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A New Dawn in the Management of Narcolepsy.
IF 7.4 2区 医学
CNS drugs Pub Date : 2025-03-01 Epub Date: 2025-03-20 DOI: 10.1007/s40263-025-01170-y
Michael J Thorpy, Anne Marie Morse
{"title":"A New Dawn in the Management of Narcolepsy.","authors":"Michael J Thorpy, Anne Marie Morse","doi":"10.1007/s40263-025-01170-y","DOIUrl":"10.1007/s40263-025-01170-y","url":null,"abstract":"","PeriodicalId":10508,"journal":{"name":"CNS drugs","volume":" ","pages":"3-7"},"PeriodicalIF":7.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11950061/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143669400","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Survey of People Living with Narcolepsy in the USA: Path to Diagnosis, Quality of Life, and Treatment Landscape from the Patient's Perspective.
IF 7.4 2区 医学
CNS drugs Pub Date : 2025-03-01 Epub Date: 2025-03-20 DOI: 10.1007/s40263-024-01142-8
Luis E Ortiz, Anne Marie Morse, Lois Krahn, Maggie Lavender, Matthew Horsnell, Dianna Cronin, Beth Schneider, Jennifer Gudeman
{"title":"A Survey of People Living with Narcolepsy in the USA: Path to Diagnosis, Quality of Life, and Treatment Landscape from the Patient's Perspective.","authors":"Luis E Ortiz, Anne Marie Morse, Lois Krahn, Maggie Lavender, Matthew Horsnell, Dianna Cronin, Beth Schneider, Jennifer Gudeman","doi":"10.1007/s40263-024-01142-8","DOIUrl":"10.1007/s40263-024-01142-8","url":null,"abstract":"<p><strong>Background: </strong>Narcolepsy is a chronic, burdensome neurologic disorder that significantly impacts the daily life of people with narcolepsy (PWN). Real-world perspectives from PWN can help address their unique experiences and treatment needs. PWN were surveyed to examine the path to a narcolepsy diagnosis, the breadth of symptom burden experienced by PWN, and current trends in treatment.</p><p><strong>Methods: </strong>A 15-min online survey was sent by email to 3959 US members of MyNarcolepsyTeam (February 2022). The survey was divided into three sections (screening [patient characteristics], diagnosis/symptoms, and patient quality of life) for a total of 27 questions.</p><p><strong>Results: </strong>In total, 110 members completed the survey. Of these, most were female (84%) and nearly half (48%) were diagnosed with narcolepsy type 1 (with cataplexy). Approximately one-third (31%) of members reported receiving a definitive diagnosis ≥ 10 years after first speaking with a clinician; most were previously diagnosed with depression (73%). Excessive daytime sleepiness (EDS, 93%) and fatigue (84%) were the most frequently reported symptoms that prompted respondents to seek a diagnosis or feel that something was wrong. Additionally, EDS was reported as the most troubling symptom (92%). Respondents' most desired treatment outcome was to stop sleeping during the day (77%). Most (76%) indicated an extremely or very severe impact on daily life. One in eight respondents were not taking any medication for their narcolepsy. Of those taking medication, 58% received polypharmacy to address narcolepsy symptoms.</p><p><strong>Conclusions: </strong>These survey findings further characterize the diagnostic delay, symptom burden, and treatment needs of PWN. Understanding the breadth of impact of narcolepsy from the patients' perspective could improve shared decision-making between PWN and their treating clinicians.</p>","PeriodicalId":10508,"journal":{"name":"CNS drugs","volume":" ","pages":"23-36"},"PeriodicalIF":7.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11950095/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143669403","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Repurposing Licensed Drugs with Activity Against Epstein-Barr Virus for Treatment of Multiple Sclerosis: A Systematic Approach. 重新利用具有抗eb病毒活性的许可药物治疗多发性硬化症:一种系统的方法。
IF 7.4 2区 医学
CNS drugs Pub Date : 2025-03-01 Epub Date: 2025-01-10 DOI: 10.1007/s40263-024-01153-5
Vivien Li, Fiona C McKay, David C Tscharke, Corey Smith, Rajiv Khanna, Jeannette Lechner-Scott, William D Rawlinson, Andrew R Lloyd, Bruce V Taylor, Julia M Morahan, Lawrence Steinman, Gavin Giovannoni, Amit Bar-Or, Michael Levy, Natalia Drosu, Andrew Potter, Nigel Caswell, Lynne Smith, Erin C Brady, Bruce Frost, Suzanne Hodgkinson, Todd A Hardy, Simon A Broadley
