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1.
Ann Vasc Surg ; 103: 9-13, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38159717

RESUMO

BACKGROUND: Together with clinical examination, surveillance duplex examination represents the Society of Vascular Surgery recommendations for follow-up after endovascular intervention on the superficial femoral artery (SFA) and popliteal arterial segments. Compliance with postprocedural follow-up remains challenging. To establish a postangioplasty physiologic baseline, our institution began obtaining immediate postprocedural surveillance studies following lower extremity arterial interventions. We reviewed the utility of immediate postprocedural surveillance to determine if these studies enhanced postoperative care. METHODS: Serial patients undergoing SFA and popliteal angioplasty and stenting from January 2014 to December 2020 were identified from our prospectively maintained Vascular Surgery database. Patient demographic information, procedural details, and procedural outcomes were subsequently analyzed from the electronic medical record. RESULTS: Two hundred and sixty-three patients underwent 385 SFA and/or popliteal angioplasty/stenting interventions. Mean patient age was 64.8 ± 10 years. Among these 385 procedures, 350 (90.9%) were followed by immediate (<4 hours) postprocedural lower extremity arterial duplex scans. These 350 procedures included percutaneous transluminal angioplasty and/or stenting of the SFA (n = 236), popliteal artery (n = 34), or both (n = 80). Of these studies, 25 results (7.1%) were abnormal. One asymptomatic patient was admitted to hospital for immediate thrombolysis; however, the remaining 24 patients were followed clinically with no immediate intervention required. Abnormal results included 13 abnormalities appreciated on the final angiogram with 9 patients with known occlusions or stenoses, and 4 patients with mild to moderate CFA stenosis. Abnormal findings not detected on the final angiogram included 7 patients with mild to moderate stenosis and 5 patients with short occlusions (1.4%). All 5 patients with short segmental occlusions not detected on final arteriogram had preprocedural anatomy classified as either TASC C (TransAtlantic Inter-Society Consensus: SFA occlusions > 15 cm in length, n = 1) or TASC D (SFA occlusions > 20 cm in lenth, n = 4). CONCLUSIONS: Immediate postprocedural duplex scans demonstrate significant vessel stenosis or occlusion in approximately 7% of cases but most stenoses and occlusions were noted on final arteriography. Duplex detected short segmental occlusions not noted on final arteriography were rare (1.4%), and occurred among patients with TASC C or TASC D occlusive disease. These duplex detected abnormalities rarely changed the patient's immediate plan of care. The performance of these immediate postprocedural duplex scans demonstrated limited clinical utility.


Assuntos
Angioplastia , Artéria Femoral , Extremidade Inferior , Artéria Poplítea , Stents , Idoso , Pessoa de Meia-Idade , Angiografia , Índice Tornozelo-Braço , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/cirurgia , Extremidade Inferior/irrigação sanguínea , Extremidade Inferior/cirurgia , Monitorização Fisiológica , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/cirurgia , Cuidados Pós-Operatórios , Humanos
2.
J Vasc Surg ; 78(6): 1559-1566.e5, 2023 12.
Artigo em Inglês | MEDLINE | ID: mdl-37201762

