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[PMID]:28460320
[Au] Autor:Redecker J; Wittstock M; Rösche J
[Ad] Endereço:Department of Neurology, University of Rostock, Germany.
[Ti] Título:The efficacy of different kinds of intravenously applied antiepileptic drugs in the treatment of status epilepticus. How can it be determined?
[So] Source:Epilepsy Behav;71(Pt A):35-38, 2017 Jun.
[Is] ISSN:1525-5069
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:We explored the influence of four different efficacy criteria on the results of observational studies concerning the treatment of status epilepticus (SE) and its subtypes. We compared and contrasted the results of four different efficacy criteria for the effectiveness of phenytoin, valproate, levetiracetam, and lacosamide. Criterion 1=the last antiepileptic drug (AED) administered before SE termination. Criterion 2=the last drug introduced into the antiepileptic therapy within 72h before the cessation of SE and without changes in dosage or number of the co-medication. Criterion 3=the last drug introduced into the antiepileptic therapy or increased in dose within 24h before termination of the SE without changes in the co-medication. Criterion 4=the last drug introduced into the antiepileptic therapy within 72h before the cessation of SE even allowing changes in the co-medication. We used two-tailed χ -tests with the Yates adjustment for small samples to evaluate statistical differences between efficacy rates of different AEDs in the entire group and in subgroups of SE according to the second level of subdivisions in axis 1 and according to axis 2 of the new ILAE classification. A total of 145 treatment episodes in 124 patients (47 male, 77 female) were evaluated. There were 23 significant differences in efficacy according to the different criteria. Only criteria 1 and 3 led to significant results in our analysis. When incorporating theoretical considerations and the results of this study, criterion 3 seems to be the most appropriate measure for the evaluation of efficacy of an AED in the treatment of SE, because it seems to be more reasonable than criterion 1.
[Mh] Termos MeSH primário: Anticonvulsivantes/administração & dosagem
Estado Epiléptico/diagnóstico
Estado Epiléptico/tratamento farmacológico
[Mh] Termos MeSH secundário: Acetamidas/administração & dosagem
Administração Intravenosa
Adulto
Idoso
Idoso de 80 Anos ou mais
Feminino
Comportamentos Relacionados com a Saúde
Seres Humanos
Masculino
Meia-Idade
Fenitoína/administração & dosagem
Piracetam/administração & dosagem
Piracetam/análogos & derivados
Estudos Retrospectivos
Resultado do Tratamento
Ácido Valproico/administração & dosagem
[Pt] Tipo de publicação:JOURNAL ARTICLE; OBSERVATIONAL STUDY
[Nm] Nome de substância:
0 (Acetamides); 0 (Anticonvulsants); 230447L0GL (etiracetam); 563KS2PQY5 (lacosamide); 614OI1Z5WI (Valproic Acid); 6158TKW0C5 (Phenytoin); ZH516LNZ10 (Piracetam)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180206
[Lr] Data última revisão:
180206
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170502
[St] Status:MEDLINE


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[PMID]:28467333
[Au] Autor:Inchingolo F; Vermesan D; Inchingolo AD; Malcangi G; Santacroce L; Scacco S; Benagiano V; Girolamo F; Cagiano R; Caprio M; Longo L; Abbinante A; Inchingolo AM; Dipalma G; Tarullo A; Tattoli M
[Ti] Título:Bedsores successfully treated with topical phenytoin.
[So] Source:Acta Biomed;88(1):45-48, 2017 04 28.
[Is] ISSN:0392-4203
[Cp] País de publicação:Italy
[La] Idioma:eng
[Ab] Resumo:Phenytoin is normally used in epilepsy treatment. One of the side effect affecting a significative part of the treated patients is the gingival overgrowth. It could surely be a correlation between this stimulatory effect and the assessment of phenytoin in wound healing. In fact, some studies of the literature have shown that topical phenytoin promotes healing of traumatic wounds, burns and ulcers by decubitus or stasis (diabetic or venous) and we emphasize, in vitiligo, a particular attention into repigmentation. The related mechanism of action seems to be multifactorial. In the present paper topical phenytoin has been used as wound-healing agent in 19 documented cases of bedsores, divided in treated and placebo group. The used concentration of phenytoin was 5 mg/L dissolved in a water solution of 9 g NaCl /L (0.9% P/V of NaCl). Patches soaked with phenytoin solution were applied over the bedsores along 3 hours every 12 hours. Results showed that phenytoin treated patients healed their wounds significantly before (p<0.001) with respect to controls.
