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[PMID]:29250981
[Au] Autor:Evangelista E; Lopez R; Dauvilliers Y
[Ad] Endereço:a Centre National de Référence Narcolepsie Hypersomnies, Unité des Troubles du Sommeil, Service de Neurologie , Hôpital Gui-de-Chauliac Montpellier , Montpellier , France.
[Ti] Título:Update on treatment for idiopathic hypersomnia.
[So] Source:Expert Opin Investig Drugs;27(2):187-192, 2018 Feb.
[Is] ISSN:1744-7658
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:INTRODUCTION: Idiopathic hypersomnia (IH) is a poorly characterized orphan central disorder of hypersomnolence responsible for excessive daytime sleepiness (EDS), prolonged nighttime sleep and sleep inertia that often require long-term symptomatic stimulant medication. To date, no drug has currently the authorization for the treatment of IH patients worldwide. Areas covered: The authors reviewed data on pharmacological treatment of IH obtained from published literature (Medline/PubMed/Web of Science) and Clinicaltrial.gov database from 1997 to 2017. Most of data on treatment of IH derived from observational studies and case series with only three well-designed clinical trials available. Expert opinion: In two recent randomized, double-blind, placebo-controlled trials, modafinil improves EDS in IH. Most of other wakefulness-promoting agents labeled for narcolepsy have similar efficacy in cases series of IH patients. Pitolisant and sodium oxybate show promising results in two retrospective studies. The efficacy of γ-aminobutyric acid-A receptor antagonists on objective EDS needs to be clarified. All these medications are used off-label for the management of EDS in IH. Specific clinical instruments and objective tests are required in IH to better evaluate the severity of EDS and responsiveness to medications, but also prolonged sleep and sleep inertia, to optimize the whole management of IH patients.
[Mh] Termos MeSH primário: Estimulantes do Sistema Nervoso Central/uso terapêutico
Hipersonolência Idiopática/tratamento farmacológico
Promotores da Vigília/uso terapêutico
[Mh] Termos MeSH secundário: Aprovação de Drogas
Antagonistas de Receptores de GABA-A/uso terapêutico
Seres Humanos
Hipersonolência Idiopática/fisiopatologia
Uso Off-Label
Ensaios Clínicos Controlados Aleatórios como Assunto
Índice de Gravidade de Doença
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Central Nervous System Stimulants); 0 (GABA-A Receptor Antagonists); 0 (Wakefulness-Promoting Agents)
[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:171219
[St] Status:MEDLINE
[do] DOI:10.1080/13543784.2018.1417385


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[PMID]:28449891
[Au] Autor:Kollb-Sielecka M; Demolis P; Emmerich J; Markey G; Salmonson T; Haas M
[Ad] Endereço:European Medicines Agency (EMA), London, United Kingdom. Electronic address: marta.kollb-sielecka@ema.europa.
[Ti] Título:The European Medicines Agency review of pitolisant for treatment of narcolepsy: summary of the scientific assessment by the Committee for Medicinal Products for Human Use.
[So] Source:Sleep Med;33:125-129, 2017 May.
[Is] ISSN:1878-5506
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:On 31 March 2016, the European Commission issued a decision for a marketing authorisation valid throughout the European Union (EU) for pitolisant (Wakix) for the treatment of narcolepsy with or without cataplexy in adults. Pitolisant is an antagonist/inverse agonist of the human histamine H3 receptor. The dose should be selected using an up-titration scheme depending on individual patient response and tolerance and should not exceed 36 mg/day. The main evidence of efficacy of pitolisant was based on two Phase III clinical trials. The improvement on excessive daytime sleepiness was shown against placebo in the Harmony I study (-3.33 points; 95% confidence interval (CI) [-5.83; -0.83]; p = 0.024) and in Harmony CTP (-3.41 points; 95% CI [-4.95; -1.87]; p < 0.0001). The daily cataplexy rate in Harmony I improved against placebo with a rate ratio (rR) of 0.38 whilst in the Harmony CTP the ratio of improvement on weekly cataplexy rate against placebo was 0.512. The most commonly reported adverse reactions were headache, insomnia and nausea. This article summarizes the scientific review leading to approval of pitolisant in the EU. The assessment report and product information are available on the European Medicines Agency website (http://www.ema.europa.eu).
