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1.
Medicine (Baltimore) ; 99(32): e21480, 2020 Aug 07.
Artigo em Inglês | MEDLINE | ID: mdl-32769882

RESUMO

BACKGROUND: The introduction of biological disease-modifying anti-rheumatic drugs into clinical practice has dramatically improved the clinical outcomes of individuals with rheumatoid arthritis (RA). We are conducting the IFX-SIRIUS STUDY I that evaluates whether switching from originator infliximab (IFX) to its biosimilar, CT-P13, is not inferior in maintaining nonclinical relapse to continue treatment with originator IFX in patients with RA achieving clinical remission. It is the next great issue whether disease activity can be maintained in good condition after discontinuation of CT-P13 because no evidence is available regarding the clinical value of discontinuing biosimilars in patients with RA. Thus, we will evaluate whether a condition without clinical relapse will be maintained after discontinuation of CT-P13 in patients with RA, achieving clinical remission or low disease activity during the IFX-SIRIUS STUDY I. METHODS/DESIGN: This study is an interventional, multicenter, open-label, single-arm clinical trial with a 48-week follow-up. Patients with RA who are treated with CT-P13 and sustained nonclinical relapse during the IFX-SIRIUS STUDY I will be included. Patients will discontinue CT-P13 after the study period of the IFX-SIRIUS STUDY I. We will evaluate disease activity by clinical disease activity indices and musculoskeletal ultrasound (MSUS). The primary endpoint is the proportion of patients who do not have clinical relapse during the study period. Important secondary endpoints are the changes from the baseline of the MSUS scores. We will also comprehensively analyze the serum levels of multiple biomarkers, such as cytokines and chemokines. In addition, if a clinical relapse occurs in patients after the discontinuation of CT-P13, we will evaluate the effectiveness and safety of restarting CT-P13. DISCUSSION: The study results are expected to show the clinical benefit of the discontinuation of CT-P13 and effectiveness and safety of restarting CT-P13 after clinical relapse. The strength of this study is to prospectively evaluate the therapeutic effectiveness by not only clinical disease activity indices but also standardized MSUS findings in multiple centers. We will explore whether parameters at baseline can predict a nonclinical relapse after the discontinuation of CT-P13 by integrating multilateral assessments, that is, patient's characteristics, clinical disease activity indices, MSUS findings, and serum biomarkers. TRIAL REGISTRATION: This study was registered in the Japan Registry of Clinical Trials (https://jrct.niph.go.jp) on April 20, 2020 as jRCTs071200007.


Assuntos
Anticorpos Monoclonais/administração & dosagem , Antirreumáticos/administração & dosagem , Artrite Reumatoide/patologia , Medicamentos Biossimilares/administração & dosagem , Substituição de Medicamentos , Infliximab/administração & dosagem , Adulto , Artrite Reumatoide/diagnóstico por imagem , Artrite Reumatoide/tratamento farmacológico , Biomarcadores/análise , Estudos de Equivalência como Asunto , Feminino , Humanos , Quimioterapia de Indução , Japão , Masculino , Recidiva , Resultado do Tratamento , Ultrassonografia
2.
Medicine (Baltimore) ; 99(30): e21151, 2020 Jul 24.
Artigo em Inglês | MEDLINE | ID: mdl-32791688

RESUMO

BACKGROUND: The introduction of biological disease-modifying anti-rheumatic drugs (bDMARDs) into clinical practice has dramatically improve the clinical outcomes of individuals with rheumatoid arthritis (RA). However, bDMARDs are associated with high costs, which has resulted in restricted treatment access and a burden on medical insurance finances. Although biosimilars offer cost-saving, their effectiveness and safety must be established in Post-Marketing Surveillance (PMS). Infliximab (IFX), a chimeric monoclonal antibody to TNF-alpha, is the first bDMARD; its biosimilar, CT-P13, is the first biosimilar DMARD approved for RA treatment in Japan. We will evaluate whether switching from originator IFX to CT-P13 is not inferior for maintaining non-clinical relapse to continued treatment with originator IFX in RA patients achieving clinical remission. METHODS/DESIGN: This study is an interventional, multicenter, open-label, single-arm against historical control and noninferiority clinical trial with a 24-week follow-up. Eighty RA patients who are treated by originator IFX for ≥24 weeks and are achieving clinical remission will be included. Patients will be switched to CT-P13 with the unchanged dosing regimen. We will evaluate disease activity by measuring clinical disease activity indices and by using musculoskeletal ultrasound (MSUS). The primary endpoint is the ratio of patients who experience a nonclinical relapse during the study period. Important secondary endpoints are the changes from the baseline of the MSUS scores. We will also comprehensively analyze the serum levels of many biomarkers such as cytokines and chemokines. DISCUSSION: The study results are expected to show the noninferiority of switching to CT-P13 over the continuation of originator IFX. The strength of this study is its prospective evaluation of therapeutic efficacy using not only clinical disease activity indices but also MSUS to accurately and objectively evaluate disease activity at the joint level among patients drawn from multiple centers with a standardized evaluation by MSUS. We will explore whether parameters at baseline can predict a nonclinical relapse after switching from originator IFX to CT-P13 by integrating multilateral assessments, i.e., clinical disease activity indices, MSUS findings, and serum biomarkers. TRIAL REGISTRATION: This study was registered in the Japan Registry of Clinical Trials (https://jrct.niph.go.jp) on October 11, 2019 as jRCTs071190030.