RESUMO

BACKGROUND: Thoracic endovascular aortic repair (TEVAR) involving the aortic arch may increase the opportunity for stroke owing to disruption of cerebral circulation and embolization. In this study, a systematic meta-analysis was performed to examine the impact of proximal landing zone location on stroke and 30-day mortality after TEVAR. METHODS: MEDLINE and Cochrane Library were searched for all original studies of TEVAR reporting outcomes of stroke or 30-day mortality for at least two adjacent proximal landing zones, based on the Ishimaru classification scheme. Forest plots were created using relative risks (RR) with 95% confidence intervals (CI). An I2 of <40% was regarded as minimal heterogeneity. A P value of <.05 was considered significant. RESULTS: Of the 57 studies examined, a total of 22,244 patients (male 73.1%, aged 71.9 ± 11.5 years) were included in the meta-analysis, with 1693 undergoing TEVAR with proximal landing zone 0, 1931 with zone 1, 5839 with zone 2, and 3089 with zone 3 and beyond. The overall risk of clinically evident stroke was 2.7% for zones ≥3, 6.6% for zone 2, 7.7% for zone 1, and 14.2% for zone 0. More proximal landing zones were associated with higher risks of stroke compared with distal (zone 2 vs ≥3: RR, 2.14; 95% CI, 1.43-3.20; P = .0002; I2 = 56%; zone 1 vs 2: RR, 1.48; 95% CI, 1.20-1.82; P = .0002; I2 = 0%; zone 0 vs 1: RR, 1.85; 95% CI, 1.52-2.24; P < .00001; I2 = 0%). Mortality at 30 days was 2.9% for zones ≥3, 2.4% for zone 2, 3.7% for zone 1, and 9.3% for zone 0. Zone 0 was associated with higher mortality compared with zone 1 (RR, 2.30; 95% CI, 1.75-3.03; P < .00001; I2 = 0%). No significant differences were found in 30-day mortality between zones 1 and 2 (P = .13) and between zone 2 and zones ≥3 (P = .87). CONCLUSIONS: The risk of stroke from TEVAR is lowest in zone 3 and beyond, increasing significantly as the landing zone is moved proximally. Furthermore, perioperative mortality is increased with zone 0 compared with zone 1. Therefore, risk of stent grafting in the proximal arch should be weighed against alternative surgical or nonoperative options. It is anticipated that the risk of stroke will improve with further development of stent graft technology and implantation technique.


Assuntos
Embolização Terapêutica , Acidente Vascular Cerebral , Humanos , Masculino , Correção Endovascular de Aneurisma , Circulação Cerebrovascular , Acidente Vascular Cerebral/etiologia
3.
Ann Vasc Surg ; 92: 172-177, 2023 May.
Artigo em Inglês | MEDLINE | ID: mdl-36572095

RESUMO

BACKGROUND: Post endovascular aneurysm repair (EVAR), surveillance with computed tomography-aortography (CTA) remains the most common practice, per Society for Vascular Surgery (SVS) guidelines. Chronic exposure to both radiation and intravenous (IV) contrast has raised concerns about long-term CTA follow-up (FU). As we have selectively used ultrasound (US) as a sole modality for post-EVAR surveillance, we sought to review our outcomes in this subset of patients. METHODS: Retrospective review of our institution's vascular database identified 213 EVAR patients from 2013 to 2021. Fenestrated-EVAR and snorkel reconstructions were excluded. Patient demographics/outcomes, abdominal aortic aneurysm (AAA) characteristics, and FU modalities and outcomes were analyzed. Unpaired Student's t-test, ANOVA, and chi-squared test were used to assess group differences. RESULTS: Eighty-five of the 213 EVAR patients (39.9%) were lost to FU within 3 months. Among the 128 remaining patients, 91 underwent FU using initial US, while 37 patients underwent post-EVAR FU initially using CTA. There were no significant differences (P > 0.05) between patient age (75.5 ± 9.4 vs. 75.3 ± 8.5), body mass index (BMI) (27.7 ± 5.4 vs. 28.9 ± 7.4), or mean AAA size (5.6 ± 1.1 vs. 5.9 ± 1.2) in US-surveilled and computed tomography (CT)-surveilled groups, respectively. Of the 91 patients, initially surveilled with US, 15 patients demonstrated endoleak and/or AAA growth (>5 mm). The 15 patients with US-demonstrated endoleak and/or growth underwent confirmatory CTA, with 3 patients eventually requiring EVAR revision. Among 37 patients initially surveilled with CT, 10 demonstrated significant growth and 2 patients eventually required EVAR revision. There were no patients with AAA rupture during post-EVAR surveillance. FU data were analyzed among a select lower-risk group of patients (preoperative AAA diameter ≤5.5 cm, BMI ≤30, and no endoleak at completion of EVAR). Among this group, there were no surveilled patients who required EVAR reintervention, regardless of surveillance modality (US n = 32; CT n = 4). The average FU was 29.5 ± 26.4 months in the US group and 26.4 ± 22.3 months in the CT group (P > 0.05). CONCLUSIONS: Although initial CT surveillance following EVAR remains ideal, in select lower-risk patients, US is a viable alternative even for the initial post-procedure study. Advantages include decreased radiation exposure and cost. Our data suggest that US is a safe sole modality for surveillance following EVAR in selective patients.


