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[PMID]:29279555
[Au] Autor:Masuda R; Ajimi J; Murata T
[Ad] Endereço:Department of Anesthesiology, Tokai University Hachioji Hospital.
[Ti] Título:Pharmacotherapy for Neuropathic Pain in Japan.
[So] Source:J Nippon Med Sch;84(6):258-267, 2017.
[Is] ISSN:1347-3409
[Cp] País de publicação:Japan
[La] Idioma:eng
[Ab] Resumo:Neuropathic pain (NeP) results from injury to, or disease of, the peripheral or central components of the neural systems involved in pain. In contrast to inflammatory pain, NeP can persist after healing from the initial injury has resolved. Antipyretic agents, such as non-steroidal anti-inflammatory drugs, steroids, and acetaminophen are ineffective, while specific agents such as gabapentinoids, antidepressants, antiepileptics, and opioids are effective in treating NeP. In this review, we address the definition of NeP, pharmacotherapy for NeP in Japan, pain classification, setting goals for successful NeP medication, and the Japanese algorithm for the pharmacotherapy of NeP with specific prescription guidance.
[Mh] Termos MeSH primário: Aminas/administração & dosagem
Analgésicos Opioides/administração & dosagem
Anticonvulsivantes/administração & dosagem
Antidepressivos/administração & dosagem
Ácidos Cicloexanocarboxílicos/administração & dosagem
Cloridrato de Duloxetina/administração & dosagem
Neuralgia/tratamento farmacológico
Pregabalina/administração & dosagem
Ácido gama-Aminobutírico/administração & dosagem
[Mh] Termos MeSH secundário: Idoso
Algoritmos
Aminas/efeitos adversos
Analgésicos Opioides/efeitos adversos
Anticonvulsivantes/efeitos adversos
Antidepressivos/efeitos adversos
Ácidos Cicloexanocarboxílicos/efeitos adversos
Esquema de Medicação
Cloridrato de Duloxetina/efeitos adversos
Feminino
Seres Humanos
Japão
Neuralgia/classificação
Manejo da Dor
Pregabalina/efeitos adversos
Ácido gama-Aminobutírico/efeitos adversos
[Pt] Tipo de publicação:CASE REPORTS; JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Amines); 0 (Analgesics, Opioid); 0 (Anticonvulsants); 0 (Antidepressive Agents); 0 (Cyclohexanecarboxylic Acids); 55JG375S6M (Pregabalin); 56-12-2 (gamma-Aminobutyric Acid); 6CW7F3G59X (gabapentin); 9044SC542W (Duloxetine Hydrochloride)
[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:171228
[St] Status:MEDLINE
[do] DOI:10.1272/jnms.84.258


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[PMID]:29172829
[Au] Autor:El Sharawy AM; Shukr MH; Elshafeey AH
[Ad] Endereço:a National Organization for Drug Control and Research (NODCAR) , Cairo , Egypt.
[Ti] Título:Formulation and optimization of duloxetine hydrochloride buccal films: in vitro and in vivo evaluation.
[So] Source:Drug Deliv;24(1):1762-1769, 2017 Nov.
[Is] ISSN:1521-0464
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Duloxetine hydrochloride (DH) is a serotonin-norepinephrine reuptake inhibitor (SSNRI) indicated for the treatment of depression. Duloxetine suffers from reduced oral bioavailability (≈50%) due to hepatic metabolism. This study aims to develop DH buccoadhesive films to improve its bioavailability. DH buccoadhesive films were prepared adopting the solvent casting method using hydroxypropyl methylcellulose (HPMC) and polyvinyl alcohol (PVA). The prepared films were evaluated for weight uniformity, drug content, surface pH, swelling index, mucoadhesion strength and drug release percentages. Accelerated stability and bioavailability studies in healthy human volunteers were also performed for the selected films. Results of the evaluation tests showed that the optimum physicochemical characters were obtained by the films prepared with 2% HPMC using 10% propylene glycol (F2 films). Accelerated stability studies revealed that DH showed proved stability throughout the experiment time. DH bioavailability from F2 films was determined and compared with that of the marketed oral capsules (Cymbalta 30 mg). The pharmacokinetic results showed that C for F2 was higher than the market product. In addition, ANOVA analysis showed that a T of F2 film was significantly lower, while, the AUC of F2 was significantly higher than that of Cymbalta capsules. The percentage relative bioavailability of DH from F2 was found to be 296.39%. Therefore, the prepared buccal films offer an alternative route for the administration of DH with the possibility of improving its bioavailability.