{"title":"Repurposing Licensed Drugs with Activity Against Epstein-Barr Virus for Treatment of Multiple Sclerosis: A Systematic Approach.","authors":"Vivien Li, Fiona C McKay, David C Tscharke, Corey Smith, Rajiv Khanna, Jeannette Lechner-Scott, William D Rawlinson, Andrew R Lloyd, Bruce V Taylor, Julia M Morahan, Lawrence Steinman, Gavin Giovannoni, Amit Bar-Or, Michael Levy, Natalia Drosu, Andrew Potter, Nigel Caswell, Lynne Smith, Erin C Brady, Bruce Frost, Suzanne Hodgkinson, Todd A Hardy, Simon A Broadley","doi":"10.1007/s40263-024-01153-5","DOIUrl":"10.1007/s40263-024-01153-5","url":null,"abstract":"<p><strong>Background: </strong>Epstein-Barr virus (EBV) is implicated as a necessary factor in the development of multiple sclerosis (MS) and may also be a driver of disease activity. Although it is not clear whether ongoing viral replication is the driver for MS pathology, MS researchers have considered the prospect of using drugs with potential efficacy against EBV in the treatment of MS. We have undertaken scientific and lived experience expert panel reviews to shortlist existing licensed therapies that could be used in later-stage clinical trials in MS.</p><p><strong>Methods: </strong>A list of therapies with anti-EBV effects was developed from existing reviews. A detailed review of pre-clinical and clinical data was undertaken to assess these candidates for potential usefulness and possible harm in MS. A 'drug-CV' and a plain language version focusing on tolerability aspects was created for each candidate. We used validated criteria to score each candidate with an international scientific panel and people living with MS.</p><p><strong>Results: </strong>A preliminary list of 11 drug candidates was generated. Following review by the scientific and lived experience expert panels, six yielded the same highest score. A further review by the expert panel shortlisted four drugs (famciclovir, tenofovir alafenamide, maribavir and spironolactone) deemed to have the best balance of efficacy, safety and tolerability for use in MS.</p><p><strong>Conclusions: </strong>Scientific and lived experience expert panel review of anti-EBV therapies selected four candidates with evidence for efficacy against EBV and acceptable safety and tolerability for potential use in phase III clinical trials for MS.</p>","PeriodicalId":10508,"journal":{"name":"CNS drugs","volume":" ","pages":"305-320"},"PeriodicalIF":7.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142945885","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Negative Symptoms in Schizophrenia: An Update on Research Assessment and the Current and Upcoming Treatment Landscape. 精神分裂症的阴性症状:研究评估的最新进展以及当前和未来的治疗前景。
IF 7.4 2区 医学
CNS drugs Pub Date : 2025-03-01 Epub Date: 2025-01-12 DOI: 10.1007/s40263-024-01151-7
Preetika Govil, Joshua T Kantrowitz
{"title":"Negative Symptoms in Schizophrenia: An Update on Research Assessment and the Current and Upcoming Treatment Landscape.","authors":"Preetika Govil, Joshua T Kantrowitz","doi":"10.1007/s40263-024-01151-7","DOIUrl":"10.1007/s40263-024-01151-7","url":null,"abstract":"<p><p>The negative symptoms of schizophrenia include diminished emotional expression, avolition, alogia, anhedonia, and asociality, and due to their low responsiveness to available treatments, are a primary driver of functional disability in schizophrenia. This narrative review has the aim of providing a comprehensive overview of the current research developments in the treatment of negative symptoms in schizophrenia, and begins by introducing the concepts of primary, secondary, prominent, predominant, and broadly defined negative symptoms. We then compare and contrast commonly used research assessment scales for negative symptoms and review the evidence for the specific utility of widely available off-label and investigational treatments that have been studied for negative symptoms. Mechanism of action/putative treatments included are antipsychotics (D<sub>2</sub>R antagonists), N-methyl-D-aspartate receptor (NMDAR) and other glutamatergic modulators, serotonin receptor (5-HTR) modulators, anti-inflammatory agents, antidepressants, pro-dopaminergic modulators (non-D<sub>2</sub>R antagonists), acetylcholine modulators, oxytocin, and phosphodiesterase (PDE) inhibitors. With the caveat that no compounds are definitively proven as gold-standard treatments for broadly defined negative symptoms, the evidence base supports several potentially beneficial off-label and investigational medications for treating negative symptoms in schizophrenia, such as monotherapy with cariprazine, olanzapine, clozapine, and amisulpride, or adjunctive use of