Assuntos
Artrite Reumatoide/tratamento farmacológico , Medicamentos Biossimilares/uso terapêutico , Quimiocinas/sangue , Infliximab/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Artrite Reumatoide/sangue , Artrite Reumatoide/diagnóstico por imagem , Biomarcadores/sangue , Substituição de Medicamentos , Estudos de Equivalência como Asunto , Humanos , Japão , Quimioterapia de Manutenção , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Índice de Gravidade de Doença , Ultrassonografia , Adulto Jovem
3.
PLoS One ; 15(7): e0235205, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32658918

RESUMO

BACKGROUND: Generic medicines are similar to innovator medicine in terms of safety, quality, efficacy, dosage form, strength, and route of administration. They have the same therapeutic use to innovator medicines and available at a far lower price. However, health professionals' poor knowledge and attitude may limit its utilization. The present study aimed at assessing the knowledge, attitude, and practice of pharmacy professionals towards generic medicines in Harar city, Eastern Ethiopia. METHODS: A cross-sectional survey was conducted among community pharmacists in Harar city. A self-administered thirty-three item questionnaire on Knowledge, attitude, and practice of community pharmacists was utilized. Logistic regression analysis was performed to predict the determinants of knowledge and attitude of pharmacists. An odds ratio at 95% confidence interval along with a p-value < 0.05 was considered significant. RESULTS: Among 80 community pharmacists' approached, 74 completed the survey, providing a response rate of 92.5%. Sixty-seven percent of the respondents knew that generic drugs are bioequivalent to brand drugs and claimed generic medicines are cheaper (86.5%). Nearly half (48.6%) of participants believe that generic medicines are less effective and slower in the onset of action (58.1%). More than half (54.1%) of study participants revealed their lack of belief in generic medicine as a factor hindering the selection and dispensing of generic medicines. In multivariate logistic regression, experience in community pharmacy practice (Adjusted odds ratio (AOR = 2.18, 95%CI: 1.21-63.1) and Sex (AOR = 3.88, 95%CI: 2.12-39.62) were significantly associated with knowledge and attitude toward generic medicines, respectively. CONCLUSION: The current study revealed that there is a gap in the knowledge and attitude of community pharmacists towards generic and brand drugs. More than averages of the respondents have known the concept of generic medicine including their right to perform generic substitution and had a positive attitude toward generics. Female pharmacists were more likely to have a positive attitude and the overall knowledge was higher in those who have more than 5 years of work experience.


Assuntos
Serviços Comunitários de Farmácia/estatística & dados numéricos , Medicamentos Genéricos/uso terapêutico , Conhecimentos, Atitudes e Prática em Saúde , Farmacêuticos/psicologia , Competência Profissional/estatística & dados numéricos , Adulto , Estudos Transversais , Substituição de Medicamentos , Medicamentos Genéricos/farmacologia , Etiópia , Feminino , Humanos , Masculino , Farmacêuticos/estatística & dados numéricos , Fatores Sexuais , Inquéritos e Questionários/estatística & dados numéricos , Equivalência Terapêutica , Adulto Jovem
5.
Clin Rheumatol ; 39(9): 2817-2821, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32712743

RESUMO

COVID-19 has significantly affected healthcare systems around the world. To prepare for this unprecedented emergency, elective patient care was put on hold across the National Health Service (NHS). Rheumatology service had to be reorganised with a cancellation of elective clinics and clinical reconfiguration to continue to deliver care to patients, support frontline, and prevent viral transmission. The rheumatology community's responsibility of providing a continuity of care for patients had to be balanced with measures to reduce the risk of viral transmission and also protection of both the patients and staff. We describe our experience of delivering rheumatology service as recommended by the National Institute for Health and Care Excellence (NICE NG167) guidelines at a district general hospital during the current pandemic. Key Points • Prepare to deliver a rapid mass communication; ensure email and mobile phones registered in patients' records; enable access to text and video messaging. • To ensure wider access to innovative digital technology in clinical practice; implement telephone and video consultations where appropriate. • To consider setting up community OP clinics, for example, mobile and satellite clinics.