[Mh] Termos MeSH primário: Cloridrato de Duloxetina/química
Cloridrato de Duloxetina/metabolismo
[Mh] Termos MeSH secundário: Adesividade
Administração Bucal
Animais
Disponibilidade Biológica
Química Farmacêutica/métodos
Galinhas/metabolismo
Estudos Cross-Over
Sistemas de Liberação de Medicamentos/métodos
Liberação Controlada de Fármacos/fisiologia
Seres Humanos
Derivados da Hipromelose/química
Mucosa Bucal/metabolismo
Álcool de Polivinil/química
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
3NXW29V3WO (Hypromellose Derivatives); 9002-89-5 (Polyvinyl Alcohol); 9044SC542W (Duloxetine Hydrochloride)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180130
[Lr] Data última revisão:
180130
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171128
[St] Status:MEDLINE
[do] DOI:10.1080/10717544.2017.1402216


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[PMID]:28677828
[Au] Autor:Koesters M; Ostuzzi G; Guaiana G; Breilmann J; Barbui C
[Ad] Endereço:Department of Psychiatry II, Ulm University, Ludwig-Heilmeyer-Str. 2, Guenzburg, Germany, D-89312.
[Ti] Título:Vortioxetine for depression in adults.
[So] Source:Cochrane Database Syst Rev;7:CD011520, 2017 Jul 05.
[Is] ISSN:1469-493X
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Major depressive disorder is a common mental disorder affecting a person's mind, behaviour and body. It is expressed as a variety of symptoms and is associated with substantial impairment. Despite a range of pharmacological and non-pharmacological treatment options, there is still room for improvement of the pharmacological treatment of depression in terms of efficacy and tolerability. The latest available antidepressant is vortioxetine. It is assumed that vortioxetine's antidepressant action is related to a direct modulation of serotonergic receptor activity and inhibition of the serotonin transporter. The mechanism of action is not fully understood, but it is claimed to be novel. Vortioxetine was placed in the category of "Other" antidepressants and may therefore provide an alternative to existing antidepressant drugs. OBJECTIVES: To assess the efficacy and acceptability of vortioxetine compared with placebo and other antidepressant drugs in the treatment of acute depression in adults. SEARCH METHODS: We searched Cochrane's Depression, Anxiety and Neurosis Review Group's Specialised Register to May 2016 without applying any restrictions to date, language or publication status. We checked reference lists of relevant studies and reviews, regulatory agency reports and trial databases. SELECTION CRITERIA: We included randomised controlled trials comparing the efficacy, tolerability, or both of vortioxetine versus placebo or any other antidepressant agent in the treatment of acute depression in adults. DATA COLLECTION AND ANALYSIS: Two review authors independently selected the studies and extracted data. We extracted data on study characteristics, participant characteristics, intervention details and outcome measures in terms of efficacy, acceptability and tolerability. We analysed intention-to-treat (ITT) data only and used risk ratios (RR) as effect sizes for dichotomous data and mean differences (MD) for continuous data with 95% confidence intervals (CI). Meta-analyses used random-effects models. MAIN RESULTS: We included 15 studies (7746 participants) in this review. Seven studies were placebo controlled; eight studies compared vortioxetine to serotonin-norepinephrine reuptake inhibitors (SNRIs). We were unable to identify any study that compared vortioxetine to antidepressant drugs from other classes, such as selective serotonin reuptake inhibitors (SSRIs).Vortioxetine may be more effective than placebo across the three efficacy outcomes: response (Mantel-Haenszel RR 1.35, 95% CI 1.22 to 1.49; 14 studies, 6220 participants), remission (RR 1.32, 95% CI 1.15 to 1.53; 14 studies, 6220 participants) and depressive symptoms measured using the Montgomery-Åsberg Depression Scale (MADRS) (score range: 0 to 34; higher score means worse outcome: MD -2.94, 95% CI -4.07 to -1.80; 14 studies, 5566 participants). The quality of the evidence was low for response and remission and very low for depressive symptoms. We found no evidence of a difference in total dropout rates (RR 1.05, 95% CI 0.93 to 1.19; 14 studies, 6220 participants). More participants discontinued vortioxetine than placebo because of adverse effects (RR 1.41, 95% CI 1.09 to 1.81; 14 studies, 6220 participants) but fewer discontinued due to inefficacy (RR 0.56, 95% CI 0.34 to 0.90, P = 0.02; 14 studies, 6220 participants). The quality of the evidence for dropouts was moderate.The subgroup and sensitivity analyses did not reveal factors that significantly influenced the results.In comparison with other antidepressants, very low-quality evidence from eight studies showed no clinically significant difference between vortioxetine and SNRIs as a class for response (RR 0.91, 95% CI 0.82 to 1.00; 3159 participants) or remission (RR 0.89, 95% CI 0.77 to 1.03; 3155 participants). There was a small difference favouring SNRIs for depressive symptom scores on the MADRS (MD 1.52, 95% CI 0.50 to 2.53; 8 studies, 2807 participants). Very