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1.
Drugs Today (Barc) ; 56(8): 505-514, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-33025946

RESUMO

Peficitinib hydrobromide is a small Janus kinase inhibitor (JAK1, JAK2, JAK3 and TYK2) molecule for the treatment of rheumatoid arthritis (RA). Phase II and phase III clinical trials and extension studies with different doses have been conducted to assess the drug's efficacy and safety with substantially improved outcomes observed in RA. This JAK inhibitor oral drug demonstrated clinical response as once-daily monotherapy in patients with moderate to severe RA, also in combination with methotrexate (MTX), who had an inadequate response to MTX. The findings from studies of this new JAK inhibitor have shown that, both in monotherapy as well as in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), it has efficacy, safety and tolerability in RA patients.


Assuntos
Adamantano/análogos & derivados , Artrite Reumatoide/tratamento farmacológico , Niacinamida/análogos & derivados , Adamantano/uso terapêutico , Ensaios Clínicos como Assunto , Humanos , Janus Quinases/antagonistas & inibidores , Niacinamida/uso terapêutico , Resultado do Tratamento
2.
Drugs Today (Barc) ; 56(8): 515-530, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-33025947

RESUMO

There is a need for new and effective topical treatment options for psoriasis. Recent phase I and II clinical trials have demonstrated efficacy of the novel nonsteroidal drug tapinarof to treat mild to moderate plaque psoriasis. Tapinarof is an aryl hydrocarbon receptor (AHR) agonist that induces antioxidant, immunomodulatory and epidermal differentiation regulation pathways. In this review, we examine the current preclinical and clinical studies with a focus on the mechanism of action, pharmacokinetics, safety and efficacy of tapinarof to treat psoriasis.


Assuntos
Psoríase/tratamento farmacológico , Resorcinóis/uso terapêutico , Estilbenos/uso terapêutico , Administração Tópica , Ensaios Clínicos como Assunto , Humanos , Receptores de Hidrocarboneto Arílico/agonistas
3.
Drugs Today (Barc) ; 56(8): 541-554, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-33025949

RESUMO

At the 56th Global Annual Meeting of the Drug Information Association (DIA), attendees met virtually during the height of the global COVID-19 pandemic for "rapid cross-stakeholder, cross-border collaboration" to support health worldwide. Sessions included presenters and speakers from regulatory, patient advocacy and academia sectors, with patients at the forefront of those discussions. This report covers various presentations and panel discussions from the 4-day meeting that focus on COVID-19, innovative trial designs spurred by a need to adapt amid a pandemic, digital health, novel products inspiring new regulatory standards, clinical trials, data collection and management, the need for more and better data and the ever-increasing importance of the patient perspective.


Assuntos
Infecções por Coronavirus , Pandemias , Pneumonia Viral , Betacoronavirus , Ensaios Clínicos como Assunto , Congressos como Assunto , Coleta de Dados , Gerenciamento de Dados , Humanos
4.
Drugs Today (Barc) ; 56(9): 561-571, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-33025950

RESUMO

Avapritinib is a tyrosine kinase inhibitor (TKI) that has recently received Food and Drug Administration (FDA) approval for the treatment of metastatic or unresectable gastrointestinal stromal tumors harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation. Mutations in the activation loop of PDGFRA or KIT confer resistance to conventional TKIs due to structural changes in the receptor. Avapritinib was developed to selectively target these mutations, thereby offering a new treatment option for patients in whom imatinib, sunitinib, and regorafenib have failed. This review covers the basic science and preclinical studies that guided avapritinib's development, in addition to the data currently available from early clinical studies as well as those later-stage trials that led to its approval.


Assuntos
Tumores do Estroma Gastrointestinal/tratamento farmacológico , Pirazóis/uso terapêutico , Pirróis/uso terapêutico , Triazinas/uso terapêutico , Ensaios Clínicos como Assunto , Tumores do Estroma Gastrointestinal/genética , Humanos , Mutação , Inibidores de Proteínas Quinases/uso terapêutico , Proteínas Proto-Oncogênicas c-kit/genética , Receptor alfa de Fator de Crescimento Derivado de Plaquetas/genética , Estados Unidos
5.
Drugs Today (Barc) ; 56(9): 583-598, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-33025952