[Mh] Termos MeSH primário: Fármacos Dermatológicos/uso terapêutico
Fenitoína/uso terapêutico
Lesão por Pressão/tratamento farmacológico
Adesivo Transdérmico
[Mh] Termos MeSH secundário: Administração Tópica
Idoso
Idoso de 80 Anos ou mais
Feminino
Seres Humanos
Masculino
Meia-Idade
Cicatrização
[Pt] Tipo de publicação:JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Dermatologic Agents); 6158TKW0C5 (Phenytoin)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180125
[Lr] Data última revisão:
180125
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170504
[St] Status:MEDLINE
[do] DOI:10.23750/abm.v88i1.5794


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[PMID]:29199252
[Au] Autor:Imai T
[Ad] Endereço:Department of Pharmacy, Nihon University Itabashi Hospital.
[Ti] Título:[Evaluation of Pharmacotherapy on Emergency and Intensive Care Medicine: The Influence of Intensity and Duration of Invasion].
[So] Source:Yakugaku Zasshi;137(12):1427-1430, 2017.
[Is] ISSN:1347-5231
[Cp] País de publicação:Japan
[La] Idioma:jpn
[Ab] Resumo:Critically ill patients who receive high-level invasion show physiological changes different from those under more normal conditions, along with variable therapeutic effects and pharmacokinetics. The concept of systemic inflammatory response syndrome (SIRS) has been introduced to describe the clinical state resulting from invasive actions taken under acute circumstances, resulting in an acute-phase systemic response. In particular, dosages of vancomycin (VCM) and phenytoin (PHT) need to be adjusted by therapeutic drug monitoring (TDM) because of their narrow therapeutic concentration windows. However, there are few reports on the pharmacokinetics of VCM and PHT in patients with SIRS. We performed a retrospective cohort study of patients treated with VCM and PHT. These studies suggest that the pharmacokinetics of VCM are affected by SIRS score and duration. Furthermore, the concentration of PHT was also shown to be higher in SIRS patients compared with non-SIRS patients. These findings suggest that the pharmacokinetics of VCM and PHT may be affected by the pathology of SIRS, rather than by other patient characteristics. Modifying dosing according to SIRS will improve the prediction accuracy of drug concentration based on TDM. In this review, I introduce work conducted by pharmacists in the clinical study of critically ill patients, and will be discussing the evaluation of pharmacotherapy in emergency and intensive care medicine.
[Mh] Termos MeSH primário: Cuidados Críticos
Estado Terminal/terapia
Tratamento Farmacológico
Serviços Médicos de Emergência
[Mh] Termos MeSH secundário: Monitoramento de Medicamentos
Seres Humanos
Fenitoína/administração & dosagem
Fenitoína/farmacocinética
Síndrome de Resposta Inflamatória Sistêmica/tratamento farmacológico
Vancomicina/administração & dosagem
Vancomicina/farmacocinética
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
6158TKW0C5 (Phenytoin); 6Q205EH1VU (Vancomycin)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180112
[Lr] Data última revisão:
180112
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171205
[St] Status:MEDLINE
[do] DOI:10.1248/yakushi.17-00139-1


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[PMID]:28956451
[Au] Autor:Motawea A; Borg T; Abd El-Gawad AEH
[Ad] Endereço:a Department of Pharmaceutics, Faculty of Pharmacy , Mansoura University , Mansoura , Egypt.
[Ti] Título:Topical phenytoin nanostructured lipid carriers: design and development.
[So] Source:Drug Dev Ind Pharm;44(1):144-157, 2018 Jan.
