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[PMID]:29258368
[Au] Autor:Ward K; Citrome L
[Ad] Endereço:a University of Michigan College of Pharmacy , Ann Arbor , MI , USA.
[Ti] Título:Lisdexamfetamine: chemistry, pharmacodynamics, pharmacokinetics, and clinical efficacy, safety, and tolerability in the treatment of binge eating disorder.
[So] Source:Expert Opin Drug Metab Toxicol;14(2):229-238, 2018 Feb.
[Is] ISSN:1744-7607
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:INTRODUCTION: The indications for lisdexamfetamine (LDX), a central nervous system stimulant, were recently expanded to include treatment of moderate to severe binge eating disorder (BED). Areas covered: This review aims to describe the chemistry and pharmacology of LDX, as well as the clinical trials investigating the efficacy and safety of this medication for the management of BED. Expert opinion: LDX is the first medication with United States Food and Drug Administration approval for the treatment of BED. It is an inactive prodrug of d-amphetamine that extends the half-life of d-amphetamine to allow for once daily dosing. D-amphetamine acts primarily to increase the concentrations of synaptic dopamine and norepinephrine. Metabolism of LDX to d-amphetamine occurs when peptidases in red blood cells cleave the covalent bond between d-amphetamine and l-lysine. D-amphetamine is then further metabolized by CYP2D6. Excretion is primarily through renal mechanisms. In clinical trials, LDX demonstrated statistical and clinical superiority over placebo in reducing binge eating days per week at doses of 50 and 70 mg daily. Commonly reported side effects of LDX include dry mouth, insomnia, weight loss, and headache, and its use should be avoided in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia or coronary artery disease. As with all CNS stimulants, risk of abuse needs to be assessed prior to prescribing.
[Mh] Termos MeSH primário: Transtorno da Compulsão Alimentar/tratamento farmacológico
Estimulantes do Sistema Nervoso Central/administração & dosagem
Dimesilato de Lisdexanfetamina/administração & dosagem
[Mh] Termos MeSH secundário: Animais
Transtorno da Compulsão Alimentar/fisiopatologia
Estimulantes do Sistema Nervoso Central/efeitos adversos
Estimulantes do Sistema Nervoso Central/farmacocinética
Esquema de Medicação
Meia-Vida
Seres Humanos
Dimesilato de Lisdexanfetamina/efeitos adversos
Dimesilato de Lisdexanfetamina/farmacocinética
Metildopa/metabolismo
Norepinefrina/metabolismo
Pró-Fármacos
Índice de Gravidade de Doença
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Central Nervous System Stimulants); 0 (Prodrugs); 56LH93261Y (Methyldopa); SJT761GEGS (Lisdexamfetamine Dimesylate); X4W3ENH1CV (Norepinephrine)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180222
[Lr] Data última revisão:
180222
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171221
[St] Status:MEDLINE
[do] DOI:10.1080/17425255.2018.1420163


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[PMID]:28467032
[Au] Autor:Peat CM; Berkman ND; Lohr KN; Brownley KA; Bann CM; Cullen K; Quattlebaum MJ; Bulik CM
[Ad] Endereço:Department of Psychiatry, University of North Carolina, Chapel Hill, NC, USA.
[Ti] Título:Comparative Effectiveness of Treatments for Binge-Eating Disorder: Systematic Review and Network Meta-Analysis.
[So] Source:Eur Eat Disord Rev;25(5):317-328, 2017 Sep.
[Is] ISSN:1099-0968
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Psychological and pharmacological interventions for binge-eating disorder have previously demonstrated efficacy (compared with placebo or waitlist control); thus, we aimed to expand that literature with a review of comparative effectiveness. We searched MEDLINE,® EMBASE,® Cochrane Library, Academic OneFile, CINAHL® for binge-eating disorder treatment articles and selected studies using predetermined inclusion and exclusion criteria. Data were sufficient for network meta-analysis comparing two pharmacological interventions; psychological interventions were analysed qualitatively. In all, 28 treatment comparisons were included in this review: one pharmacological comparison (second-generation antidepressants versus lisdexamfetamine) and 26 psychological comparisons. Only three statistically significant differences emerged: lisdexamfetamine was better at increasing binge abstinence than second-generation antidepressants; therapist-led cognitive behavioural therapy was better at reducing binge-eating frequency than behavioural weight loss, but behavioural weight loss was better at reducing weight. The majority of other treatment comparisons revealed few significant differences between groups. Thus, patients and clinicians can choose from several effective treatment options. Copyright © 2017 John Wiley & Sons, Ltd and Eating Disorders Association.