Assuntos
Infecções por Coronavirus/epidemiologia , Assistência à Saúde/métodos , Pneumonia Viral/epidemiologia , Doenças Reumáticas/terapia , Reumatologia/métodos , Telemedicina , Administração Intravenosa , Assistência Ambulatorial , Antirreumáticos/uso terapêutico , Betacoronavirus , Continuidade da Assistência ao Paciente , Infecções por Coronavirus/prevenção & controle , Infecções por Coronavirus/transmissão , Substituição de Medicamentos , Hospitais de Distrito , Hospitais Gerais , Humanos , Infusões Subcutâneas , Enfermeiras e Enfermeiros , Pandemias/prevenção & controle , Admissão e Escalonamento de Pessoal , Pneumonia Viral/prevenção & controle , Pneumonia Viral/transmissão , Reumatologistas , Medição de Risco , Medicina Estatal , Reino Unido
6.
Yakugaku Zasshi ; 140(7): 937-941, 2020.
Artigo em Japonês | MEDLINE | ID: mdl-32612059

RESUMO

Studies on the drug saxagliptin (marketed in Japan since 2013) suggest favorable efficacy in hemodialysis patients, but included small sample sizes. Noting that some hemodialysis patients at our medical institution had been switched to saxagliptin 2.5 mg from treatment with other dipeptidyl peptidase-4 inhibitors, we decided to evaluate the effects of switching to saxagliptin on blood glucose control in these patients. The study included 11 patients. Before switching drugs, six of the patients used teneligliptin 20 mg and five used linagliptin 5 mg. Mean glycated albumin (GA) from before to 4 months after switching tended to increase in the previous users of teneligliptin 20 mg (18.4±3.0% to 19.5±2.7%) and tended to decrease in the previous users of linagliptin 5 mg (18.8±3.3% to 17.7±1.4%). Lack of a substantial change in GA when the previous users of teneligliptin 20 mg and linagliptin 5 mg were switched to saxagliptin 2.5 mg indicates that these three agents might have comparable antihyperglycemic profiles when used in patients on hemodialysis. Future research following from this pilot study must evaluate the risk of cardiac failure and incidences of adverse events in a larger population, to investigate the long-term efficacy and safety of switching to saxagliptin.


Assuntos
Adamantano/análogos & derivados , Glicemia/metabolismo , Diabetes Mellitus/tratamento farmacológico , Dipeptídeos/administração & dosagem , Substituição de Medicamentos , Diálise Renal , Adamantano/administração & dosagem , Adamantano/efeitos adversos , Adamantano/economia , Idoso , Idoso de 80 Anos ou mais , Redução de Custos , Diabetes Mellitus/sangue , Dipeptídeos/efeitos adversos , Dipeptídeos/economia , Feminino , Humanos , Linagliptina , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Pirazóis , Albumina Sérica/metabolismo , Tiazolidinas
7.
Québec; INESSS; 20 juil. 2020.
Não convencional em Francês | BRISA/RedTESA | ID: biblio-1103660