[Mh] Termos MeSH primário: Narcolepsia/tratamento farmacológico
Piperidinas/uso terapêutico
Receptores Histamínicos H3/efeitos dos fármacos
[Mh] Termos MeSH secundário: Adolescente
Adulto
Idoso
Animais
Atenção/efeitos dos fármacos
Cataplexia/tratamento farmacológico
Ensaios Clínicos Fase III como Assunto
Cognição/efeitos dos fármacos
Agonismo Inverso de Drogas
Seres Humanos
Meia-Idade
Piperidinas/administração & dosagem
Piperidinas/efeitos adversos
Piperidinas/metabolismo
Receptores Histamínicos H3/fisiologia
Resultado do Tratamento
Promotores da Vigília/farmacologia
Adulto Jovem
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Piperidines); 0 (Receptors, Histamine H3); 0 (Wakefulness-Promoting Agents); 4BC83L4PIY (1-(3-(3-(4-chlorophenyl)propoxy)propyl)piperidine)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180216
[Lr] Data última revisão:
180216
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170429
[St] Status:MEDLINE


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[PMID]:28603108
[Au] Autor:Venkateswarlu K; Rangareddy A; Narasimhaiah K; Sharma H; Bandi NMR
[Ad] Endereço:Department of Pharmaceutics, JNTUA- Oil Technological and Pharmaceutical Research Institute, Ananthapuramu, Andhra Pradesh, India.
[Ti] Título:A validated stability indicating RP-HPLC method for estimation of Armodafinil in pharmaceutical dosage forms and characterization of its base hydrolytic product.
[So] Source:Pak J Pharm Sci;30(1):23-28, 2017 Jan.
[Is] ISSN:1011-601X
[Cp] País de publicação:Pakistan
[La] Idioma:eng
[Ab] Resumo:The main objective of present study was to develop a RP-HPLC method for estimation of Armodafinil in pharmaceutical dosage forms and characterization of its base hydrolytic product. The method was developed for Armodafinil estimation and base hydrolytic products were characterized. The separation was carried out on C18 column by using mobile phase as mixture of water and methanol (45:55%v/v). Eluents were detected at 220nm at 1ml/min. Stress studies were performed with milder conditions followed by stronger conditions so as to get sufficient degradation around 20%. A total of five degradation products were detected and separated from analyte. The linearity of the proposed method was investigated in the range of 20-120µg/ml for Armodafinil. The detection limit and quantification limit was found to be 0.01183µg/ml and 0.035µg/ml respectively. The precision % RSD was found to be less than 2% and the recovery was between 98-102%. Armodafinil was found to be more sensitive to the base hydrolysis and yielded its carboxylic acid as degradant. The developed method was stability indicating assay, suitable to quantify Armodafinil in presence of possible degradants. The drug was sensitive to acid, base &photolytic stress and resistant to thermal &oxidation.
[Mh] Termos MeSH primário: Compostos Benzidrílicos/análise
Cromatografia Líquida de Alta Pressão
Cromatografia de Fase Reversa
Tecnologia Farmacêutica/métodos
Promotores da Vigília/análise
[Mh] Termos MeSH secundário: Calibragem
Cromatografia Líquida de Alta Pressão/normas
Cromatografia de Fase Reversa/normas
Formas de Dosagem
Composição de Medicamentos
Contaminação de Medicamentos
Estabilidade de Medicamentos
Hidrólise
Modelos Lineares
Padrões de Referência
Reprodutibilidade dos Testes
Tecnologia Farmacêutica/normas
[Pt] Tipo de publicação:JOURNAL ARTICLE; VALIDATION STUDIES
[Nm] Nome de substância:
0 (Benzhydryl Compounds); 0 (Dosage Forms); 0 (Wakefulness-Promoting Agents); V63XWA605I (armodafinil)
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171103
[Lr] Data última revisão:
171103
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170613
[St] Status:MEDLINE


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Yamamoto, Mihoko
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[PMID]:28481358
[Au] Autor:Alexandre C; Latremoliere A; Ferreira A; Miracca G; Yamamoto M; Scammell TE; Woolf CJ
[Ad] Endereço:Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.
