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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EThis article reviews multiple late-breaking clinical trials focusing on combination therapy and hospital utilization improvements. Specific trials include the phase 3 AMBITION [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01178073\u0026amp;atom=%2Fspmdc%2F14%2F45%2F8.atom\u0022\u003ENCT01178073\u003C\/a\u003E], the Comprehensive Respiratory Outcome Management program, as well as trials investigating the use of noninvasive open ventilation, end-of-rotation handoffs, and 2 phase 3 randomized controlled studies [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01957163\u0026amp;atom=%2Fspmdc%2F14%2F45%2F8.atom\u0022\u003ENCT01957163\u003C\/a\u003E;  \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT02119286\u0026amp;atom=%2Fspmdc%2F14%2F45%2F8.atom\u0022\u003ENCT02119286\u003C\/a\u003E] looking at umeclidinium for the treatment of COPD.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ENursing\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EAcute Lung Injury \u0026amp; Respiratory Failure\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EPulmonary Clinical Trials Chronic Obstructive Pulmonary Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EThromboembolic Disease\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ENursing\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EAcute Lung Injury \u0026amp; Respiratory Failure\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EPulmonary Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EPulmonary \u0026amp; Respiratory Medicine\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EChronic Obstructive Pulmonary Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EThromboembolic Disease\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EMORTALITY INCREASES AND TRANSITION OF CARE\u003C\/h2\u003E\n         \u003Cp id=\u0022p-2\u0022\u003EMandated resident duty-hour restrictions have increased the total number of patient handoffs; however, little data exist as to how these transitions affect outcomes. Joshua L. Denson, MD, New York University School of Medicine, New York, New York, USA, presented data indicating there is a significant increase in all-cause hospital mortality the week following end-of-rotation handoffs.\u003C\/p\u003E\n         \u003Cp id=\u0022p-3\u0022\u003EThis study investigated mortality rates during periods of resident handoff and whether these rates were affected by the Accreditation Council for Graduate Medical Education (ACGME) duty-hour rule amendments instituted in July 2011. This was a 2-year retrospective cohort study (July 2010 through June 2012) of 24 739 adult discharges from internal medical services at a public, university-affiliated hospital. The primary study outcome was unadjusted and adjusted mortality during the 7 days following a change in resident physician team (handoff) compared with the remaining 3 weeks of each 4-week rotation (control). The effect of the 2011 ACGME duty-hour changes on mortality was also evaluated.\u003C\/p\u003E\n         \u003Cp id=\u0022p-4\u0022\u003ETwo diagnoses were significantly more common in the control group, anemia (\u003Cem\u003EP\u003C\/em\u003E = .003) and other neurologic disorders (\u003Cem\u003EP\u003C\/em\u003E = .02); otherwise the groups were similar. Over 2 years, both unadjusted and adjusted all-cause hospital mortality were significantly higher during the handoff period vs the control period, as well as for discharges occurring prior to implementation of the duty-hour adjustments. After duty-hour reform, the unadjusted hospital mortality rate remained higher during the handoff vs the control period (2.74% vs 2.32%; \u003Cem\u003EP\u003C\/em\u003E = .004). The risk remained higher for all-cause mortality, pre-duty hour mortality, and post-duty hour mortality during the handoff period vs the control period, with odds ratios of 1.29 (\u003Cem\u003EP\u003C\/em\u003E = .013), 1.42 (\u003Cem\u003EP\u003C\/em\u003E = .012), and 1.15 (\u003Cem\u003EP\u003C\/em\u003E = .330), respectively, adjusted for age, sex, length of stay, month, and Elixhauser Comorbidity Index.\u003C\/p\u003E\n         \u003Cp id=\u0022p-5\u0022\u003EAlthough improved by the 2011 ACGME duty-hour amendments, there remains a trend toward higher mortality during times of resident handoff.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-2\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EINITIAL THERAPY WITH AMBRISENTAN PLUS TADALAFIL EFFECTIVE FOR PAH\u003C\/h2\u003E\n         \u003Cp id=\u0022p-6\u0022\u003EData presented by Lewis J. Rubin, MD, Gilead Sciences, Foster City, California, USA, demonstrated that initial combination therapy with ambrisentan + tadalafil may be beneficial across a variety of patients with pulmonary arterial hypertension (PAH).