RESUMO

CONTEXTE: Le présent document ainsi que les constats qu'il énonce ont été rédigés en réponse à une interpellation du ministère de la Santé et des Services sociaux. L'annonce d'un arrêt de commercialisation de toutes les teneurs de ce produit utilisé par quelque 100000 patients au Québec en période de confinement a suscité des questions quant à la sécurité de la substitution pouvant être validée par des tests de laboratoire, notamment la nécessité de faire un suivi plus étroit du ratio normalisé international (RNI). L'objectif était de réaliser une recension sommaire des données publiées et de mobiliser les savoirs clés afin d'informer les décideurs publics et les professionnels de la santé et des services sociaux. Vu la nature rapide de cette réponse, les constats qui en découlent ne reposent pas sur un repérage exhaustif des données publiées, une évaluation de la qualité méthodologique des études avec une méthode systématique ou sur un processus de consultation élaboré. PRÉSENTATION DE LA DEMANDE: BRISTOL-MYERS SQUIBB CANADA cessera, dans les prochains mois, la vente de CoumadinMD au Canada en raison de problèmes de fabrication. Au Québec, une grande proportion des personnes qui utilisent de la warfarine reçoivent actuellement ce produit novateur. Ces personnes devront donc éventuellement recevoir une version générique de la warfarine pour la poursuite de leur traitement anticoagulant. Il a été demandé à l'INESSS, le 23 avril dernier, d'évaluer les enjeux associés à cette situation, notamment l'impact sur le suivi du RNI. MÉTHODOLOGIE: Revue de littérature Questions d'évaluation : Chez les personnes anticoagulées par la warfarine, est-ce que la substitution du CoumadinMD pour une version générique de la warfarine doit être accompagnée de précautions particulières? Critères de sélection : Aucune limite temporelle ni limitation sur le type de publication n'ont été imposées dans le cadre de cette recension sommaire. Méthodes de recension : La recherche documentaire a été effectuée dans Pubmed avec les mots-clés switch, warfarin et generic. Une recherche manuelle de la littérature a également été effectuée en consultant les sites Internet d'organismes gouvernementaux canadiens et le moteur de recherche Google. Les guides de pratique clinique (GPC) recensés par l'INESSS en 2019 pour l'élaboration d'un guide d'usage optimal (GUO) sur la fibrillation auriculaire chez l'adulte et d'un GUO sur la thrombose veineuse profonde et l'embolie pulmonaire chez l'adulte ont été consultés afin de savoir s'ils contenaient de l'information sur le passage du produit de marque à une version générique de la warfarine. Les monographies des versions génériques de la warfarine ont aussi été consultées, tout comme les différentes lois en vigueur. SOMMAIRE DES RÉSULTATS: État des connaissances scientifiques, expérience d'autres juridictions et contexte législatif: Les auteurs de deux revues systématiques, l'une publiée en 2011 et l'autre en 2008, ont conclu que les versions génériques de la warfarine sont aussi sécuritaires et efficaces que le produit de marque et que le passage du produit de marque à une version générique (jugée bioéquivalente par les autorités) est sécuritaire. Les auteurs précisent toutefois que le passage doit être accompagné d'un suivi étroit du ratio normalisé international (RNI), particulièrement chez les patients à risque [Dentali et al., 2011; Kesselheim et al., 2008]. Dans une étude québécoise publiée en 2019, les auteurs ont rapporté qu'entre le 2 janvier 1996 et le 2 janvier 2016, le taux moyen de visites à l'hôpital (consultation à l'urgence ou admission à l'hôpital, toutes causes confondues) était de 113 pour 100 utilisateurs de warfarine (produit de marque ou version générique) par période de 6 mois et que ce taux moyen était similaire avant et après l'arrivée des génériques de la warfarine sur le marché (le 2 janvier 2001) [Leclerc et al., 2019]. Les GPC recensés dans le cadre de l'élaboration des deux GUO de l'INESSS ne contenaient pas d'information sur le passage du produit de marque à une version générique de la warfarine. Dans les monographies des produits Apo-warfarinMC et Taro-warfarinMC, il est mentionné que pour garantir une maîtrise satisfaisante, il est recommandé d'effectuer des tests de mesure du temps de prothrombine lorsque la warfarine sodique en comprimé est remplacée par d'autres produits à base de warfarine et lorsqu'un traitement par un autre médicament est instauré, interrompu ou administré de façon irrégulière. Il est également mentionné que lorsqu'on passe d'un produit à base de warfarine à un autre, on doit mettre l'accent principalement sur la maîtrise du RNI. Du point de vue légal, au Québec, selon l'article 21 de la Loi sur la pharmacie (Loi sur la pharmacie, article 21. L.R.Q, Chapitre P-10), un pharmacien doit exécuter une ordonnance suivant sa teneur intégrale. Il peut toutefois, pourvu qu'il en avise le client et qu'il l'inscrive à son dossier, substituer au médicament prescrit un médicament dont la dénomination commune est la même, à moins d'indication contraire formulée par l'auteur de l'ordonnance lorsque la situation de la personne le requiert. L'expérience de l'Ontario et la Colombie-Britannique : Les autorités de l'Ontario et de la Colombie-Britannique n'ont pas identifié d'enjeu particulier lorsqu'une majeure partie des personnes traitées avec la warfarine dans leur province respective sont passées du produit de marque à une version générique de la warfarine il y a de cela plusieurs années. D'ailleurs, l'expérience ontarienne a fait l'objet d'une publication scientifique en 2006. Dans cette publication, il est mentionné que le régime provincial d'assurance-médicaments ontarien a instauré le 7 juin 2001 une politique demandant aux pharmaciens d'effectuer la substitution, chez les patients traités par la warfarine, du produit de marque par une version générique. Les médecins étaient informés de ce changement une semaine à l'avance. Les patients pouvaient continuer de recevoir le CoumadinMD en payant la différence de prix. Pour savoir si ce passage a eu des répercussions sur la santé ou les coûts, Paterson et ses collègues ont étudié toutes les prescriptions de warfarine au cours des 40 mois précédant l'adoption de la politique, au cours du mois pendant lequel la politique est entrée en vigueur et au cours des neuf mois suivants. Trois mois après l'entrée en vigueur de la politique, 87% des ordonnances de warfarine impliquaient une formulation générique. Entre les périodes précédant et suivant l'entrée en vigueur de la politique, il n'y a eu aucun changement dans les taux de mesures de RNI et d'hospitalisation pour hémorragie majeure ou thromboembolie cérébrale.