[Ti] Título:Decreased alertness due to sleep loss increases pain sensitivity in mice.
[So] Source:Nat Med;23(6):768-774, 2017 Jun.
[Is] ISSN:1546-170X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Extended daytime and nighttime activities are major contributors to the growing sleep deficiency epidemic, as is the high prevalence of sleep disorders like insomnia. The consequences of chronic insufficient sleep for health remain uncertain. Sleep quality and duration predict presence of pain the next day in healthy subjects, suggesting that sleep disturbances alone may worsen pain, and experimental sleep deprivation in humans supports this claim. We demonstrate that sleep loss, but not sleep fragmentation, in healthy mice increases sensitivity to noxious stimuli (referred to as 'pain') without general sensory hyper-responsiveness. Moderate daily repeated sleep loss leads to a progressive accumulation of sleep debt and also to exaggerated pain responses, both of which are rescued after restoration of normal sleep. Caffeine and modafinil, two wake-promoting agents that have no analgesic activity in rested mice, immediately normalize pain sensitivity in sleep-deprived animals, without affecting sleep debt. The reversibility of mild sleep-loss-induced pain by wake-promoting agents reveals an unsuspected role for alertness in setting pain sensitivity. Clinically, insufficient or poor-quality sleep may worsen pain and this enhanced pain may be reduced not by analgesics, whose effectiveness is reduced, but by increasing alertness or providing better sleep.
[Mh] Termos MeSH primário: Comportamento Animal/fisiologia
Hiperalgesia/fisiopatologia
Limiar da Dor/fisiologia
Dor/fisiopatologia
Privação do Sono/fisiopatologia
[Mh] Termos MeSH secundário: Doença Aguda
Analgésicos/farmacologia
Animais
Comportamento Animal/efeitos dos fármacos
Compostos Benzidrílicos/farmacologia
Cafeína/farmacologia
Doença Crônica
Corticosterona/sangue
Eletroencefalografia
Eletromiografia
Feminino
Hiperalgesia/sangue
Ibuprofeno/farmacologia
Masculino
Camundongos
Morfina/farmacologia
Dor/sangue
Limiar da Dor/efeitos dos fármacos
Privação do Sono/sangue
Vigília
Promotores da Vigília/farmacologia
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Analgesics); 0 (Benzhydryl Compounds); 0 (Wakefulness-Promoting Agents); 3G6A5W338E (Caffeine); 76I7G6D29C (Morphine); R3UK8X3U3D (modafinil); W980KJ009P (Corticosterone); WK2XYI10QM (Ibuprofen)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170829
[Lr] Data última revisão:
170829
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170509
[St] Status:MEDLINE
[do] DOI:10.1038/nm.4329


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[PMID]:28443381
[Au] Autor:Kallweit U; Bassetti CL
[Ad] Endereço:a Department of Neurology , Bern University Hospital and University of Bern , Bern , Switzerland.
[Ti] Título:Pharmacological management of narcolepsy with and without cataplexy.
[So] Source:Expert Opin Pharmacother;18(8):809-817, 2017 Jun.
[Is] ISSN:1744-7666
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:INTRODUCTION: Narcolepsy is an orphan neurological disease and presents with sleep-wake, motoric, neuropsychiatric and metabolic symptoms. Narcolepsy with cataplexy is most commonly caused by an immune-mediated process including genetic and environmental factors, resulting in the selective loss of hypocretin-producing neurons. Narcolepsy has a major impact on workableness and quality of life. Areas covered: This review provides an overview of the temporal available treatment options for narcolepsy (type 1 and 2) in adults, including authorization status by regulatory agencies. First- and second-line options are discussed as well as combination therapies. In addition, treatment options for frequent coexisting co-morbidities and different phenotypes of narcolepsy are presented. Finally, this review considers potential future management strategies. Non-pharmacological approaches are important in the management of narcolepsy but will not be covered in this review. Expert opinion: Concise evaluation of symptoms and type of narcolepsy, coexisting co-morbidities and patients´ distinct needs is mandatory in order to identify a suitable, individual pharmacological treatment. First-line options include Modafinil/Armodafinil (for excessive daytime sleepiness, EDS), Sodium Oxybate (for EDS and/with cataplexy), Pitolisant (for EDS and cataplexy) and Venlafaxine (for cataplexy (off-label) and co-morbid depression). New symptomatic and causal treatment most probably will be completed by hypocretin-replacement and immune-modifying strategies.