[Mh] Termos MeSH primário: Transtorno da Compulsão Alimentar/terapia
[Mh] Termos MeSH secundário: Antidepressivos de Segunda Geração/uso terapêutico
Transtorno da Compulsão Alimentar/tratamento farmacológico
Terapia Cognitiva
Seres Humanos
Dimesilato de Lisdexanfetamina/uso terapêutico
Ensaios Clínicos Controlados Aleatórios como Assunto
Resultado do Tratamento
[Pt] Tipo de publicação:JOURNAL ARTICLE; META-ANALYSIS; REVIEW
[Nm] Nome de substância:
0 (Antidepressive Agents, Second-Generation); SJT761GEGS (Lisdexamfetamine Dimesylate)
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171130
[Lr] Data última revisão:
171130
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170504
[St] Status:MEDLINE
[do] DOI:10.1002/erv.2517


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[PMID]:28700805
[Au] Autor:Hudson JI; McElroy SL; Ferreira-Cornwell MC; Radewonuk J; Gasior M
[Ad] Endereço:McLean Hospital/Harvard Medical School, Belmont, Massachusetts.
[Ti] Título:Efficacy of Lisdexamfetamine in Adults With Moderate to Severe Binge-Eating Disorder: A Randomized Clinical Trial.
[So] Source:JAMA Psychiatry;74(9):903-910, 2017 Sep 01.
[Is] ISSN:2168-6238
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Importance: The ability of pharmacotherapies to prevent relapse and maintain efficacy with long-term treatment in psychiatric conditions is important. Objective: To assess lisdexamfetamine dimesylate maintenance of efficacy in adults with moderate to severe binge-eating disorder. Design, Setting, and Participants: A multinational, phase 3, double-blind, placebo-controlled, randomized withdrawal study including 418 participants was conducted at 49 clinical research study sites from January 27, 2014, to April 8, 2015. Eligible adults met DSM-IV-R binge-eating disorder criteria and had moderate to severe binge eating disorder (≥3 binge-eating days per week for 14 days before open-label baseline; Clinical Global Impressions-Severity [CGI-S] scores ≥4 [moderate severity] at screening and open-label baseline). Following a 12-week, open-label phase (dose optimization, 4 weeks [lisdexamfetamine dimesylate, 50 or 70 mg]; dose maintenance, 8 weeks), lisdexamfetamine responders (≤1 binge eating day per week for 4 consecutive weeks and CGI-S scores ≤2 at week 12) were randomized to placebo or continued lisdexamfetamine during a 26-week, double-blind, randomized withdrawal phase. Interventions: Lisdexamfetamine administration. Main Outcomes and Measures: The primary outcome variable, time to relapse (≥2 binge-eating days per week for 2 consecutive weeks and ≥2-point CGI-S score increases from randomized withdrawal baseline), was analyzed using a log-rank test (primary analysis); the analysis was stratified for dichotomized 4-week cessation status. Safety assessments included treatment-emergent adverse events. Results: Of the 418 participants enrolled in the open-label phase of the study, 411 (358 [87.1%] women; mean [SD] age, 38.3 [10.4] years) were included in the safety analysis set. Of 275 randomized lisdexamfetamine responders (placebo, n = 138; lisdexamfetamine, n = 137), the observed proportions of participants meeting relapse criteria were 3.7% (5 of 136) for lisdexamfetamine and 32.1% (42 of 131) for placebo. Lisdexamfetamine demonstrated superiority over placebo on the log-rank test (χ21, 40.37; P < .001) for time to relapse; the hazard ratio, based on a Cox proportional hazards model for lisdexamfetamine vs placebo, was 0.09 (95% CI, 0.04-0.23). The treatment-emergent adverse events observed were generally consistent with the known profile of lisdexamfetamine. Conclusions and Relevance: Risk of binge-eating relapse over 6 months was lower in participants continuing lisdexamfetamine than in those randomized to placebo. The hazard for relapse was lower with lisdexamfetamine than placebo. Trial Registration: clinicaltrials.gov Identifier: NCT02009163.