Assuntos
Varfarina/uso terapêutico , Infecções por Coronavirus/tratamento farmacológico , Substituição de Medicamentos , Avaliação da Tecnologia Biomédica , Avaliação em Saúde
8.
Québec; INESSS; 16 juil. 2020.
Não convencional em Francês | BRISA/RedTESA | ID: biblio-1103470

RESUMO

CONTEXTE: Le présent document ainsi que les constats qu'il énonce ont été rédigés en réponse à une interpellation du ministère de la Santé et des Services sociaux dans le contexte de l'urgence sanitaire liée à la maladie à coronavirus (COVID-19) au Québec. L'objectif est de réaliser une recension sommaire des données publiées et de mobiliser les savoirs clés afin d'informer les décideurs publics et les professionnels de la santé et des services sociaux. Vu la nature rapide de cette réponse, les constats ou les positions qui en découlent ne reposent pas sur un repérage exhaustif des données publiées, une évaluation de la qualité méthodologique des études avec une méthode systématique ou sur un processus de consultation élaboré. Dans les circonstances d'une telle urgence de santé publique, l'INESSS reste à l'affût de toutes nouvelles données susceptibles de lui faire modifier cette réponse rapide. PRÉSENTATION DE LA DEMANDE: Le midazolam (VersedMC), lorazépam (AtivanMC) ainsi que le phénobarbital font partie des médicaments administrés en soins palliatifs. Le contexte actuel d'urgence sanitaire lié à la COVID-19 exerce une forte pression sur l'usage de ces médicaments. Afin d'être en mesure d'offrir des soins palliatifs de qualité aux personnes qui le nécessitent, et ce, même en cas de pénurie, le MSSS a demandé à l'INESSS de rechercher les médicaments pouvant constituer des alternatives au lorazépam, midazolam et au phénobarbital en soins palliatifs, tout en tenant compte des ruptures de stock actuelles et anticipées de ces médicaments. Une attention particulière a été portée aux moyens permettant de limiter les pertes de produits, ainsi que l'usage du matériel pouvant être appelé à manquer, tels les pompes volumétriques. MÉTHODOLOGIE: Revue de littérature Questions d'évaluation: 1. Quelles sont les alternatives au midazolam (VersedMC), au lorazépam (AtivanMC) et au phénobarbital en soins palliatifs? 2. Quels seraient les moyens permettant de limiter les pertes de ces médicaments? Repérage des publications : Date de la recherche: 9 avril. Une recherche rapide a été effectuée en utilisant les bases de données Pubmed, Medline, Embase, EBM Reviews et le moteur de recherche Google avec les mots-clés suivants: midazolam, lorazepam, phenobarbital, palliative care, palliative sedation, drug shortage. Une recherche manuelle de la littérature a également été effectuée en consultant les sites Web des agences règlementaires, d'agences d'évaluation des technologies de la santé ainsi que ceux d'organismes gouvernementaux, d'associations ou ordres professionnels en lien avec le thème des travaux. CONSTATS DE L'INESSS: Basé sur la documentation scientifique disponible au moment de sa rédaction, et sur les consultations menées, malgré l'incertitude existante dans cette documentation et dans la démarche utilisée, l'INESSS met en lumière que: La pénurie de médicaments, réelle ou potentielle, doit être communiquée localement dès maintenant aux différents intervenants et des actions mises en place immédiatement, si ce n'est pas déjà fait, dans tous les centres hospitaliers du Québec, qu'ils reçoivent ou non des patients atteints de la COVID-19. L'utilisation des options alternatives devrait donc être favorisée dès maintenant afin d'éviter une pression à la baisse sur les stocks des molécules déjà à risque de pénurie. Dans un contexte d'approvisionnement limité et incertain, il faut éviter le gaspillage et minimiser les pertes; de plus, l'usage de certains produits critiques devrait être priorisé et réservé aux situations pour lesquelles les options alternatives sont peu ou pas envisageables. Il est important de bien adapter le choix des médicaments en fonction des symptômes que l'on souhaite soulager, de l'état du patient et du degré de sédation désiré. Pour soutenir les plus petits centres hospitaliers dans l'usage des options alternatives en soins palliatifs, il serait important de faciliter le partage des connaissances développées dans les grands centres hospitaliers au moyen, par exemple, d'un programme de mentorat. Les patients atteints de COVID-19 chez qui l'approche préconisée est palliative devront faire l'objet d'une prise en charge adaptée qui tient compte de la mitigation des risques de transmission ou contamination. Considérant l'évolution de la pandémie et les milieux d'exercice des soins de fin de vie, les pratiques devront néanmoins s'adapter en tenant compte des éléments d'expertise locale et de capacité du milieu à offrir certains soins.


