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2.
BMJ ; 367: l5205, 2019 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-31578187

RESUMO

OBJECTIVES: To determine how clinicians vary in their response to new guidance on existing or new interventions, by measuring the timing and magnitude of change at healthcare institutions. DESIGN: Automated change detection in longitudinal prescribing data. SETTING: Prescribing data in English primary care. PARTICIPANTS: English general practices. MAIN OUTCOME MEASURES: In each practice the following were measured: the timing of the largest changes, steepness of the change slope (change in proportion per month), and magnitude of the change for two example time series (expiry of the Cerazette patent in 2012, leading to cheaper generic desogestrel alternatives becoming available; and a change in antibiotic prescribing guidelines after 2014, favouring nitrofurantoin over trimethoprim for uncomplicated urinary tract infection (UTI)). RESULTS: Substantial heterogeneity was found between institutions in both timing and steepness of change. The range of time delay before a change was implemented was large (interquartile range 2-14 months (median 8) for Cerazette, and 5-29 months (18) for UTI). Substantial heterogeneity was also seen in slope following a detected change (interquartile range 2-28% absolute reduction per month (median 9%) for Cerazette, and 1-8% (2%) for UTI). When changes were implemented, the magnitude of change showed substantially less heterogeneity (interquartile range 44-85% (median 66%) for Cerazette and 28-47% (38%) for UTI). CONCLUSIONS: Substantial variation was observed in the speed with which individual NHS general practices responded to warranted changes in clinical practice. Changes in prescribing behaviour were detected automatically and robustly. Detection of structural breaks using indicator saturation methods opens up new opportunities to improve patient care through audit and feedback by moving away from cross sectional analyses, and automatically identifying institutions that respond rapidly, or slowly, to warranted changes in clinical practice.


Assuntos
Prescrições de Medicamentos/estatística & dados numéricos , Padrões de Prática Médica/estatística & dados numéricos , Avaliação de Processos (Cuidados de Saúde)/métodos , Indicadores de Qualidade em Assistência à Saúde/estatística & dados numéricos , Medicina Estatal/estatística & dados numéricos , Anti-Infecciosos/uso terapêutico , Conjuntos de Dados como Assunto , Substituição de Medicamentos/estatística & dados numéricos , Medicamentos Genéricos/uso terapêutico , Inglaterra , Medicina Geral/organização & administração , Medicina Geral/normas , Medicina Geral/estatística & dados numéricos , Humanos , Guias de Prática Clínica como Assunto , Padrões de Prática Médica/normas , Avaliação de Processos (Cuidados de Saúde)/estatística & dados numéricos , Medicina Estatal/normas , Fatores de Tempo , Infecções Urinárias/tratamento farmacológico
3.
Medicine (Baltimore) ; 98(42): e17588, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31626129

RESUMO

In 2014/2015, tyrosine kinase inhibitors (TKIs) were introduced as a secondary treatment for refractory differentiated thyroid cancer (DTC) in Japan. While renal dysfunction is an adverse event of TKI, data on this adverse event in TKI-treated DTC remains insufficient. Here, we investigated renal function in patients undergoing TKI treatment for DTC and evaluated the efficacy of dose reduction/withdrawal for cases of renal dysfunction.A total of 73 cases of radioactive iodine-refractory DTC treated with sorafenib (n = 22) or lenvatinib (n = 51) were included. Patient data evaluated were TKI treatment period, estimated glomerular filtration rate (eGFR) before and after TKI therapy, incidence and degree (maximum value at time of TKI treatment) of proteinuria, and albumin levels before and after TKI therapy were compared.The mean ΔeGFR was -6.75% with lenvatinib and +5.90% with sorafenib. It was not significant (P = .15). The mean Δalbumin was -8.90% and -5.85% with lenvatinib and sorafenib, respectively; there was no significant difference between the lenvatinib and sorafenib groups (P = .77). According to our program of TKI dose reduction and withdrawal, all patients except 2 with diabetes were successfully continuing treatment.Overall, the present results demonstrated that renal function is negatively affected by long-term TKI treatment for RAI-refractory DTC. However, heightened proteinuria, decreased eGFR and albumin levels, and significant but apparently reversible renal dysfunction were more frequent with lenvatinib than sorafenib.