Assuntos
Aneurisma da Aorta Abdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Humanos , Correção Endovascular de Aneurisma , Implante de Prótese Vascular/efeitos adversos , Seguimentos , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/cirurgia , Aneurisma da Aorta Abdominal/etiologia , Procedimentos Endovasculares/efeitos adversos , Resultado do Tratamento , Aortografia/efeitos adversos , Aortografia/métodos , Endoleak/diagnóstico por imagem , Endoleak/etiologia , Endoleak/cirurgia , Fatores de Risco , Estudos Retrospectivos
4.
Am J Respir Crit Care Med ; 205(1): 17-35, 2022 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-34658302

RESUMO

The Global Initiative for Asthma (GINA) Strategy Report provides clinicians with an annually updated evidence-based strategy for asthma management and prevention, which can be adapted for local circumstances (e.g., medication availability). This article summarizes key recommendations from GINA 2021, and the evidence underpinning recent changes. GINA recommends that asthma in adults and adolescents should not be treated solely with short-acting ß2-agonist (SABA), because of the risks of SABA-only treatment and SABA overuse, and evidence for benefit of inhaled corticosteroids (ICS). Large trials show that as-needed combination ICS-formoterol reduces severe exacerbations by ⩾60% in mild asthma compared with SABA alone, with similar exacerbation, symptom, lung function, and inflammatory outcomes as daily ICS plus as-needed SABA. Key changes in GINA 2021 include division of the treatment figure for adults and adolescents into two tracks. Track 1 (preferred) has low-dose ICS-formoterol as the reliever at all steps: as needed only in Steps 1-2 (mild asthma), and with daily maintenance ICS-formoterol (maintenance-and-reliever therapy, "MART") in Steps 3-5. Track 2 (alternative) has as-needed SABA across all steps, plus regular ICS (Step 2) or ICS-long-acting ß2-agonist (Steps 3-5). For adults with moderate-to-severe asthma, GINA makes additional recommendations in Step 5 for add-on long-acting muscarinic antagonists and azithromycin, with add-on biologic therapies for severe asthma. For children 6-11 years, new treatment options are added at Steps 3-4. Across all age groups and levels of severity, regular personalized assessment, treatment of modifiable risk factors, self-management education, skills training, appropriate medication adjustment, and review remain essential to optimize asthma outcomes.


Assuntos
Asma/diagnóstico , Asma/terapia , Adolescente , Adulto , Antiasmáticos/uso terapêutico , Asma/etiologia , Criança , Pré-Escolar , Terapia Combinada , Progressão da Doença , Quimioterapia Combinada , Humanos , Lactente , Gravidade do Paciente , Guias de Prática Clínica como Assunto , Fatores de Risco , Autocuidado
5.
Pharmacol Res ; 182: 106281, 2022 08.
Artigo em Inglês | MEDLINE | ID: mdl-35661711

RESUMO

Homeostasis was initially conceptualized by Bernard and Cannon around a century ago as a steady state of physiological parameters that vary within a certain range, such as blood pH, body temperature, and heart rate [1,2]. The underlying mechanisms that maintain homeostasis are explained by negative feedbacks that are executed by the neuronal, endocrine, and immune systems. At the cellular level, homeostasis, such as that of redox and energy steady state, also exists and is regulated by various cell signaling pathways. The induction of homeostatic mechanism is critical for human to adapt to various disruptive insults (stressors); while on the other hand, adaptation occurs at the expense of other physiological processes and thus runs the risk of collateral damages, particularly under conditions of chronic stress. Conceivably, anti-stress protection can be achieved by stressor-mimicking medicinals that elicit adaptive responses prior to an insult and thereby serve as health risk countermeasures; and in situations where maladaptation may occur, downregulating medicinals could be used to suppress the responses and prevent subsequent pathogenesis. Both strategies are preemptive interventions particularly suited for individuals who carry certain lifestyle, environmental, or genetic risk factors. In this article, we will define and characterize a new modality of prophylactic intervention that forestalls diseases via modulating homeostatic signaling. Moreover, we will provide evidence from the literature that support this concept and distinguish it from other homeostasis-related interventions such as adaptogen, hormesis, and xenohormesis.


