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A clinical audit of thrombolytic therapy in patients with normotensive pulmonary embolism and intermediate risk.

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A clinical audit of thrombolytic therapy in patients with normotensive pulmonary embolism and intermediate risk.

Acute Card Care. 2014 Mar 12;

Authors: Nobre C, Mesquita D, Thomas B, Ponte T, Santos L, Tavares J

Abstract
Introduction: There is considerable debate regarding the use of thrombolytic therapy in patients with pulmonary embolism, normal blood pressure and intermediate clinical risk, as defined by right ventricular dysfunction on transthoracic echocardiography or elevated serum markers of cardiac necrosis. Aims and objectives: A clinical audit of normotensive patients diagnosed with acute pulmonary embolism using multi- detector computerized tomography pulmonary angiography (MDCTPA) and intermediate risk, was conducted to determine clinical outcomes at 30 days. The specific role played by imaging findings and clinical severity, on the decision to thrombolyse, was assessed. Methods: The two cohorts who did (n = 15) and did not receive thrombolysis (n = 20) were compared for age, heart rate, blood pressure and oxyhemoglobin saturation at presentation, and the simplified PESI score was calculated in each patient. MDCTPA findings suggestive of adverse clinical outcome including central PE and an increased RV/LV diameter were determined for each patient. RV dysfunction on echocardiography was compared to clinical scoring, and findings on MDCTPA. Results: The patients who received thrombolytic therapy were younger (48.6 ± 19.11 years versus 64.2 ± 13.83 years) (P < 0.01) and had a higher heart rate (107.6 ± 17.1/min versus 91.7 ± 17.8/min) (P < 0.05). More patients with a higher clinical severity, as determined by the simplified PESI score (12/20) and a higher shock index (0.94 ± 0.23), were thrombolysed as compared to the proportion with a lower score (3/15) (P < 0.05) or index (0.70 ± 0.20) (P < 0.005). In-hospital mortality and hemorrhagic complications at 30 days were zero in both groups. RV dysfunction by echocardiography was not a strong determinant for choosing thrombolytic therapy while central PE on MDCTPA tilted the decision towards thrombolysis. Conclusion: Our clinical audit revealed a predilection to use thrombolysis in younger patients with clinical severity and imaging findings on MDCTPA being the key drivers. A perception of a fragile hemodynamic status, as implied by a higher heart rate and shock index, despite a normal BP probably inclined us to thrombolyse.

PMID: 24617753 [PubMed - as supplied by publisher]

Community-based recruitment of patients with COPD into clinical research.

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Community-based recruitment of patients with COPD into clinical research.

Thorax. 2014 Mar 4;

Authors: Brill SE, El-Emir E, Allinson JP, Donaldson GC, Nazareth I, Wedzicha JA

Abstract
Identifying subjects for clinical trials is difficult and the evidence base for recruitment strategies is limited, particularly in the field of COPD. We compared the efficiency and patient characteristics of different community-based recruitment strategies during a non-commercial COPD trial in the UK. Recruiting from general practice COPD registers was less efficient and identified patients with significantly milder disease than recruiting through pulmonary rehabilitation and patient groups. We report our experience and propose that pulmonary rehabilitation and patient groups may represent an enriched pool of COPD patients to recruit into clinical trials.
TRIAL REGISTRATION NUMBER: EudraCT 2011-001063-43.

PMID: 24595667 [PubMed - as supplied by publisher]

Efficacy and safety of coadministration of once-daily indacaterol and glycopyrronium versus indacaterol alone in COPD patients: the GLOW6 study.

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Efficacy and safety of coadministration of once-daily indacaterol and glycopyrronium versus indacaterol alone in COPD patients: the GLOW6 study.