Assuntos
Taxa de Filtração Glomerular/fisiologia , Radioisótopos do Iodo/uso terapêutico , Nefropatias/etiologia , Compostos de Fenilureia/uso terapêutico , Proteínas Tirosina Quinases/antagonistas & inibidores , Quinolinas/uso terapêutico , Sorafenibe/uso terapêutico , Neoplasias da Glândula Tireoide/terapia , Idoso , Substituição de Medicamentos , Feminino , Seguimentos , Humanos , Nefropatias/fisiopatologia , Masculino , Pessoa de Meia-Idade , Inibidores de Proteínas Quinases/uso terapêutico , Tolerância a Radiação , Estudos Retrospectivos , Neoplasias da Glândula Tireoide/complicações , Neoplasias da Glândula Tireoide/diagnóstico , Tomografia Computadorizada por Raios X , Resultado do Tratamento
4.
Arerugi ; 68(7): 869-873, 2019.
Artigo em Japonês | MEDLINE | ID: mdl-31406083

RESUMO

The two biologic therapies, anti-IgE (omalizumab) and anti-IL-5 antibodies (mepolizumab), are used in the treatment of severe pediatric asthma. We present here a case study of a 13-year-old girl with severe asthma who switched from omalizumab to mepolizumab therapy and achieved good control over her asthma. The patient was diagnosed with asthma at one year of age and presented with poor disease control, even while taking high doses of inhaled corticosteroids (ICS). As such, she was considered to have severe persistent asthma. At 10 years old, she began omalizumab therapy which improved asthma control. However, after two years of this therapy, she manifested frequent acute exacerbations. At 12 years old, she switched to mepolizumab and has since maintained good control of asthma. Additionally, total serum IgE levels and peripheral eosinophil counts decreased. As the underlying mechanisms of omalizumab and mepolizumab therapy are distinct, it is recommended to use either one if the other proves ineffective.


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Asma/tratamento farmacológico , Produtos Biológicos/uso terapêutico , Substituição de Medicamentos , Omalizumab/uso terapêutico , Adolescente , Corticosteroides , Criança , Feminino , Humanos
5.
Medicine (Baltimore) ; 98(32): e16646, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31393363

RESUMO

To examine whether the Medicare Part D program had an impact on the generic drug prescription rate among residents in long-term care facilities.We analyzed prescription data for 3 drug classes (atypical antipsychotic, proton pump inhibitor, and statin) obtained from a regional online pharmacy serving long-term care centers in Pennsylvania from January 2004 to December 2007.Difference-in-difference is used as a primary analysis method, and different regression methods (probit and multinomial) are used to accommodate different types of outcome measures.Contrary to expectations, the Part D program did not have a statistically significant impact on the generic prescription rate in the long-term care setting during the study period. Only the statin class showed a dramatic increase in generic drug prescriptions, mainly due to the loss of patent protection for one of the most popular brand-name drugs in the class.The complex dynamics of the prescription drug market, particularly the availability of generic versions of popular prescription medications, had a bigger role in increasing the prescription rate of generic drugs than the Part D program. This warrants the need to relax prescription medicines' patent policies and for further study on the impact of such policies.


Assuntos
Prescrições de Medicamentos/estatística & dados numéricos , Medicamentos Genéricos , Seguro de Serviços Farmacêuticos/estatística & dados numéricos , Medicare Part D/estatística & dados numéricos , Padrões de Prática Médica/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Antipsicóticos , Estudos de Casos e Controles , Prescrições de Medicamentos/classificação , Substituição de Medicamentos , Revisão de Uso de Medicamentos , Feminino , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases , Assistência de Longa Duração/estatística & dados numéricos , Masculino , Inibidores da Bomba de Prótons , Estados Unidos
6.
Vasc Endovascular Surg ; 53(7): 602-605, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31272299

RESUMO

INTRODUCTION: Carotid angioplasty and stenting (CAS) represents an effective procedure for treating carotid artery disease. The acute in-stent thrombosis is an extremely rare complication of CAS especially when it occurs postprocedurally during the first 24 hours. Improper antiplatelet therapy or poor response to antiplatelet medications is known to be associated with a higher risk of in-stent thrombosis during early postprocedural period following a successful intervention. MATERIAL AND METHODS: A patient who experienced acute carotid in-stent thrombosis in early postprocedural period is described. He had been taking dual antiplatelet therapy for 2 weeks before undergoing a successful CAS. Moreover, pharmacogenetics studies showed the patient to be a clopidogrel ultrarapid metabolizer, which theoretically confers hyperresponsivity to medication. Alongside the report itself, a brief literature review of relevant sources pertinent to the case has been conducted. RESULTS: According to the available literature, this is the first case report describing an ultrarapid clopidogrel metabolizer who underwent an uneventful CAS but experienced acute carotid in-stent thrombosis in early postprocedural period. A rescue procedure included an endovascular intervention consisting of thrombectomy and local alteplase application, followed by postprocedural administration of intravenous eptifibatide. At discharge, patient's dual antiplatelet therapy included ticagrelor instead of clopidogrel. CONCLUSION: Acute carotid in-stent thrombosis is a highly unexpected complication of CAS and can occur despite ultrarapid clopidogrel metabolism trait.