[Is] ISSN:1520-5762
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Phenytoin (PHT) is an antiepileptic drug that was reported to exhibit high wound healing activity. Nevertheless, its limited solubility, bioavailability, and inefficient distribution during topical administration limit its use. Therefore, this study aims to develop, characterize nanostructured lipid carriers (NLCs), and evaluate their potential in topical delivery of PHT to improve the drug entrapment efficiency and sustained release. The NLCs were prepared by hot homogenization followed by ultra sonication method using 2 factorial design. NLC formulations were characterized regarding their particle size (PS), zeta potential (ZP), entrapment efficiency percent (%EE), surface morphology, physicochemical stability, and in vitro release studies. The optimized NLC (F7) was further incorporated in 1%w/v carbopol gel and then characterized for appearance, pH, viscosity, stability, and in vitro drug release. The prepared NLCs were spherical in shape and possessed an average PS of 121.4-258.2 nm, ZP of (-15.4)-(-32.2) mV, and 55.24-88.80 %EE. Solid-state characterization revealed that the drug is dispersed in an amorphous state with hydrogen bond interaction between the drug and the NLC components. NLC formulations were found to be stable at 25 °C for six months. The stored F7-hydrogel showed insignificant changes in viscosity and drug content (p>.05) up to six months at 25 °C that pave a way for industrial fabrication of efficient PHT products. In vitro release studies showed a sustained release from NLC up to 48 h at pH 7.4 following non-Fickian Higuchi kinetics model. These promising findings encourage the potential use of phenytoin loaded lipid nanoparticles for future topical application.
[Mh] Termos MeSH primário: Hidrogel de Polietilenoglicol-Dimetacrilato/química
Lipídeos/farmacocinética
Nanopartículas/química
Nanoestruturas/química
Fenitoína/farmacocinética
[Mh] Termos MeSH secundário: Administração Tópica
Química Farmacêutica
Portadores de Fármacos
Lipídeos/química
Fenitoína/química
Fenitoína/metabolismo
Absorção Cutânea
Solubilidade
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Drug Carriers); 0 (Lipids); 25852-47-5 (Hydrogel, Polyethylene Glycol Dimethacrylate); 6158TKW0C5 (Phenytoin)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180111
[Lr] Data última revisão:
180111
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170929
[St] Status:MEDLINE
[do] DOI:10.1080/03639045.2017.1386204


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[PMID]:28458439
[Au] Autor:Maharshi V; Nagar P
[Ad] Endereço:Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, India.
[Ti] Título:Chronic administration of phenytoin and pleomorphic adenoma: A case report and review of literature.
[So] Source:Indian J Pharmacol;49(1):130-131, 2017 Jan-Feb.
[Is] ISSN:1998-3751
[Cp] País de publicação:India
[La] Idioma:eng
[Ab] Resumo:Adverse drug effects that are uncommon or appear only on chronic administration of a drug may not be detected in clinical trials. This explains the need of strict post-marketing vigilance on drug use. Phenytoin administration has been shown in the literature to be associated with development of neoplasia (benign/malignant). In our knowledge current work represents the first case of pleomorphic-adenoma of sub-mandibular salivary gland developed following chronic phenytoin use. A 40 year old male having a history of head trauma twenty years back, had been on tablet phenytoin 100 mg thrice daily since then. One year back he noticed a small swelling in left sub-mandibular region and gradually increasing in size. FNAC and CECT revealed the diagnosis of pleomorphic-adenoma of sub-mandibular salivary gland. Other causes were ruled out. Surgical excision was performed successfully and continuing follow-up with no recurrence at the end of 6 months. Histo-pathogical examination of the tissue did not show any malignant changes.
[Mh] Termos MeSH primário: Adenoma Pleomorfo/induzido quimicamente
Anticonvulsivantes/efeitos adversos
Fenitoína/efeitos adversos
Neoplasias da Glândula Submandibular/induzido quimicamente
[Mh] Termos MeSH secundário: Adenoma Pleomorfo/diagnóstico
Adenoma Pleomorfo/cirurgia
Adulto
Anticonvulsivantes/administração & dosagem
Seguimentos
Seres Humanos
Masculino
Fenitoína/administração & dosagem
Neoplasias da Glândula Submandibular/diagnóstico
Neoplasias da Glândula Submandibular/cirurgia
Fatores de Tempo
[Pt] Tipo de publicação:CASE REPORTS; JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Anticonvulsants); 6158TKW0C5 (Phenytoin)
[Em] Mês de entrada:1712
[Cu] Atualização por classe:171229
[Lr] Data última revisão:
171229
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170502
[St] Status:MEDLINE
[do] DOI:10.4103/0253-7613.201018


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[PMID]:29061822
[Au] Autor:Sladowska K; Opydo-Chanek M; Król T; Trybus W; Trybus E; Kopacz-Bednarska A; Handzlik J; Kiec-Kononowicz K; Mazur L
[Ad] Endereço:Department of Experimental Hematology, Jagiellonian University, Krakow, Poland.