low quality evidence from eight studies (3159 participants) showed no significant differences between vortioxetine and the SNRIs as a class for total dropout rates (RR 0.89, 95% CI 0.73 to 1.08), dropouts due to adverse events (RR 0.74, 95% CI 0.51 to 1.08) and dropouts due to inefficacy (RR 1.52, 95% CI 0.70 to 3.30).Against individual antidepressants, analyses suggested that vortioxetine may be less effective than duloxetine in terms of response rates (RR 0.86, 95% CI 0.79 to 0.94; 6 studies, 2392 participants) and depressive symptoms scores on the MADRS scale (MD 1.99, 95% CI 1.15 to 2.83; 6 studies; 2106 participants). Against venlafaxine, meta-analysis of two studies found no statistically significant differences (response: RR 1.03, 95% CI 0.85 to 1.25; 767 participants; depressive symptom scores: MD 0.02, 95% CI -2.49 to 2.54; 701 participants). In terms of number of participants reporting at least one adverse effect (tolerability), vortioxetine was better than the SNRIs as a class (RR 0.90, 95% CI 0.86 to 0.94; 8 studies, 3134 participants) and duloxetine (RR 0.89, 95% CI 0.84 to 0.95; 6 studies; 2376 participants). However, the sensitivity analysis casts some doubts on this result, as only two studies used comparable dosing.We judged none of the studies to have a high risk of bias for any domain, but we rated all studies to have an unclear risk of bias of selective reporting and other biases. AUTHORS' CONCLUSIONS: The place of vortioxetine in the treatment of acute depression is unclear. Our analyses showed vortioxetine may be more effective than placebo in terms of response, remission and depressive symptoms, but the clinical relevance of these effects is uncertain. Furthermore, the quality of evidence to support these findings was generally low. In comparison to SNRIs, we found no advantage for vortioxetine. Vortioxetine was less effective than duloxetine, but fewer people reported adverse effects when treated with vortioxetine compared to duloxetine. However, these findings are uncertain and not well supported by evidence. A major limitation of the current evidence is the lack of comparisons with the SSRIs, which are usually recommended as first-line treatments for acute depression. Studies with direct comparisons to SSRIs are needed to address this gap and may be supplemented by network meta-analyses to define the role of vortioxetine in the treatment of depression.
[Mh] Termos MeSH primário: Antidepressivos/uso terapêutico
Transtorno Depressivo Maior/tratamento farmacológico
Piperazinas/uso terapêutico
Sulfetos/uso terapêutico
[Mh] Termos MeSH secundário: Adulto
Cloridrato de Duloxetina/uso terapêutico
Seres Humanos
Pacientes Desistentes do Tratamento/estatística & dados numéricos
Placebos/uso terapêutico
Ensaios Clínicos Controlados Aleatórios como Assunto
Indução de Remissão
Inibidores da Recaptação de Serotonina e Norepinefrina/uso terapêutico
Cloridrato de Venlafaxina/uso terapêutico
[Pt] Tipo de publicação:JOURNAL ARTICLE; META-ANALYSIS; REVIEW
[Nm] Nome de substância:
0 (Antidepressive Agents); 0 (Piperazines); 0 (Placebos); 0 (Serotonin and Noradrenaline Reuptake Inhibitors); 0 (Sulfides); 3O2K1S3WQV (vortioxetine); 7D7RX5A8MO (Venlafaxine Hydrochloride); 9044SC542W (Duloxetine Hydrochloride)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:170908
[Lr] Data última revisão:
170908
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170706
[St] Status:MEDLINE
[do] DOI:10.1002/14651858.CD011520.pub2


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[PMID]:28541026
[Au] Autor:Várkonyi T; Körei A; Putz Z; Martos T; Keresztes K; Lengyel C; Nyiraty S; Stirban A; Jermendy G; Kempler P
[Ad] Endereço:First Department of Medicine, University of Szeged, Szeged, Hungary - varkonyitamas@gmail.com.
[Ti] Título:Advances in the management of diabetic neuropathy.
[So] Source:Minerva Med;108(5):419-437, 2017 Oct.
[Is] ISSN:1827-1669
[Cp] País de publicação:Italy
[La] Idioma:eng
[Ab] Resumo:The authors review current advances in the therapy of diabetic neuropathy. The role of glycemic control and management of cardiovascular risk factors in the prevention and treatment of neuropathic complications are discussed. As further options of pathogenetically oriented treatment, recent knowledge on benfotiamine and alpha-lipoic acid is comprehensively reviewed. Alpha-lipoic acid is a powerful antioxidant and clinical trials have proven its efficacy in ameliorating neuropathic signs and symptoms. Benfotiamine acts via the activation of transketolase and thereby inhibits alternative pathways triggered by uncontrolled glucose influx in the cells comprising polyol, hexosamine, protein-kinase-C pathways and formation of advanced glycation end products. Beyond additional forms of causal treatment, choices of symptomatic treatment will be summarized. The latter is mostly represented by the anticonvulsive agents pregabalin and gabapentin as well as duloxetine widely acknowledged as antidepressant. Finally, non-pharmacological therapeutic alternatives are summarized. The authors conclude that combination therapy should be more often suggested to our patients; especially the combination of pathogenetic and symptomatic agents.