\u003C\/p\u003E\n         \u003Cp id=\u0022p-7\u0022\u003EAMBITION was a phase 3 trial [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01178073\u0026amp;atom=%2Fspmdc%2F14%2F45%2F8.atom\u0022\u003ENCT01178073\u003C\/a\u003E] showing that initial combination therapy with ambrisentan + tadalafil reduced the time to first clinical failure (TcF; all-cause death, hospitalization for worsening PAH, disease progression, and unsatisfactory long-term response) in treatment-na\u00efve patients with PAH with World Health Organization (WHO) functional class (FC) II or III compared with initial monotherapy with ambrisentan or tadalafil. The primary analysis set comprised 500 patients with a median age of about 54 years and a median baseline 6-minute walk distance (6MWD) of about 360 meters. Dr Rubin presented the results of a prespecified subanalysis by disease etiology (idiopathic\/heritable [I\/HPAH] vs associated PAH [APAH]), FC (II vs III), and median age and baseline 6MWD vs the study population.\u003C\/p\u003E\n         \u003Cp id=\u0022p-8\u0022\u003EInitial treatment with combination therapy was associated with a significant 50% reduction in TcF compared with initial monotherapy. Initial combination of ambrisentan and tadalafil consistently outperformed pooled monotherapy on the end point of TcF across a variety of subgroups. There was a significant improvement of about 50 meters in 6MWD from baseline to week 24 with combination therapy compared with monotherapy. Patients with I\/HPAH as well as those with APAH had similar and significant improvements in 6MWD compared with those randomized to monotherapy. Similar results in favor of combination therapy were seen regardless of functional class, age vs the median age of the study population, and as a function of baseline 6MWD. More patients on initial combination therapy achieved a satisfactory clinical response at week 24. The safety profile was consistent with the known profiles of ambrisentan and tadalafil.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-3\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003ENONINVASIVE OPEN VENTILATION IMPROVES DYSPNEA AND RESPIRATORY SYMPTOMS\u003C\/h2\u003E\n         \u003Cp id=\u0022p-9\u0022\u003ENoninvasive open ventilation (NIOV) has been shown to significantly improve respiratory muscle unloading, exercise tolerance, and dyspnea. Brian W. Carlin, MD, Allegheny General Hospital, Pittsburgh, Pennsylvania, USA, presented study results demonstrating that the use of NIOV in addition to standard medical therapy is associated with significant improvements in dyspnea and respiratory symptoms.\u003C\/p\u003E\n         \u003Cp id=\u0022p-10\u0022\u003EThis was a retrospective study evaluating the impact of NIOV on the Modified Medical Research Council Dyspnea Scale (mMRC) and chronic obstructive pulmonary disease (COPD) assessment test (CAT) scores of patients with chronic lung disease, who remained symptomatic despite receiving optimal medical therapy. All patients completed the mMRC and received a CAT score prior to (average 14.6 months) and after (average 10.3 months) treatment. The decision to use NIOV was made by the care provider and patients were instructed to use it as needed.\u003C\/p\u003E\n         \u003Cp id=\u0022p-11\u0022\u003EA total of 21 patients (mean age, 70.2 years; range, 56 to 93 years) were included in the study. Nineteen patients had COPD, 1 had pulmonary hypertension, and 1 had bronchiolitis obliterans. The mean time from diagnosis to initiation of therapy was 16.8 months.\u003C\/p\u003E\n         \u003Cp id=\u0022p-12\u0022\u003EPrior to initiating NIOV, patients had an mMRC score of 3.38 \u00b1 0.80 (range, 2 to 4) and a CAT score of 26.71 \u00b1 7.22 (range, 10 to 37). At the end of therapy the mMRC score declined to 1.43 \u00b1 1.08 (range, 0 to 4) and the CAT score decreased to 12.33 \u00b1 7.16 (range, 4 to 27).\u003C\/p\u003E\n         \u003Cp id=\u0022p-13\u0022\u003EBy reducing symptoms, patients may ultimately be able to enhance general exercise tolerance, increase ability to participate in pulmonary rehabilitation, increase ability to engage in activities of daily living, and improve overall health-related quality of life.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-4\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003ENEW HEALTH MANAGEMENT SYSTEM REDUCES COST FOR PATIENTS WITH CHRONIC RESPIRATORY FAILURE\u003C\/h2\u003E\n         \u003Cp id=\u0022p-14\u0022\u003EPatients with chronic respiratory failure have a hospital utilization rate that is among the highest in the nation. Dov Hirsch, MA, Alana HealthCare, Nashville, Tennessee, USA, discussed the Comprehensive Respiratory Outcome Management (CROM) program, a new health management program that has decreased hospital utilization among patients with COPD and chronic respiratory failure.\u003C\/p\u003E\n         \u003Cp id=\u0022p-15\u0022\u003EThe home-based program consisted of visits by a respiratory therapist to perform clinical assessments, intensive education, behavior modification, skill training, smoking cessation, and training in management and mitigation of exacerbations. Respiratory therapists also conducted scheduled and unscheduled phone interviews.