Risk factors for exacerbations and pneumonia in patients with chronic obstructive pulmonary disease: a pooled analysis.

BACKGROUND: Patients with chronic obstructive pulmonary disease (COPD) are at risk of exacerbations and pneumonia; how the risk factors interact is unclear. METHODS: This post-hoc, pooled analysis included studies of COPD patients treated with inhaled corticosteroid (ICS)/long-acting β2 agonist (LABA) combinations and comparator arms of ICS, LABA, and/or placebo. Backward elimination via Cox's proportional hazards regression modelling evaluated which combination of risk factors best predicts time to first (a) pneumonia, and (b) moderate/severe COPD exacerbation. RESULTS: Five studies contributed: NCT01009463, NCT01017952, NCT00144911, NCT00115492, and NCT00268216. Low body mass index (BMI), exacerbation history, worsening lung function (Global Initiative for Chronic Obstructive Lung Disease [GOLD] stage), and ICS treatment were identified as factors increasing pneumonia risk. BMI was the only pneumonia risk factor influenced by ICS treatment, with ICS further increasing risk for those with BMI <25 kg/m2. The modelled probability of pneumonia varied between 3 and 12% during the first year. Higher exacerbation risk was associated with a history of exacerbations, poorer lung function (GOLD stage), female sex and absence of ICS treatment. The influence of the other exacerbation risk factors was not modified by ICS treatment. Modelled probabilities of an exacerbation varied between 31 and 82% during the first year. CONCLUSIONS: The probability of an exacerbation was considerably higher than for pneumonia. ICS reduced exacerbations but did not influence the effect of risks associated with prior exacerbation history, GOLD stage, or female sex. The only identified risk factor for ICS-induced pneumonia was BMI <25 kg/m2. Analyses of this type may help the development of COPD risk equations

Efficacy and safety of 4 weeks' treatment with combined fluticasone furoate/vilanterol in a single inhaler given once daily in COPD: a placebo-controlled randomised trial

Background: Fluticasone furoate/vilanterol (FF/VI) is a novel once-daily (OD) inhaled corticosteroid/long-acting beta(2) agonist combination in development for chronic obstructive pulmonary disease (COPD) and asthma. Trial design: A multicentre, randomised, double-blind, parallel-group, placebo-controlled study. Methods: Participants were patients with moderate-to-severe COPD treated with placebo or FF/VI 400/25 mu g OD for 4 weeks. Study objectives were to assess the safety and efficacy of FF/VI 400/25 mg OD administered for 4 weeks via a novel dry powder inhaler. Co-primary end points were change from baseline in weighted mean (wm) heart rate 0-4 h postdose at day 28 and the incidence of adverse events (AEs). Secondary end points included change from baseline in trough forced expiratory volume in one second (FEV1) (23-24 h postdose; day 29) and wm FEV1 (0-4 h postdose; day 28). Patients were randomised to receive FF/VI 400/25 mg or placebo in a 2: 1 ratio; all patients and investigators were blinded to active or placebo treatment. Results: 60 patients (mean age 64 years) were randomised (FF/VI: n=40; placebo: n=20), and all contributed data to the analysis. Mean screening post-bronchodilator FEV1 per cent predicted was comparable between groups (FF/VI: 58.5%; placebo: 60.1%). The wm heart rate 0-4 h postdose was similar between groups (difference: 0.6 beats per minute; 95% CI -3.9 to 5.1). More on-treatment AEs were reported in the FF/VI group (68%) compared with the placebo group (50%). The most common drug-related AEs in the FF/VI group were oral candidiasis (8%) and dysphonia (5%). There were no clinically relevant effects on laboratory values, including glucose and potassium, or on vital signs or ECGs/Holters. The FF/VI group had statistically greater improvements compared with placebo in trough FEV1 (mean difference 183 ml) and 0-4 h postdose wm FEV1 (mean difference 236 ml). Conclusion: FF/VI has a good safety and tolerability profile and improves lung function compared with placebo in patients with COPD. Trial registration number: clinical trials. gov-NCT00731822