[Ti] Título: Effects of Bromoalkyl Phenytoin Derivatives on Regulated Death, Cell Cycle and Ultrastructure of Leukemia Cells.
[So] Source:Anticancer Res;37(11):6373-6380, 2017 11.
[Is] ISSN:1791-7530
[Cp] País de publicação:Greece
[La] Idioma:eng
[Ab] Resumo:BACKGROUND/AIM: To search for new antileukemic agents, the chemical structure of phenytoin was modified. A possible cytotoxic activity of three bromoalkyl phenytoin analogs, methyl 2-(1-(3-bromopropyl)-2,4-dioxo-5,5-diphenylimidazolidin-3-yl) propanoate (PH2), 1-(3-bromopropyl)-3-methyl-5,5-diphenylimidazolidine-2,4-dione (PH3) and 1-(4-bromobutyl)-3-methyl-5,5-diphenylimidazolidine-2,4-dione (PH4) on regulated cell death, the cell cycle and cell ultrastructure was assessed. MATERIALS AND METHODS: The experiments were performed in vitro on HL-60 and U937 cells, using flow cytometry and electron microscopy methods. RESULTS: Application of PH2, PH3, and PH4 resulted in cell surface exposure of phosphatidylserine and plasma membrane impairment, caspase-8, -9, and -3/7 activation, dissipation of mitochondrial membrane potential, DNA breakage, cell-cycle disturbance and cell ultrastructural changes. In general, PH3 appeared to be the most active against the leukemia cells, and all bromoalkyl hydantoins, PH2-PH4, were more active in HL-60 cells than in U937 cells. CONCLUSION: The antileukemic activity of the bromoalkyl phenytoin analogs depended on the combination of N-hydantoin substituents and the human cell line used.
[Mh] Termos MeSH primário: Antineoplásicos/farmacologia
Caspases/metabolismo
Leucemia/metabolismo
Fenitoína/análogos & derivados
[Mh] Termos MeSH secundário: Antineoplásicos/síntese química
Antineoplásicos/química
Ciclo Celular/efeitos dos fármacos
Membrana Celular/efeitos dos fármacos
Quebras de DNA
Ensaios de Seleção de Medicamentos Antitumorais
Regulação Neoplásica da Expressão Gênica/efeitos dos fármacos
Células HL-60
Seres Humanos
Leucemia/tratamento farmacológico
Leucemia/genética
Potencial da Membrana Mitocondrial/efeitos dos fármacos
Estrutura Molecular
Fenitoína/química
Células U937
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antineoplastic Agents); 6158TKW0C5 (Phenytoin); EC 3.4.22.- (Caspases)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171026
[Lr] Data última revisão:
171026
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171025
[St] Status:MEDLINE


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[PMID]:28931642
[Au] Autor:Canafoglia L; Ferlazzo E; Michelucci R; Striano P; Magaudda A; Gambardella A; Pasini E; Belcastro V; Riguzzi P; Fanella M; Granata T; Beccaria F; Trentini C; Bianchi A; Aguglia U; Panzica F; Franceschetti S
[Ad] Endereço:From the Department of Neurophysiopathology and Epilepsy Centre (L.C., C.T., F.P., S.F.) and Pediatric Neurology (T.G.), IRCCS Foundation C. Besta Neurological Institute, Milan; Department of Medical and Surgical Sciences (E.F., A.G., U.A.), Magna Graecia University, Catanzaro; Regional Epilepsy Cen
[Ti] Título:Variable course of Unverricht-Lundborg disease: Early prognostic factors.