Assuntos
Angioplastia com Balão/instrumentação , Estenose das Carótidas/terapia , Clopidogrel/metabolismo , Citocromo P-450 CYP2C19/metabolismo , Inibidores da Agregação de Plaquetas/metabolismo , Stents , Trombose/etiologia , Doença Aguda , Administração Intravenosa , Angiografia Digital , Angioplastia com Balão/efeitos adversos , Estenose das Carótidas/diagnóstico por imagem , Estenose das Carótidas/fisiopatologia , Clopidogrel/administração & dosagem , Angiografia por Tomografia Computadorizada , Citocromo P-450 CYP2C19/genética , Substituição de Medicamentos , Eptifibatida/administração & dosagem , Genótipo , Humanos , Masculino , Pessoa de Meia-Idade , Variantes Farmacogenômicos , Fenótipo , Inibidores da Agregação de Plaquetas/administração & dosagem , Fatores de Risco , Trombectomia , Trombose/diagnóstico por imagem , Trombose/terapia , Ticagrelor/administração & dosagem , Resultado do Tratamento
7.
Int J Clin Pharmacol Ther ; 57(9): 474-477, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31232277

RESUMO

OBJECTIVES: Dipeptidyl peptidase-4 inhibitors (DPP-4Is) can be classified into three categories according to their binding subsites. We wished to clarify the efficacy of switching between DPP-4Is according to their binding subsites. MATERIALS AND METHODS: We undertook a retrospective study of the medical records of patients who switched from one DPP-4I to another. RESULTS: Among 62 patients eligible for study inclusion, the mean change in the glycated hemoglobin (HbA1c) level between different categories of DPP-4I was -0.35 (95% CI, -0.12 to -0.58; n = 59). The mean change in the HbA1c level between each class of DPP-4I was calculated. From class 3 to class 2 it was -0.45 (n = 25); from class 3 to class 1 it was -0.36 (n = 17); from class 1 to class 2 it was -0.24 (n = 7); from class 1 to class 3 it was 0.33 (n = 4); from class 2 to class 1 it was -0.30 (n = 5); from class 2 to class 3 it was -1.30 (n = 1). CONCLUSIONS: When switching DPP-4Is because of insufficient efficacy, consideration of their DPP-4 binding site may be beneficial.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Inibidores da Dipeptidil Peptidase IV/uso terapêutico , Substituição de Medicamentos , Hipoglicemiantes/uso terapêutico , Humanos , Estudos Retrospectivos , Resultado do Tratamento
9.
J Stroke Cerebrovasc Dis ; 28(7): 1886-1890, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31078387

RESUMO

OBJECTIVE: To summarize the characteristics of and therapeutic options for cancer patients whose treatments may be vasotoxic and cause intracranial arterial stenotic disease and stroke. METHODS: We describe 3 patients with symptomatic cerebrovascular pathology that were being actively treated for cancer. RESULTS: Two of the patients were being treated with tyrosine kinase inhibitors (TKIs); and the third was being treated with 2 monoclonal antibodies, one of which was targeting an endothelial growth factor. These agents have been associated with vascular adverse events. Surgical revascularization was done in the first 2 patients, as they were suffering from cerebral ischemia. The third patient had suffered a significant brain hemorrhage, and therapeutic options were limited. In the first 2 patients, treatments also included antiplatelet agents and stopping/changing the TKI. In one of these patients we demonstrated regression of arterial stenosis after changing the TKI. CONCLUSIONS: Possibilities for treatment in this population, beyond the usual medical and surgical administrations, may include stopping or changing cancer drugs that may be related to the development of arterial pathology. Collaboration with oncologists is essential in this subset of patients. While aware of the potential for vascular toxicity, oncologists are often not fully appreciative of the fact that their therapeutic agents can cause stroke.