[Mh] Termos MeSH primário: Narcolepsia/tratamento farmacológico
Sono/efeitos dos fármacos
Promotores da Vigília/uso terapêutico
[Mh] Termos MeSH secundário: Adulto
Compostos Benzidrílicos/administração & dosagem
Compostos Benzidrílicos/uso terapêutico
Cataplexia/complicações
Cataplexia/diagnóstico
Cataplexia/tratamento farmacológico
Quimioterapia Combinada
Seres Humanos
Narcolepsia/complicações
Narcolepsia/diagnóstico
Neuropeptídeos/metabolismo
Uso Off-Label
Orexinas/metabolismo
Piperidinas/administração & dosagem
Piperidinas/uso terapêutico
Qualidade de Vida
Oxibato de Sódio/administração & dosagem
Oxibato de Sódio/uso terapêutico
Cloridrato de Venlafaxina/administração & dosagem
Cloridrato de Venlafaxina/uso terapêutico
Promotores da Vigília/administração & dosagem
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Benzhydryl Compounds); 0 (Neuropeptides); 0 (Orexins); 0 (Piperidines); 0 (Wakefulness-Promoting Agents); 4BC83L4PIY (1-(3-(3-(4-chlorophenyl)propoxy)propyl)piperidine); 7D7RX5A8MO (Venlafaxine Hydrochloride); 7G33012534 (Sodium Oxybate); R3UK8X3U3D (modafinil); V63XWA605I (armodafinil)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:170925
[Lr] Data última revisão:
170925
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170427
[St] Status:MEDLINE
[do] DOI:10.1080/14656566.2017.1323877


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[PMID]:28404841
[Au] Autor:Bivard A; Lillicrap T; Krishnamurthy V; Holliday E; Attia J; Pagram H; Nilsson M; Parsons M; Levi CR
[Ad] Endereço:From the Departments of Neurology, John Hunter Hospital (A.B., T.L., V.K., M.P., C.R.L.), Hunter Medical Research Institute (A.B., T.L., V.K., E.H., J.A., H.P., M.N., M.P., C.R.L.), and Centre for Clinical Epidemiology and Biostatistics, School of Medicine and Public Health (J.A.), University of New
[Ti] Título:MIDAS (Modafinil in Debilitating Fatigue After Stroke): A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial.
[So] Source:Stroke;48(5):1293-1298, 2017 May.
[Is] ISSN:1524-4628
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND AND PURPOSE: This study aimed to assess the efficacy of modafinil, a wakefulness-promoting agent in alleviating post-stroke fatigue ≥3 months after stroke. We hypothesized that 200 mg of modafinil daily for 6 weeks would result in reduced symptoms of fatigue compared with placebo. METHODS: This single-center phase 2 trial used a randomized, double-blind, placebo-controlled, crossover design. The key inclusion criterion was a multidimensional fatigue inventory score of ≥60. Patients were randomized to either modafinil or placebo for 6 weeks of therapy, then after a 1 week washout period swapped treatment arms for a second 6 weeks of therapy. The primary outcome was the multidimensional fatigue inventory; secondary outcomes included the Montreal cognitive assessment, the Depression, Anxiety, and Stress Scale (DASS), and the Stroke-Specific Quality of Life (SSQoL) scale. The multidimensional fatigue inventory is a self-administered questionnaire with a range of 0 to 100. Treatment efficacy was assessed using linear regression by estimating within-person, baseline-adjusted differences in mean outcomes after therapy. This trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12615000350527). RESULTS: A total of 232 stroke survivors were screened and 36 were randomized. Participants receiving modafinil reported a significant decrease in fatigue (multidimensional fatigue inventory, -7.38; 95% CI, -21.76 to -2.99; <0.001) and improved quality of life (SSQoL, 11.81; 95% CI, 2.31 to 21.31; =0.0148) compared with placebo. Montreal cognitive assessment and DASS were not significantly improved with modafinil therapy during the study period ( >0.05). CONCLUSIONS: Stroke survivors with nonresolving fatigue reported reduced fatigue and improved quality of life after taking 200 mg daily treatment with modafinil. CLINICAL TRIAL REGISTRATION: URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368268. Unique identifier: ACTRN12615000350527.