Assuntos
Hormese , Transdução de Sinais , Homeostase/fisiologia , Humanos , Oxirredução
6.
Respirology ; 27(1): 14-35, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34668278

RESUMO

The Global Initiative for Asthma (GINA) Strategy Report provides clinicians with an annually updated evidence-based strategy for asthma management and prevention, which can be adapted for local circumstances (e.g., medication availability). This article summarizes key recommendations from GINA 2021, and the evidence underpinning recent changes. GINA recommends that asthma in adults and adolescents should not be treated solely with short-acting ß2 -agonist (SABA), because of the risks of SABA-only treatment and SABA overuse, and evidence for benefit of inhaled corticosteroids (ICS). Large trials show that as-needed combination ICS-formoterol reduces severe exacerbations by ≥60% in mild asthma compared with SABA alone, with similar exacerbation, symptom, lung function, and inflammatory outcomes as daily ICS plus as-needed SABA. Key changes in GINA 2021 include division of the treatment figure for adults and adolescents into two tracks. Track 1 (preferred) has low-dose ICS-formoterol as the reliever at all steps: as needed only in Steps 1-2 (mild asthma), and with daily maintenance ICS-formoterol (maintenance-and-reliever therapy, "MART") in Steps 3-5. Track 2 (alternative) has as-needed SABA across all steps, plus regular ICS (Step 2) or ICS-long-acting ß2 -agonist (Steps 3-5). For adults with moderate-to-severe asthma, GINA makes additional recommendations in Step 5 for add-on long-acting muscarinic antagonists and azithromycin, with add-on biologic therapies for severe asthma. For children 6-11 years, new treatment options are added at Steps 3-4. Across all age groups and levels of severity, regular personalized assessment, treatment of modifiable risk factors, self-management education, skills training, appropriate medication adjustment, and review remain essential to optimize asthma outcomes.


Assuntos
Antiasmáticos , Asma , Administração por Inalação , Adolescente , Corticosteroides , Adulto , Asma/diagnóstico , Criança , Quimioterapia Combinada , Fumarato de Formoterol/uso terapêutico , Humanos
7.
Ann Vasc Surg ; 77: 146-152, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-34437975

RESUMO

OBJECTIVES: Acute limb ischemia (ALI) is a surgical emergency that generally develops in the outpatient setting. Hospitalized patients are also at risk for acute limb ischemia, but their presentation may be atypical or altered by medical therapy. Our institution developed an alert system to facilitate the prompt recognition and treatment of ALI that occurs in the inpatient population. We aimed to evaluate the usage of the system after the first 2 years of operation. METHODS: All ALI alerts from October 2017 to December 2019 were collected from paging records and analyzed for location, timing, and the need for intervention. Alerts undergoing vascular intervention were classified as urgent (within 8 hours) or delayed (after 8 hr). Time and location data were evaluated to determine patterns of usage and true-positive rate of the system. RESULTS: From October 2017 to December 2019, there were 237 ALI alerts obtained from paging records containing time and location information for the alert. More alerts originated from ICUs relative to non-ICU floors (68% vs. 33%, P< 0.001), however a greater proportion of non-ICU floor alerts required intervention compared to ICU alerts (32.0% vs. 5.1%, P < .0001). The highest number of ALI alerts were from the Medical ICU (MRICU) (45.9%) and medical/surgical floors (33.3%), followed by Surgical ICU (20.2%). Alerts were more common within 3 hr of morning and evening nursing shift changes (47.3%, P < 0.001). From the 237 total alerts, the patient was able to be identified retrospectively in 186 cases, and of these 27 resulted in operative interventions (14.5%, positive predictive value), with 11 patients (40.7%) requiring urgent intervention with a median time to intervention of 3.5 hr (range 2.2-4.8), and 16 (59%) alerts undergoing a delayed intervention at a mean of 3 days (range 2-4). A total of 73 (39.2%) alert patients died during their admission, of which 65 (89.0%) were in an ICU, and no deaths were directly related to ALI. The median time to death was 2 days (range 0-95 days), and in 22 cases death occurred <24 hr from time of alert. CONCLUSION: Our novel hospital-wide ALI alert system demonstrates a 14.5% positive predictive value for ischemia that resulted in an intervention. Alerts were more likely to originate from the ICU setting and during nursing shift changes. Alerts originating from non-ICU floors were 5 times more likely to undergo surgical intervention for ALI. Further analysis is required to assess the effect of this system on patient safety, outcome, and allocation of institutional resources.


