Clinical and Functional Effects of Inhaled Dual Therapy Umeclidinium/Vilanterol in Patients with Chronic Obstructive Pulmonary Disease: A Real-Life Study.

Background: The pharmacological association umeclidinium/vilanterol (UMEC/VI) allows to implement a very effective dual bronchodilation in chronic obstructive pulmonary disease (COPD), thus optimizing bronchodilating therapy. Methods: The main purpose of our real-world observational study was to evaluate in COPD patients the effects of UMEC/VI on lung function and respiratory symptoms. Functional and clinical parameters were assessed at baseline, and after 52 weeks of treatment with this combined double inhaled therapy. Results: We enrolled 110 subjects suffering from COPD. A 12-month UMEC/VI treatment induced significant improvements in total lung capacity (TLC) (p < 0.05), and residual volume (RV) (p < 0.0001). Pulmonary deflation was paralleled by significant increases of forced expiratory volume in one second (FEV1) (p < 0.0001), forced vital capacity (FVC) (p < 0.01), forced expiratory flow between 25% and 75% of FVC (FEF25-75) (p < 0.0001) and diffusion capacity of the lung (DLCOcSB) (p < 0.05). In addition, in the same period, we also observed significant reductions of airway resistance including total resistance (Rtot) (p < 0.0001) and specific effective resistance (sReff) (p < 0.0001). Other improvements were detected with regard to modified British Medical Research Council (mMRC) questionnaire score (p < 0.0001), COPD Assessment Test (CAT) score (p < 0.0001), and COPD exacerbation rate (p < 0.0001). In particular, the reported changes of mMRC/CAT scores and COPD exacerbation numbers were significantly correlated with UMEC/VI-induced modifications of TLC, RV, FVC and FEV1. Conclusion: In conclusion, our study corroborates in a real-life context the effectiveness of UMEC/VI in COPD treatment. Indeed, our broad investigational strategy has allowed to better characterize the functional mechanisms underpinning the therapeutic properties of UMEC/VI association.

Real-life therapeutic effects of beclomethasone dipropionate/formoterol fumarate/glycopyrronium combined triple therapy in patients with chronic obstructive pulmonary disease.

BACKGROUND: The small airway disease has been recognized as a central feature of chronic obstructive pulmonary disease (COPD). Triple fixed combination beclomethasone dipropionate/formoterol fumarate/glycopyrronium (BDP/FF/G) is provided as a pressurized single-dose inhaler based on an extra-fine formulation, which has been approved for patients with COPD experiencing frequent disease exacerbations. METHODS: The aim of our real-life single-center observational study was to investigate, in 22 patients with COPD, the effects of BDP/FF/G on lung function, respiratory symptoms, health status, and exacerbation rate. Several clinical and lung functional parameters were evaluated at baseline and after 12 months of treatment with combined inhaled triple therapy. RESULTS: With respect to baseline, after 12 months of treatment with BDP/FF/G, significant changes were recorded with regard to forced expiratory flow at 75% of forced vital capacity (FVC) (p < 0.01), forced expiratory flow at 50% of FVC (p < 0.01), forced expiratory flow at 25% of FVC (p < 0.05), and forced mid-expiratory flow between 25% and 75% of FVC (p < 0.01). Moreover, we observed reductions of total resistance (p < 0.01), effective resistance (p < 0.01), and effective specific resistance (p < 0.01). In the same period, residual volume diminished (p < 0.01) and forced expiratory volume in 1 s increased (p < 0.01). Moreover, in a subgroup of 16 patients, an enhancement of diffusion lung capacity (p < 0.01) was also detected. These functional results were paralleled by concomitant clinical effects, as evidenced by the improvements of modified British Medical Research Council (mMRC) dyspnea scale (p < 0.001), COPD Assessment Test (CAT) score (p < 0.0001), and COPD exacerbations (p < 0.0001). CONCLUSION: In conclusion, the valuable findings of our observational study consist in the corroboration in a real-life context of the therapeutic effects evidenced by randomized controlled trials with regard to the use of the triple inhaled BDP/FF/G therapy in patients with COPD.

Albumin administration prevents the onset of pressure ulcers in intensive care unit patients.