Assuntos
Humanos , Cuidados Paliativos/organização & administração , Fenobarbital/uso terapêutico , Midazolam/uso terapêutico , Infecções por Coronavirus/epidemiologia , Substituição de Medicamentos , Lorazepam/uso terapêutico , Avaliação da Tecnologia Biomédica , Avaliação em Saúde
9.
J Stroke Cerebrovasc Dis ; 29(8): 104982, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32689586

RESUMO

We report a case of ophthalmic artery occlusion (OAO) in a young patient with COVID-19 infection that was on therapeutic anticoagulation with apixaban for deep venous thrombosis (DVT). A 48-year-old man with obesity was hospitalized with a severe form of COVID-19 infection, complicated with acute respiratory failure, septic shock, dilated cardiomyopathy and fungemia. Despite treatment with prophylactic enoxaparin (initial D-Dimer 1.14 µg/ml FEU (normal < 0.05 µg/ml FEU), D-Dimer increased to above 20 µg/ml FEU and patient continued to spike high fevers. This prompted further investigations and upper and lower extremities DVTs were confirmed and managed with enoxaparin 1 mg/kg twice daily. D-dimer level decreased to 4.98 µg/ml FEU while on therapeutic anticoagulation. Three weeks later pending hospital discharge, the anticoagulation was switched to oral apixaban 10 mg twice daily. Patient developed acute severe right eye visual loss of no light perception and was diagnosed with incomplete OAO. D-Dimer was elevated at 2.13 µg/ml FEU. Stroke etiological work-up found no embolic sources, resolution of the dilated cardiomyopathy and negative antiphospholipid antibodies. Treatment was changed to enoxaparin and no thrombotic events were encountered to date. Ocular vascular complications have not yet been reported in COVID-19. Controversy exists on the best management algorithm for the hypercoagulable state associated to COVID-19 Either direct oral anticoagulants or low-molecular-weight-heparin are considered appropriate at discharge for patients with venous thromboembolism. The optimum regimen for ischemic stroke prevention and the significance of D-Dimer for anticoagulation monitoring in COVID-19 remain unclear.


Assuntos
Arteriopatias Oclusivas/etiologia , Infecções por Coronavirus/tratamento farmacológico , Inibidores do Fator Xa/administração & dosagem , Artéria Oftálmica , Pneumonia Viral/tratamento farmacológico , Pirazóis/administração & dosagem , Piridonas/administração & dosagem , Trombose Venosa/tratamento farmacológico , Arteriopatias Oclusivas/diagnóstico por imagem , Betacoronavirus/patogenicidade , Infecções por Coronavirus/sangue , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/virologia , Substituição de Medicamentos , Enoxaparina/administração & dosagem , Inibidores do Fator Xa/efeitos adversos , Interações entre Hospedeiro e Microrganismos , Humanos , Masculino , Pessoa de Meia-Idade , Artéria Oftálmica/diagnóstico por imagem , Pandemias , Pneumonia Viral/sangue , Pneumonia Viral/diagnóstico , Pneumonia Viral/virologia , Pirazóis/efeitos adversos , Piridonas/efeitos adversos , Fatores de Risco , Resultado do Tratamento , Trombose Venosa/sangue , Trombose Venosa/diagnóstico , Trombose Venosa/virologia
12.
Ann Rheum Dis ; 79(9): 1203-1209, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32581090