Int J Chron Obstruct Pulmon Dis. 2014;9:215-28

Authors: Vincken W, Aumann J, Chen H, Henley M, McBryan D, Goyal P

Abstract
BACKGROUND: Addition of a second bronchodilator from a different pharmacological class may benefit patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) whose symptoms are insufficiently controlled by bronchodilator monotherapy. GLOW6 evaluated the efficacy and safety of once-daily coadministration of the long-acting β2-agonist indacaterol (IND) and the long-acting muscarinic antagonist glycopyrronium (GLY) versus IND alone in patients with moderate-to-severe COPD.
MATERIALS AND METHODS: In this randomized, double-blind, parallel group, placebo-controlled, 12-week study, patients were randomized 1:1 to IND 150 μg and GLY 50 μg daily (IND + GLY) or IND 150 μg daily and placebo (IND + PBO) (all delivered via separate Breezhaler® devices). The primary objective was to demonstrate the superiority of IND + GLY versus IND + PBO for trough forced expiratory volume in 1 second (FEV1) at week 12. Other end points included trough FEV1 at day 1, FEV1 area under the curve from 30 minutes to 4 hours (AUC30min-4h), peak FEV1, inspiratory capacity and trough forced vital capacity (FVC) at day 1 and week 12, and transition dyspnea index (TDI) focal score, COPD symptoms, and rescue medication use over 12 weeks.
RESULTS: A total of 449 patients were randomized (IND + GLY, 226; IND + PBO, 223); 94% completed the study. On day 1 and at week 12, IND + GLY significantly improved trough FEV1 versus IND + PBO, with treatment differences of 74 mL (95% CI 46-101 mL) and 64 mL (95% CI 28-99 mL), respectively (both P<0.001). IND + GLY significantly improved postdose peak FEV1, FEV1 AUC30min-4h, and trough FVC at day 1 and week 12 versus IND + PBO (all P<0.01). TDI focal score and COPD symptoms (percentage of days able to perform usual daily activities and change from baseline in mean daytime respiratory score) were significantly improved with IND + GLY versus IND + PBO (P<0.05). The incidence of adverse events was similar for the two treatment groups.
CONCLUSION: In patients with moderate-to-severe COPD, once-daily coadministration of IND and GLY provides significant and sustained improvement in bronchodilation versus IND alone from day 1, with significant improvements in patient-centered outcomes.

PMID: 24596459 [PubMed - in process]

Profile of fluticasone furoate/vilanterol dry powder inhaler combination therapy as a potential treatment for COPD.

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Profile of fluticasone furoate/vilanterol dry powder inhaler combination therapy as a potential treatment for COPD.

Int J Chron Obstruct Pulmon Dis. 2014;9:249-256

Authors: Caramori G, Chung KF, Adcock IM

Abstract
Currently, there is no cure for chronic obstructive pulmonary disease (COPD). The limited efficacy of current therapies for COPD indicates a pressing need to develop new treatments to prevent the progression of the disease, which consumes a significant amount of health care resources and is an important cause of mortality worldwide. Current national and international guidelines for the management of stable COPD patients recommend the use of inhaled long-acting bronchodilators, inhaled corticosteroids, and their combination for maintenance treatment of moderate to severe stable COPD. Once-daily fluticasone furoate/vilanterol dry powder inhaler combination therapy has recently been approved by the US Food and Drug Administration and the European Medicines Agency as a new regular treatment for patients with stable COPD. Fluticasone furoate/vilanterol dry powder inhaler combination therapy has been shown to be effective in many controlled clinical trials involving thousands of patients in the regular treatment of stable COPD. This is the first once-daily combination of ultra-long-acting inhaled β2-agonists and inhaled glucocorticoids that is available for the treatment of stable COPD and has great potential to improve compliance to long-term regular inhaled therapy and hence to improve the natural history and prognosis of COPD patients.

PMID: 24596460 [PubMed - as supplied by publisher]

Pathogenesis of hyperinflation in chronic obstructive pulmonary disease.

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Pathogenesis of hyperinflation in chronic obstructive pulmonary disease.

Int J Chron Obstruct Pulmon Dis. 2014;9:187-201

Authors: Gagnon P, Guenette JA, Langer D, Laviolette L, Mainguy V, Maltais F, Ribeiro F, Saey D

Abstract
Chronic obstructive pulmonary disease (COPD) is a preventable and treatable lung disease characterized by airflow limitation that is not fully reversible. In a significant proportion of patients with COPD, reduced lung elastic recoil combined with expiratory flow limitation leads to lung hyperinflation during the course of the disease. Development of hyperinflation during the course of COPD is insidious. Dynamic hyperinflation is highly prevalent in the advanced stages of COPD, and new evidence suggests that it also occurs in many patients with mild disease, independently of the presence of resting hyperinflation. Hyperinflation is clinically relevant for patients with COPD mainly because it contributes to dyspnea, exercise intolerance, skeletal muscle limitations, morbidity, and reduced physical activity levels associated with the disease. Various pharmacological and nonpharmacological interventions have been shown to reduce hyperinflation and delay the onset of ventilatory limitation in patients with COPD. The aim of this review is to address the more recent literature regarding the pathogenesis, assessment, and management of both static and dynamic lung hyperinflation in patients with COPD. We also address the influence of biological sex and obesity and new developments in our understanding of hyperinflation in patients with mild COPD and its evolution during progression of the disease.

PMID: 24600216 [PubMed - as supplied by publisher]

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