Assuntos
Anticorpos Monoclonais/efeitos adversos , Antineoplásicos Imunológicos/efeitos adversos , Arteriopatias Oclusivas/terapia , Doenças Arteriais Cerebrais/terapia , Artérias Cerebrais/cirurgia , Revascularização Cerebral/métodos , Inibidores de Proteínas Quinases/efeitos adversos , Idoso de 80 Anos ou mais , Arteriopatias Oclusivas/induzido quimicamente , Arteriopatias Oclusivas/diagnóstico por imagem , Arteriopatias Oclusivas/fisiopatologia , Angiografia Cerebral/métodos , Doenças Arteriais Cerebrais/induzido quimicamente , Doenças Arteriais Cerebrais/diagnóstico por imagem , Doenças Arteriais Cerebrais/fisiopatologia , Artérias Cerebrais/diagnóstico por imagem , Artérias Cerebrais/efeitos dos fármacos , Artérias Cerebrais/fisiopatologia , Circulação Cerebrovascular , Angiografia por Tomografia Computadorizada , Tratamento Conservador , Constrição Patológica , Substituição de Medicamentos , Evolução Fatal , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Imagem de Perfusão/métodos , Inibidores da Agregação de Plaquetas/uso terapêutico , Resultado do Tratamento , Grau de Desobstrução Vascular
10.
Graefes Arch Clin Exp Ophthalmol ; 257(8): 1671-1677, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31144055

RESUMO

PURPOSE: To assess the morphological and functional outcome and stability of the "treat and extend" protocol using aflibercept compared to ranibizumab for the treatment of eyes with neovascular age-related macular degeneration. PATIENTS AND METHODS: This retrospective study included 100 eyes of 94 patients with primary onset neovascular age-related macular degeneration followed up for 12 months. We studied two groups of eyes: group 1, 50 eyes treated with 0.5 mg/0.05 mL ranibizumab and group 2, 50 eyes treated with 2.0 mg/0.05 mL aflibercept. During the first year, all eyes received 3 aflibercept or ranibizumab injections monthly as upload phase. Then, eyes were treated with a treat and extend algorithm. Main outcome measures included: best corrected visual acuity (BCVA), central macular thickness (CMT), and the number of injections. In addition, we compared recurrence rates between the two groups. RESULTS: BCVA (log MAR) in group 1 vs group 2 was 0.54 ± 0.31 vs 0.49 ± 0.30 (p = 0.38) before treatment and 0.49 ± 0.33 vs 0.47 ± 0.32 (p = 0.85) after treatment. The visual improvement (decimal) was 0.05 ± 0.13 vs 0.04 ± 0.12 (p = 0.91). CMT in group 1 vs group 2 was 375.6 ± 98.3 µm vs 369.6 ± 103.7 µm (p = 0.73) before treatment and 306.3 ± 71.8 µm vs 294.8 ± 96 µm (p = 0.54) after treatment. The decrease in CMT was 69.3 ± 93 µm vs 74.8 ± 96 µm (p = 0.77). The number of injections/eye after upload phase in group 1 vs group 2 was 5.88 ± 1.4 vs 6.16 ± 1.3 (p = 0.25). Finally, major recurrence rates were statistically significantly different between the two groups (2% vs 6%, p = 0.04). CONCLUSIONS: Significant differences regarding BCVA, central macular thickness, and the number of injections were not found between aflibercept and ranibizumab during the first year following the treat and extend protocol. However, the significantly higher major recurrence rates in the aflibercept group after extending the treatment interval to 10 weeks might suggest that aflibercept should better not to be used in longer than 8 weeks intervals during the first year of treatment.


Assuntos
Macula Lutea/patologia , Ranibizumab/administração & dosagem , Receptores de Fatores de Crescimento do Endotélio Vascular/administração & dosagem , Proteínas Recombinantes de Fusão/administração & dosagem , Acuidade Visual , Degeneração Macular Exsudativa/tratamento farmacológico , Idoso , Inibidores da Angiogênese/administração & dosagem , Substituição de Medicamentos , Feminino , Angiofluoresceinografia/métodos , Seguimentos , Fundo de Olho , Humanos , Injeções Intravítreas , Masculino , Receptores de Fatores de Crescimento do Endotélio Vascular/antagonistas & inibidores , Estudos Retrospectivos , Tomografia de Coerência Óptica/métodos , Resultado do Tratamento , Degeneração Macular Exsudativa/diagnóstico
11.
Am Soc Clin Oncol Educ Book ; 39: 24-35, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31099619

RESUMO

Use of opioids for the treatment of pain is necessary for the majority of patients with advanced cancer, however its use has become challenging in the face of the opioid epidemic and the emerging evidence that patients with cancer are also at risk for nonmedical opioid use. This article proposes an assessment and treatment plan that incorporates universal screening with monitoring for all patients with cancer who are considered for opioid treatment to assess their risk for opioid misuse and harm. Timely identification with appropriate management, including referral of at-risk patients, will allow oncology professionals to optimize the risk-to-benefit and support the safe use of opioids for patients with cancer.