[Mh] Termos MeSH primário: Transtorno da Compulsão Alimentar/tratamento farmacológico
Dimesilato de Lisdexanfetamina/uso terapêutico
[Mh] Termos MeSH secundário: Adulto
Estimulantes do Sistema Nervoso Central/efeitos adversos
Estimulantes do Sistema Nervoso Central/uso terapêutico
Método Duplo-Cego
Feminino
Seres Humanos
Dimesilato de Lisdexanfetamina/efeitos adversos
Masculino
Pró-Fármacos/efeitos adversos
Pró-Fármacos/uso terapêutico
Recidiva
Resultado do Tratamento
Adulto Jovem
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE III; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Central Nervous System Stimulants); 0 (Prodrugs); SJT761GEGS (Lisdexamfetamine Dimesylate)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:170926
[Lr] Data última revisão:
170926
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170713
[St] Status:MEDLINE
[do] DOI:10.1001/jamapsychiatry.2017.1889


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[PMID]:28383364
[Au] Autor:Gasior M; Hudson J; Quintero J; Ferreira-Cornwell MC; Radewonuk J; McElroy SL
[Ad] Endereço:*Formerly of Shire, Lexington, MA; †McLean Hospital/Harvard Medical School, Belmont, MA; ‡Hospital Universitario Infanta Leonor, Madrid, Spain; §Lindner Center of HOPE, Mason; and ∥University of Cincinnati College of Medicine, Cincinnati, OH.
[Ti] Título:A Phase 3, Multicenter, Open-Label, 12-Month Extension Safety and Tolerability Trial of Lisdexamfetamine Dimesylate in Adults With Binge Eating Disorder.
[So] Source:J Clin Psychopharmacol;37(3):315-322, 2017 Jun.
[Is] ISSN:1533-712X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: A 12-month, open-label extension study assessed the long-term safety and tolerability of lisdexamfetamine dimesylate (LDX) in adults with binge eating disorder (BED). METHODS: Adults (aged 18-55 y) with BED who completed 1 of 3 antecedent studies were enrolled in a 52-week, open-label extension study (dose optimization, 4 weeks [initial titration dose, 30-mg LDX; target doses, 50- or 70-mg LDX]; dose maintenance, 48 weeks). Safety evaluations included the occurrence of treatment-emergent adverse events (TEAEs), vital sign and weight assessments, and Columbia-Suicide Severity Rating Scale responses. RESULTS: Of the 604 enrolled participants, 599 (521 women and 78 men) comprised the safety analysis set, and 369 completed the study. Mean (SD) LDX exposure was 284.3 (118.84) days; cumulative LDX exposure duration was 12 months or longer in 344 participants (57.4%). A total of 506 participants (84.5%) reported TEAEs (TEAEs leading to treatment discontinuation, 54 [9.0%]; severe TEAEs, 42 [7.0%]; serious TEAEs, 17 [2.8%]). Treatment-emergent adverse events reported in greater than or equal to 10% of participants were dry mouth (27.2%), headache (13.2%), insomnia (12.4%), and upper respiratory tract infection (11.4%). Mean (SD) changes from antecedent study baseline in systolic and diastolic blood pressure, pulse, and weight at week 52/early termination (n = 597) were 2.19 (11.043) and 1.77 (7.848) mm Hg, 6.58 (10.572) beats per minute, and -7.04 (7.534) kg, respectively. On the Columbia-Suicide Severity Rating Scale, there were 2 positive responses for any active suicidal ideations; there were no positive responses for suicidal behavior or completed suicides. CONCLUSIONS: In this 12-month, open-label, extension study, the long-term safety and tolerability of LDX in adults with BED were generally consistent with its established profile for attention-deficit/hyperactivity disorder.