Assuntos
Alarmes Clínicos , Pacientes Internados , Isquemia/diagnóstico , Doença Arterial Periférica/diagnóstico , Doença Aguda , Algoritmos , Enfermagem de Cuidados Críticos , Procedimentos Clínicos , Diagnóstico Precoce , Mortalidade Hospitalar , Humanos , Unidades de Terapia Intensiva , Isquemia/mortalidade , Isquemia/fisiopatologia , Isquemia/cirurgia , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/fisiopatologia , Doença Arterial Periférica/cirurgia , Admissão e Escalonamento de Pessoal , Valor Preditivo dos Testes , Estudos Retrospectivos , Fatores de Tempo , Tempo para o Tratamento , Resultado do Tratamento
8.
Ann Vasc Surg ; 63: 204-208, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31536797

RESUMO

In this retrospective study, we review the outcome of femoral eversion endarterectomy (EE) and standard endarterectomy with patch angioplasty (SEP) over a 10-year period. EE technique involves transection of common femoral artery (CFA), eversion endarterectomy of the distal CFA, and primary end-to-end reconstruction. One hundred forty-two patients underwent femoral endarterectomy, among which 38 (26.8%) endarterectomies were performed using the eversion technique. The cumulative 2-year primary patency of EE with or without a concurrent procedure was greater than 86% and did not statistically differ from SEP. EE is a feasible technique when the use of a patch needs to be avoided.


Assuntos
Endarterectomia , Artéria Femoral/cirurgia , Doença Arterial Periférica/cirurgia , Idoso , Constrição Patológica , Endarterectomia/efeitos adversos , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular
9.
Ann Vasc Surg ; 66: 669.e11-669.e15, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32018021

RESUMO

Vasculitides are rare manifestations of human immunodeficiency virus (HIV) infection. They encompass a wide range of different pathologies, both infectious and noninfectious. We present the case of a 68-year-old female with HIV, being treated with antiretrovirals, who presented with a symptomatic abdominal aortic aneurysm. The aneurysm developed within one week. The patient underwent endovascular aneurysm repair, and her aneurysm completely resolved on follow-up computed tomography imaging 16 months later. We also present a review of HIV-associated vascular pathologies.


Assuntos
Aneurisma da Aorta Abdominal/etiologia , Aortite/etiologia , Infecções por HIV/complicações , Idoso , Antibacterianos/uso terapêutico , Antirretrovirais/uso terapêutico , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/cirurgia , Aortite/diagnóstico por imagem , Aortite/tratamento farmacológico , Implante de Prótese Vascular , Progressão da Doença , Procedimentos Endovasculares , Feminino , Infecções por HIV/diagnóstico , Infecções por HIV/tratamento farmacológico , Infecções por HIV/virologia , Humanos , Fatores de Tempo , Resultado do Tratamento
10.
Biomed Chromatogr ; 34(9): e4854, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32302415

RESUMO

Endogenous glutathione (GSH) and glutathione disulfide (GSSG) status is highly sensitive to oxidative conditions and have broad application as a surrogate indicator of redox status in vivo. Established methods for GSH and GSSG quantification in whole blood display limited utility in human plasma, where GSH and GSSG levels are ~3-4 orders of magnitude below those observed in whole blood. This study presents simplified sample processing and analytical LC-MS/MS approaches exhibiting the sensitivity and accuracy required to measure GSH and GSSG concentrations in human plasma samples, which after 5-fold dilution to suppress matrix interferences range from 200 to 500 nm (GSH) and 5-30 nm (GSSG). The utility of the methods reported herein is demonstrated by assay performance and validation parameters which indicate good sensitivity [lower limits of quantitation of 4.99 nm (GSH) and 3.65 nm (GSSG), and high assay precision (intra-assay CVs 3.6 and 1.9%, and inter-assay CVs of 7.0 and 2.8% for GSH and GSSG, respectively). These methods also exhibited exceptional recovery of analyte-spiked plasma samples (98.0 ± 7.64% for GSH and 98.5 ± 12.7% for GSSG). Good sample stability at -80°C was evident for GSH for up to 55 weeks and GSSG for up to 46 weeks, with average CVs <15 and <10%, respectively.