RESUMO

Acute bacterial skin and skin structure infections (ABSSSIs) are one of the most common types of infections due to methicillin-resistant Staphylococcus aureus (MRSA). The standard of care for ABSSSI includes glycopeptides such as vancomycin, teicoplanin, oxazolidinones and fluoroquinolones, which are potent broad-spectrum antibacterial agents. Unfortunately, due to indiscriminate utilization, resistance to these agents is rising and identification of novel agents is an urgent unmet medical need. In this context, levonadifloxacin (WCK-771) is a novel, hydrate arginine salt of nadifloxacin with improved bactericidal activity against MRSA as well as fluoroquinolone-resistant S. aureus by targeting bacterial DNA supercoiling enzymes DNA gyrase and topoisomerase IV. Levonadifloxacin displays a broad-spectrum bactericidal activity against Gram-positive and Gram-negative bacteria, atypical bacteria, anaerobic bacteria and bioterror pathogens with a very low frequency of mutation. Levonadifloxacin also displays improved activity under low pH biofilm environments. The drug has successfully completed phase I, phase II and phase III clinical trials in India. The U.S. Food and Drug Administration (FDA) granted a Qualified Infectious Disease Product (QIDP) designation to levonadifloxacin for the treatment of MRSA infections in August 2014.


Assuntos
Antibacterianos/uso terapêutico , Quinolizinas/uso terapêutico , Quinolonas/uso terapêutico , Infecções Cutâneas Estafilocócicas/tratamento farmacológico , Ensaios Clínicos como Assunto , Humanos , Staphylococcus aureus Resistente à Meticilina/efeitos dos fármacos , Staphylococcus aureus/efeitos dos fármacos
6.
Drugs Today (Barc) ; 56(9): 599-608, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-33025953

RESUMO

Ripasudil (K-115) is a novel Rho-associated protein kinase (ROCK) inhibitor. The Rho-ROCK pathway regulates key downstream effectors involved in many cellular functions, in particular in the actin cytoskeleton activity. The clinical effects of ripasudil expected on the eye include an intraocular pressure-lowering effect and a wound-healing activity on corneal endothelial cells, but many other functions are currently under investigation. To date, ripasudil has been approved in Japan (2014) for the treatment of glaucoma and ocular hypertension, and several clinical trials are currently investigating its role in the treatment of Fuchs' corneal dystrophy. In this review, we will discuss its pharmacokinetics, pharmacodynamics and clinical efficacy, focusing also on its safety and tolerability profile.


Assuntos
Glaucoma/tratamento farmacológico , Isoquinolinas/uso terapêutico , Hipertensão Ocular/tratamento farmacológico , Sulfonamidas/uso terapêutico , Ensaios Clínicos como Assunto , Células Endoteliais , Humanos , Japão , Quinases Associadas a rho/antagonistas & inibidores
7.
Curr Atheroscler Rep ; 22(12): 72, 2020 10 03.
Artigo em Inglês | MEDLINE | ID: mdl-33009957

RESUMO

PURPOSE OF REVIEW: The review highlights selected studies related to cardiovascular disease (CVD) prevention that were presented at the 2020 European Society of Cardiology (ESC) Congress-The Digital Experience. RECENT FINDINGS: The studies reviewed include clinical trials on novel RNA interference-based lipid-lowering therapies AKCEA-APOCIII-LRx and vupanorsen (AKCEA-ANGPTL3-LRx); the EVAPORATE trial assessing the effects of icosapent ethyl on coronary plaque volume progression; the LoDoCo2 trial evaluating the efficacy of low-dose colchicine in cardiovascular disease risk reduction among patients with chronic coronary artery disease; as well as the EMPEROR-Reduced trial evaluating cardiovascular and renal outcomes with empagliflozin in patients with heart failure and reduced ejection fraction. In addition, we review the BPLTTC analysis on blood pressure treatment across blood pressure levels and CVD status and discuss findings from the BRACE CORONA study that examined continuing versus suspending angiotensin-converting enzyme inhibitor or angiotensin receptor blockers in patients on these antihypertensive medications who were hospitalized with COVID-19 infection. The studies presented at the 2020 digital ESC Congress highlight the continuing advancements in the field of CVD prevention.