[Mh] Termos MeSH primário: Transtorno da Compulsão Alimentar/tratamento farmacológico
Inibidores da Captação de Dopamina/farmacologia
Dimesilato de Lisdexanfetamina/farmacologia
Avaliação de Resultados (Cuidados de Saúde)
[Mh] Termos MeSH secundário: Adolescente
Adulto
Inibidores da Captação de Dopamina/administração & dosagem
Inibidores da Captação de Dopamina/efeitos adversos
Esquema de Medicação
Feminino
Seres Humanos
Dimesilato de Lisdexanfetamina/administração & dosagem
Dimesilato de Lisdexanfetamina/efeitos adversos
Masculino
Meia-Idade
Adulto Jovem
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE III; JOURNAL ARTICLE; MULTICENTER STUDY
[Nm] Nome de substância:
0 (Dopamine Uptake Inhibitors); SJT761GEGS (Lisdexamfetamine Dimesylate)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170804
[Lr] Data última revisão:
170804
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170407
[St] Status:MEDLINE
[do] DOI:10.1097/JCP.0000000000000702


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[PMID]:28246413
[Au] Autor:Norkus CL; Keir I; Means C
[Ad] Endereço:Allegheny Veterinary Emergency Trauma & Specialty, 4224 Northern Pike, Monroeville, Pennsylvania, 15146, USA (Norkus, Keir); ASPCA Animal Poison Control Center, 1717 S Philo Road, Suite 36 Urbana, Illinois 61802, USA (Means).
[Ti] Título:Dexmedetomidine to control signs associated with lisdexamfetamine dimesylate toxidrome in a cat.
[So] Source:Can Vet J;58(3):261-264, 2017 Mar.
[Is] ISSN:0008-5286
[Cp] País de publicação:Canada
[La] Idioma:eng
[Ab] Resumo:A 5-month-old intact female domestic shorthaired cat had mydriasis, agitation, and increased locomotion after ingestion of lisdexamfetamine, 10.3 mg/kg body weight (BW). Despite treatment with IV fluids, IV acepromazine, oral cyproheptadine and intravenous lipid emulsion the patient's clinical signs worsened. Dexmedetomidine administered at 2 µg/kg BW and continued at 0.5 µg/kg BW per hour rapidly controlled the patient's signs. An episode of vomiting and hematuria developed. Follow-up 5 days after discharge revealed that the cat appeared normal.
[Mh] Termos MeSH primário: Agonistas de Receptores Adrenérgicos alfa 2/uso terapêutico
Doenças do Gato/induzido quimicamente
Dexmedetomidina/uso terapêutico
Dimesilato de Lisdexanfetamina/envenenamento
Síndrome da Serotonina/veterinária
[Mh] Termos MeSH secundário: Animais
Doenças do Gato/tratamento farmacológico
Gatos
Feminino
Síndrome da Serotonina/tratamento farmacológico
[Pt] Tipo de publicação:CASE REPORTS; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Adrenergic alpha-2 Receptor Agonists); 67VB76HONO (Dexmedetomidine); SJT761GEGS (Lisdexamfetamine Dimesylate)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:170913
[Lr] Data última revisão:
170913
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170302
[St] Status:MEDLINE


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[PMID]:28125174
[Au] Autor:McElroy SL
[Ad] Endereço:Lindner Center of HOPE, 4075 Old Western Rd, Mason, OH 45040. susan.mcelroy@lindnercenter.org.
[Ti] Título:Pharmacologic Treatments for Binge-Eating Disorder.
[So] Source:J Clin Psychiatry;78 Suppl 1:14-19, 2017.
[Is] ISSN:1555-2101
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Binge-eating disorder (BED) is the most common eating disorder and is associated with poor physical and mental health outcomes. Psychological and behavioral interventions have been a mainstay of treatment for BED, but as understanding of this disorder has grown, pharmacologic agents have become promising treatment options for some patients. At this time, only one drug-the stimulant prodrug lisdexamfetamine-is approved for the treatment of BED. Numerous classes of medications including antidepressants, anticonvulsants, and antiobesity drugs have been explored as off-label treatments for BED with variable success. Although not all patients with BED may be suitable candidates for pharmacotherapy, all patients should be considered for and educated about pharmacologic treatment options.
[Mh] Termos MeSH primário: Transtorno da Compulsão Alimentar/tratamento farmacológico
Dimesilato de Lisdexanfetamina/uso terapêutico
Psicotrópicos/uso terapêutico
[Mh] Termos MeSH secundário: Adulto
Transtorno da Compulsão Alimentar/diagnóstico
Transtorno da Compulsão Alimentar/psicologia
Terapia Cognitiva
Terapia Combinada
Seres Humanos
Obesidade/diagnóstico
Obesidade/tratamento farmacológico
Obesidade/psicologia
Uso Off-Label
Educação de Pacientes como Assunto
Ensaios Clínicos Controlados Aleatórios como Assunto
Resultado do Tratamento
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Psychotropic Drugs); SJT761GEGS (Lisdexamfetamine Dimesylate)
[Em] Mês de entrada:1706
[Cu] Atualização por classe:170607
[Lr] Data última revisão:
170607
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170127
[St] Status:MEDLINE
[do] DOI:10.4088/JCP.sh16003su1c.03


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[PMID]:28007050
[Au] Autor:Vinther S; Klarskov P; Borgeskov H; Darsø P; Christophersen AK; Borck B; Christensen C; Hansen MV; Halladin NM; Christensen MB; Harboe KM; Lund M; Jimenez-Solem E
[Ad] Endereço:espen.jimenez.solem@regionh.dk.