[Mh] Termos MeSH primário: Compostos Benzidrílicos/farmacologia
Fadiga/tratamento farmacológico
Avaliação de Resultados (Cuidados de Saúde)
Índice de Gravidade de Doença
Acidente Vascular Cerebral/complicações
Promotores da Vigília/farmacologia
[Mh] Termos MeSH secundário: Idoso
Idoso de 80 Anos ou mais
Compostos Benzidrílicos/administração & dosagem
Estudos Cross-Over
Método Duplo-Cego
Fadiga/etiologia
Feminino
Seres Humanos
Masculino
Meia-Idade
Qualidade de Vida
Promotores da Vigília/administração & dosagem
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE II; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Benzhydryl Compounds); 0 (Wakefulness-Promoting Agents); R3UK8X3U3D (modafinil)
[Em] Mês de entrada:1706
[Cu] Atualização por classe:170630
[Lr] Data última revisão:
170630
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170414
[St] Status:MEDLINE
[do] DOI:10.1161/STROKEAHA.116.016293


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[PMID]:28364419
[Au] Autor:Hodges SE; Pittman B; Morgan PT
[Ad] Endereço:Department of Psychiatry, Yale University,34 Park Street, New Haven, CT 06519.
[Ti] Título:Sleep Perception and Misperception in Chronic Cocaine Users During Abstinence.
[So] Source:Sleep;40(3), 2017 Mar 01.
[Is] ISSN:1550-9109
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Study Objectives: During abstinence, chronic cocaine users experience an objective worsening of sleep that is perceived as qualitatively improving. This phenomenon has been termed "occult insomnia." The objective of this study was to determine whether chronic cocaine users experience positive sleep state misperception during abstinence. Methods: Forty-three cocaine-dependent persons were admitted to an inpatient research facility for 12 days and 11 nights to participate in a treatment study of modafinil. Polysomnographic sleep recordings were performed on study nights 3, 4, 10, and 11, when participants were on average 1 and 2 weeks abstinent from cocaine. Participants also completed sleep diary questionnaires every evening before bed and every morning upon awakening. Polysomnographic and sleep diary measurements of total sleep time, sleep latency, time awake after sleep onset, and time in bed after final awakening were compared. Results: Chronic cocaine users accurately reported total sleep time after 1 week of abstinence but overreported total sleep time by an average of 40 min after 2 weeks of abstinence. Underestimating sleep latency and time spent awake after sleep onset were responsible for this difference. Conclusions: Positive sleep state misperception is revealed in chronic cocaine users after 2 weeks of abstinence and is consistent with the previously identified "occult insomnia" in this population.
[Mh] Termos MeSH primário: Transtornos Relacionados ao Uso de Cocaína/fisiopatologia
Transtornos Relacionados ao Uso de Cocaína/psicologia
Percepção/fisiologia
Distúrbios do Início e da Manutenção do Sono/fisiopatologia
Distúrbios do Início e da Manutenção do Sono/psicologia
Sono/fisiologia
[Mh] Termos MeSH secundário: Adulto
Compostos Benzidrílicos/farmacologia
Transtornos Relacionados ao Uso de Cocaína/epidemiologia
Método Duplo-Cego
Feminino
Seres Humanos
Masculino
Meia-Idade
Percepção/efeitos dos fármacos
Polissonografia/efeitos dos fármacos
Polissonografia/métodos
Sono/efeitos dos fármacos
Distúrbios do Início e da Manutenção do Sono/epidemiologia
Vigília/efeitos dos fármacos
Vigília/fisiologia
Promotores da Vigília/farmacologia
[Pt] Tipo de publicação:JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Benzhydryl Compounds); 0 (Wakefulness-Promoting Agents); R3UK8X3U3D (modafinil)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171004
[Lr] Data última revisão:
171004
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170402
[St] Status:MEDLINE
[do] DOI:10.1093/sleep/zsw069


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[PMID]:28253393
[Au] Autor:Mustian KM; Alfano CM; Heckler C; Kleckner AS; Kleckner IR; Leach CR; Mohr D; Palesh OG; Peppone LJ; Piper BF; Scarpato J; Smith T; Sprod LK; Miller SM
[Ad] Endereço:Department of Surgery, Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.