Pressure ulcers (PUs) are a common problem in critically ill patients admitted to the intensive care units (ICUs) and they account for more than 70% of patients with low serum albumin at admission. The aim of this study was to test the efficacy of intravenous administration of albumin in patients with low serum albumin < 3·3 g/dl. In a 1-year period, a total of 73 patients were admitted to the ICU (males 45, 61·64% and females 28, 38·36%); of these, 21 patients were admitted with hypoalbuminaemia (serum albumin < 3·3 g/dl) and randomised into two groups: 11 patients were treated with 25 g intravenous albumin for the first 3 days within the first week of ICU stay (group A) and 10 patients did not receive albumin (group B). Three patients (27·27%) showed the onset of PUs in group A, whereas seven patients (70%) showed the onset of PUs within the first 7 days of stay in group B. Moreover, ulcers of group B were more severe than those of group A. This study shows that intravenous administration of albumin reduces the onset of PUs in patients admitted to the ICU and in some cases it also reduces the risk of progression to advanced stages of PUs.

Low serum albumin level as an independent risk factor for the onset of pressure ulcers in intensive care unit patients.

Critically ill patients are at high risk of developing pressure ulcers (PUs) and patients who develop PUs remain significantly longer in the intensive care unit (ICU) with significantly increased morbidity and mortality. Therefore, the identification of patients at truly increased risk is important. The aim of this study was to examine the association of low serum albumin present at admission in ICU patients with the onset of PUs. We conducted a retrospective cohort study on 610 patients who were admitted to intensive care unit. Level of serum albumin and other biochemical indices, recorded at the time of admission, were collected. We collected information about PU occurrence after admission and conducted a statistical analysis with biomarkers at ICU admission and during hospital stay. The incidence of PU in the ICUs was 31% and about 70% of patients with PUs had hypoalbuminemia at admission. The lowest values of serum albumin in patients with PUs were directly proportional to the severity of ulcers. In this study, we found a close association between serum albumin and PUs. In fact serum albumin was negatively correlated with PU and may be considered one of the independent determinants of PU occurrence in patients admitted to ICUs.

Coupled plasma filtration adsorption reduces serum bilirubine in a case of acute hypoxic hepatitis secondary to cardiogenic shock.

Hypoxic hepatitis (HH) is a severe complication of postoperative low output syndrome, associated with high mortality rates despite appropriate drug therapy. Recently several extracorporeal supportive techniques have become available. We describe the case of a 70-year-old woman who developed HH secondary to cardiogenic shock after cardiac surgery. CPFA proved to be a valid tool for concomitant hemodynamic support and organ replacement therapy.

Trastuzumab plus weekly epirubicin and paclitaxel for locally advanced and metastatic breast cancer: preliminary results of a feasibility-phase II study aimed at cardiotoxicity.

A feasibility-phase II study was conducted to assess the cardiotoxicity of weekly trastuzumab, epirubicin, and paclitaxel in patients with human epidermal growth factor receptor-2-positive metastatic breast cancer. Untreated patients with human epidermal growth factor receptor-2-positive advanced breast cancer received trastuzumab (day 1), and epirubicin (25 mg/m2) and paclitaxel (80 mg/m2) (day 2) on a weekly basis. The rate of patients with left-ventricular ejection fraction (L-VEF) reduction greater than 10% after 12 weeks was the primary end point. According to a two-stage model, an initial step with 15 patients was required; after 11 patients without toxicity, a second step with 21 patients was planned. After 255 courses in 15 patients (median treatment weeks: 18), the relative dose intensity was 94.7%. At 12 weeks, three patients (20%) displayed a L-VEF reduction greater than 10%, six and six (40%) patients showed a L-VEF reduction < or =10% or no change, respectively. Baseline, -12 weeks, and -24 weeks median L-VEF was 69% (range 61-77), 65% (range 60-76), and 65% (range 55-73), respectively. No EKG/cardiac signs were present. Thirteen patients had grade 3 alopecia and two patients had grade 3 asthenia, in the absence of severe hematological toxicity. Objective responses were observed in 11 patients (73.3%, 95% confidence interval 51.0-95.7), with 10 partial. The weekly administration of trastuzumab-epirubicin-paclitaxel is extremely tolerable, also with regard to L-VEF reduction. These results allowed entrance to the second step of the study.