scholarly journals Effect of smoking status on lung function, patient-reported outcomes, and safety among COPD patients treated with glycopyrrolate inhalation powder: pooled analysis of GEM1 and GEM2 studies

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Donald P. Tashkin ◽  
Thomas Goodin ◽  
Alyssa Bowling ◽  
Barry Price ◽  
Ayca Ozol-Godfrey ◽  
...  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Daniel J. Weiss ◽  
Karen Segal ◽  
Richard Casaburi ◽  
Jack Hayes ◽  
Donald Tashkin

Abstract Background We previously reported a Phase 1/2 randomized placebo-controlled trial of systemic administration of bone marrow-derived allogeneic MSCs (remestemcel-L) in COPD. While safety profile was good, no functional efficacy was observed. However, in view of growing recognition of effects of inflammatory environments on MSC actions we conducted a post-hoc analysis with stratification by baseline levels of a circulating inflammatory marker, C-reactive protein (CRP) to determine the effects of MSC administration in COPD patients with varying circulating CRP levels. Methods Time course of lung function, exercise performance, patient reported responses, and exacerbation frequency following four monthly infusions of remestemcel-L vs. placebo were re-assessed in subgroups based on baseline circulating CRP levels. Results In COPD patients with baseline CRP ≥ 4 mg/L, compared to COPD patients receiving placebo (N = 17), those treated with remestemcel-L (N = 12), demonstrated significant improvements from baseline in forced expiratory volume in one second, forced vital capacity, and six minute walk distance at 120 days with treatment differences evident as early as 10 days after the first infusion. Significant although smaller benefits were also detected in those with CRP levels ≥ 2 or ≥ 3 mg/L. These improvements persisted variably over the 2-year observational period. No significant benefits were observed in patient reported responses or number of COPD exacerbations between treatment groups. Conclusion In an inflammatory environment, defined by elevated circulating CRP, remestemcel-L administration yielded at least transient meaningful pulmonary and functional improvements. These findings warrant further investigation of potential MSC-based therapies in COPD and other inflammatory pulmonary diseases. Trial registration: Clinicaltrials.gov NCT00683722.


2021 ◽  
Vol 141 (9) ◽  
pp. B12
Author(s):  
J. Harper ◽  
A. Armstrong ◽  
R. Fried ◽  
E. Rieder ◽  
A. Alvarez-Dieppa ◽  
...  

2021 ◽  
Vol 162 (5) ◽  
pp. 185-191
Author(s):  
Mónika Fekete ◽  
Vince Fazekas-Pongor ◽  
Gergő Szőllősi ◽  
János Tamás Varga

Összefoglaló. Bevezetés: Krónikus obstruktív tüdőbetegségben (COPD) az obesitas mellett a csökkent fizikai aktivitás nagymértékben fokozza a metabolikus szindróma kialakulásának valószínűségét. Célkitűzés: Kutatásunk célja volt felmérni a metabolikus szindróma prevalenciáját COPD-ben, valamint azt, hogy milyen mértékben függ össze az életkorral, a nemmel, a társbetegségekkel, a tüdőfunkció károsodásának mértékével, a tápláltsági állapottal, a fizikai terhelhetőséggel és az életminőséggel. Módszer: Keresztmetszeti vizsgálatot végeztünk az Országos Korányi Pulmonológiai Intézet Légzésrehabilitációs Osztályán fekvő betegek körében 2019. július 1. és december 31. között. A véletlenszerűen kiválasztott 300, 40 év feletti betegnek ismertük az antropometriai, légzésfunkciós vizsgálati eredményét és laboratóriumi paramétereit. Adatokat gyűjtöttünk a dohányzási szokásokról, az előző évi exacerbatiók számáról és a kortikoszteroidok használatáról is. Az életminőség mérésére a betegségspecifikus Szent György-féle Légzési Kérdőív magyar nyelvre validált változatát használtuk. A metabolikus szindrómát a Nemzetközi Diabetes Szövetség kritériumai alapján határoztuk meg. Eredmények: A metabolikus szindróma a betegek 72%-ánál fordult elő, férfi: 65,9% nő: 77,2% (p = 0,031). A metabolikus szindrómás betegek esetében rövidebb 6 perces sétatávolságot mértünk ([m] 250 [150–330] vs. 295 [162–360]; p = 0,384), és szignifikánsan több volt az előző évi exacerbatiók száma (3 [0–6] vs. 1 [1–2]; p<0,001) a nem metabolikus szindrómás betegekhez képest. A BMI-re történő stratifikáció után a metabolikus szindróma jelenléte nagyobb volt BMI≥25 kg/m2 esetén. A hasi elhízás, a magas vérnyomás, a hyperlipidaemia és a hyperglykaemia szignifikánsan gyakoribb volt BMI≥25 kg/m2 esetén (p<0,001). Következtetés: Eredményeink azt sugallják, hogy a metabolikus szindrómás betegekben megnő az együttes morbiditási index, különösen azok körében, akik túlsúlyosak vagy elhízottak. Ezért a COPD-s betegekben nagyon fontos időben felismerni és megfelelően kezelni a metabolikus szindrómát. Orv Hetil. 2021; 162(5): 185–191. Summary. Introduction: Both obesity and the lack of physical activity among chronic obstructive pulmonary disease (COPD) patients increase the risk of developing metabolic syndrome. Objective: The goal of our study was to assess the prevalence of metabolic syndrome among COPD patients and to examine its correlation with age, gender, comorbidities, lung function values, nutritional status, exercise capacity, and quality of life. Method: A cross-sectional study was performed at the Department of Pulmonary Rehabilitation of the Hungarian National Korányi Institute for Pulmonology between July 1st and December 31st, 2019. A total of 300 patients aged over 40 were selected at random. Anthropometric data were collected along with lung function values, laboratory parameters, smoking status, the number of exacerbations in the previous year, and the use of corticosteroids. Quality of life was measured by the validated Hungarian, COPD-specific Saint George Respiratory Questionnaire. Metabolic syndrome was defined according to the International Diabetes Federation criteria. Results: Metabolic syndrome affected 72% of COPD patients (male: 65.9%, female 77.2%; p = 0.031). In patients with metabolic syndrome, shorter 6-minute walking distance was measured ([m] 250 [150–330] vs. 295 [162–360]; p = 0.384) and the number of exacerbations in the previous year was significantly higher (3 [0–6] vs. 1 [1–2]; p<0.001) compared to patients with no metabolic syndrome. After stratification for BMI, metabolic syndrome was more frequent in the case of BMI≥25 kg/m2. Central adiposity, hypertension, hyperlipidemia, and hyperglycemia were also significantly more frequent among patients with BMI≥25 kg/m2 (p<0.001). Conclusion: Our results suggest that the co-morbidity index increases in patients with metabolic syndrome, especially in overweight or obese patients. Therefore, early detection and appropriate treatment of metabolic syndrome in patients with COPD is very important. Orv Hetil. 2021; 162(5): 185–191.