[Ti] Título:Comparison of Pharmaceutical, Psychological, and Exercise Treatments for Cancer-Related Fatigue: A Meta-analysis.
[So] Source:JAMA Oncol;3(7):961-968, 2017 Jul 01.
[Is] ISSN:2374-2445
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Importance: Cancer-related fatigue (CRF) remains one of the most prevalent and troublesome adverse events experienced by patients with cancer during and after therapy. Objective: To perform a meta-analysis to establish and compare the mean weighted effect sizes (WESs) of the 4 most commonly recommended treatments for CRF-exercise, psychological, combined exercise and psychological, and pharmaceutical-and to identify independent variables associated with treatment effectiveness. Data Sources: PubMed, PsycINFO, CINAHL, EMBASE, and the Cochrane Library were searched from the inception of each database to May 31, 2016. Study Selection: Randomized clinical trials in adults with cancer were selected. Inclusion criteria consisted of CRF severity as an outcome and testing of exercise, psychological, exercise plus psychological, or pharmaceutical interventions. Data Extraction and Synthesis: Studies were independently reviewed by 12 raters in 3 groups using a systematic and blinded process for reconciling disagreement. Effect sizes (Cohen d) were calculated and inversely weighted by SE. Main Outcomes and Measures: Severity of CRF was the primary outcome. Study quality was assessed using a modified 12-item version of the Physiotherapy Evidence-Based Database scale (range, 0-12, with 12 indicating best quality). Results: From 17 033 references, 113 unique studies articles (11 525 unique participants; 78% female; mean age, 54 [range, 35-72] years) published from January 1, 1999, through May 31, 2016, had sufficient data. Studies were of good quality (mean Physiotherapy Evidence-Based Database scale score, 8.2; range, 5-12) with no evidence of publication bias. Exercise (WES, 0.30; 95% CI, 0.25-0.36; P < .001), psychological (WES, 0.27; 95% CI, 0.21-0.33; P < .001), and exercise plus psychological interventions (WES, 0.26; 95% CI, 0.13-0.38; P < .001) improved CRF during and after primary treatment, whereas pharmaceutical interventions did not (WES, 0.09; 95% CI, 0.00-0.19; P = .05). Results also suggest that CRF treatment effectiveness was associated with cancer stage, baseline treatment status, experimental treatment format, experimental treatment delivery mode, psychological mode, type of control condition, use of intention-to-treat analysis, and fatigue measures (WES range, -0.91 to 0.99). Results suggest that the effectiveness of behavioral interventions, specifically exercise and psychological interventions, is not attributable to time, attention, and education, and specific intervention modes may be more effective for treating CRF at different points in the cancer treatment trajectory (WES range, 0.09-0.22). Conclusions and Relevance: Exercise and psychological interventions are effective for reducing CRF during and after cancer treatment, and they are significantly better than the available pharmaceutical options. Clinicians should prescribe exercise or psychological interventions as first-line treatments for CRF.
[Mh] Termos MeSH primário: Estimulantes do Sistema Nervoso Central/uso terapêutico
Terapia Cognitiva
Terapia por Exercício
Fadiga/terapia
Glucocorticoides/uso terapêutico
Neoplasias/complicações
Inibidores da Captação de Serotonina/uso terapêutico
Promotores da Vigília/uso terapêutico
[Mh] Termos MeSH secundário: Compostos Benzidrílicos/uso terapêutico
Cloridrato de Dexmetilfenidato/uso terapêutico
Dextroanfetamina/uso terapêutico
Fadiga/etiologia
Seres Humanos
Metilfenidato/uso terapêutico
Metilprednisolona/uso terapêutico
Paroxetina/uso terapêutico
Psicoterapia
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; META-ANALYSIS; REVIEW
[Nm] Nome de substância:
0 (Benzhydryl Compounds); 0 (Central Nervous System Stimulants); 0 (Glucocorticoids); 0 (Serotonin Uptake Inhibitors); 0 (Wakefulness-Promoting Agents); 1678OK0E08 (Dexmethylphenidate Hydrochloride); 207ZZ9QZ49 (Methylphenidate); 41VRH5220H (Paroxetine); R3UK8X3U3D (modafinil); TZ47U051FI (Dextroamphetamine); V63XWA605I (armodafinil); X4W7ZR7023 (Methylprednisolone)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170828
[Lr] Data última revisão:
170828
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170303
[St] Status:MEDLINE
[do] DOI:10.1001/jamaoncol.2016.6914


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[PMID]:28105576
[Au] Autor:Peoples AR; Garland SN; Perlis ML; Savard J; Heckler CE; Kamen CS; Ryan JL; Mustian KM; Janelsins MC; Peppone LJ; Morrow GR; Roscoe JA
[Ad] Endereço:Department of Surgery, University of Rochester Medical Center, 265 Crittenden Blvd., CU 420658, Rochester, NY, 14642-0658, USA. Anita_Peoples@urmc.rochester.edu.