[Ti] Título:An adverse drug event manager facilitates spontaneous reporting of adverse drug reactions.
[So] Source:Dan Med J;64(1), 2017 Jan.
[Is] ISSN:2245-1919
[Cp] País de publicação:Denmark
[La] Idioma:eng
[Ab] Resumo:INTRODUCTION: Spontaneous reporting of adverse drug reactions (ADRs) is used for continuous risk-benefit evaluation of marketed pharmaceutical products and for signal detection. The Adverse Drug Event Manager (ADEM) is a service offered to clinicians employed at hospitals in the Capital Region of Denmark. The ADEM assists healthcare professionals in reporting suspected ADRs to the Danish Health Authority. The aim of this retrospective observational study was to quantify and describe ADRs reported via the ADEM in 2014. METHODS: All ADR reports handled by the ADEM in 2014 were recorded anonymously and analysed descriptively. RESULTS: A total of 484 ADRs were reported through the ADEM in 2014 (the median number of reports per month was 37; range: 17-78). The majority of the reports came from departments of internal medicine (61%), psychiatry (14%) and dermatology, ophthalmology or otorhinolaryngology (11%). The drugs most frequently reported were lisdexamphetamine (n = 40), rivaroxaban (n = 16) and warfarin (n = 15) (vaccines excluded). In 13 out of 484 reports, the ADR was associated with a fatal outcome. CONCLUSION: The findings of this study indicate that an ADEM promotes and facilitates spontaneous ADR reporting and helps raise awareness about ADRs, including how and why they should be reported. Hopefully, this will assist national and European spontaneous reporting systems in their work to increase patient safety nationally and abroad. FUNDING: none. TRIAL REGISTRATION: not relevant. .
[Mh] Termos MeSH primário: Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos
Departamentos Hospitalares/estatística & dados numéricos
Hospitais/estatística & dados numéricos
[Mh] Termos MeSH secundário: Adolescente
Adulto
Idoso
Idoso de 80 Anos ou mais
Anticoagulantes/efeitos adversos
Estimulantes do Sistema Nervoso Central/efeitos adversos
Criança
Pré-Escolar
Dinamarca
Dermatologia/estatística & dados numéricos
Inibidores do Fator Xa/efeitos adversos
Feminino
Seres Humanos
Lactente
Recém-Nascido
Medicina Interna/estatística & dados numéricos
Dimesilato de Lisdexanfetamina/efeitos adversos
Masculino
Meia-Idade
Oftalmologia/estatística & dados numéricos
Otolaringologia/estatística & dados numéricos
Vigilância de Produtos Comercializados/métodos
Unidade Hospitalar de Psiquiatria/estatística & dados numéricos
Estudos Retrospectivos
Rivaroxabana/efeitos adversos
Varfarina/efeitos adversos
Adulto Jovem
[Pt] Tipo de publicação:JOURNAL ARTICLE; OBSERVATIONAL STUDY
[Nm] Nome de substância:
0 (Anticoagulants); 0 (Central Nervous System Stimulants); 0 (Factor Xa Inhibitors); 5Q7ZVV76EI (Warfarin); 9NDF7JZ4M3 (Rivaroxaban); SJT761GEGS (Lisdexamfetamine Dimesylate)
[Em] Mês de entrada:1703
[Cu] Atualização por classe:170316
[Lr] Data última revisão:
170316
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161224
[St] Status:MEDLINE


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[PMID]:27991835
[Au] Autor:Babinski DE; Waxmonsky JG; Waschbusch DA; Humphery H; Pelham WE
[Ad] Endereço:1 Penn State College of Medicine , Hershey, Pennsylvania.