Assuntos
Analgésicos Opioides/uso terapêutico , Dor do Câncer/epidemiologia , Dor do Câncer/etiologia , Neoplasias/complicações , Neoplasias/epidemiologia , Manejo da Dor , Analgésicos Opioides/administração & dosagem , Analgésicos Opioides/efeitos adversos , Dor do Câncer/diagnóstico , Cognição , Comorbidade , Gerenciamento Clínico , Prescrições de Medicamentos , Substituição de Medicamentos , Humanos , Estadiamento de Neoplasias , Neoplasias/patologia , Transtornos Relacionados ao Uso de Opioides/diagnóstico , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Transtornos Relacionados ao Uso de Opioides/etiologia , Manejo da Dor/métodos , Manejo da Dor/estatística & dados numéricos , Medição da Dor , Fatores de Risco , Síndrome
12.
Braz J Infect Dis ; 23(2): 86-94, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31078574

RESUMO

BACKGROUND: Early antibiotic switch and early discharge protocols have not been widely studied in Latin America. Our objective was to describe real-world treatment patterns, resource use, and estimate opportunities for early switch from intravenous to oral antibiotics and early discharge for patients hospitalized with methicillin-resistant Staphylococcus aureus complicated skin and soft-tissue infections. MATERIALS/METHODS: This retrospective medical chart review recruited 72 physicians from Brazil to collect data from patients hospitalized with documented methicillin-resistant Staphylococcus aureus complicated skin and soft tissue infections between May 2013 and May 2015, and discharged alive by June 2015. Data collected included clinical characteristics and outcomes, hospital length of stay, methicillin-resistant Staphylococcus aureus-targeted intravenous and oral antibiotic use, and early switch and early discharge eligibility using literature-based and expert-validated criteria. RESULTS: A total of 199 patient charts were reviewed, of which 196 (98.5%) were prescribed methicillin-resistant Staphylococcus aureus -active therapy. Only four patients were switched from intravenous to oral antibiotics while hospitalized. The mean length of methicillin-resistant Staphylococcus aureus-active treatment was 14.7 (standard deviation, 10.1) days, with 14.6 (standard deviation, 10.1) total days of intravenous therapy. The mean length of hospital stay was 22.2 (standard deviation, 23.0) days. The most frequent initial methicillin-resistant Staphylococcus aureus-active therapies were intravenous vancomycin (58.2%), intravenous clindamycin (19.9%), and intravenous daptomycin (6.6%). Thirty-one patients (15.6%) were discharged with methicillin-resistant Staphylococcus aureus -active antibiotics of which 80.6% received oral antibiotics. Sixty-two patients (31.2%) met early switch criteria and potentially could have discontinued intravenous therapy 6.8 (standard deviation, 7.8) days sooner, and 65 patients (32.7%) met early discharge criteria and potentially could have been discharged 5.3 (standard deviation, 7.0) days sooner. CONCLUSIONS: Only 2% of patients were switched from intravenous to oral antibiotics in our study while almost one-third were early switch eligible. Additionally, one-third of hospitalized patients with methicillin-resistant Staphylococcus aureus complicated skin and soft tissue infections were early discharge eligible indicating opportunity for reducing intravenous therapy and days of hospital stay. These results provide insight into possible benefits of implementation of early switch/early discharge protocols in Brazil.


Assuntos
Antibacterianos/administração & dosagem , Substituição de Medicamentos/estatística & dados numéricos , Staphylococcus aureus Resistente à Meticilina , Alta do Paciente/estatística & dados numéricos , Infecções dos Tecidos Moles/tratamento farmacológico , Infecções Estafilocócicas/tratamento farmacológico , Infecções Cutâneas Estafilocócicas/tratamento farmacológico , Administração Intravenosa , Administração Oral , Brasil , Feminino , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Tempo
13.
Rev Med Chil ; 147(2): 153-160, 2019 Feb.
Artigo em Espanhol | MEDLINE | ID: mdl-31095162