Assuntos
Betacoronavirus/fisiologia , Cardiologia , Fármacos Cardiovasculares/farmacologia , Doenças Cardiovasculares , Infecções por Coronavirus , Reguladores do Metabolismo de Lipídeos/farmacologia , Pandemias , Pneumonia Viral , Compostos Benzidrílicos/farmacologia , Cardiologia/métodos , Cardiologia/tendências , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/prevenção & controle , Ensaios Clínicos como Assunto , Congressos como Assunto , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/terapia , Ácido Eicosapentaenoico/análogos & derivados , Ácido Eicosapentaenoico/farmacologia , Europa (Continente) , Glucosídeos/farmacologia , Humanos , Oligonucleotídeos/farmacologia , Pneumonia Viral/epidemiologia , Pneumonia Viral/terapia , Sociedades Médicas , Telecomunicações
8.
Dtsch Med Wochenschr ; 145(20): 1464-1468, 2020 10.
Artigo em Alemão | MEDLINE | ID: mdl-33022727

RESUMO

Vaccination practices in Germany are driven by scientific developments and a complex regulatory environment. Some important developments in 2019/20 are described here: Work-related vaccination recommendations for measles, rubella, and chickenpox have been streamlined and expanded. In addition, measles vaccination or documentation of immunity is now mandatory for employment at and attendance of many institutions, specifically including day care centers and schools. Owing to the shift of pneumococcal serotypes since the introduction of conjugate vaccines the US ACIP no longer recommends these for the routine administration to healthy persons of older age. Reduced series of 2 or even 1 dose of an HPV vaccine may be sufficient, however definitive RCT data are not yet available. After years of development and clinical studies the first vaccine against Ebolavirus disease has been licensed by EMA in November and by FDA in December 2019. More than 150 SARS-CoV-2 vaccine candidates are being developed with massive financial support, several phase 1/2 trials have started. A licensed vaccine may actually be available in 2021 and thus dramatically faster compared to any other modern vaccine development.


Assuntos
Vacinação em Massa , Vacinas , Adulto , Ensaios Clínicos como Assunto , Infecções por Coronavirus/prevenção & controle , Alemanha , Humanos , Esquemas de Imunização , Vacinas Virais
9.
Annu Int Conf IEEE Eng Med Biol Soc ; 2020: 3936-3939, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-33018861

RESUMO

Functional status of patients is an important concept in clinical trials. It subsumes functional capacity, which is traditionally estimated by exercise tests, and functional performance, which is often estimated by questionnaires. Objectively measured physical activity by means of wearables devices containing accelerometers (PA) have recently been proposed as a novel and advantageous way to estimate physical status including capacity and performance. There is nonetheless insufficient evidence of the association between PA and traditional ways to estimate functional status. In the ACTIVATE clinical trial, cycle ergometry tests were performed multiple times in all 267 patients, PA was measured for a week prior to each cycle ergometry test, and questionnaires were answered daily during the same week. Pearson's correlation tests and clustering analysis revealed that PA, physical activity experience as assessed by questionnaires, and exercise endurance time as measured by the cycle ergometry test, are largely independent. Therefore, all three approaches together might achieve a complete assessment of the functional status of patients in clinical trials, as they each independently correlate with health-related quality of life and important clinical outcomes such as hospitalizations but are weakly associated among themselves.


Assuntos
Terapia por Exercício , Exercício Físico , Qualidade de Vida , Ensaios Clínicos como Assunto , Ergometria , Teste de Esforço , Nível de Saúde , Humanos
12.
Bull World Health Organ ; 98(9): 588-589, 2020 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-33012858

RESUMO

Melanie Saville talks to Gary Humphreys about the specific challenges faced in developing and distributing SARS-CoV-2 vaccines and the need to fund end-to-end approaches to support those aims.


Assuntos
Infecções por Coronavirus/prevenção & controle , Desenvolvimento de Medicamentos , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Vacinas Virais , Betacoronavirus , Ensaios Clínicos como Assunto , Humanos
14.
J Am Coll Cardiol ; 76(15): 1777-1794, 2020 10 13.
Artigo em Inglês | MEDLINE | ID: mdl-33032740

RESUMO

Viral respiratory infections are risk factors for cardiovascular disease (CVD). Underlying CVD is also associated with an increased risk of complications following viral respiratory infections, including increased morbidity, mortality, and health care utilization. Globally, these phenomena are observed with seasonal influenza and with the current coronavirus disease 2019 (COVID-19) pandemic. Persons with CVD represent an important target population for respiratory virus vaccines, with capacity developed within 3 large ongoing influenza vaccine cardiovascular outcomes trials to determine the potential cardioprotective effects of influenza vaccines. In the context of COVID-19, these international trial networks may be uniquely positioned to redeploy infrastructure to study therapies for primary and secondary prevention of COVID-19. Here, we describe mechanistic links between influenza and COVID-19 infection and the risk of acute cardiovascular events, summarize the data to date on the potential cardioprotective effects of influenza vaccines, and describe the ongoing influenza vaccine cardiovascular outcomes trials, highlighting important lessons learned that are applicable to COVID-19.