Comparison of Calorie Counting vs. Self Evaluation Methodology for Weight Loss

INTRODUCTION: Obesity is a major health concern in the United States and one way to control it is through proper nutrition techniques (BRFSS, 2007, 2009). One technique, calorie counting, is used to control energy intake. Mindful eating, another technique, requires individuals to understand and interpret internal cues that control hunger (Timmerman, 2012). Smartphone applications have been created in order to facilitate these two techniques. Although both techniques have been proven efficacious in specific settings, the two techniques when supported by digital applications have never been compared. The purpose of this study was to analyze the effectiveness of digital support in both methodologies for weight loss and compare their effectiveness to each other. METHODS: 39 adults (36 female) were recruited, 27 of which completed the post test. Inclusion criteria was BMI of \u3e/=25, between and 18 and 80, free of major disease, not currently pregnant, own and use and smart phone, and not currently following an established weight loss regimen. All participants were randomly assigned into four groups: 1-Mindful Eating, 2-Mindful Eating with the Healthy Bytes digital application, 3- Calorie Control through MyPlate Portions, and 4-Calorie Control with Myfitnesspal digital application. Each individual received education based on the group they were placed in. Participants were asked to implement their assigned weight loss plan for four weeks. Pre and post assessments included weight, height, BMI, blood pressure, waist to hip ratio, fasting glucose levels, fasting total cholesterol, and body composition for every participant. RESULTS: A repeated measure ANOVA revealed that only Group 4 had a significant decrease in weight loss (p=0.032). One-way ANOVA‘s were used to compare between group differences for changes in assessed variables. These analyses showed significantly greater decreases in BMI and diastolic BP in Group 4 than the other three groups (p=0.017; p=.009). Group 3 showed a significant increase in diastolic BP when compared to the other groups (p=.033). No other significant differences were detected. CONCLUSION: A combination of portion size education and an electronic medium for calorie counting was the superior weight loss technique compared to portion education alone without an app to log calories. While a larger sample size and a longer duration would have been beneficial, there is evidence that continuing to educate the American public on portion sizes and appropriate caloric intake is important for combating the obesity epidemic

Efficacy and safety of once-daily fluticasone furoate/vilanterol (100/25 mcg) versus twice-daily fluticasone propionate/salmeterol (250/50 mcg) in COPD patients

SummaryBackgroundFluticasone furoate/vilanterol (FF/VI) is an inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA), recently approved as once-daily maintenance therapy for COPD. We compared the lung function effects of FF/VI with those of twice-daily fluticasone propionate/salmeterol (FP/SAL).MethodsThree 12 week studies comparing FF/VI and FP/SAL were conducted. Patients aged ≥40 years with moderate-to-very severe COPD were randomized to receive double-blind, double-dummy FF/VI 100/25 mcg once-daily, or FP/SAL 250/50 mcg twice-daily for 12 weeks following a 2 week placebo run-in period. The primary endpoint of each study was change from baseline trough in 0–24 h weighted mean FEV1 (wmFEV1) on Day 84. Safety was also assessed.ResultsIn Study 1 (HZC113109) (intent-to-treat n: FF/VI = 260; FP/SAL = 259), the increase from baseline in 0–24 h wmFEV1 was significantly greater with FF/VI than FP/SAL (Δ80 mL, P < 0.001). In Study 2 (HZC112352) (intent-to-treat n: FF/VI = 259; FP/SAL = 252) and Study 3 (RLV116974) (intent-to-treat n: FF/VI = 412; FP/SAL = 416), the increase from baseline in 0–24 h wmFEV1 was not significantly greater with FF/VI than FP/SAL (Δ29 mL, P = 0.267; Δ25 mL, P = 0.137). The treatment difference was statistically but not clinically significant in a pooled analysis (Δ41 mL, P < 0.001). Pooled adverse events (FF/VI 27%; FP/SAL 28%) and serious adverse events (FF/VI 2%; FP/SAL 3%) were similar between treatments.ConclusionsOur data suggest that once-daily FF/VI 100/25 mcg provides FEV1 improvement in COPD that is at least comparable with that conferred by twice-daily FP/SAL 250/50 mcg, although interpretation is limited by differences in individual study outcomes. The safety profiles of FF/VI 100/25 mcg and FP/SAL 250/50 mcg are similar.Clinical trial registrationclinicaltrials.gov: NCT01323634; NCT01323621; NCT01706328. GlaxoSmithKline study codes: HZC113109; HZC112352; RLV116974

Efficacy and safety of 4 weeks' treatment with combined fluticasone furoate/vilanterol in a single inhaler given once daily in COPD: a placebo-controlled randomised trial

