripentol for the treatment of seizures in Dravet syndrome. Expert Review of Clinical Pharmacology 12:5, pages 379-388.
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Articles from other publishers (35)

Hinde El Mouhi, Meriame Abbassi, Meryem Jalte, Abdelhafid Natiq, Laila Bouguenouch & Sana Chaouki. (2024) The Genetic Facets of Dravet Syndrome: Recent Insights. Annals of Child Neurology 32:2, pages 67-82.
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Dujiang Xia, Peng Zhang, Yankun Chen, Xi Liu & Yangmei Chen. (2024) Efficacy of pharmacological treatments for Dravet syndrome: Systematic review and network meta-analysis. Seizure: European Journal of Epilepsy 117, pages 90-97.
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Joseph Sullivan, Lieven Lagae, J. Helen Cross, Orrin Devinsky, Renzo Guerrini, Kelly G. Knupp, Linda Laux, Marina Nikanorova, Tilman Polster, Dinesh Talwar, Berten Ceulemans, Rima Nabbout, Gail M. Farfel, Bradley S. Galer, Arnold R. Gammaitoni, Michael Lock, Anupam Agarwal & Ingrid E. Scheffer. (2023) Fenfluramine in the treatment of Dravet syndrome: Results of a third randomized, placebo‐controlled clinical trial. Epilepsia 64:10, pages 2653-2666.
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James E. Frampton. (2023) Fenfluramine: A Review in Dravet and Lennox-Gastaut Syndromes. Drugs 83:10, pages 923-934.
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Jo Sourbron & Lieven Lagae. (2023) Fenfluramine: a plethora of mechanisms?. Frontiers in Pharmacology 14.
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Payam Tabaee Damavandi, Natalia Fabin, Riccardo Giossi, Sara Matricardi, Cinzia Del Giovane, Pasquale Striano, Stefano Meletti, Francesco Brigo, Eugen Trinka & Simona Lattanzi. (2023) Efficacy and Safety of Fenfluramine in Epilepsy: A Systematic Review and Meta-analysis. Neurology and Therapy 12:2, pages 669-686.
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Edmund Przegaliński, Kacper Witek, Karolina Wydra, Jolanta H. Kotlińska & Małgorzata Filip. (2023) 5-HT2C Receptor Stimulation in Obesity Treatment: Orthosteric Agonists vs. Allosteric Modulators. Nutrients 15:6, pages 1449.
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Graeme J. Sills. (2023) Pharmacological diversity amongst approved and emerging antiseizure medications for the treatment of developmental and epileptic encephalopathies. Therapeutic Advances in Neurological Disorders 16.
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Renzo Guerrini, Nicola Specchio, Ángel Aledo‐Serrano, Milka Pringsheim, Francesca Darra, Thomas Mayer, Antonio Gil‐Nagel, Tilman Polster, Sameer M. Zuberi, Amélie Lothe, Arnold Gammaitoni & Adam Strzelczyk. (2022) An examination of the efficacy and safety of fenfluramine in adults, children, and adolescents with Dravet syndrome in a real‐world practice setting: A report from the Fenfluramine European Early Access Program . Epilepsia Open 7:4, pages 578-587.
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Anupam Agarwal, Gail M. Farfel, Arnold R. Gammaitoni, Pierre C. Wong, Fausto J. Pinto & Bradley S. Galer. (2022) Long-term cardiovascular safety of fenfluramine in patients with Dravet syndrome treated for up to 3 years: Findings from serial echocardiographic assessments. European Journal of Paediatric Neurology 39, pages 35-39.
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Ersida Buraniqi, Hicham Dabaja & Elaine C. Wirrell. (2022) Impact of Antiseizure Medications on Appetite and Weight in Children. Pediatric Drugs 24:4, pages 335-363.
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Jo Sourbron & Lieven Lagae. (2022) Serotonin receptors in epilepsy: Novel treatment targets?. Epilepsia Open 7:2, pages 231-246.
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Alejandra Vasquez, Ersida Buraniqi & Elaine C. Wirrell. (2022) New and emerging pharmacologic treatments for developmental and epileptic encephalopathies. Current Opinion in Neurology 35:2, pages 145-154.
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An‐Sofie Schoonjans, Laurence Roosens, Wendy Dewals, Bernard P. Paelinck & Berten Ceulemans. (2022) Therapeutic drug monitoring of fenfluramine in clinical practice: Pharmacokinetic variability and impact of concomitant antiseizure medications. Epilepsia 63:3, pages 686-696.
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Reem Odi, Roberto William Invernizzi, Tamar Gallily, Meir Bialer & Emilio Perucca. (2021) Fenfluramine repurposing from weight loss to epilepsy: What we do and do not know. Pharmacology & Therapeutics 226, pages 107866.
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A.-S. Schoonjans & B. Ceulemans. (2021) Dravet syndrome—toward an optimal and disease-specific treatmentDravet-Syndrom – auf dem Weg zu einer optimalen und krankheitsspezifischen Behandlung. Zeitschrift für Epileptologie 34:2, pages 146-153.
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Ibitayo Abigail Ademuwagun, Solomon Oladapo Rotimi, Steffen Syrbe, Yvonne Ukamaka Ajamma & Ezekiel Adebiyi. (2021) Voltage Gated Sodium Channel Genes in Epilepsy: Mutations, Functional Studies, and Treatment Dimensions. Frontiers in Neurology 12.
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Adam Strzelczyk & Susanne Schubert-Bast. (2021) Expanding the Treatment Landscape for Lennox-Gastaut Syndrome: Current and Future Strategies. CNS Drugs 35:1, pages 61-83.
