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Cincinnati, OH, United States
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News Article | October 26, 2016

A newly published study of people with chronic obstructive pulmonary disease (COPD) concludes that long-term supplemental oxygen treatment results in little or no change in time to death, time to first hospitalizations or significant quality of life improvements for those with moderately low blood oxygen levels. The findings, published in the New England Journal of Medicine on Oct. 27, are based on research examining oxygen treatment outcomes in 738 COPD patients with moderately low blood oxygen levels at 42 clinical centers in the United States. The study began in 2009 and ended in 2015. Patients who received supplemental oxygen over the course of the study showed no significant differences in rate of hospitalizations, time to death after diagnosis, exercise capacity or quality of life when compared to patients who did not receive supplemental oxygen. The results of the study, believed by the investigators to be the largest of its kind to date, show that most people with moderately low blood oxygen levels do not receive the same benefits from long-term oxygen therapy as COPD patients with severely low blood oxygen levels. "The benefits of long-term oxygen supplements for COPD patients with severe oxygen deficiency are clear," says Robert Wise, M.D., professor of medicine in the Johns Hopkins University School of Medicine's Division of Pulmonary and Critical Care Medicine and the paper's corresponding author. "However, it's never been established what benefits, if any, exist for patients with less severe oxygen deficiency." For the study, moderate oxygen deficiency was defined as having a blood oxygen saturation between 89 and 93 percent at rest, or a blood oxygen saturation below 90 percent during a six-minute walk test. A normal blood oxygen saturation level is generally defined as between 94 and 99 percent. Blood oxygen saturation levels are a measure of oxygen-carrying hemoglobin in circulating blood and a marker of lung function, and low levels are a hallmark of people with COPD. To examine the benefits of supplemental oxygen, the researchers studied two types of COPD patients: those who suffered from moderate oxygen deficiency while resting, and those who suffered from moderate oxygen deficiency only during exercise. Some 133 patients had resting oxygen deficiency, 319 had only exercise-induced oxygen deficiency and 268 had both. Participants in each of the two groups were randomly assigned to get supplemental oxygen or no supplemental oxygen at the start of the study, and all visited clinics annually for follow-up examinations that included oxygen levels at rest and exercise, oxygen use, respiratory symptoms and quality of life. All participants also completed telephone interviews biannually and completed mailed questionnaires regarding symptoms and health care use at four and 16 months. Of the 738 total patients studied with moderate oxygen deficiency, 368 received supplemental oxygen, and 370 did not. Wise says the primary outcomes measured -- time to death or time to first hospitalization -- were essentially the same in both groups. The risk of death in the no-oxygen group was 5.7 percent per year, compared to 5.2 percent per year for the oxygen group. Overall, the risk of death or hospitalization was not different between the two treatment groups. The researchers also found no significant differences between the oxygen treatment and non-oxygen treatment groups in all hospitalization rates; COPD exacerbations, defined as sudden worsening of COPD symptoms, such as shortness of breath and phlegm production that lasts for several days; self-reported quality of life; lung function; or measures of walk distance. Even when researchers controlled for variables such as total hours of oxygen use, race, sex and smoking status, no significant differences in the primary outcomes arose, Wise says. "No matter what measure we looked at, it made no apparent difference whether a patient with moderate oxygen deficiency received long-term oxygen treatments or not. I think the evidence is strong and shows that some patients may not need those treatments at all," says Wise. Wise cautioned that "we don't want to imply that everyone with COPD now using oxygen should stop; some individual patients may find that they can do more activities or have more effective exercise training if they use oxygen. Every patient should discuss his or her specific needs with his or her health care provider, but the data show, very clearly, that for many COPD patients with moderately low blood oxygen levels, supplemental oxygen won't help you live any longer or keep you out of the hospital." Supplemental oxygen therapy can be considered burdensome and expensive for many. From 2009 to 2011, Medicare reimbursements for oxygen-related costs for COPD patients exceeded $2 billion per year. Supplemental oxygen therapy requires those using it to carry or cart around heavy and bulky oxygen delivery equipment, sometimes resulting in adverse events, such as tripping over equipment or the start of fires. According to the COPD Foundation, an estimated 24 million people in the U.S. suffer from COPD, and it is the third leading cause of death in the nation. Other authors on this study include Amanda L. Blackford, David Shade, James Tonascia and Alice L. Sternberg of The Johns Hopkins University; Richard K. Albert of the University of Colorado at Denver; Richard Casaburi of the University of California at Los Angeles Medical Center; Allen Cooper Jr. of the Birmingham Veterans Administration Medical Center; Gerard J. Criner of the Lewis Katz School of Medicine at Temple University; Philip Diaz of Ohio State University; Anne L. Fuhlbrigge of Brigham and Women's Hospital; Steven E. Gay of the University of Michigan; Richard E. Kanner of the University of Utah Health Sciences Center; Neil MacIntyre of the Duke University Medical Center; Fernando J. Martinez of the Weill Cornell Medical Center; Ralph J. Panos of Cincinnati Veterans Administration Medical Center; Steven Piantadosi of the Cedars-Sinai Medical Center; Frank Sciurba of the University of Pittsburgh; Thomas Stibolt of the Kaiser Permanente Center for Health Research; Roger D. Yusen of the Washington University School of Medicine; and William Bailey of the University of Alabama. This study was funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health (HHSN268200736183C, HHSN268200736184C, HHSN268200736185C, HHSN268200736186C, HHSN268200736187C, HHSN268200736188C, HHSN268200736189C, HHSN268200736190C, HHSN268200736191C, HHSN268200736192C, HHSN268200736193C, HHSN268200736194C, HHSN268200736195C, HHSN268200736196C, HHSN268200736197C, Y1-HR-7019-01, Y1-HR-8076-01) in cooperation with the Centers for Medicare and Medicaid Services.