Background. Fluticasone furoate/vilanterol (FF/VI) is a novel once-daily (OD) inhaled corticosteroid/long-acting β2 agonist combination in development for chronic obstructive pulmonary disease (COPD) and asthma. Trial design. A multicentre, randomised, double-blind, parallel-group, placebo-controlled study. Methods. Participants were patients with moderate-to-severe COPD treated with placebo or FF/VI 400/25 μg OD for 4 weeks. Study objectives were to assess the safety and efficacy of FF/VI 400/25 μg OD administered for 4 weeks via a novel dry powder inhaler. Co-primary end points were change from baseline in weighted mean (wm) heart rate 0–4 h postdose at day 28 and the incidence of adverse events (AEs). Secondary end points included change from baseline in trough forced expiratory volume in one second (FEV1) (23–24 h postdose; day 29) and wm FEV1 (0–4 h postdose; day 28). Patients were randomised to receive FF/VI 400/25 μg or placebo in a 2:1 ratio; all patients and investigators were blinded to active or placebo treatment. Results. 60 patients (mean age 64 years) were randomised (FF/VI: n=40; placebo: n=20), and all contributed data to the analysis. Mean screening post-bronchodilator FEV1 per cent predicted was comparable between groups (FF/VI: 58.5%; placebo: 60.1%). The wm heart rate 0–4 h postdose was similar between groups (difference: 0.6 beats per minute; 95% CI −3.9 to 5.1). More on-treatment AEs were reported in the FF/VI group (68%) compared with the placebo group (50%). The most common drug-related AEs in the FF/VI group were oral candidiasis (8%) and dysphonia (5%). There were no clinically relevant effects on laboratory values, including glucose and potassium, or on vital signs or ECGs/Holters. The FF/VI group had statistically greater improvements compared with placebo in trough FEV1 (mean difference 183 ml) and 0–4 h postdose wm FEV1 (mean difference 236 ml). Conclusion. FF/VI has a good safety and tolerability profile and improves lung function compared with placebo in patients with COPD.publishedVersio

IDENTIFICAZIONE DELLE LESIONI POLMONARI IN RM CON UNA SEQUENZA VIBE MODIFICATA E CON UNA SEQUENZA VIBE STANDARD: UN CONFRONTO CON LA TC.

Scopo valutare l\u2019accuratezza della RM a 3 Tesla nell\u2019individuazione di lesioni polmonari con una sequenza VIBE modificata e con una sequenza VIBE standard, usando la TC come riferimento. Materiale e metodi abbiamo rivalutato retrospettivamente 37 pazienti oncologici (11 pediatrici e 26 adulti; 19 F) sottoposti a TC e PET/RM da 3T il cui protocollo prevedeva una sequenza VIBE acquisita a respiro trattenuto con echo time (TE) di 0.89 ms e flip angle (FA) di 3\ub0. Le VIBE sono state valutate da tre osservatori per l'identificazione di noduli >5mm o =5mm. Un quarto osservatore ha valutato delle sequenze VIBE standard (TE di 1.2 ms e FA di 10\ub0), anch\u2019esse incluse nel protocollo, ed infine un quinto lettore ha analizzato le immagini TC (considerate come standard di riferimento).Sia per paziente che per singola lesione sono state calcolate sensibilit\ue0 e specificit\ue0 per le due categorie di noduli ed il coefficiente di correlazione intraclasse (ICC) per i lettori delle VIBE modificate. Risultati analisi per paziente (positivit\ue0=1 lesione): sensibilit\ue0 84.6% e specificit\ue0 di 100% per noduli>5mm (VIBE standard 69.2% e 100%) e 44.4% e 100% per noduli=5mm (VIBE standard 33.3% e 100%). Analisi per lesione (presenza/assenza): sensibilit\ue0 di 83.9% per noduli>5mm (VIBE standard 67.74%) e 37.5% per noduli=5mm (VIBE standard 18.7%). L\u2019ICC nell\u2019analisi per paziente era 0.911 per noduli>5mm e 0.902 per noduli=5mm; nell\u2019analisi per lesione 0.866 per noduli>5mm e 0.699 per noduli=5mm. Conclusioni la sequenza VIBE modificata \ue8 riproducibile ed accurata per l\u2019individuazione di noduli >5mm, mentre l\u2019accuratezza risulta meno soddisfacente per i noduli=5mm. L\u2019utilizzo della sequenza modificata nei protocolli RM sembra ragionevole per migliorare la visualizzazione del polmone

Low forced expiratory volume is associated with blunted cardiac reactions to acute psychological stress in a community sample of middle-aged men and women

It has been argued recently that blunted cardiovascular reactions to acute psychological stress have adverse behavioural and health corollaries that reflect dysregulation of the neural systems that support motivation. We examined the association between cardiovascular reactions to a standard stress task, the paced auditory serial arithmetic rest, and forced expiratory volume in one second, an effort, hence motivation, dependent assessment of lung function measured by spirometry. Low forced expiratory volume, expressed as a ratio to height squared was associated with blunted heart rate, but not blood pressure, stress reactivity, r = .17, p &#60; .001. The association survived adjustment for smoking, a range of anthropometric and sociodemographic covariates, resting heart rate and stress task performance, β = .11, p = .005. As such, our results provide support for the hypothesis that blunted stress reactivity may be a peripheral marker of a dysfunction in the brain systems that support motivated behaviour