[Ti] Título:Effects of cognitive behavioral therapy for insomnia and armodafinil on quality of life in cancer survivors: a randomized placebo-controlled trial.
[So] Source:J Cancer Surviv;11(3):401-409, 2017 Jun.
[Is] ISSN:1932-2267
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:PURPOSE: Cancer-related insomnia is associated with diminished quality of life (QOL), suggesting that improvement in insomnia may improve QOL in cancer survivors. Cognitive behavioral therapy for insomnia (CBT-I) has been shown to improve insomnia, but less is known regarding its effect on QOL and whether improvement in insomnia corresponds to improved QOL. The present analysis examines the effects of CBT-I, with and without armodafinil, on QOL both directly and indirectly through improvements of insomnia. METHODS: This is an analysis of 95 cancer survivors for a specified secondary aim of a four-arm randomized controlled trial assessing the combined and individual effects of CBT-I and armodafinil to improve insomnia. QOL and insomnia severity were assessed before, during the intervention, at post-intervention, and 3 months later by Functional Assessment of Cancer Therapy-General and Insomnia Severity Index, respectively. RESULTS: Mean change in QOL from pre- to post-intervention for CBT-I + placebo, CBT-I + armodafinil, armodafinil, and placebo was 9.6 (SE = 1.8; p < 0.0001), 11.6 (SE = 1.8; p < 0.0001), -0.2 (SE = 3.2; p = 0.964), and 3.3 (SE = 2.0; p = 0.124), respectively. ANCOVA controlling for pre-intervention scores showed that participants receiving CBT-I had significantly improved QOL at post-intervention compared to those not receiving CBT-I (p < 0.0001, effect size = 0.57), with benefits being maintained at the 3-month follow-up. Path analysis revealed that this improvement in QOL was due to improvement in insomnia severity (p = 0.002), and Pearson correlations showed that changes in QOL from pre- to post-intervention were significantly associated with concurrent changes in insomnia severity (r = -0.56; p < 0.0001). Armodafinil had no effect on QOL for those who did or did not receive it (p = 0.976; effect size = -0.004). CONCLUSION: In cancer survivors with insomnia, CBT-I resulted in clinically significant improvement in QOL via improvement in insomnia. This improvement in QOL remained stable even 3 months after completing CBT-I. IMPLICATIONS FOR CANCER SURVIVORS: Considering the high prevalence of insomnia and its detrimental impact on QOL in cancer survivors and the effectiveness of CBT-I in alleviating insomnia, it is important that evidence-based non-pharmacological sleep interventions such as CBT-I be provided as an integral part of cancer care.
[Mh] Termos MeSH primário: Compostos Benzidrílicos/uso terapêutico
Terapia Cognitiva/métodos
Neoplasias/complicações
Qualidade de Vida/psicologia
Distúrbios do Início e da Manutenção do Sono/tratamento farmacológico
Promotores da Vigília/uso terapêutico
[Mh] Termos MeSH secundário: Adulto
Idoso
Compostos Benzidrílicos/administração & dosagem
Compostos Benzidrílicos/farmacologia
Feminino
Seres Humanos
Masculino
Meia-Idade
Neoplasias/mortalidade
Sobreviventes
Resultado do Tratamento
Promotores da Vigília/administração & dosagem
Promotores da Vigília/farmacologia
[Pt] Tipo de publicação:JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Benzhydryl Compounds); 0 (Wakefulness-Promoting Agents); V63XWA605I (armodafinil)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171030
[Lr] Data última revisão:
171030
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170121
[St] Status:MEDLINE
[do] DOI:10.1007/s11764-017-0597-0


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[PMID]:28067776
[Au] Autor:Gahr M; Connemann BJ; Schönfeldt-Lecuona C; Zeiss R
[Ad] Endereço:Department of Psychiatry and Psychotherapy III, University of Ulm, Leimgrubenweg 12-14, 89075 Ulm, Germany. maximilian.gahr@uni-ulm.de.