memantine, setrons such as ondansetron, minocycline, and antidepressants. These medications are widely available worldwide, generally tolerable and could be considered for an off-label, time-limited trial for a predesignated period of time, after which a decision to switch or stay can be made based on clinical response. Among investigational medications, NMDAR agonists, muscarinic agonists, and LB-102 remain under study. Suggestions for future research include reducing placebo effects by designing studies with a smaller number of high-quality study sites, potentially increasing the use of more precise rating scales for negative symptoms, and focused studies in people with predominant negative symptoms.</p>","PeriodicalId":10508,"journal":{"name":"CNS drugs","volume":" ","pages":"243-262"},"PeriodicalIF":7.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142968837","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Author's Reply to Liu et al.: "A Prospective Longitudinal Study of the Effects of Eslicarbazepine Acetate Treatment on Bone Density and Metabolism in Patients with Focal‑Onset Epilepsy".
IF 7.4 2区 医学
CNS drugs Pub Date : 2025-03-01 Epub Date: 2025-01-30 DOI: 10.1007/s40263-025-01156-w
Martin Hirsch
{"title":"Author's Reply to Liu et al.: \"A Prospective Longitudinal Study of the Effects of Eslicarbazepine Acetate Treatment on Bone Density and Metabolism in Patients with Focal‑Onset Epilepsy\".","authors":"Martin Hirsch","doi":"10.1007/s40263-025-01156-w","DOIUrl":"10.1007/s40263-025-01156-w","url":null,"abstract":"","PeriodicalId":10508,"journal":{"name":"CNS drugs","volume":" ","pages":"335-336"},"PeriodicalIF":7.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11850453/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143064230","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Narcolepsy: Beyond the Classic Pentad.
IF 7.4 2区 医学
CNS drugs Pub Date : 2025-03-01 Epub Date: 2025-03-20 DOI: 10.1007/s40263-024-01141-9
Anne Marie Morse, Seung Yun Kim, Shelby Harris, Monica Gow
{"title":"Narcolepsy: Beyond the Classic Pentad.","authors":"Anne Marie Morse, Seung Yun Kim, Shelby Harris, Monica Gow","doi":"10.1007/s40263-024-01141-9","DOIUrl":"10.1007/s40263-024-01141-9","url":null,"abstract":"<p><p>Narcolepsy is a rare, disabling, chronic neurologic disorder that requires lifelong management of symptoms with pharmacologic and nonpharmacologic methods. The pentad symptoms of narcolepsy include excessive daytime sleepiness, cataplexy, disrupted nighttime sleep, sleep paralysis, and hypnagogic/hypnopompic hallucinations. However, people with narcolepsy often experience additional symptoms and disability related to nonpentad symptoms and comorbidities, such as cognitive, psychiatric, metabolic, and sleep disturbances. Current treatment strategies have focused primarily on addressing two of the pentad symptoms, excessive daytime sleepiness, and cataplexy, mainly owing to medication options being approved by the US Food and Drug Administration for these specific indications, neglecting the full 24-h impact and spectrum of symptoms. Meanwhile, the burden of disease extends far beyond these symptoms, and optimal management should reflect a comprehensive, patient-specific approach that not only addresses the entire pentad, but also goes beyond it to include the complete clinical presentation and manifestations of the disease. Individualized treatment must consider the patient's age and stage of life, most debilitating symptoms, support system and structure, comorbid conditions, treatment goals, and overall health. This review discusses care considerations for people living with narcolepsy in the context of their clinical characteristics beyond the hallmark features of narcolepsy.</p>","PeriodicalId":10508,"journal":{"name":"CNS drugs","volume":" ","pages":"9-22"},"PeriodicalIF":7.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11950085/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143668765","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Sodium Oxybate: Practical Considerations and Patient Perspectives. 羟丁酸钠:实际考虑因素和患者观点。
IF 7.4 2区 医学
CNS drugs Pub Date : 2025-03-01 Epub Date: 2025-03-20 DOI: 10.1007/s40263-024-01144-6
Maggie Lavender, Cecile Martin, Diana Anderson