RESUMO

OBJECTIVE: To compare effectiveness of treatment with secukinumab (SEC) with that of alternative tumour necrosis factor inhibitors (TNFis) in patients with axial spondyloarthritis (axSpA) after withdrawal from one or more TNFis. METHODS: Patients diagnosed as having axSpA in the Swiss Clinical Quality Management cohort were included if they had initiated SEC (n=106) or an alternative TNFi (n=284) after experiencing TNFi failure. Drug retention was investigated with matching weights propensity score (PS) analyses and multiple adjusted Cox proportional hazards models. Matching weights PS-based analyses and multiple-adjusted logistic regression analyses were used to assess the proportion of patients reaching 50% reduction in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI50) at 1 year. RESULTS: SEC was more often used as third-line or later-line biological drug (76% vs 40% for TNFi). Patients starting SEC had higher BASDAI, Bath Ankylosing Spondylitis Functional Index, Bath Ankylosing Spondylitis Metrology Index and C reactive protein levels. A comparable risk of drug discontinuation was found for SEC versus TNFi (HR 1.14, 95% CI 0.78 to 1.68 in the PS-based analysis and HR 1.16, 95% CI 0.79 to 1.71 in the multiple-adjusted analysis). No significant difference in BASDAI50 responses at 1 year was demonstrated between the two modes of biological drug action, with CI of estimates being, however, wide (OR for SEC vs TNFi 0.76, 95% CI 0.26 to 2.18 and 0.78, 95% CI 0.24 to 2.48 in the PS-based and the covariate-adjusted model, respectively). CONCLUSION: Our data suggest a comparable effectiveness of SEC versus an alternative TNFi after prior TNFi exposure.


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Antirreumáticos/uso terapêutico , Espondilartrite/tratamento farmacológico , Inibidores do Fator de Necrose Tumoral/uso terapêutico , Adulto , Estudos de Coortes , Pesquisa Comparativa da Efetividade , Substituição de Medicamentos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Índice de Gravidade de Doença , Suíça , Resultado do Tratamento
15.
PLoS One ; 15(4): e0232226, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32353006

RESUMO

OBJECTIVES: To examine patterns of generic escitalopram initiation and substitution among Medicare beneficiaries. METHODS: This retrospective new user cohort used a 5% random sample of 2013-2015 Medicare administrative claims data. Fee-for-service Medicare beneficiaries continuously enrolled in Parts A, B, and D during a 6-month washout period prior to their initial generic or brand oral escitalopram prescriptions were included (n = 12,351). The primary outcomes were generic escitalopram treatment initiation, and among brand escitalopram initiators, generic substitution within 12 months. Patient demographics, health service utilization, and prescription level factors were measured and assessed. RESULTS: Among all escitalopram initiators, about 88.2% Medicare beneficiaries initiated generic escitalopram. Beneficiaries who were younger age, male, residing in non-Northeast regions or urban area, in the Part D plan deductible benefit phase, and filling prescriptions at community/retail pharmacies were more likely to initiate generic treatment. Among brand escitalopram initiators (n = 1,464), about 20.7% switched to generic escitalopram, 31.2% switched to another alternative antidepressant, 25.1% discontinued treatment, and 8.7% were lost to follow up or passed away within 12 months after brand initiation. Factors associated with generic escitalopram substitution included region (Midwest vs. Northeast, adjusted hazard ratio (HR) = 1.46, 95% CI = 1.04-2.05), pre-index hospitalization (HR = 1.31; 95% CI = 1.16-1.48) and lower escitalopram average daily dosage (HR = 0.97; 95% CI = 0.95-0.99). CONCLUSIONS: In 2013-2015, almost 90% Medicare beneficiaries initiated generic escitalopram treatment. Among brand escitalopram initiators, about 1 in 5 patients switched to generic escitalopram within 1 year, as compared to 1 in 4 or 1 in 3 who discontinued current or switched to alternative treatment, respectively. Medicare beneficiary's geographic region was independently associated with generic escitalopram initiation and substitution. Findings from this study not only provide up-to-date evidence in generic escitalopram use patterns among Medicare population, but also can guide educational and practice interventions to further increase generic escitalopram use.


Assuntos
Citalopram/economia , Citalopram/uso terapêutico , Substituição de Medicamentos/economia , Medicamentos Genéricos/economia , Medicamentos Genéricos/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Custos de Medicamentos , Feminino , Humanos , Masculino , Medicare/economia , Farmácias/economia , Estudos Retrospectivos , Estados Unidos
18.
J Clin Psychiatry ; 81(3)2020 05 12.
Artigo em Inglês | MEDLINE | ID: mdl-32412697

RESUMO

​​​​ About 30%-50% of patients experience inadequate response to antidepressant therapy, and treatment choices for these patients include augmenting the antidepressant with another therapy, increasing the dose, switching to a different antidepressant, or combining antidepressants. Clinicians should tailor treatment strategies based on patients' response, tolerability, and disease severity. In this activity, augmentation and adjunctive strategies involving atypical antipsychotics, as well as off-label options including buspirone, stimulants, thyroid hormone, and lithium, are reviewed.​ ​.