Lee T.,University of Cincinnati | Lee T.,Cincinnati Veterans Administration Medical Center | Ullah A.,University of Cincinnati | Allon M.,University of Alabama at Birmingham | And 6 more authors.
Clinical Journal of the American Society of Nephrology | Year: 2011

Background and objectives: New arteriovenous fistulas (AVF) are frequently unsuitable for hemodialysis because of AVF nonmaturation. Aggressive endovascular or surgical interventions are often undertaken to salvage nonmaturing AVFs. The effect of early interventions to promote AVF maturation on subsequent long-term AVF outcomes is unknown. Design, setting, participants, & measurements: We evaluated 173 hemodialysis patients from two academic centers who received a new AVF. Of these, 96 (56%) required no further intervention, 54 (31%) required one intervention, and 23 (13%) required two or more interventions to achieve suitability for dialysis. We calculated AVF survival and frequency of postmaturation interventions in each group. Results: Cumulative AVF survival (access cannulation to permanent failure) in patients with two or more versus one versus zero interventions before maturation was 68% versus 78% versus 92% at 1 year, 57% versus 71% versus 85% at 2 years, and 42% versus 57% versus 75% at 3 years. Using Cox regression analysis with interventions before maturation, age, sex, race, diabetes, peripheral vascular disease, access site, and obesity in the model, intervention before maturation (two or more) was the only factor associated with cumulative AVF survival. The number of interventions required to maintain patency after maturation was 3.51 ± 2.20 versus 1.37 ± 0.31 versus 0.76 ± 0.10 per year in patients with two or more versus one versus zero interventions before maturation. Conclusions: Compared with AVF that mature without interventions, AVF that require interventions have decreased cumulative survival and require more interventions to maintain their patency for hemodialysis. Copyright © 2011 by the American Society of Nephrology.

Stoller J.K.,Cleveland Clinic | Panos R.J.,Cincinnati Veterans Administration Medical Center | Krachman S.,Temple University | Doherty D.E.,University of Kentucky | Make B.,University of Colorado at Denver
Chest | Year: 2010

Long-term use of supplemental oxygen improves survival in patients with COPD and severe resting hypoxemia. However, the role of oxygen in symptomatic patients with COPD and more moderate hypoxemia at rest and desaturation with activity is unclear. The few long-term reports of supplemental oxygen in this group have been of small size and insuffi cient to demonstrate a survival benefi t. Short-term trials have suggested benefi cial effects other than survival in patients with COPD and moderate hypoxemia at rest. In addition, supplemental oxygen appeared to improve exercise performance in small short-term investigations of patients with COPD and moderate hypoxemia at rest and desaturation with exercise, but long-term trials evaluating patient-reported outcomes are lacking. This article reviews the evidence for long-term use of supplemental oxygen therapy and provides a rationale for the National Heart, Lung, and Blood Institute Long-term Oxygen Treatment Trial. The trial plans to enroll subjects with COPD with moderate hypoxemia at rest or desaturation with exercise and compare tailored oxygen therapy to no oxygen therapy. © 2010 American College of Chest Physicians.