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Alizée Arnoux & Estelle Ayme-Dietrich. 2021. 5-HT2B Receptors. 5-HT2B Receptors 213 229 .
Joseph Sullivan, Ingrid E. Scheffer, Lieven Lagae, Rima Nabbout, Milka Pringsheim, Dinesh Talwar, Tilman Polster, Bradley Galer, Michael Lock, Anupam Agarwal, Arnold Gammaitoni, Glenn Morrison & Gail Farfel. (2020) Fenfluramine HCl (Fintepla ® ) provides long‐term clinically meaningful reduction in seizure frequency: Analysis of an ongoing open‐label extension study . Epilepsia 61:11, pages 2396-2404.
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Wyman W. Lai, Bradley S. Galer, Pierre C. Wong, Gail Farfel, Milka Pringsheim, Martin G. Keane & Anupam Agarwal. (2020) Cardiovascular safety of fenfluramine in the treatment of Dravet syndrome: Analysis of an ongoing long‐term open‐label safety extension study. Epilepsia 61:11, pages 2386-2395.
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Ganna Balagura, Marta Cacciatore, Eleonora A. Grasso, Pasquale Striano & Alberto Verrotti. (2020) Fenfluramine for the Treatment of Dravet Syndrome and Lennox–Gastaut Syndrome. CNS Drugs 34:10, pages 1001-1007.
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Rima Nabbout, Arun Mistry, Sameer Zuberi, Nathalie Villeneuve, Antonio Gil-Nagel, Rocio Sanchez-Carpintero, Ulrich Stephani, Linda Laux, Elaine Wirrell, Kelly Knupp, Catherine Chiron, Gail Farfel, Bradley S. Galer, Glenn Morrison, Michael Lock, Anupam Agarwal & Stéphane Auvin. (2020) Fenfluramine for Treatment-Resistant Seizures in Patients With Dravet Syndrome Receiving Stiripentol-Inclusive Regimens. JAMA Neurology 77:3, pages 300.
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Elisa Musto, Elena Gardella & Rikke S. Møller. (2020) Recent advances in treatment of epilepsy-related sodium channelopathies. European Journal of Paediatric Neurology 24, pages 123-128.
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J. Helen Cross, Roberto H. Caraballo, Rima Nabbout, Federico Vigevano, Renzo Guerrini & Lieven Lagae. (2020) Dravet syndrome: Treatment options and management of prolonged seizures. Epilepsia 60:S3.
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Lieven Lagae, Joseph Sullivan, Kelly Knupp, Linda Laux, Tilman Polster, Marina Nikanorova, Orrin Devinsky, J Helen Cross, Renzo Guerrini, Dinesh Talwar, Ian Miller, Gail Farfel, Bradley S Galer, Arnold Gammaitoni, Arun Mistry, Glenn Morrison, Michael Lock, Anupam Agarwal, Wyman W Lai & Berten Ceulemans. (2019) Fenfluramine hydrochloride for the treatment of seizures in Dravet syndrome: a randomised, double-blind, placebo-controlled trial. The Lancet 394:10216, pages 2243-2254.
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Elaine C. Wirrell & Rima Nabbout. (2019) Recent Advances in the Drug Treatment of Dravet Syndrome. CNS Drugs 33:9, pages 867-881.
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Leonardo B. Silenieks, Nicole K. Carroll, Annalise Van Niekerk, Emily Van Niekerk, Colleen Taylor, Neil Upton & Guy A. Higgins. (2019) Evaluation of Selective 5-HT 2C Agonists in Acute Seizure Models . ACS Chemical Neuroscience 10:7, pages 3284-3295.
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Alan S. Bass, Michael K. Pugsley, Frederick Sannajust, Takashi Yoshinaga & Jean-Pierre Valentin. (2019) Response of safety pharmacologists to challenges arising from the rapidly evolving changes in the pharmaceutical industry. Journal of Pharmacological and Toxicological Methods 98, pages 106593.
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Sarah von Spiczak & Ulrich Stephani. (2018) Therapie des Dravet-SyndromsTreatment of Dravet syndrome. Zeitschrift für Epileptologie 32:2, pages 107-115.
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Tilman Polster. (2019) Individualized treatment approaches: Fenfluramine, a novel antiepileptic medication for the treatment of seizures in Dravet syndrome. Epilepsy & Behavior 91, pages 99-102.
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Julie Ziobro, Krista Eschbach, Joseph E. Sullivan & Kelly G. Knupp. (2018) Current Treatment Strategies and Future Treatment Options for Dravet Syndrome. Current Treatment Options in Neurology 20:12.
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Meir Bialer, Svein I. Johannessen, Matthias J. Koepp, René H. Levy, Emilio Perucca, Torbjörn Tomson & H. Steve White. (2018) Progress report on new antiepileptic drugs: A summary of the Fourteenth Eilat Conference on New Antiepileptic Drugs and Devices (EILAT XIV). II. Drugs in more advanced clinical development. Epilepsia 59:10, pages 1842-1866.
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Lieven Lagae, An‐Sofie Schoonjans, Arnold R. Gammaitoni, Bradley S. Galer & Berten Ceulemans. (2018) A pilot, open‐label study of the effectiveness and tolerability of low‐dose ZX 008 (fenfluramine HC l) in Lennox‐Gastaut syndrome . Epilepsia 59:10, pages 1881-1888.
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Kelly G. Knupp & Elaine C. Wirrell. (2018) Treatment Strategies for Dravet Syndrome. CNS Drugs 32:4, pages 335-350.
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