Assuntos
Antidepressivos/uso terapêutico , Transtorno Depressivo Maior/tratamento farmacológico , Antidepressivos/administração & dosagem , Transtorno Depressivo Maior/diagnóstico , Substituição de Medicamentos , Humanos , Escalas de Graduação Psiquiátrica , Falha de Tratamento
19.
Immunol Med ; 43(3): 115-120, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32393150

RESUMO

To compare therapeutic efficacy of tumour necrosis factor inhibitor (TNFi) cyclers and non-TNFi switchers in patients with rheumatoid arthritis (RA) having inadequate response to previous TNFis (TNF-IR patients) using composite measures including imaging assessment with power Doppler ultrasonography (PDUS). Patients with RA who had inadequate response to one or more previous TNFi agents with moderate or higher disease activity were enrolled. The outcomes of 56 TNF-IR patients were analysed. Patients were divided into 19 TNFi cyclers and 37 non-TNFi switchers (16 abatacept [ABT] and 21 tocilizumab [TCZ] switchers). Retention ratio at 6 months was significantly higher in non-TNFi switchers than in TNFi cyclers (p < .05). Although there was no significant difference, non-TNFi switchers tended to have a larger decrease than TNFi cyclers in efficacy indicators based on clinical disease activity index and PDUS. Multivariate logistic regression analysis identified a following independent factor associated with both EULAR good response and retention of a biologic agent: non-TNFi switch (p < .05 for both). Non-TNFi switchers were shown to have significantly higher percentage of EULAR good response and higher retention than TNFi cyclers. A non-TNFi biologic agent may hence be a preferential next-line treatment for TNF-IR patients.


Assuntos
Abatacepte/administração & dosagem , Anticorpos Monoclonais Humanizados/administração & dosagem , Antirreumáticos/administração & dosagem , Artrite Reumatoide/diagnóstico por imagem , Artrite Reumatoide/tratamento farmacológico , Substituição de Medicamentos , Inibidores do Fator de Necrose Tumoral/administração & dosagem , Ultrassonografia , Abatacepte/efeitos adversos , Idoso , Anticorpos Monoclonais Humanizados/efeitos adversos , Estudos de Coortes , Feminino , Humanos , Japão , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do Tratamento , Inibidores do Fator de Necrose Tumoral/efeitos adversos
20.
Medicine (Baltimore) ; 99(18): e20082, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32358392

RESUMO

BACKGROUND: To systematic review the efficacy and safety of 6-thioguanine (6-TG) in the substitute of 6-mercaptopurine (6-MP) in the treatment for patients with childhood acute lymphoblastic leukemia (ALL) in the maintenance phase, and to explore its clinical application value. It provides theoretical guidance for the maintenance treatment of ALL in children from the perspective of evidence-based medicine. METHODS: By means of computer retrieval, Chinese databases were searched: Chinese Biomedical Database (CBM), China national knowledge internet (CNKI), Chongqing Weipu Database (VIP), and Wanfang Database; Foreign databases: PubMed, The Cochrane Library, Embase, and Web of Science were applied to find out randomized controlled trial (RCT) for 6-TG in childhood acute lymphoblastic leukemia. By manual retrieval, documents without electronic edition and related conference papers were retrieved. The retrieval time ranges from the beginning of the establishment of the databases to September 1st, 2019. According to the inclusion, and exclusion criteria by 3 researchers, the literature screening, data extraction, and research methodological quality evaluation were completed. RevMan 5.3 software was applied to evaluate the quality of the included literature, and Stata 12.0 software was used to conduct meta-analysis of the outcome indicators of the included literature. RESULTS: This study systematically evaluated the efficacy and safety of 6-TG in the substitute of 6-MP as a maintenance drug for childhood acute lymphoblastic leukemia. Through the key outcome indicators, this study is expected to draw a scientific, practical conclusion for 6-TG in the treatment of childhood acute lymphoblastic leukemia. This conclusion will provide evidence-based medical direction for clinical treatment. CONCLUSION: The efficacy and safety of 6-TG in the substitute of 6-MP in the maintenance treatment of childhood acute lymphoblastic leukemia will be confirmed through this study. The conclusions will be published in relevant academic journals. REGISTRATION: PROSPERO (registration number is CRD42020150466).


Assuntos
Antimetabólitos Antineoplásicos/uso terapêutico , Leucemia-Linfoma Linfoblástico de Células Precursoras/tratamento farmacológico , Tioguanina/uso terapêutico , Adolescente , Antimetabólitos Antineoplásicos/administração & dosagem , Antimetabólitos Antineoplásicos/efeitos adversos , Criança , Pré-Escolar , Substituição de Medicamentos , Humanos , Lactente , Mercaptopurina/uso terapêutico , Metástase Neoplásica , Leucemia-Linfoma Linfoblástico de Células Precursoras/patologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Recidiva , Projetos de Pesquisa , Tioguanina/administração & dosagem , Tioguanina/efeitos adversos
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