{"title":"Sodium Oxybate: Practical Considerations and Patient Perspectives.","authors":"Maggie Lavender, Cecile Martin, Diana Anderson","doi":"10.1007/s40263-024-01144-6","DOIUrl":"10.1007/s40263-024-01144-6","url":null,"abstract":"<p><p>Narcolepsy is a rare, chronic sleep disorder with significant impacts on the quality of life of people affected by the disorder. People with narcolepsy (PWN) are a diverse patient population with evolving symptoms, comorbidities, and perspectives. As PWN have varying needs, clinicians should consider a more personalized approach to therapy, including active participation of PWN in their care and shared decision-making between patient and clinician to achieve optimal outcomes. In this review, we discuss the various characteristics and challenges of PWN, present illustrative clinical case scenarios of PWN, provide clinicians with a proposed framework to best address therapy for PWN, and demystify concerns with sodium oxybate.</p>","PeriodicalId":10508,"journal":{"name":"CNS drugs","volume":" ","pages":"71-83"},"PeriodicalIF":7.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11950057/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143668869","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Raynaud Syndrome Associated with Medication for Attention-Deficit/Hyperactivity Disorder: A Systematic Review.
IF 7.4 2区 医学
CNS drugs Pub Date : 2025-03-01 Epub Date: 2025-01-29 DOI: 10.1007/s40263-024-01154-4
Frank M C Besag, Michael J Vasey, Sulagna Roy, Samuele Cortese
{"title":"Raynaud Syndrome Associated with Medication for Attention-Deficit/Hyperactivity Disorder: A Systematic Review.","authors":"Frank M C Besag, Michael J Vasey, Sulagna Roy, Samuele Cortese","doi":"10.1007/s40263-024-01154-4","DOIUrl":"10.1007/s40263-024-01154-4","url":null,"abstract":"<p><strong>Background: </strong>Raynaud syndrome (RS) is a peripheral vasculopathy characterised be impaired acral perfusion typically manifesting as skin discolouration with pallor, cyanosis and/or erythema, and increased sensitivity to cold. RS may be primary or secondary to systemic disease, lifestyle and environmental factors or medication. RS has been reported with medication to treat ADHD, but we found no recent comprehensive overview of the literature. The aim of this review is to evaluate the evidence in the published literature for Raynaud syndrome associated with medication for ADHD.</p><p><strong>Methods: </strong>We systematically searched PubMed and Embase from inception to 12 June 2024 for articles published in English describing cases of RS in individuals treated with stimulant medication, atomoxetine, guanfacine or clonidine. Identified cases were assessed against the Naranjo Adverse Drug Reaction Scale criteria to determine the probability of a causal relationship with the medication.</p><p><strong>Results: </strong>The initial search identified 197 articles. A total of 61 cases were identified from 15 case reports, 5 case series, 1 retrospective case-control study, and 1 retrospective cohort study. No randomised, controlled studies were identified. Implicated medications included methylphenidate, (dex)amfetamine and, more rarely, atomoxetine. Most cases were mild and resolved within weeks of discontinuation, dose reduction or switch to an alternative medication. A few cases associated with systemic disease were reported, leading to ulceration, gangrene and the need for amputation or revascularisation in some individuals. Assessment of 28 cases using the Naranjo criteria suggested a 'possible' causative role of ADHD medication in 13 cases, a 'probable' role in 13 cases and a 'definite' role in two cases.</p><p><strong>Conclusions: </strong>Due to the uncontrolled nature of all but one of the available studies, a causal relationship between medication for ADHD and RS could not be determined reliably. However, in view of the possibility of severe sequelae, albeit in rare cases, routine monitoring for signs of RS is recommended in individuals treated with CNS stimulants or atomoxetine, especially when initiating treatment or increasing the dose. Large database studies in which individuals act as their own controls should be conducted to clarify any association between treatment with these medications and RS, controlling for confounding factors.</p>","PeriodicalId":10508,"journal":{"name":"CNS drugs","volume":" ","pages":"213-241"},"PeriodicalIF":7.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143058231","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Assessing Early Efficacy After Initiation of Once-Nightly Sodium Oxybate (ON-SXB; FT218) in Participants with Narcolepsy Type 1 or 2: A Post Hoc Analysis from the Phase 3 REST-ON Trial.