Assuntos
Cromatografia Líquida/métodos , Dissulfeto de Glutationa/sangue , Espectrometria de Massas em Tandem/métodos , Glutationa/sangue , Humanos , Limite de Detecção , Modelos Lineares , Reprodutibilidade dos Testes
12.
Ann Vasc Surg ; 59: 184-189, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31009725

RESUMO

BACKGROUND: Virtual reality (VR) provides an immersive image-viewing experience that has recently been expanding in use in clinical medicine. We developed a three-dimensional (3D) model of an abdominal aortic aneurysm (AAA) for patients with a diagnosis of an AAA to view in VR to assess the use of VR in patient education. METHODS: This was a cross-sectional study using an educational intervention. A standardized 3D model of an AAA was generated from a computed tomography scan and uploaded onto a 3D image-hosting website. Patients with an AAA who participated in the study wore a Google Cardboard VR headset, with a mobile device displaying the digital 3D AAA image in VR. Patients completed a survey afterward for assessing satisfaction with VR on a 5-point agreement Likert scale. RESULTS: Between September 2017 and January 2018, 19 patients participated in our study (90% participation rate). Most participants had no prior experience with VR (n = 15; 79%), and the mean age was 69 ± 8 years. Seventeen (89%) participants agreed or strongly agreed that they felt better informed about their health status after using VR and would like to see VR used more in their health care, while sixteen (84%) agreed or strongly agreed that they felt more engaged in their health care because of using VR. Almost all participants felt comfortable using VR (n = 17; 90%) and enjoyed using the technology (n = 16; 84%). CONCLUSIONS: VR proved to be an engaging learning tool that patients perceived as beneficial in understanding their health status. Further efforts to investigate the role of VR in education and health care should be explored.


Assuntos
Aneurisma da Aorta Abdominal/diagnóstico por imagem , Educação de Pacientes como Assunto/métodos , Realidade Virtual , Idoso , Aneurisma da Aorta Abdominal/terapia , Aortografia/métodos , Compreensão , Angiografia por Tomografia Computadorizada , Estudos Transversais , Feminino , Comunicação em Saúde , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Imageamento Tridimensional , Masculino , Pessoa de Meia-Idade , Participação do Paciente , Satisfação do Paciente , Valor Preditivo dos Testes , Interpretação de Imagem Radiográfica Assistida por Computador
15.
Am Univ Law Rev ; 66(1): 247-303, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-28225582

RESUMO

Now, more than ever before, pharmacologists are contributing medical advances to confront ravaging disease. They are developing drugs to mitigate the effects of Alzheimer's, HIV, multiple sclerosis, and various forms of cancer. To capitalize on the opportunity, brand-name pharmaceutical firms are patenting these drugs, consequently guarding formulas and, with it, profits. Patents grant brand-name firms market exclusivity, which essentially allows them to set their own prices. Even though brand-name firms are investing some of their capital to cultivate new drugs, they also are enjoying gigantic revenue streams, absurd profit margins, and seemingly unfettered control of their respective markets. Consequently, sick patients are unable to afford their medication; high prices are bankrupting consumers in the absence of reasonably-priced generic alternatives. Despite the fact that generic drugs contain identical ingredients, cure the same symptoms, and cost 70% less, brand-name drugs persistently dominate their generic counterparts. Indeed, brand-name firms are improperly preventing generic market entry. Without generic competition, no watchdog exists to curb big pharma's prohibitive prices. Despite the Supreme Court's fleeting fix in FTC v. Actavis, which condemned reverse payment settlements that precluded competition, brand-name firms are employing other tactics predatorily to extend their market exclusivity and charge consumers unaffordable prices. To prevent brand-name abuse and help infirm patients afford their medication, this Comment proposes that courts apply federal antitrust law to brand-name firms that attempt to monopolize a pharmaceutical market through anticompetitive means, particularly by abusing Risk Evaluation & Mitigation Strategies (REMS) and by "product hopping." To combat exclusionary conduct, courts should mirror the "rule of reason" framework set forth in Actavis and apply an "enhanced" version specifically tailored to the pharmaceutical industry, giving stronger credence to generic challengers. In addition to finding brand-name tactics exclusionary, this Comment also proposes that courts adopt a bright-line rule prohibiting brand-name firms from exploiting the "legitimate business" defense to immunize their destructive conduct. The current framework perpetuates abuse and grants brand-name firms ostensibly indefinite monopolies. Analyzing brand-name defensive tactics under federal antitrust law would facilitate generic market entry and consequently moderate drug prices. Even after sacrificing their entire financial portfolios, patients are still unable to afford their medication. This Comment interprets Actavis as prohibiting the "legitimate business" defense and provides a remedy to deserving consumers by preventing REMS abuse and product hopping, fostering generic competition, and tempering excessive drug prices.