\u003C\/p\u003E\n         \u003Cp id=\u0022p-16\u0022\u003EEligible patients had COPD (GOLD Stage III to IV) and chronic respiratory failure requiring supplementary oxygen (2\u20134 L) and noninvasive positive pressure ventilation (NIPPV). A total of 459 patients (average age 66 years; 64% women) were enrolled. Of these, 211 (46%) had experienced \u2265 1 hospital admission in the 12 months prior to enrollment and 61 (13%) had experienced \u2265 1 30-day hospital readmission during that period.\u003C\/p\u003E\n         \u003Cp id=\u0022p-17\u0022\u003EAfter participating in the program, patients experienced a 51% reduction (483 days to 236 days) in hospital admissions, a 56% reduction in total days spent in the hospital, and a 48% reduction in 30-day hospital readmissions.\u003C\/p\u003E\n         \u003Cp id=\u0022p-18\u0022\u003EDr Hirsch concluded that additional research is needed to determine whether the therapy or the program provides the benefits, who is best equipped to deliver the program (eg, nurse, respiratory therapist, care coordinator), the actual cost of home- vs hospital-based therapy (not just clinical outcomes), and how long patients should stay in the program.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-5\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003ECOMBINATION THERAPY SAFE AND EFFECTIVE In MODERATE-TO-VERY-SEVERE COPD\u003C\/h2\u003E\n         \u003Cp id=\u0022p-19\u0022\u003EUmeclidinium (UMEC) is a long-acting muscarinic antagonist approved for maintenance treatment of COPD. Fluticasone furoate\/vilanterol (FF\/VI; combination inhaled corticosteroid + long-acting \u03b2\u003Csub\u003E2\u003C\/sub\u003E agonist) is indicated for long-term, once-daily maintenance treatment of airflow obstruction in COPD. Thomas Siler, MD, Midwest Chest Consultants, St Charles, Missouri, USA, presented data from 2 phase 3 randomized controlled studies [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01957163\u0026amp;atom=%2Fspmdc%2F14%2F45%2F8.atom\u0022\u003ENCT01957163\u003C\/a\u003E;  \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT02119286\u0026amp;atom=%2Fspmdc%2F14%2F45%2F8.atom\u0022\u003ENCT02119286\u003C\/a\u003E], which found combination therapy with UMEC + FF\/VI to be a safe and effective treatment for moderate-to-very-severe COPD, compared with placebo + FF\/VI.\u003C\/p\u003E\n         \u003Cp id=\u0022p-20\u0022\u003EThese were 12-week, parallel-group studies comprising patients (n = 1238) aged \u2265 40 years diagnosed with COPD. Patients were required to be current or former cigarette smokers with a pre- and post-albuterol forced expiratory volume at 1 second (FEV\u003Csub\u003E1\u003C\/sub\u003E)\/forced vital capacity (FVC) ratio \u0026lt; 0.7 and FEV\u003Csub\u003E1\u003C\/sub\u003E \u2264 70% predicted. Treatment with inhaled corticosteroids was permitted prior to the first study visit. At the end of the 4-week run-in period during which they received FF\/VI 100\/25 mcg once daily, patients were randomized 1:1:1 to once-daily UMEC 62.5 mcg, UMEC 125 mcg, or placebo, and open-label FF\/VI for 12 weeks. All patients were followed for an additional week. The primary end point was trough FEV\u003Csub\u003E1\u003C\/sub\u003E on day 85. Other end points included weighted mean FEV\u003Csub\u003E1\u003C\/sub\u003E over 0 to 6 hours on day 84, serial FEV\u003Csub\u003E1\u003C\/sub\u003E, rescue use, and St George\u0027s Respiratory Questionnaire (SGRQ) score. Safety was measured by on-treatment adverse events (AEs) and serious AEs.\u003C\/p\u003E\n         \u003Cp id=\u0022p-21\u0022\u003EBoth doses of UMEC + FF\/VI in both studies produced statistically significant and clinically meaningful improvements in trough FEV\u003Csub\u003E1\u003C\/sub\u003E at day 85 (\u003Cem\u003EP\u003C\/em\u003E \u2264 .001) and 0 to 6-hour weighted mean FEV\u003Csub\u003E1\u003C\/sub\u003E at day 84 (\u003Cem\u003EP\u003C\/em\u003E \u2264 .001).\u003C\/p\u003E\n         \u003Cp id=\u0022p-22\u0022\u003EBoth doses of UMEC + FF\/VI increased the percentage of rescue-free days vs baseline (range, 5.9% to 14.2%) vs placebo (2.3% and 3.8%). There was a significant reduction in puffs per day in both studies for UMEC 62.5 mcg + FF\/VI dose and for the UMEC 125 mcg + FF\/ VI in study 1 (but not study 2). SGRQ scores at day 84 were significantly improved with UMEC 62.5 mcg + FF\/ VI. The incidence of on-treatment AEs was similar across all groups in both studies (30% to 39%).\u003C\/p\u003E\n         \u003Cp id=\u0022p-23\u0022\u003ECompared with placebo + FF\/VI in patients with COPD, once-daily UMEC (62.5 or 125 mcg) added to once-daily FF\/VI resulted in improvements in lung function and rescue use, with consistent safety profiles across all treatment groups.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2014 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/14\/45\/8.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzohv1\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}