IF 7.4 2区 医学
CNS drugs Pub Date : 2025-03-01 Epub Date: 2025-03-20 DOI: 10.1007/s40263-024-01143-7
Lois Krahn, Asim Roy, John W Winkelman, Anne Marie Morse, Jennifer Gudeman
{"title":"Assessing Early Efficacy After Initiation of Once-Nightly Sodium Oxybate (ON-SXB; FT218) in Participants with Narcolepsy Type 1 or 2: A Post Hoc Analysis from the Phase 3 REST-ON Trial.","authors":"Lois Krahn, Asim Roy, John W Winkelman, Anne Marie Morse, Jennifer Gudeman","doi":"10.1007/s40263-024-01143-7","DOIUrl":"10.1007/s40263-024-01143-7","url":null,"abstract":"<p><strong>Background: </strong>Once-nightly sodium oxybate (LUMRYZ™; ON-SXB; FT218) significantly improved narcolepsy symptoms in the phase 3 REST-ON trial. The objective of this post hoc analysis was to investigate the early efficacy of ON-SXB at weeks 1 (4.5-g dose) and 2 (6-g dose).</p><p><strong>Methods: </strong>In REST-ON, participants (≥ 16 years) with narcolepsy type 1 or 2 were randomized 1:1 to ON-SXB (4.5 g, 1 week; 6 g, 2 weeks; 7.5 g, 5 weeks; 9 g, 5 weeks) or placebo. Protocol-prespecified efficacy assessments were conducted at weeks 3 (6-g dose), 8 (7.5-g dose), and 13 (9-g dose). A post hoc analysis was conducted to assess the early efficacy of ON-SXB, defined as efficacy at weeks 1 (4.5-g dose) and 2 (6-g dose) on Epworth Sleepiness Scale (ESS) score, visual analog scale (VAS) sleep quality, and VAS refreshing nature of sleep. Least squares mean differences (LSMD) in change from baseline to weeks 1 and 2, 95% confidence intervals (CIs), and P values were calculated using mixed-effects models for repeated measures.</p><p><strong>Results: </strong>In the modified intent-to-treat population (n = 190; ON-SXB, n = 97; placebo, n = 93), baseline ESS scores were 16.6 and 17.5, sleep quality scores were 53.8 and 55.9, and refreshing nature of sleep scores were 46.5 and 49.9 with ON-SXB and placebo, respectively. At week 1 (4.5 g), numerical improvement in ESS score (LSMD [95% CI], - 0.7 [- 1.6 to 0.2]) and significant improvements in sleep quality (3.6 [1.1-6.1]; P < 0.01) and refreshing nature of sleep (3.2 [0.5-5.9]; P < 0.05) were observed with ON-SXB versus placebo. At week 2 (6 g), significant improvements with ON-SXB versus placebo were observed for ESS score (- 1.3 [- 2.4 to - 0.2]; P < 0.02), sleep quality (7.0 [3.8-10.1]; P < 0.001), and refreshing nature of sleep (5.8 [2.3-9.4]; P = 0.001).</p><p><strong>Conclusions: </strong>ON-SXB improved daytime sleepiness, sleep quality, and refreshing nature of sleep, with observable benefits beginning in the first week of treatment. These data may help clinicians set expectations with patients.</p><p><strong>Clinical trial id: </strong>NCT02720744.</p>","PeriodicalId":10508,"journal":{"name":"CNS drugs","volume":" ","pages":"53-59"},"PeriodicalIF":7.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11950099/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143669409","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Exploring the Effectiveness of Adjunctive Cenobamate in Focal Epilepsy: A Time-Based Analysis.