Assuntos
Leis Antitruste , Custos de Medicamentos/legislação & jurisprudência , Indústria Farmacêutica/legislação & jurisprudência , Prescrições de Medicamentos/economia , Medicamentos Genéricos/economia , Patentes como Assunto/legislação & jurisprudência , Indústria Farmacêutica/economia , Humanos , Legislação de Medicamentos , Estados Unidos
17.
Eur Respir J ; 46(3): 622-39, 2015 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-26206872

RESUMO

Over the past 20 years, the Global Initiative for Asthma (GINA) has regularly published and annually updated a global strategy for asthma management and prevention that has formed the basis for many national guidelines. However, uptake of existing guidelines is poor. A major revision of the GINA report was published in 2014, and updated in 2015, reflecting an evolving understanding of heterogeneous airways disease, a broader evidence base, increasing interest in targeted treatment, and evidence about effective implementation approaches. During development of the report, the clinical utility of recommendations and strategies for their practical implementation were considered in parallel with the scientific evidence.This article provides a summary of key changes in the GINA report, and their rationale. The changes include a revised asthma definition; tools for assessing symptom control and risk factors for adverse outcomes; expanded indications for inhaled corticosteroid therapy; a framework for targeted treatment based on phenotype, modifiable risk factors, patient preference, and practical issues; optimisation of medication effectiveness by addressing inhaler technique and adherence; revised recommendations about written asthma action plans; diagnosis and initial treatment of the asthma-chronic obstructive pulmonary disease overlap syndrome; diagnosis in wheezing pre-school children; and updated strategies for adaptation and implementation of GINA recommendations.


Assuntos
Asma/tratamento farmacológico , Gerenciamento Clínico , Saúde Global , Guias de Prática Clínica como Assunto , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Administração por Inalação , Corticosteroides/administração & dosagem , Antiasmáticos/administração & dosagem , Asma/diagnóstico , Asma/mortalidade , Feminino , Previsões , Humanos , Masculino , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/mortalidade , Índice de Gravidade de Doença
18.
Cytokine ; 71(2): 132-8, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25461390

RESUMO

The purpose of this study was to determine if vitamin D status before supplementation influences the cytokine response after supplemental vitamin D. Forty-six reportedly healthy adults (mean(SD); age, 32(7) y; body mass index (BMI), 25.3(4.5) kg/m(2); serum 25-hydroxyvitamin D (25(OH)D), 34.8(12.2) ng/mL) were randomly assigned (double blind) to one of three groups: (1) placebo (n=15), or supplemental vitamin D (cholecalciferol) at (2) 4000 (n=14) or (3) 8000IU (n=17). Supplements were taken daily for 35days. Fasting blood samples were obtained before (Baseline, Bsl) and 35-days after (35-d) supplementation. Serum 25(OH)D, 1,25-dihydroxyvitamin D (1,25(OH)D), cytokines, and intact parathyroid hormone with calcium were measured in each blood sample. Supplemental vitamin D increased serum 25(OH)D (4000IU, ≈29%; 8000IU, ≈57%) and 1,25(OH)D (4000IU, ≈12%; 8000IU, ≈38%) without altering intact parathyroid hormone or calcium. The vitamin D metabolite increases in the supplemental vitamin D groups (n=31) were dependent on initial levels as serum 25(OH)D (r=-0.63, p<0.05) and 1,25(OH)D (r=-0.45, p<0.05) at Bsl correlated with their increases after supplementation. Supplemental vitamin D increased interferon (IFN)-γ and interleukin (IL)-10 in subjects that were vitamin D insufficient (serum 25(OH)D<29ng/mL) compared to sufficient (serum 25(OH)D⩾30ng/mL) at Bsl. We conclude that supplemental vitamin D increase a pro- and anti-inflammatory cytokine in those with initially low serum 25(OH)D.