[Mh] Termos MeSH primário: Antioxidantes/uso terapêutico
Doenças Cardiovasculares/prevenção & controle
Neuropatias Diabéticas/tratamento farmacológico
Ácido Tióctico/uso terapêutico
[Mh] Termos MeSH secundário: Adjuvantes Imunológicos/administração & dosagem
Aminas/administração & dosagem
Anticonvulsivantes/administração & dosagem
Antidepressivos/administração & dosagem
Ensaios Clínicos como Assunto
Ácidos Cicloexanocarboxílicos/administração & dosagem
Quimioterapia Combinada
Cloridrato de Duloxetina/administração & dosagem
Medicina Baseada em Evidências
Seres Humanos
Pregabalina/administração & dosagem
Ensaios Clínicos Controlados Aleatórios como Assunto
Tiamina/administração & dosagem
Tiamina/análogos & derivados
Resultado do Tratamento
Ácido gama-Aminobutírico/administração & dosagem
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Adjuvants, Immunologic); 0 (Amines); 0 (Anticonvulsants); 0 (Antidepressive Agents); 0 (Antioxidants); 0 (Cyclohexanecarboxylic Acids); 55JG375S6M (Pregabalin); 56-12-2 (gamma-Aminobutyric Acid); 6CW7F3G59X (gabapentin); 73Y7P0K73Y (Thioctic Acid); 9044SC542W (Duloxetine Hydrochloride); X66NSO3N35 (Thiamine); Y92OUS2H9B (benphothiamine)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:170904
[Lr] Data última revisão:
170904
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170526
[St] Status:MEDLINE
[do] DOI:10.23736/S0026-4806.17.05257-0


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[PMID]:28335624
[Au] Autor:Dunlop BW; Kelley ME; Aponte-Rivera V; Mletzko-Crowe T; Kinkead B; Ritchie JC; Nemeroff CB; Craighead WE; Mayberg HS; PReDICT Team
[Ad] Endereço:From the Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta; the Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta; the Department of Psychiatry and Behavioral Sciences, Tulane University School of M
[Ti] Título:Effects of Patient Preferences on Outcomes in the Predictors of Remission in Depression to Individual and Combined Treatments (PReDICT) Study.
[So] Source:Am J Psychiatry;174(6):546-556, 2017 Jun 01.
[Is] ISSN:1535-7228
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE: The Predictors of Remission in Depression to Individual and Combined Treatments [PReDICT] study aimed to identify clinical and biological factors predictive of treatment outcomes in major depressive disorder among treatment-naive adults. The authors evaluated the efficacy of cognitive-behavioral therapy (CBT) and two antidepressant medications (escitalopram and duloxetine) in patients with major depression and examined the moderating effect of patients' treatment preferences on outcomes. METHOD: Adults aged 18-65 with treatment-naive major depression were randomly assigned with equal likelihood to 12 weeks of treatment with escitalopram (10-20 mg/day), duloxetine (30-60 mg/day), or CBT (16 50-minute sessions). Prior to randomization, patients indicated whether they preferred medication or CBT or had no preference. The primary outcome was change in the 17-item Hamilton Depression Rating Scale (HAM-D), administered by raters blinded to treatment. RESULTS: A total of 344 patients were randomly assigned, with a mean baseline HAM-D score of 19.8 (SD=3.8). The mean estimated overall decreases in HAM-D score did not significantly differ between treatments (CBT: 10.2, escitalopram: 11.1, duloxetine: 11.2). Last observation carried forward remission rates did not significantly differ between treatments (CBT: 41.9%, escitalopram: 46.7%, duloxetine: 54.7%). Patients matched to their preferred treatment were more likely to complete the trial but not more likely to achieve remission. CONCLUSIONS: Treatment guidelines that recommend either an evidence-based psychotherapy or antidepressant medication for nonpsychotic major depression can be extended to treatment-naive patients. Treatment preferences among patients without prior treatment exposure do not significantly moderate symptomatic outcomes.