RESUMO

BACKGROUND: Physical activity may improve quality of life in patients with chronic kidney disease. AIM: To assess the relationship between physical activity and quality of life in patients with Chronic Kidney Disease. MATERIAL AND METHODS: The Kidney Disease Quality of Life-36 (KDQOL-36) and the International Physical Activity questionnaire were answered by 130 patients with chronic kidney disease (74 women, 80 receiving renal substitution therapy). Sociodemographic variables were recorded. RESULTS: Patients on renal substitution therapy with a time lapse since diagnosis of 0 to 6 months had higher levels of physical activity than those with longer time lapses (51.4 ± 12.5 and 34.6 ± 8.1 minutes respectively). Disease burden scores were lower among patients with renal substitution therapy. There was a direct correlation between levels of vigorous and moderate physical activity and the physical functioning dimension in the quality of life questionnaire for patients with more than 19 months of disease. The dimension general physical health was significantly associated with physical activity in women and patients with 7 to 18 months of diagnosis. The dimension disease burden was associated with physical activity in women, patients not receiving substitution therapy and those with 7 to 18 months of diagnosis. CONCLUSIONS: Moderate and vigorous physical activity is directly related to the dimensions physical functioning, the general perception of physical health and inversely related with the dimension burden of disease.


Assuntos
Exercício/psicologia , Qualidade de Vida/psicologia , Insuficiência Renal Crônica/psicologia , Adulto , Estudos Transversais , Diagnóstico Tardio/estatística & dados numéricos , Substituição de Medicamentos/estatística & dados numéricos , Exercício/fisiologia , Feminino , Humanos , Masculino , Insuficiência Renal Crônica/terapia , Distribuição por Sexo , Fatores Socioeconômicos , Inquéritos e Questionários
14.
Postgrad Med ; 131(5): 335-341, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31081414

RESUMO

Non-medical switching of medication, whereby a patient's treatment regimen is changed for reasons other than efficacy, side effects, or adherence, is often related to drug formulary changes aimed at reducing drug costs. In the era of health care reform, while cost-cutting measures are important, there is considerable evidence that non-medical switching, particularly when applied to medication used to treat chronic conditions such as diabetes, may impact patient outcomes, medication-taking behavior, and use of health care services. Ultimately, overall costs may be increased, as savings by insurers are cancelled out by higher costs to the health care system as a whole, such as extra administration, treatment failure from new medicines, and increased adverse events. The emergence of biosimilar and follow-on biologic treatments raises further questions among patients receiving biologic treatments, with patient advocacy groups calling for clear legislation to ensure that patients with complex or chronic conditions continue to receive effective, evidence-based medications for their disease. This article will discuss non-medical switching in the US, taking into account the different parties involved, such as patients, health care providers, pharmacists, payers, and pharmacy benefit managers, with the aim of providing a detailed overview of this complex and evolving topic.


Assuntos
Substituição de Medicamentos/estatística & dados numéricos , Medicamentos Genéricos/uso terapêutico , Custos de Cuidados de Saúde/estatística & dados numéricos , Conduta do Tratamento Medicamentoso/organização & administração , Medicamentos sob Prescrição/uso terapêutico , Substituição de Medicamentos/economia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/economia , Medicamentos Genéricos/economia , Humanos , Seguro de Serviços Farmacêuticos/estatística & dados numéricos , Conduta do Tratamento Medicamentoso/economia , Medicamentos sob Prescrição/economia , Estados Unidos
16.
Int J Clin Pharmacol Ther ; 57(6): 323-328, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30990409

RESUMO

AIMS: Biosimilars are becoming more and more important for the treatment of many diseases. However, it is not understood how they are tolerated. Our aim was to analyze the behavior of switching from two anti-TNF biosimilars back to biologic reference products in German patients. MATERIALS AND METHODS: Patients switching from etanercept reference to an etanercept biosimilar between February 2016 and December 2017 and those switching from the infliximab reference product to an infliximab biosimilar between February 2015 and December 2017 were included in the study (index date). The main outcome of this study, the rate of switching from these two biosimilars back to reference products, was analyzed using Kaplan-Meier curves. A multivariate Cox regression model was used to predict the switch-back behavior. RESULTS: A total of 2,956 patients were included in this study. After 3 months, 14.7% and, after 12 months, 30.2% of them were switched back from a biosimilar to the reference product. Sex, age, physician specialty, and co-therapy were not significantly associated with this switch. CONCLUSION: Almost one third of the patients treated with one of two biosimilar drugs after previous biologic therapy are switched back to reference products in Germany.