Assuntos
Doenças Cardiovasculares , Infecções por Coronavirus , Vacinas contra Influenza/farmacologia , Influenza Humana , Pandemias , Pneumonia Viral , Betacoronavirus , Cardiotônicos/farmacologia , Doenças Cardiovasculares/mortalidade , Doenças Cardiovasculares/prevenção & controle , Ensaios Clínicos como Assunto , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Humanos , Influenza Humana/epidemiologia , Influenza Humana/prevenção & controle , Pandemias/prevenção & controle , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle , Saúde Pública , Fatores de Risco , Vacinação/métodos
18.
Zhonghua Yu Fang Yi Xue Za Zhi ; 54(9): 915-917, 2020 Sep 06.
Artigo em Chinês | MEDLINE | ID: mdl-32907278

RESUMO

Development of an effective vaccine requires a long and complicated process. Preclinical studies and phase Ⅰ, Ⅱ, Ⅲ clinical trials mainly focused on the assessment of the vaccine's safety (tolerability), immunogenicity and efficacy before license. After license, it is necessary to further evaluate the actual effectiveness and safety in the general population through phase Ⅳ clinical trials and optimize the immunization strategies with the disease's epidemiology data. In this special issue, published several articles, which reported the main results of pre-license clinical trials and post-marketing evaluation of various vaccines, it was extremely useful to support vaccine licensing and market use. We encourage the continuous clinical studies and post-marketing evaluation of vaccines, including the novel corona virus-19 vaccines, to provide technical support for the population use, under the situation of COVID-19 pandemic.


Assuntos
Ensaios Clínicos como Assunto/organização & administração , Imunização/métodos , Vacinas , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Humanos , Pandemias/prevenção & controle , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle , Vacinas Virais
19.
Zhonghua Yu Fang Yi Xue Za Zhi ; 54(9): 963-967, 2020 Sep 06.
Artigo em Chinês | MEDLINE | ID: mdl-32907286

RESUMO

Objective: To evaluate and share the novel method for recruiting participants in clinical trials of vaccines in emergency situations. Methods: To publish recruitment notice in local areas of Wuhan through websites and medium, and guide interested persons to log in to the"Clinical Trials of SARS-CoV-2 Vaccine Reservation and Health Declaration System"to appoint and register their health information. The "Health Declaration System" provides each volunteer evaluation and risk levels to preliminarily exclude those who do not meet the inclusion criteria. Researchers review the qualified volunteers by telephone, organize them to go to the vaccination site, and finally conduct a strict medical screening to determine the final subjects. Results: A total of 4 819 people and 5 132 people registered in the Phase Ⅰ and Phase Ⅱ recruitment system respectively, with men 2 912 (60.43%) and 2 887 (56.25%) more than women 1 907 (39.57%) and 2 245 (43.75%), mostly in the 20-39 age group, with 3 211 (66.63%) and 3 966 (77.28%). All 13 districts in Wuhan have interested residents to participate clinical research.The initial qualified rate of the Phase Ⅱ recruitment system was higher than that of Phase Ⅰ, with men 2 047 (70.28%) and 2 135(73.95%), higher than women 1 083 (56.80%) and 1 472 (65.57%); 440 and 689 people were reviewed by telephone in Phase Ⅰ and Phase Ⅱ respectively, and the number of verified volunteers was about 440 (35.00%) and 689 (67.20%); Of the 201 603 people who arrived at the vaccination site, 12 and 26 of them were positive for the SARS-CoV-2 antibody with an antibody positive rate of 6.00% and 4.31% respectively. Conclusion: The novel method for recruiting subjects in this clinical study is efficient and reliable, and the recruitment situation of Phase Ⅰ had set a good example for Phase Ⅱ but the medium-and long-term compliance of subjects and the separation of willingness and behaviors still need to be further studied.


Assuntos
Ensaios Clínicos como Assunto/organização & administração , Seleção de Pacientes , Vacinas Virais , Adulto , China/epidemiologia , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Emergências , Feminino , Humanos , Masculino , Pandemias/prevenção & controle , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle , Voluntários/estatística & dados numéricos , Adulto Jovem
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