[Mh] Termos MeSH primário: Antidepressivos/uso terapêutico
Citalopram/uso terapêutico
Terapia Cognitiva
Transtorno Depressivo Maior/terapia
Cloridrato de Duloxetina/uso terapêutico
Avaliação de Resultados (Cuidados de Saúde)
Preferência do Paciente
[Mh] Termos MeSH secundário: Adulto
Terapia Combinada
Transtorno Depressivo Maior/diagnóstico
Transtorno Depressivo Maior/psicologia
Feminino
Seres Humanos
Masculino
Meia-Idade
Escalas de Graduação Psiquiátrica/estatística & dados numéricos
Psicometria
Resultado do Tratamento
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Antidepressive Agents); 0DHU5B8D6V (Citalopram); 9044SC542W (Duloxetine Hydrochloride)
[Em] Mês de entrada:1706
[Cu] Atualização por classe:170626
[Lr] Data última revisão:
170626
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170325
[St] Status:MEDLINE
[do] DOI:10.1176/appi.ajp.2016.16050517


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[PMID]:28335622
[Au] Autor:Dunlop BW; Rajendra JK; Craighead WE; Kelley ME; McGrath CL; Choi KS; Kinkead B; Nemeroff CB; Mayberg HS
[Ad] Endereço:From the Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta; the Department of Psychology, Emory University, Atlanta; the Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta; the Department of Psychiat
[Ti] Título:Functional Connectivity of the Subcallosal Cingulate Cortex And Differential Outcomes to Treatment With Cognitive-Behavioral Therapy or Antidepressant Medication for Major Depressive Disorder.
[So] Source:Am J Psychiatry;174(6):533-545, 2017 Jun 01.
[Is] ISSN:1535-7228
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE: The purpose of this article was to inform the first-line treatment choice between cognitive-behavioral therapy (CBT) or an antidepressant medication for treatment-naive adults with major depressive disorder by defining a neuroimaging biomarker that differentially identifies the outcomes of remission and treatment failure to these interventions. METHOD: Functional MRI resting-state functional connectivity analyses using a bilateral subcallosal cingulate cortex (SCC) seed was applied to 122 patients from the Prediction of Remission to Individual and Combined Treatments (PReDICT) study who completed 12 weeks of randomized treatment with CBT or antidepressant medication. Of the 122 participants, 58 achieved remission (Hamilton Depression Rating Scale [HAM-D] score ≤7 at weeks 10 and 12), and 24 had treatment failure (<30% decrease from baseline in HAM-D score). A 2×2 analysis of variance using voxel-wise subsampling permutation tests compared the interaction of treatment and outcome. Receiver operating characteristic curves constructed using brain connectivity measures were used to determine possible classification rates for differential treatment outcomes. RESULTS: The resting-state functional connectivity of the following three regions with the SCC was differentially associated with outcomes of remission and treatment failure to CBT and antidepressant medication and survived application of the subsample permutation tests: the left anterior ventrolateral prefrontal cortex/insula, the dorsal midbrain, and the left ventromedial prefrontal cortex. Using the summed SCC functional connectivity scores for these three regions, overall classification rates of 72%-78% for remission and 75%-89% for treatment failure was demonstrated. Positive summed functional connectivity was associated with remission with CBT and treatment failure with medication, whereas negative summed functional connectivity scores were associated with remission to medication and treatment failure with CBT. CONCLUSIONS: Imaging-based depression subtypes defined using resting-state functional connectivity differentially identified an individual's probability of remission or treatment failure with first-line treatment options for major depression. This biomarker should be explored in future research through prospective testing and as a component of multivariate treatment prediction models.
[Mh] Termos MeSH primário: Antidepressivos/uso terapêutico
Citalopram/uso terapêutico
Terapia Cognitiva
Transtorno Depressivo Maior/fisiopatologia
Transtorno Depressivo Maior/terapia
Cloridrato de Duloxetina/uso terapêutico
Giro do Cíngulo/fisiopatologia
Interpretação de Imagem Assistida por Computador
Imagem por Ressonância Magnética
Rede Nervosa/fisiopatologia
Córtex Pré-Frontal/fisiopatologia
[Mh] Termos MeSH secundário: Adolescente
Adulto
Idoso
Transtorno Depressivo Maior/diagnóstico por imagem
Dominância Cerebral/efeitos dos fármacos
Dominância Cerebral/fisiologia
Feminino
Giro do Cíngulo/diagnóstico por imagem
Giro do Cíngulo/efeitos dos fármacos
Seres Humanos
Masculino
Meia-Idade
Rede Nervosa/diagnóstico por imagem
Rede Nervosa/efeitos dos fármacos
Avaliação de Resultados (Cuidados de Saúde)
Córtex Pré-Frontal/diagnóstico por imagem
Córtex Pré-Frontal/efeitos dos fármacos
Escalas de Graduação Psiquiátrica
Adulto Jovem
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Antidepressive Agents); 0DHU5B8D6V (Citalopram); 9044SC542W (Duloxetine Hydrochloride)
[Em] Mês de entrada:1706
[Cu] Atualização por classe:170626
[Lr] Data última revisão:
170626
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170325
[St] Status:MEDLINE
[do] DOI:10.1176/appi.ajp.2016.16050518


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[PMID]:28280069
[Au] Autor:Braillon A
[Ad] Endereço:Senior consultant, University Hospital, Amiens, France.
[Ti] Título:Duloxetine: urinary incontinence and marketing authorization incontinence.
[So] Source:CMAJ;189(9):E373, 2017 03 06.