[Ti] Título:Parent-Reported Improvements in Family Functioning in a Randomized Controlled Trial of Lisdexamfetamine for Treatment of Parental Attention-Deficit/Hyperactivity Disorder.
[So] Source:J Child Adolesc Psychopharmacol;27(3):250-257, 2017 Apr.
[Is] ISSN:1557-8992
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE: This study examines the effects of parental stimulant medication treatment on parent ratings of parent-child functioning. Ratings of parent-child functioning in the home setting and immediately following a laboratory-based parent-child interaction were collected. METHOD: Participants were 20 parents who along with their children (ages 5-12 years) were diagnosed with Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) attention-deficit/hyperactivity disorder (ADHD). Parents completed an open-label titration to determine their optimal dose of lisdexamfetamine (30, 50, or 70 mg/day) and then completed a month-long double-blind randomized pharmacological intervention for parental ADHD. Effects of parental stimulant medication administered for an extended duration were assessed by parent ratings of parent-child functioning in the home setting and immediately following a laboratory parent-child interaction task conducted at an academic mental health center. Data were collected from September 2010 to June 2013. RESULTS: Stimulant medication versus placebo was associated with larger reductions in parental ADHD (d = 1.01-1.09), impairment (d = 0.67-0.82), and executive dysfunction (d = 0.74-0.94) in the home setting. No significant benefits of stimulant medication emerged in measures of parenting or child behavior at home. In the laboratory setting, parents treated with stimulant medication versus placebo reported fewer ADHD symptoms (d = 1.01-1.05) and their interaction was more successful (d = 0.83) and pleasant (d = 0.92). Several additional trends emerged showing beneficial effects of stimulant medication on parent-child functioning. CONCLUSION: Parents treated with stimulant medication evidenced some improvements in parent-child functioning, which support the use of pharmacological intervention to improve functioning in families with parent-child ADHD. CLINICAL TRIALS REGISTRATION: NCT01127607.
[Mh] Termos MeSH primário: Transtorno do Deficit de Atenção com Hiperatividade/tratamento farmacológico
Transtorno do Deficit de Atenção com Hiperatividade/psicologia
Estimulantes do Sistema Nervoso Central/uso terapêutico
Dimesilato de Lisdexanfetamina/uso terapêutico
Poder Familiar/psicologia
Pais/psicologia
[Mh] Termos MeSH secundário: Adulto
Criança
Preparações de Ação Retardada
Manual Diagnóstico e Estatístico de Transtornos Mentais
Método Duplo-Cego
Função Executiva
Feminino
Seres Humanos
Relações Interpessoais
Masculino
Relações Pais-Filho
Escalas de Graduação Psiquiátrica
Inquéritos e Questionários
[Pt] Tipo de publicação:JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Central Nervous System Stimulants); 0 (Delayed-Action Preparations); SJT761GEGS (Lisdexamfetamine Dimesylate)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170809
[Lr] Data última revisão:
170809
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161220
[St] Status:MEDLINE
[do] DOI:10.1089/cap.2016.0129


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[PMID]:27518755
[Au] Autor:Comiran E; Barreto F; Meneghini LZ; Carlos G; Fröehlich PE; Limberger RP
[Ad] Endereço:Graduate Studies Program in Pharmaceutical Sciences, Faculty of Pharmacy, Federal University of Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil.
[Ti] Título:Method validation and determination of lisdexamfetamine and amphetamine in oral fluid, plasma and urine by LC-MS/MS.
[So] Source:Biomed Chromatogr;31(3), 2017 Mar.
[Is] ISSN:1099-0801
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Lisdexamfetamine (LDX) is a long-acting prodrug stimulant indicated for the treatment of attention-deficit/hyperactivity disorder and binge-eating disorder symptoms. In vivo hydrolysis of LDX amide bond releases the therapeutically active d-amphetamine (d-AMPH). Since toxicological tests in biological samples can detect AMPH from the use of some legal medications, efficient methods are needed in order to correctly interpret the results. The aim of this study was to develop and validate an LC-MS/MS method for the simultaneous quantification of LDX and its main biotransformation product AMPH in human oral fluid, plasma and urine. Calibration curve range for both analytes was 1-128 ng/mL in oral fluid and plasma and 4-256 ng/mL in urine, being the lowest concentration the limit of quantification. Accuracy of the determined values of the target analytes for the five control levels ranged from 94.8 to 111.7% for oral fluid, from 91.3 to 100.2% for plasma and from 94.8 to 109.8% for urine. Imprecision for the five control levels did not exceeded 12.8% for oral fluid, 16.2% for plasma and 17.1% for urine. The method developed for the three matrices was validated and was also successfully applied to assess real samples, showing for the first time the detection of LDX in oral fluid.