[Ti] Título:Sensitivity of Quantitative Signal Detection in Regards to Pharmacological Neuroenhancement.
[So] Source:Int J Mol Sci;18(1), 2017 Jan 05.
[Is] ISSN:1422-0067
[Cp] País de publicação:Switzerland
[La] Idioma:eng
[Ab] Resumo:Pharmacological neuroenhancement (PNE) is a form of abuse and has not yet been addressed by methods of pharmacovigilance. In the present study, we tested if quantitative signal detection may be sensitive in regards to PNE. We evaluated the risk of drug abuse and dependence (DAAD) related to substances that are known to be used for PNE and divided this group into agents with (methylphenidate) and without a known abuse potential outside the field of PNE (atomoxetine, modafinil, acetylcholine esterase inhibitors, and memantine). Reporting odds ratios (RORs) were calculated using a case/non-case approach based on global and country-specific drug safety data from the Uppsala Monitoring Centre (UMC). Both control substances (diazepam and lorazepam) and methylphenidate were statistically associated with DAAD in all datasets (except methylphenidate in Italy). Modafinil was associated with DAAD in the total dataset (ROR, 2.7 (95% confidence interval (CI), 2.2-3.3)), Germany (ROR, 4.6 (95% CI, 1.8-11.5)), and the USA (ROR, 2.0 (95% CI, 1.6-2.5)). Atomoxetine was associated with DAAD in the total dataset (ROR, 1.3 (95% CI, 1.2-1.5)) and in the UK (ROR, 3.3 (95% CI, 1.8-6.1)). Apart from memantine, which was associated with DAAD in Germany (ROR, 1.8 (95% CI, 1.0-3.2)), no other antidementia drug was associated with DAAD. Quantitative signal detection is suitable to detect agents with a risk for DAAD. Its sensitivity regarding PNE is limited, although atomoxetine and modafinil, which do not have a known abuse potential outside PNE, and no antidementia drugs, whose use in PNE is presumably low, were associated with DAAD in our analysis.
[Mh] Termos MeSH primário: Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia
Metilfenidato/efeitos adversos
Farmacovigilância
[Mh] Termos MeSH secundário: Inibidores da Captação Adrenérgica/efeitos adversos
Cloridrato de Atomoxetina/efeitos adversos
Austrália/epidemiologia
Compostos Benzidrílicos/efeitos adversos
Canadá/epidemiologia
Estimulantes do Sistema Nervoso Central/efeitos adversos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/classificação
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia
Antagonistas de Aminoácidos Excitatórios/efeitos adversos
França/epidemiologia
Alemanha/epidemiologia
Seres Humanos
Itália/epidemiologia
Memantina/efeitos adversos
Espanha/epidemiologia
Transtornos Relacionados ao Uso de Substâncias/classificação
Transtornos Relacionados ao Uso de Substâncias/epidemiologia
Transtornos Relacionados ao Uso de Substâncias/etiologia
Reino Unido/epidemiologia
Estados Unidos/epidemiologia
Promotores da Vigília/efeitos adversos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Adrenergic Uptake Inhibitors); 0 (Benzhydryl Compounds); 0 (Central Nervous System Stimulants); 0 (Excitatory Amino Acid Antagonists); 0 (Wakefulness-Promoting Agents); 207ZZ9QZ49 (Methylphenidate); 57WVB6I2W0 (Atomoxetine Hydrochloride); R3UK8X3U3D (modafinil); W8O17SJF3T (Memantine)
[Em] Mês de entrada:1704
[Cu] Atualização por classe:170428
[Lr] Data última revisão:
170428
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170110
[St] Status:MEDLINE



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