Assuntos
Colecalciferol/administração & dosagem , Citocinas/sangue , Suplementos Nutricionais , Vitamina D/análogos & derivados , Adulto , Índice de Massa Corporal , Cálcio/sangue , Relação Dose-Resposta a Droga , Método Duplo-Cego , Jejum/sangue , Feminino , Humanos , Contração Isométrica/efeitos dos fármacos , Joelho , Masculino , Músculo Esquelético/fisiologia , Hormônio Paratireóideo/sangue , Fatores de Tempo , Torque , Vitamina D/sangue , Vitaminas/administração & dosagem
19.
Ann Vasc Surg ; 29(5): 920-6, 2015 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-25752986

RESUMO

BACKGROUND: The proximal radial artery fistula (PRA) has been established as an early viable surgical option for arteriovenous fistula creation. The overall assisted primary patency reported in the literature approaches 100% at 1 year. We hypothesize that this excellent patency does not represent a functional result when seen in light of successful cannulation and fistula utilization. METHODS: We retrospectively queried our Veterans Administration Hospital operative database to identify 284 male patients who had 571 access procedures performed by a senior vascular surgeon attending (R.K.D.) from January 1, 2003, to December 31, 2008. Operative details, patient comorbidities, fistula maturation time (time to first cannulation), functional patency (date of access to abandonment, revision to another fistula type, conversion to a prosthetic graft, thrombosis of the fistula, conversion to peritoneal dialysis, renal transplant, or patient death), and total duration (creation of the fistula to the end of its functional patency) were collected and analyzed. RESULTS: A total of 144 PRAs were placed during the study period. In all, 87 patients underwent primary proximal radial artery fistula (P-PRA) placement in a limb without previous access; 57 patients had a secondary proximal radial artery fistula (S-PRA) after a failed previous fistula or graft in the same limb. There were no differences between the 2 groups in terms of age, comorbidities, and operative details. A total of 91 patients (63.2%) were receiving hemodialysis at the time of P-PRA or S-PRA placement. Outcomes of P-PRA and S-PRA populations on hemodialysis were examined. There was increased cannulation success (33% vs. 55%; P = 0.00354, Fisher's exact test), functional patency (755.2 ± 661.2 days vs. 405.4 ± 531.9 days; P = 0.0220, Wilcoxon two-sample test), and total duration (859.5 ± 650.7 days vs. 516.8 ± 547.2 days; P = 0.0361, Wilcoxon two-sample test) of S-PRA over P-PRA. There was no difference in endovascular interventions between the 2 groups (1.6 ± 1.0 interventions per access versus 1.1 ± 0.7 interventions per access; P = 0.2109, Wilcoxon two-sample test). Subgroup analysis (analysis of variance) of the S-PRA group indicated that a patent but failing previous access in the same arm was not superior in terms of successful cannulation, functional patency, or total duration when compared with a thrombosed previous access. CONCLUSIONS: The PRA remains a viable first access procedure undertaken at our institution. Compared with the reported 12-month assisted primary patency of this fistula type, we found a small percentage of PRAs actually being accessed for successful hemodialysis treatment. The S-PRA appears to have a significantly higher successful cannulation rate, functional patency, and total duration time when compared with the P-PRA in patients receiving hemodialysis treatments. The mechanism of these improved outcomes is not known; considering patency or thrombosis of a previous access in the S-PRA group did not predict future access success in the same extremity.


Assuntos
Derivação Arteriovenosa Cirúrgica/métodos , Artéria Radial/cirurgia , Diálise Renal , Idoso , Idoso de 80 Anos ou mais , Derivação Arteriovenosa Cirúrgica/efeitos adversos , Cateterismo Periférico , Oclusão de Enxerto Vascular/etiologia , Hospitais de Veteranos , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Punções , Artéria Radial/fisiopatologia , Reoperação , Estudos Retrospectivos , Fatores de Risco , Trombose/etiologia , Fatores de Tempo , Resultado do Tratamento , Estados Unidos , Grau de Desobstrução Vascular
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