Assuntos
Medicamentos Biossimilares/farmacocinética , Substituição de Medicamentos/estatística & dados numéricos , Etanercepte/farmacocinética , Infliximab/farmacocinética , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Alemanha , Humanos
17.
Scand J Rheumatol ; 48(4): 266-270, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31012365

RESUMO

Objectives: Inadequate response to adalimumab can be caused by insufficient blockade of the target tumour necrosis factor (TNF) at low serum concentrations. In such cases, patients may respond to another TNF inhibitor. We investigated whether the serum adalimumab concentration is related to the efficacy of a second TNF inhibitor, etanercept, in rheumatoid arthritis (RA). Methods: Patients with RA starting etanercept treatment were prospectively observed in the Reade Rheumatology Registry. In patients previously on adalimumab, serum concentrations were determined before treatment discontinuation. According to this concentration, three subgroups were formed: < 0.5 µg/mL, 0.5-5.0 µg/mL, and ≥ 5.0 µg/mL. The European League Against Rheumatism (EULAR) good/moderate response rate after 52 weeks of etanercept was compared between the switcher subgroups and biologic-naive patients. Results: In total, 449 consecutive patients were included, of whom 69 switched from adalimumab (15%) and 380 were biologic naive (85%). EULAR good or moderate response was achieved by 74% of the biologic-naive patients and by 72%, 50%, and 52% of switchers with adalimumab concentration < 0.5 µg/mL, 0.5-5.0 µg/mL, and ≥ 5.0 µg/mL, respectively (p = 0.15). Patients with an adalimumab concentration ≥ 0.5 µg/mL were significantly less likely to achieve EULAR good/moderate response on etanercept compared to biologic-naive patients, whereas patients with a concentration < 0.5 µg/mL did not significantly differ from patients starting etanercept without prior biologic treatment. Conclusion: RA patients with an inadequate response to adalimumab, in the presence of sufficient drug concentrations, benefit less from switching to another TNF inhibitor, etanercept.


Assuntos
Adalimumab , Artrite Reumatoide , Substituição de Medicamentos/métodos , Etanercepte , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Adalimumab/administração & dosagem , Adalimumab/efeitos adversos , Adalimumab/sangue , Adulto , Antirreumáticos/administração & dosagem , Antirreumáticos/efeitos adversos , Antirreumáticos/sangue , Artrite Reumatoide/sangue , Artrite Reumatoide/tratamento farmacológico , Artrite Reumatoide/epidemiologia , Monitoramento de Medicamentos/métodos , Etanercepte/administração & dosagem , Etanercepte/efeitos adversos , Etanercepte/sangue , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Países Baixos/epidemiologia , Seleção de Pacientes , Sistema de Registros/estatística & dados numéricos , Resultado do Tratamento
18.
Int J STD AIDS ; 30(7): 710-714, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30961466

RESUMO

Organ transplantation among people living with human immunodeficiency virus (PLHIV) is increasing. Guidelines recommend any changes in antiretroviral therapy (ART) prior to transplantation, but there are limited data regarding ART changes post transplantation. We report a case where an ART switch from a protease inhibitor-based regimen to dolutegravir plus emtricitabine/tenofovir alafenamide in a renal transplant recipient led to subtherapeutic tacrolimus concentrations and an increased serum creatinine (SCr). A workup for graft rejection was performed (including kidney biopsy and cytomegalovirus and BK virus polymerase chain reaction) following the rise in SCr, which was higher than expected from dolutegravir initiation (via organ cation transporter 2 inhibition). This case highlights the potential challenges of switching ART regimens in PLHIV post transplantation.


Assuntos
Fármacos Anti-HIV/efeitos adversos , Antirretrovirais/efeitos adversos , Interações de Medicamentos , Substituição de Medicamentos , Infecções por HIV/tratamento farmacológico , Fármacos Anti-HIV/uso terapêutico , Antirretrovirais/administração & dosagem , Antirretrovirais/uso terapêutico , Creatinina/sangue , Compostos Heterocíclicos com 3 Anéis , Humanos , Rim/patologia , Falência Renal Crônica/cirurgia , Transplante de Rim , Masculino , Pessoa de Meia-Idade , Ritonavir/uso terapêutico , Resultado do Tratamento
19.
Lancet ; 393(10182): 1699-1707, 2019 04 27.
Artigo em Inglês | MEDLINE | ID: mdl-30929895