[So] Source:Neurology;89(16):1691-1697, 2017 Oct 17.
[Is] ISSN:1526-632X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE: To explore the course of Unverricht-Lundborg disease (EPM1) and identify the risk factors for severity, we investigated the time course of symptoms and prognostic factors already detectable near to disease onset. METHODS: We retrospectively evaluated the features of 59 Italian patients carrying the expansion mutation, and coded the information every 5 years after the disease onset in order to describe the cumulative time-dependent probability of reaching disabling myoclonus, relevant cognitive impairment, and inability to work, and evaluated the influence of early factors using the log-rank test. The risk factors were included in a Cox multivariate proportional hazards regression model. RESULTS: Disabling myoclonus occurred an average of 32 years after disease onset, whereas cognitive impairment occurred a little later. An age at onset of less than 12 years, the severity of myoclonus at the time of first assessment, and seizure persistence more than 10 years after onset affected the timing of disabling myoclonus and cognitive decline. Most patients became unable to work years before the appearance of disabling myoclonus or cognitive decline. CONCLUSIONS: A younger age at onset, early severe myoclonus, and seizure persistence are predictors of a more severe outcome. All of these factors may be genetically determined, but the greater hyperexcitability underlying more severe seizures and myoclonus at onset may also play a role by increasing cell damage due to reduced cystatin B activity.
[Mh] Termos MeSH primário: Síndrome de Unverricht-Lundborg/diagnóstico
Síndrome de Unverricht-Lundborg/fisiopatologia
[Mh] Termos MeSH secundário: Adolescente
Adulto
Idade de Início
Análise de Variância
Anticonvulsivantes/uso terapêutico
Catepsina B/genética
Eletroencefalografia
Potenciais Somatossensoriais Evocados/efeitos dos fármacos
Feminino
Seres Humanos
Itália
Masculino
Meia-Idade
Fenitoína/uso terapêutico
Prognóstico
Estudos Retrospectivos
Síndrome de Unverricht-Lundborg/tratamento farmacológico
Síndrome de Unverricht-Lundborg/genética
Ácido Valproico/uso terapêutico
Adulto Jovem
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Anticonvulsants); 614OI1Z5WI (Valproic Acid); 6158TKW0C5 (Phenytoin); EC 3.4.22.1 (CTSB protein, human); EC 3.4.22.1 (Cathepsin B)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171024
[Lr] Data última revisão:
171024
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170922
[St] Status:MEDLINE
[do] DOI:10.1212/WNL.0000000000004518


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[PMID]:28797767
[Au] Autor:Dong XY; Bai CB; Nao JF
[Ad] Endereço:Department of Neurology, Shengjing Hospital of China Medical University, 36 Sanhao Street, Heping District, China.
[Ti] Título:Clinical and radiological features of posterior reversible encephalopathy syndrome in patients with pre-eclampsia and eclampsia.
[So] Source:Clin Radiol;72(10):887-895, 2017 Oct.
[Is] ISSN:1365-229X
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:AIM: To analyse and summarise clinical and radiological features among patients with posterior reversible encephalopathy syndrome (PRES), to assess related factors with eclampsia and pre-eclampsia, and to compare the different factors between cytotoxic and vasogenic oedema among PRES patients. MATERIALS AND METHODS: The clinical and radiological findings of 237 pre-eclamptic or eclamptic patients with neurological symptoms were evaluated retrospectively. Multiple logistic regression analyses were performed to compare the differences among these parameters. RESULTS: Seventy-six patients (32.07%) were diagnosed with PRES. Multiple logistic regression indicated that seizure (odds ratio [OR], 2.760; 95% confidence interval [CI]: 1.087-7.011; p=0.033), visual disturbances (OR=2.062 95%CI, 1.033-4.115; p=0.004), multiple production history (OR=3.637; 95% CI: 1.068-8.228; p=0.002) were independent risk factors for PRES. PRES+ (OR=3.217; 95%CI, 1.346-7.686; p=0.009), Visual disturbances (OR=4.283; 95% CI: 1.843-9.953; p=0.001) had strong association with eclampsia. Visual disturbances (OR=7.200; 95% CI: 2.116-24.496; p=0.002) had strong correlation with eclampsia among PRES+ patients. Visual disturbances (OR=2.947; 95% CI: 1.135-7.648; p=0.026) were independently related to cytotoxic oedema. CONCLUSIONS: Nearly one-third of pre-eclampsia or eclampsia patients with neurological symptoms have PRES. Visual disturbances, seizure, multiple production history are independent risk factors for PRES. Visual disturbances have a strong association with eclampsia whether patients have PRES or not. Visual disturbances are independently related to cytotoxic oedema among PRES+ patients.