[Mh] Termos MeSH primário: Anfetamina/análise
Cromatografia Líquida
Testes de Química Clínica/métodos
Dimesilato de Lisdexanfetamina/análise
Espectrometria de Massas em Tandem
[Mh] Termos MeSH secundário: Anfetamina/sangue
Anfetamina/urina
Testes de Química Clínica/normas
Seres Humanos
Dimesilato de Lisdexanfetamina/sangue
Dimesilato de Lisdexanfetamina/urina
Reprodutibilidade dos Testes
Saliva/química
[Pt] Tipo de publicação:JOURNAL ARTICLE; VALIDATION STUDIES
[Nm] Nome de substância:
CK833KGX7E (Amphetamine); SJT761GEGS (Lisdexamfetamine Dimesylate)
[Em] Mês de entrada:1703
[Cu] Atualização por classe:170308
[Lr] Data última revisão:
170308
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160813
[St] Status:MEDLINE
[do] DOI:10.1002/bmc.3812


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Fotocópia
[PMID]:27905916
[Au] Autor:Ezard N; Dunlop A; Clifford B; Bruno R; Carr A; Bissaker A; Lintzeris N
[Ad] Endereço:Alcohol and Drug Service, O'Brien Centre, St Vincent's Hospital, Sydney, Darlinghurst, 2010, NSW, Australia.
[Ti] Título:Study protocol: a dose-escalating, phase-2 study of oral lisdexamfetamine in adults with methamphetamine dependence.
[So] Source:BMC Psychiatry;16(1):428, 2016 Dec 01.
[Is] ISSN:1471-244X
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: The treatment of methamphetamine dependence is a continuing global health problem. Agonist type pharmacotherapies have been used successfully to treat opioid and nicotine dependence and are being studied for the treatment of methamphetamine dependence. One potential candidate is lisdexamfetamine, a pro-drug for dexamphetamine, which has a longer lasting therapeutic action with a lowered abuse potential. The purpose of this study is to determine the safety of lisdexamfetamine in this population at doses higher than those currently approved for attention deficit hyperactivity disorder or binge eating disorder. METHODS/DESIGN: This is a phase 2 dose escalation study of lisdexamfetamine for the treatment of methamphetamine dependence. Twenty individuals seeking treatment for methamphetamine dependence will be recruited at two Australian drug and alcohol services. All participants will undergo a single-blinded ascending-descending dose regime of 100 to 250 mg lisdexamfetamine, dispensed daily on site, over an 8-week period. Participants will be offered counselling as standard care. For the primary objectives the outcome variables will be adverse events monitoring, drug tolerability and regimen completion. Secondary outcomes will be changes in methamphetamine use, craving, withdrawal, severity of dependence, risk behaviour and other substance use. Medication acceptability, potential for non-prescription use, adherence and changes in neurocognition will also be measured. DISCUSSION: Determining the safety of lisdexamfetamine will enable further research to develop pharmacotherapies for the treatment of methamphetamine dependence. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12615000391572 Registered 28 April 2015.
[Mh] Termos MeSH primário: Transtornos Relacionados ao Uso de Anfetaminas/tratamento farmacológico
Estimulantes do Sistema Nervoso Central/uso terapêutico
Dimesilato de Lisdexanfetamina/uso terapêutico
Metanfetamina
[Mh] Termos MeSH secundário: Adulto
Austrália
Estimulantes do Sistema Nervoso Central/efeitos adversos
Aconselhamento/métodos
Relação Dose-Resposta a Droga
Feminino
Seres Humanos
Dimesilato de Lisdexanfetamina/efeitos adversos
Masculino
Método Simples-Cego
Resultado do Tratamento
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE II; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Central Nervous System Stimulants); 44RAL3456C (Methamphetamine); SJT761GEGS (Lisdexamfetamine Dimesylate)
[Em] Mês de entrada:1706
[Cu] Atualização por classe:170605
[Lr] Data última revisão:
170605
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161202
[St] Status:MEDLINE



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