RESUMO

BACKGROUND: The infliximab biosimilar CT-P13 was approved for use in Crohn's disease after clinical comparison with originator infliximab in ankylosing spondylitis and rheumatoid arthritis; however, concerns about such indication extrapolation have been expressed. This study investigated whether CT-P13 is non-inferior to infliximab in patients with Crohn's disease who were naive to biological therapy. METHODS: In this randomised, multicentre, double-blind, phase 3 non-inferiority study, we enrolled patients with active Crohn's disease who had not responded to, or were intolerant to, non-biological treatments. Patients were randomly assigned (1:1:1:1) to receive CT-P13 then CT-P13, CT-P13 then infliximab, infliximab then infliximab, or infliximab then CT-P13, with switching occurring at week 30. Patients received 5 mg/kg CT-P13 or infliximab at weeks 0, 2, 6, and then every 8 weeks up to week 54. The primary endpoint was the proportion of patients with a decrease of 70 points or more in Crohn's Disease Activity Index (CDAI) from baseline to week 6. A non-inferiority margin of -20% was set (CT-P13 was non-inferior to infliximab if the lower limit of the two-sided 95% CI for the treatment difference was greater than -20). This trial is registered with ClinicalTrials.gov, number NCT02096861, and is completed. FINDINGS: Between Aug 20, 2014, and Feb 15, 2017, 308 patients were assessed for eligibility, and 220 patients were enrolled: 111 were randomly assigned to initiate CT-P13 (56 to the CT-P13-CT-P13 group and 55 to the CT-P13-infliximab group) and 109 to initiate infliximab (54 to the infliximab-infliximab group and 55 to the infliximab-CT-P13 group). CDAI-70 response rates at week 6 were similar for CT-P13 (77 [69·4%, 95% CI 59·9 to 77·8] of 111) and infliximab (81 [74·3%, 95% CI 65·1 to 82·2] of 109; difference -4·9% [95% CI -16·9 to 7·3]), thereby establishing non-inferiority. Over the total study period, 147 (67%) patients experienced at least one treatment-emergent adverse event (36 [64%] in the CT-P13-CT-P13 group, 34 [62%] in the CT-P13-infliximab group, 37 [69%] in the infliximab-infliximab group, and 40 [73%] in the infliximab-CT-P13 group). INTERPRETATION: This study showed non-inferiority of CT-P13 to infliximab in patients with active Crohn's disease. Biosimilar CT-P13 could be a new option for the treatment of active Crohn's disease. FUNDING: Celltrion, Pfizer.


Assuntos
Anticorpos Monoclonais/uso terapêutico , Medicamentos Biossimilares/uso terapêutico , Doença de Crohn/tratamento farmacológico , Fármacos Gastrointestinais/uso terapêutico , Infliximab/uso terapêutico , Adulto , Anticorpos Monoclonais/efeitos adversos , Medicamentos Biossimilares/efeitos adversos , Método Duplo-Cego , Substituição de Medicamentos , Feminino , Fármacos Gastrointestinais/efeitos adversos , Humanos , Infliximab/efeitos adversos , Masculino , Pessoa de Meia-Idade , Índice de Gravidade de Doença , Resultado do Tratamento , Adulto Jovem
20.
Korean J Ophthalmol ; 33(2): 122-130, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30977321

RESUMO

PURPOSE: To evaluate the efficacy of switching to aflibercept in diabetic macular edema (DME) with suboptimal response to previous anti-vascular endothelial growth factor (anti-VEGF) injections. METHODS: A prospective interventional case series study recruited patients from a single center diagnosed with DME with suboptimal response to anti-VEGF injections. Three consecutive monthly injections of aflibercept were performed. The primary outcome measure was mean change in visual acuity after switching to aflibercept. RESULTS: Forty-two patients (42 eyes) were included. Baseline logarithm of the minimum angle of resolution (logMAR) visual acuity was 0.87 ± 0.23 and improved significantly to 0.62 ± 0.29, 0.56 ± 0.34, and 0.46 ± 0.35 at 1, 2, and 3 months, respectively, after the first injection. Mean baseline retinal thickness was 451.57 ± 107.09 µm and decreased significantly at 1, 2, and 3 months after switching to aflibercept (346.52 ± 79.03, 328.24 ± 81.98, and 313.71 ± 85.79 µm, respectively). Both visual improvement and mean change in retinal thickness were significant in patients with pre-aflibercept best-corrected visual acuity less than 1.0 logMAR but were not significant in patients with best-corrected visual acuity more than 1.0 logMAR. CONCLUSIONS: Switching to aflibercept in DME patients with an unsatisfactory response to previous anti-VEGF injections provided acceptable short-term visual and retinal architectural improvement.


Assuntos
Bevacizumab/administração & dosagem , Substituição de Medicamentos/métodos , Edema Macular/tratamento farmacológico , Receptores de Fatores de Crescimento do Endotélio Vascular/administração & dosagem , Proteínas Recombinantes de Fusão/administração & dosagem , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidores , Acuidade Visual , Inibidores da Angiogênese/administração & dosagem , Relação Dose-Resposta a Droga , Feminino , Seguimentos , Humanos , Injeções Intravítreas , Macula Lutea/diagnóstico por imagem , Edema Macular/diagnóstico , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Tomografia de Coerência Óptica , Resultado do Tratamento
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