[Mh] Termos MeSH primário: Eclampsia/diagnóstico
Imagem por Ressonância Magnética
Síndrome da Leucoencefalopatia Posterior/diagnóstico por imagem
Pré-Eclâmpsia/diagnóstico
[Mh] Termos MeSH secundário: Adulto
Anticonvulsivantes/uso terapêutico
Anti-Hipertensivos/uso terapêutico
Encéfalo/diagnóstico por imagem
Diazepam/uso terapêutico
Eclampsia/terapia
Feminino
Seres Humanos
Labetalol/uso terapêutico
Sulfato de Magnésio/uso terapêutico
Neuroimagem/métodos
Fenitoína/uso terapêutico
Síndrome da Leucoencefalopatia Posterior/diagnóstico
Síndrome da Leucoencefalopatia Posterior/tratamento farmacológico
Pré-Eclâmpsia/terapia
Gravidez
Estudos Retrospectivos
Fatores de Risco
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Anticonvulsants); 0 (Antihypertensive Agents); 6158TKW0C5 (Phenytoin); 7487-88-9 (Magnesium Sulfate); Q3JTX2Q7TU (Diazepam); R5H8897N95 (Labetalol)
[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:170812
[St] Status:MEDLINE


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[PMID]:28681416
[Au] Autor:Duke JD; Ryan PB; Suchard MA; Hripcsak G; Jin P; Reich C; Schwalm MS; Khoma Y; Wu Y; Xu H; Shah NH; Banda JM; J Schuemie M
[Ad] Endereço:Observational Health Data Sciences and Informatics (OHDSI) Collaborative.
[Ti] Título:Risk of angioedema associated with levetiracetam compared with phenytoin: Findings of the observational health data sciences and informatics research network.
[So] Source:Epilepsia;58(8):e101-e106, 2017 Aug.
[Is] ISSN:1528-1167
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Recent adverse event reports have raised the question of increased angioedema risk associated with exposure to levetiracetam. To help address this question, the Observational Health Data Sciences and Informatics research network conducted a retrospective observational new-user cohort study of seizure patients exposed to levetiracetam (n = 276,665) across 10 databases. With phenytoin users (n = 74,682) as a comparator group, propensity score-matching was conducted and hazard ratios computed for angioedema events by per-protocol and intent-to-treat analyses. Angioedema events were rare in both the levetiracetam and phenytoin groups (54 vs. 71 in per-protocol and 248 vs. 435 in intent-to-treat). No significant increase in angioedema risk with levetiracetam was seen in any individual database (hazard ratios ranging from 0.43 to 1.31). Meta-analysis showed a summary hazard ratio of 0.72 (95% confidence interval [CI] 0.39-1.31) and 0.64 (95% CI 0.52-0.79) for the per-protocol and intent-to-treat analyses, respectively. The results suggest that levetiracetam has the same or lower risk for angioedema than phenytoin, which does not currently carry a labeled warning for angioedema. Further studies are warranted to evaluate angioedema risk across all antiepileptic drugs.