Epstein T.G.,University of Cincinnati | Epstein T.G.,Cincinnati Veterans Administration Medical Center | Liss G.M.,University of Toronto | Murphy-Berendts K.,Bernstein Clinical Research Center | And 2 more authors.
Annals of Allergy, Asthma and Immunology | Year: 2013

Objective: To define the incidence of and clinical practices associated with subcutaneous immunotherapy (SCIT)-related systemic reactions (SRs). Methods: From 2008-2011, American Academy of Allergy, Asthma & Immunology and American College of Allergy, Asthma & Immunology members completed an annual survey of SCIT-related SRs of varying severity (with grade 1 indicating mild; grade 2, moderate; and grade 3, severe anaphylaxis). From 2010-2011 (year 3) data were collected regarding SCIT-related procedures, including screening of patients with asthma, dose adjustment during peak pollen seasons, build-up regimens (conventional, cluster, or rush), and premedication. Results: No fatal reactions were directly or indirectly reported from 2008-2011. The SR rates were similar for all 3 years (0.1% of injection visits; 83% of practices), as were severity grades. On average, for all 3 years, there were 7.1 grade 1, 2.6 grade 2, and 0.4 grade 3 SRs per 10,000 injection visits. Screening for worsening asthma symptoms was highly prevalent (86% always screened). Practices that always reduced doses during peak pollen season were significantly less likely to report grade 2 or 3 SRs (44% vs 65%; P =.04). Cluster and rush build-up were associated with significantly more SRs (P <.001). Practices that premedicated were significantly more likely to report grade 2 and 3 SRs (P <.01). Conclusion: Fatal reactions to SCIT appear to be declining, possibly related to almost universal screening of asthmatic patients. Adjusting doses during the pollen season may be associated with decreased risk for severe SRs. Cluster and rush immunotherapy were associated with increased risk for SRs. Premedication by practices reporting SRs likely reflects past experience with SRs. © 2013 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Epstein T.G.,University of Cincinnati | Epstein T.G.,Cincinnati Veterans Administration Medical Center | Liss G.M.,University of Toronto | Murphy-Berendts K.,Bernstein Clinical Research Center | And 2 more authors.
Annals of Allergy, Asthma and Immunology | Year: 2011

Background: Incidences of subcutaneous immunotherapy (SCIT) related systemic reactions (SRs) and fatal reactions (FRs) are not well defined, nor are delayed-onset SRs and their treatment. Objectives: To estimate SCIT-related SRs/FRs, and the incidence and treatment of delayed-onset SRs. Methods: In 2008 and 2009, American Academy of Allergy, Asthma & Immunology (AAAAI) and American College of Allergy Asthma & Immunology (ACAAI) members completed a survey about SCIT-related SR severity (grade 1 = mild; grade 2 = moderate; grade 3 = severe anaphylaxis). In 2009, members reported the time of onset and use of epinephrine (EPI), with early onset defined as beginning ≤30 minutes, and delayed onset beginning more than 30 minutes after injections. Results: As in year 1, no FRs were reported during year 2 (630 total practices responded). Among 267 practices providing data on the timing of SRs, 1,816 early-onset SRs (86%) and 289 (14%) delayed-onset SRs were reported. Fifteen percent (226/1,519) of grade 1, 10% (54/538) of grade 2, and 12.5% (9/72) of grade 3 SRs were delayed-onset. Among early-onset SRs, EPI was given for 71% of grade 1, 93% of grade 2, and 94% of grade 3s. Among delayed-onset SRs, EPI was given for 56% of grade 1, 67% of grade 2, and 100% of grade 3s (P =.0008 for difference in EPI administration based on severity; P =.07 based on time of onset). Conclusions: Delayed-onset SRs are less frequent than previously reported. Epinephrine was given less frequently for grades 1 and 2 (but not grade 3) delayed-onset SRs compared with early-onset SRs. Further study of prescribing self-injectable EPI for SCIT patients in the event of delayed-onset SRs may be warranted. © 2011 American College of Allergy.

Hughes G.C.,University of Washington | Choubey D.,Cincinnati Veterans Administration Medical Center
Nature Reviews Rheumatology | Year: 2014

Sexual dimorphism is evident in the risk and expression of several human autoimmune diseases. Differences in disease manifestations observed between sexes are likely to involve immunomodulation by sex steroids, nonhormonal factors encoded by genes on the X and Y chromosomes, and immunological phenomena unique to pregnancy. In systemic lupus erythematosus (SLE), and perhaps other autoantibody-mediated diseases, oestrogen seems to increase the risk of disease in genetically predisposed women by targeting key immune pathways, including the type 1 interferon (IFN) response, differentiation of CD4 + T helper cells and survival of autoreactive B cells. By contrast, progesterone seems to reduce the risk of SLE by counteracting the effects of oestrogen on some of these same pathways, which suggests that the balance between oestrogen and progesterone can determine disease expression. In this Review we focus on the roles of the sex steroid hormones oestrogen and progesterone in modulating the risk and expression of SLE and rheumatoid arthritis. Intensive research in this area promises to identify novel therapeutic strategies and improve understanding of the immunological requirements and complications of pregnancy, and is expected to define the mechanisms behind sexual dimorphism in autoimmunity, immunity and other aspects of human health - a newly announced directive of the NIH. © 2014 Macmillan Publishers Limited. All rights reserved.