[Is] ISSN:1488-2329
[Cp] País de publicação:Canada
[La] Idioma:eng
[Mh] Termos MeSH primário: Cloridrato de Duloxetina
Incontinência Urinária
[Mh] Termos MeSH secundário: Seres Humanos
Marketing
Inibidores da Captação de Serotonina
Tiofenos
[Pt] Tipo de publicação:LETTER; COMMENT
[Nm] Nome de substância:
0 (Serotonin Uptake Inhibitors); 0 (Thiophenes); 9044SC542W (Duloxetine Hydrochloride)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171011
[Lr] Data última revisão:
171011
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170311
[St] Status:MEDLINE
[do] DOI:10.1503/cmaj.732561


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[PMID]:28272220
[Au] Autor:Zhang M; Li H; Ji Z; Dong D; Yan S
[Ad] Endereço:Department of Urology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital, Beijing, China.
[Ti] Título:Clinical study of duloxetine hydrochloride combined with doxazosin for the treatment of pain disorder in chronic prostatitis/chronic pelvic pain syndrome: An observational study.
[So] Source:Medicine (Baltimore);96(10):e6243, 2017 Mar.
[Is] ISSN:1536-5964
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:To explore the safety and efficacy of the selective 5-serotonin and norepinephrine reuptake inhibitor duloxetine hydrochloride and alpha-adrenergic receptor blocker (alpha-blocker) doxazosin mesylate-controlled tablets in the treatment of pain disorder in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS).In all, 150 patients were enrolled and 126 patients completed the study (41 patients in the doxazosin group, 41 patients in the sertraline group, and 44 patients in the duloxetine group). This was an open randomized 6-month study. CP/CPPS patients who met the diagnostic criteria were randomized into 3 groups. The patients in the duloxetine group received doxazosin 4 mg + duloxetine 30 mg once a day, and the dosage of duloxetine was increased to 60 mg after a week. The patients in the doxazosin group received doxazosin 4 mg once a day. The patients in the sertraline group received doxazosin 4 mg + sertraline 50 mg once a day. National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score, the short-form McGill Pain questionnaire (SF-MPQ), and the hospital anxiety and depression scale (HAD) were applied for evaluations during follow-up of 1, 3, and 6 months after treatment.There were slight positive significant correlations between NIH-CPSI scores and HAD scores, moderate positive significant correlations between the quality of life (QOL) and SF-MPQ, and slight positive significant correlations between HAD and QOL. The effective rate in the doxazosin group was 4.88%, 19.51%, and 56.10% after 1, 3, and 6 months, respectively (P < 0.05). The SF-MPQ score in the doxazosin group decreased to 1.80 ±â€Š1.29, 2.66 ±â€Š1.57, and 3.24 ±â€Š1.67 after 1, 3, and 6 months, respectively (P < 0.05). The HAD score in the doxazosin group decreased to 2.24 ±â€Š2.17, 4 ±â€Š2.11, and 4.90 ±â€Š2.62 after 1, 3, and 6 months, respectively (P < 0.05). The effective rate in the sertraline group was 9.76%, 36.59%, and 63.41% after 1, 3, and 6 months, respectively. The SF-MPQ score in the sertraline group decreased to 1.76 ±â€Š1.28, 3.07 ±â€Š2, and 3.93 ±â€Š2.53 after 1, 3, and 6 months, respectively (P < 0.05). The HAD score in the sertraline group decreased to 3.56 ±â€Š4.11, 5.73 ±â€Š5.26, and 7.27 ±â€Š6.50 after 1, 3, and 6 months, respectively (P < 0.05). The effective rate in the duloxetine group was 36.36%, 88.64%, and 88.64% after 1, 3, and 6 months, respectively. The SF-MPQ score in the duloxetine group decreased to 3.61 ±â€Š2.54, 6.05 ±â€Š3.66, and 7.41 ±â€Š4.26 after 1, 3, and 6 months, respectively (P < 0.05). The HAD score in the duloxetine group decreased to 3.14 ±â€Š3.28, 6.93 ±â€Š3.90, and 9.43 ±â€Š4.67 after 1, 3, and 6 months, respectively (P < 0.05). There were significant differences in the reduction of the NIH-CPSI score and the SF-MPQ score between the duloxetine group and the sertraline group and between the duloxetine group and the doxazosin group (P < 0.01). There were significant differences in the reduction of the HAD score at 3 months between the duloxetine group and the doxazosin group, and there were significant differences in the reduction of the HAD score at 6 months among the groups (P < 0.05). The incidence rates of adverse reactions in the duloxetine group, the sertraline group, and the duloxetine group were 29.5%, 17%, and 7.3%, respectively, with adverse events ranging from mild to moderate.There was a clear relationship between the extent of pain and mental factors in CP/CPPS with the main symptom of pain. Doxazosin combined with duloxetine exhibited good safety and efficacy in the treatment of pain disorder in CP/CPPS.