[Mh] Termos MeSH primário: Angioedema/induzido quimicamente
Angioedema/epidemiologia
Epilepsia/tratamento farmacológico
Fenitoína/efeitos adversos
Piracetam/análogos & derivados
[Mh] Termos MeSH secundário: Redes Comunitárias/estatística & dados numéricos
Bases de Dados Factuais/estatística & dados numéricos
Feminino
Seres Humanos
Masculino
Piracetam/efeitos adversos
[Pt] Tipo de publicação:JOURNAL ARTICLE; OBSERVATIONAL STUDY
[Nm] Nome de substância:
230447L0GL (etiracetam); 6158TKW0C5 (Phenytoin); ZH516LNZ10 (Piracetam)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170817
[Lr] Data última revisão:
170817
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170707
[St] Status:MEDLINE
[do] DOI:10.1111/epi.13828


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[PMID]:28661008
[Au] Autor:Nevitt SJ; Sudell M; Weston J; Tudur Smith C; Marson AG
[Ad] Endereço:Department of Biostatistics, University of Liverpool, Block F, Waterhouse Building, 1-5 Brownlow Hill, Liverpool, UK, L69 3GL.
[Ti] Título:Antiepileptic drug monotherapy for epilepsy: a network meta-analysis of individual participant data.
[So] Source:Cochrane Database Syst Rev;6:CD011412, 2017 06 29.
[Is] ISSN:1469-493X
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Epilepsy is a common neurological condition with a worldwide prevalence of around 1%. Approximately 60% to 70% of people with epilepsy will achieve a longer-term remission from seizures, and most achieve that remission shortly after starting antiepileptic drug treatment. Most people with epilepsy are treated with a single antiepileptic drug (monotherapy) and current guidelines from the National Institute for Health and Care Excellence (NICE) in the United Kingdom for adults and children recommend carbamazepine or lamotrigine as first-line treatment for partial onset seizures and sodium valproate for generalised onset seizures; however a range of other antiepileptic drug (AED) treatments are available, and evidence is needed regarding their comparative effectiveness in order to inform treatment choices. OBJECTIVES: To compare the time to withdrawal of allocated treatment, remission and first seizure of 10 AEDs (carbamazepine, phenytoin, sodium valproate, phenobarbitone, oxcarbazepine, lamotrigine, gabapentin, topiramate, levetiracetam, zonisamide) currently used as monotherapy in children and adults with partial onset seizures (simple partial, complex partial or secondary generalised) or generalised tonic-clonic seizures with or without other generalised seizure types (absence, myoclonus). SEARCH METHODS: We searched the following databases: Cochrane Epilepsy's Specialised Register, CENTRAL, MEDLINE and SCOPUS, and two clinical trials registers. We handsearched relevant journals and contacted pharmaceutical companies, original trial investigators, and experts in the field. The date of the most recent search was 27 July 2016. SELECTION CRITERIA: We included randomised controlled trials of a monotherapy design in adults or children with partial onset seizures or generalised onset tonic-clonic seizures (with or without other generalised seizure types). DATA COLLECTION AND ANALYSIS: This was an individual participant data (IPD) review and network meta-analysis. Our primary outcome was 'time to withdrawal of allocated treatment', and our secondary outcomes were 'time to achieve 12-month remission', 'time to achieve six-month remission', 'time to first seizure post-randomisation', and 'occurrence of adverse events'. We presented all time-to-event outcomes as Cox proportional hazard ratios (HRs) with 95% confidence intervals (CIs). We performed pairwise meta-analysis of head-to-head comparisons between drugs within trials to obtain 'direct' treatment effect estimates and we performed frequentist network meta-analysis to combine direct evidence with indirect evidence across the treatment network of 10 drugs. We investigated inconsistency between direct estimates and network meta-analysis via node splitting. Due to variability in methods and detail of reporting adverse events, we have not performed an analysis. We have provided a narrative summary of the most commonly reported adverse events. MAIN RESULTS: IPD was provided for at least one outcome of this review for 12,391 out of a total of 17,961 eligible participants (69% of total data) from 36 out of the 77 eligible trials (47% of total trials). We could not include IPD from the remaining 41 trials in analysis for a variety of reasons, such as being unable to contact an author or sponsor to request data, data being lost or no longer available, cost and resources required to prepare data being prohibitive, or local authority or country-specific