Kannan J.A.,University of Cincinnati | Epstein T.G.,University of Cincinnati | Epstein T.G.,Cincinnati Veterans Administration Medical Center
Current Allergy and Asthma Reports | Year: 2013

Subcutaneous allergen immunotherapy (SCIT) is beneficial for the treatment of allergic rhinitis, asthma, and in preventing stinging insect anaphylaxis, but is not without risks. Four retrospective surveillance surveys and one on-going national prospective study have attempted to characterize the incidence and risk factors for fatal and non-fatal SCIT reactions. These studies have contributed significantly to currently recommended SCIT safety guidelines. Recent surveillance studies indicate stable SR rates, and a possible decline in the incidence of fatal reactions since the implementation of evidence-based safety guidelines. This review will provide a detailed summary of the evidence from surveillance studies for risk factors associated with SCIT reactions, including: uncontrolled asthma, prior systemic reactions, dosing during peak pollen seasons, epinephrine being delayed or not given, dosing or administration errors, inadequate waiting times, reactions occurring more than 30 min after injections, injections given in medically unsupervised settings, concomitant beta-blocker and angiotensin-converting enzyme inhibitor (ACEi) use, and accelerated build-up regimens. © 2013 Springer Science+Business Media New York (outside the USA).

Salehi M.,University of Cincinnati | Aulinger B.,University of Cincinnati | D'Alessio D.A.,University of Cincinnati | D'Alessio D.A.,Cincinnati Veterans Administration Medical Center
Diabetes | Year: 2012

The incretin effect, reflecting the enhancement of postprandial insulin secretion by factors including the intestinal hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide, increases in proportion to meal size. However, it is unknown whether the incretin effect is dependent on ambient glucose. The goal of this study was to determine the effect of plasma glycemia on the incretin effect. Thirteen healthy subjects consumed 50 g oral glucose solution mixed with D-xylose during fixed hyperglycemia at 8 and 10.5 mmol/L, on 3 separate days, twice at lower glycemia (LOW) and once at higher values (HIGH). The relative increase in insulin release after glucose ingestion at fixed hyperglycemia, a surrogate for the incretin effect, was similar among all three studies. The GLP-1 response to oral glucose was significantly lower at higher plasma glycemia, as was the appearance of D-xylose after the meal. Between the two LOW studies, the reproducibility of insulin release in response to intravenous glucose alone and intravenous plus ingested glucose was similar. These findings indicate that the incretin contribution to postprandial insulin release is independent of glycemia in healthy individuals, despite differences in GLP-1 secretion. The incretin effect is a reproducible trait among humans with normal glucose tolerance. © 2012 by the American Diabetes Association.

Davis D.T.,Cincinnati Veterans Administration Medical Center
Journal of trauma nursing : the official journal of the Society of Trauma Nurses | Year: 2012

Trauma continues to be the leading cause of death among those younger than 40 years. A major cause of death within the first 24 hours is hemorrhage. Many of these patients present with severe coagulopathy and require massive transfusion. Earlier control of coagulopathy has been shown to improve survival. To address coagulopathy sooner, changes in the way we identify and resuscitate the exsanguinating trauma patient have evolved. These changes include early identification of at-risk patients and early, aggressive transfusion of plasma and platelets. This article reviews the key massive transfusion triggers and resuscitation strategy of damage control resuscitation.

Lee T.,University of Cincinnati | Lee T.,Cincinnati Veterans Administration Medical Center | Wadehra D.,University of Cincinnati
Seminars in Dialysis | Year: 2012

The major cause of hemodialysis vascular access failure is venous stenosis resulting from neointimal hyperplasia. Genetic factors have been shown to be associated with cardiovascular disease and peripheral vascular disease (PVD) in the general population. Genetic factors may also play an important role in vascular access stenosis and development of neointimal hyperplasia by affecting pathways that lead to inflammation, endothelial function, oxidative stress, and vascular smooth muscle proliferation. This review will discuss the role of genetics in understanding neointimal hyperplasia development in hemodialysis vascular access dysfunction and other disease processes with similar neointimal hyperplasia development such as coronary artery disease and PVD. © 2011 Wiley Periodicals, Inc.

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