[Mh] Termos MeSH primário: Antagonistas de Receptores Adrenérgicos alfa 1/uso terapêutico
Doxazossina/uso terapêutico
Cloridrato de Duloxetina/uso terapêutico
Dor Pélvica/tratamento farmacológico
Prostatite/tratamento farmacológico
Inibidores da Recaptação de Serotonina e Norepinefrina/uso terapêutico
[Mh] Termos MeSH secundário: Adulto
Idoso
Dor Crônica/tratamento farmacológico
Seres Humanos
Masculino
Meia-Idade
Estudos Prospectivos
Índice de Gravidade de Doença
Inquéritos e Questionários
Síndrome
Adulto Jovem
[Pt] Tipo de publicação:JOURNAL ARTICLE; OBSERVATIONAL STUDY; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Adrenergic alpha-1 Receptor Antagonists); 0 (Serotonin and Noradrenaline Reuptake Inhibitors); 9044SC542W (Duloxetine Hydrochloride); NW1291F1W8 (Doxazosin)
[Em] Mês de entrada:1703
[Cu] Atualização por classe:170324
[Lr] Data última revisão:
170324
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170309
[St] Status:MEDLINE
[do] DOI:10.1097/MD.0000000000006243


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[PMID]:28246265
[Au] Autor:Maund E; Guski LS; Gøtzsche PC
[Ad] Endereço:Nordic Cochrane Centre, Rigshospitalet, Copenhagen, Denmark em@cochrane.dk.
[Ti] Título:Considering benefits and harms of duloxetine for treatment of stress urinary incontinence: a meta-analysis of clinical study reports.
[So] Source:CMAJ;189(5):E194-E203, 2017 Feb 06.
[Is] ISSN:1488-2329
[Cp] País de publicação:Canada
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: The European Medicines Agency makes clinical study reports publicly available and publishes reasons for not approving applications for marketing authorization. Duloxetine has been approved in Europe for the treatment of stress urinary incontinence in women. The reported adverse effects of duloxetine include mental health problems and suicidality. We obtained clinical study reports from the European Medicines Agency concerning use of this drug for stress urinary incontinence. METHODS: We performed a meta-analysis of 4 randomized placebo-controlled trials of duloxetine (involving a total of 1913 patients) submitted to the European Medicines Agency for marketing approval for the indication of stress urinary incontinence in women. We used data from the clinical study reports (totalling 6870 pages and including individual patient data) to assess benefits (including frequency of incontinence and changes in quality-of-life scores, such as Patient Global Impression of Improvement rating) and harms (both general harms, including discontinuation because of adverse events, and harms related to suicidality, violent behaviour and their potential precursors, such as akathisia and activation [stimulating effects such as insomnia, anxiety and agitation]). RESULTS: Duloxetine was significantly better than placebo in terms of percentage change in weekly incontinence episodes (mean difference -13.56%, 95% confidence interval [CI] -21.59% to -5.53%) and change in Incontinence Quality of Life total score (mean difference 3.24, 95% CI 2.00 to 4.48). However, the effect sizes were small, and a sensitivity analysis (with removal of one trial) showed that the number needed to treat for a Patient Global Impression of Improvement rating of "much better or very much better" was 8 (95% CI 6 to 13). The numbers needed to harm were 7 (95% CI 6 to 8) for discontinuing because of an adverse event and 7 (95% CI 6 to 9) for experiencing an activation event. No suicidality, violence or akathisia events were noted. INTERPRETATION: Although duloxetine is effective for stress urinary incontinence in women, the rates of associated harm were high when individual patient data were analyzed, and the harms outweighed the benefits.
[Mh] Termos MeSH primário: Antidepressivos/uso terapêutico
Cloridrato de Duloxetina/uso terapêutico
Incontinência Urinária por Estresse/tratamento farmacológico
[Mh] Termos MeSH secundário: Sintomas Afetivos/induzido quimicamente
Acatisia Induzida por Medicamentos/etiologia
Ansiedade/induzido quimicamente
Feminino
Seres Humanos
Transtornos Mentais/induzido quimicamente
Psicoses Induzidas por Substâncias/etiologia
Ensaios Clínicos Controlados Aleatórios como Assunto
Medição de Risco
Distúrbios do Início e da Manutenção do Sono/induzido quimicamente
Ideação Suicida
Resultado do Tratamento
Violência
[Pt] Tipo de publicação:JOURNAL ARTICLE; META-ANALYSIS
[Nm] Nome de substância:
0 (Antidepressive Agents); 9044SC542W (Duloxetine Hydrochloride)
[Em] Mês de entrada:1704
[Cu] Atualização por classe:171010
[Lr] Data última revisão:
171010
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170302
[St] Status:MEDLINE
[do] DOI:10.1503/cmaj.151104


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[PMID]:28241180
[Au] Autor:Chekroud AM; Gueorguieva R; Krumholz HM; Trivedi MH; Krystal JH; McCarthy G
[Ad] Endereço:Department of Psychology, Yale University, New Haven, Connecticut2Spring Health, New York City, New York3Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut.