restrictions.We were able to calculate direct treatment effect estimates for between half and two thirds of comparisons across the outcomes of the review, however for many of the comparisons, data were contributed by only a single trial or by a small number of participants, so confidence intervals of estimates were wide.Network meta-analysis showed that for the primary outcome 'Time to withdrawal of allocated treatment,' for individuals with partial seizures; levetiracetam performed (statistically) significantly better than both current first-line treatments carbamazepine and lamotrigine; lamotrigine performed better than all other treatments (aside from levetiracetam), and carbamazepine performed significantly better than gabapentin and phenobarbitone (high-quality evidence). For individuals with generalised onset seizures, first-line treatment sodium valproate performed significantly better than carbamazepine, topiramate and phenobarbitone (moderate- to high-quality evidence). Furthermore, for both partial and generalised onset seizures, the earliest licenced treatment, phenobarbitone seems to perform worse than all other treatments (moderate- to high-quality evidence).Network meta-analysis also showed that for secondary outcomes 'Time to 12-month remission of seizures' and 'Time to six-month remission of seizures,' few notable differences were shown for either partial or generalised seizure types (moderate- to high-quality evidence). For secondary outcome 'Time to first seizure,' for individuals with partial seizures; phenobarbitone performed significantly better than both current first-line treatments carbamazepine and lamotrigine; carbamazepine performed significantly better than sodium valproate, gabapentin and lamotrigine. Phenytoin also performed significantly better than lamotrigine (high-quality evidence). In general, the earliest licenced treatments (phenytoin and phenobarbitone) performed better than the other treatments for both seizure types (moderate- to high-quality evidence).Generally, direct evidence and network meta-analysis estimates (direct plus indirect evidence) were numerically similar and consistent with confidence intervals of effect sizes overlapping.The most commonly reported adverse events across all drugs were drowsiness/fatigue, headache or migraine, gastrointestinal disturbances, dizziness/faintness and rash or skin disorders. AUTHORS' CONCLUSIONS: Overall, the high-quality evidence provided by this review supports current guidance (e.g. NICE) that carbamazepine and lamotrigine are suitable first-line treatments for individuals with partial onset seizures and also demonstrates that levetiracetam may be a suitable alternative. High-quality evidence from this review also supports the use of sodium valproate as the first-line treatment for individuals with generalised tonic-clonic seizures (with or without other generalised seizure types) and also demonstrates that lamotrigine and levetiracetam would be suitable alternatives to either of these first-line treatments, particularly for those of childbearing potential, for whom sodium valproate may not be an appropriate treatment option due to teratogenicity.
[Mh] Termos MeSH primário: Anticonvulsivantes/uso terapêutico
Epilepsia/tratamento farmacológico
[Mh] Termos MeSH secundário: Adulto
Aminas/uso terapêutico
Carbamazepina/análogos & derivados
Carbamazepina/uso terapêutico
Criança
Ácidos Cicloexanocarboxílicos/uso terapêutico
Epilepsias Parciais/tratamento farmacológico
Epilepsia Generalizada/tratamento farmacológico
Frutose/análogos & derivados
Seres Humanos
Isoxazóis/uso terapêutico
Metanálise em Rede
Fenobarbital/uso terapêutico
Fenitoína/uso terapêutico
Piracetam/análogos & derivados
Piracetam/uso terapêutico
Indução de Remissão
Triazinas
Ácido Valproico/uso terapêutico
Ácido gama-Aminobutírico/uso terapêutico
[Pt] Tipo de publicação:JOURNAL ARTICLE; META-ANALYSIS; RESEARCH SUPPORT, NON-U.S. GOV'T; REVIEW
[Nm] Nome de substância:
0 (Amines); 0 (Anticonvulsants); 0 (Cyclohexanecarboxylic Acids); 0 (Isoxazoles); 0 (Triazines); 0H73WJJ391 (topiramate); 230447L0GL (etiracetam); 30237-26-4 (Fructose); 33CM23913M (Carbamazepine); 459384H98V (zonisamide); 56-12-2 (gamma-Aminobutyric Acid); 614OI1Z5WI (Valproic Acid); 6158TKW0C5 (Phenytoin); 6CW7F3G59X (gabapentin); U3H27498KS (lamotrigine); VZI5B1W380 (oxcarbazepine); YQE403BP4D (Phenobarbital); ZH516LNZ10 (Piracetam)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170824
[Lr] Data última revisão:
170824
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170630
[St] Status:MEDLINE
[do] DOI:10.1002/14651858.CD011412.pub2



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