IF 7.4 2区 医学
CNS drugs Pub Date : 2025-02-27 DOI: 10.1007/s40263-025-01166-8
Roberta Roberti, Gianfranco Di Gennaro, Vittoria Cianci, Alfredo D'Aniello, Carlo Di Bonaventura, Giancarlo Di Gennaro, Francesco Fortunato, Edoardo Fronzoni, Alessandra Morano, Angelo Pascarella, Eleonora Rosati, Ilaria Sammarra, Emilio Russo, Simona Lattanzi
{"title":"Exploring the Effectiveness of Adjunctive Cenobamate in Focal Epilepsy: A Time-Based Analysis.","authors":"Roberta Roberti, Gianfranco Di Gennaro, Vittoria Cianci, Alfredo D'Aniello, Carlo Di Bonaventura, Giancarlo Di Gennaro, Francesco Fortunato, Edoardo Fronzoni, Alessandra Morano, Angelo Pascarella, Eleonora Rosati, Ilaria Sammarra, Emilio Russo, Simona Lattanzi","doi":"10.1007/s40263-025-01166-8","DOIUrl":"https://doi.org/10.1007/s40263-025-01166-8","url":null,"abstract":"<p><strong>Background: </strong>A growing body of evidence supports the effectiveness of cenobamate (CNB). This study aimed to assess the clinical response to add-on CNB through a time-to-event approach and explore the potential contribution of the concomitant classes of antiseizure medications (ASMs) to improve CNB clinical use.</p><p><strong>Patients and methods: </strong>This study is a subgroup analysis of a larger retrospective, multicenter study on adults with focal-onset seizures participating in the Italian Expanded Access Program at five pre-established centers. The primary endpoint was the time-to-baseline seizure count; secondary endpoints included the rates of seizure response, seizure freedom (defined as no seizures' occurrence since at least the previous follow-up visit), treatment discontinuation, and adverse events (AEs).</p><p><strong>Results: </strong>Data on 92 participants were extracted, with a median age of 44 (first quartile (Q<sub>1</sub>)-third quartile (Q<sub>3</sub>): 29.25-50.75) years. The number of seizures recorded during the 90-day baseline was reached by 59/92 (64.1%) subjects during the 12-month follow-up. A higher, but not statistically significant probability of reaching the baseline seizures count was shown in the subgroups of subjects taking CNB with sodium channel blockers (SCBs) (hazard ratio [HR] 2.75; 95% confidence interval [CI] 0.79-9.61, p = 0.112) and both SCBs and GABAergics (HR 1.48; 95% CI 0.43-5.09, p = 0.536) compared with subjects taking GABAergics without SCBs. At 12 months, the rates of seizure response, seizure-freedom, and treatment discontinuation were 42.0%, 13.6%, and 23.9%, respectively. A total of 47/92 (51.1%) subjects experienced AEs (mainly somnolence, dizziness, and balance disorders) at a median time of 61 (Q<sub>1</sub>-Q<sub>3</sub>: 30-101) days. There was a higher, but not statistically significant risk of AEs occurrence in subjects treated with both SCBs and GABAergics and in those taking SCBs without GABAergics (HR 2.24; 95% CI 0.51-9.82, p = 0.286 and HR 1.40; 95% CI 0.31-6.39, p = 0.661, respectively) compared with those taking GABAergics without SCBs. The main limitations are the retrospective design and the small sample size.</p><p><strong>Conclusions: </strong>This time-to-event analysis added new insights to the currently available evidence about the real-world effectiveness of add-on CNB. Explorative estimates suggested favorable trends for subjects treated with concomitant GABAergics and without SCBs, who seemed to reach baseline seizure count and experience AEs less frequently and later than subjects treated with other concomitant ASMs. Further studies are needed to identify the best combinations of CNB with other ASMs to maximize seizure control and tolerability.</p>","PeriodicalId":10508,"journal":{"name":"CNS drugs","volume":" ","pages":""},"PeriodicalIF":7.4,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143522553","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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