[Ti] Título:Reevaluating the Efficacy and Predictability of Antidepressant Treatments: A Symptom Clustering Approach.
[So] Source:JAMA Psychiatry;74(4):370-378, 2017 Apr 01.
[Is] ISSN:2168-6238
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Importance: Depressive severity is typically measured according to total scores on questionnaires that include a diverse range of symptoms despite convincing evidence that depression is not a unitary construct. When evaluated according to aggregate measurements, treatment efficacy is generally modest and differences in efficacy between antidepressant therapies are small. Objectives: To determine the efficacy of antidepressant treatments on empirically defined groups of symptoms and examine the replicability of these groups. Design, Setting, and Participants: Patient-reported data on patients with depression from the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial (n = 4039) were used to identify clusters of symptoms in a depressive symptom checklist. The findings were then replicated using the Combining Medications to Enhance Depression Outcomes (CO-MED) trial (n = 640). Mixed-effects regression analysis was then performed to determine whether observed symptom clusters have differential response trajectories using intent-to-treat data from both trials (n = 4706) along with 7 additional placebo and active-comparator phase 3 trials of duloxetine (n = 2515). Finally, outcomes for each cluster were estimated separately using machine-learning approaches. The study was conducted from October 28, 2014, to May 19, 2016. Main Outcomes and Measures: Twelve items from the self-reported Quick Inventory of Depressive Symptomatology (QIDS-SR) scale and 14 items from the clinician-rated Hamilton Depression (HAM-D) rating scale. Higher scores on the measures indicate greater severity of the symptoms. Results: Of the 4706 patients included in the first analysis, 1722 (36.6%) were male; mean (SD) age was 41.2 (13.3) years. Of the 2515 patients included in the second analysis, 855 (34.0%) were male; mean age was 42.65 (12.17) years. Three symptom clusters in the QIDS-SR scale were identified at baseline in STAR*D. This 3-cluster solution was replicated in CO-MED and was similar for the HAM-D scale. Antidepressants in general (8 of 9 treatments) were more effective for core emotional symptoms than for sleep or atypical symptoms. Differences in efficacy between drugs were often greater than the difference in efficacy between treatments and placebo. For example, high-dose duloxetine outperformed escitalopram in treating core emotional symptoms (effect size, 2.3 HAM-D points during 8 weeks, 95% CI, 1.6 to 3.1; P < .001), but escitalopram was not significantly different from placebo (effect size, 0.03 HAM-D points; 95% CI, -0.7 to 0.8; P = .94). Conclusions and Relevance: Two common checklists used to measure depressive severity can produce statistically reliable clusters of symptoms. These clusters differ in their responsiveness to treatment both within and across different antidepressant medications. Selecting the best drug for a given cluster may have a bigger benefit than that gained by use of an active compound vs a placebo.
[Mh] Termos MeSH primário: Antidepressivos/uso terapêutico
Transtorno Depressivo Maior/tratamento farmacológico
Transtorno Depressivo Maior/psicologia
[Mh] Termos MeSH secundário: Adolescente
Adulto
Afeto/efeitos dos fármacos
Idoso
Antidepressivos/efeitos adversos
Bupropiona/efeitos adversos
Bupropiona/uso terapêutico
Citalopram/efeitos adversos
Citalopram/uso terapêutico
Análise por Conglomerados
Transtorno Depressivo Maior/diagnóstico
Relação Dose-Resposta a Droga
Quimioterapia Combinada
Cloridrato de Duloxetina/efeitos adversos
Cloridrato de Duloxetina/uso terapêutico
Feminino
Seres Humanos
Masculino
Mianserina/efeitos adversos
Mianserina/análogos & derivados
Mianserina/uso terapêutico
Meia-Idade
Ensaios Clínicos Controlados Aleatórios como Assunto
Sono/efeitos dos fármacos
Síndrome
Resultado do Tratamento
Cloridrato de Venlafaxina/efeitos adversos
Cloridrato de Venlafaxina/uso terapêutico
Adulto Jovem
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antidepressive Agents); 01ZG3TPX31 (Bupropion); 0DHU5B8D6V (Citalopram); 250PJI13LM (Mianserin); 7D7RX5A8MO (Venlafaxine Hydrochloride); 9044SC542W (Duloxetine Hydrochloride); A051Q2099Q (mirtazapine)
[Em] Mês de entrada:1705
[Cu] Atualização por classe:170518
[Lr] Data última revisão:
170518
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170228
[St] Status:MEDLINE
[do] DOI:10.1001/jamapsychiatry.2017.0025



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