2020 ◽  
Author(s):  
Iva Hlapčić ◽  
Andrea Hulina-Tomašković ◽  
Marija Grdić Rajković ◽  
Sanja Popović-Grle ◽  
Andrea Vukić Dugac ◽  
...  

Abstract Background: Extracellular heat shock protein 70 (eHsp70) acts like a damage-associated molecular pattern (DAMP) and it might modulate immune responses in patients with chronic obstructive pulmonary disease (COPD). The aim of the study was to explore plasma eHsp70 concentration in patients with stable COPD, its association with disease severity and smoking status as well as its diagnostic performance in COPD assessment.Methods: Blood samples were collected from 137 COPD patients and 95 healthy individuals. COPD patients were subdivided into GOLD 2-4 stages based on airflow obstruction severity and GOLD A-D groups regarding symptoms and exacerbations. Concentration of eHsp70 was assessed in EDTA plasma by the commercially available ELISA kit. Statistic analysis was performed by MedCalc statistical software.Results: eHsp70 concentration was increased in COPD patients when compared to controls and was increasing with the severity of airflow limitation as well as symptoms burden and exacerbation history. There were no differences in eHsp70 concentrations among COPD patients based on smoking status, yet eHsp70 was increased in healthy smokers compared to healthy non-smokers. Interestingly, healthy smokers had similar eHsp70 level as COPD patients in GOLD 2 stage and those in GOLD A group. In addition, eHsp70 showed significant negative correlation with lung function parameters FEV1 and FEV1/FVC and positive correlation with COPD multicomponent indices BODCAT, BODEx, CODEx and DOSE. Finally, eHsp70 showed great predictive value (OR=7.63) and correctly classified 76% of cases.Conclusions: Plasma eHsp70 is associated with COPD prediction and disease severity and might have a potential of becoming an additional biomarker in COPD assessment.


2019 ◽  
Vol 10 (7) ◽  
pp. 832-836 ◽  
Author(s):  
Leah Y. Carreon ◽  
Erica F. Bisson ◽  
Eric A. Potts ◽  
Morgan E. Brown ◽  
Stacie Gren ◽  
...  

Study Design: Longitudinal cohort. Objective: It is unclear if patients with a recurrent disc herniation benefit from a concurrent fusion compared with a repeat decompression alone. We compared outcomes of decompression alone (D0) versus decompression and fusion (DF) for recurrent disc herniation. Methods: Patients enrolled in the Quality and Outcomes Database from 3 sites with a first episode of recurrent disc herniation were identified. Demographic, surgical, and radiographic data including the presence of listhesis and extent of facet resection on computed tomography or magnetic resonance imaging prior to the index surgery were collected. Patient-reported outcomes were collected preoperatively and at 3 and 12 months postoperatively. Results: Of 94 cases identified, 55 had D0 and 39 had DF. Patients were similar in age, sex distribution, smoking status, body mass index, American Society of Anesthesiologists grade and surgical levels. Presence of listhesis (D0 = 7, DF = 5, P = .800) and extent of facet resection (D0 = 19%, DF = 16%, P = .309) prior to index surgery were similar between the 2 groups. Estimated blood loss (D0 = 26 cm3, DF = 329 cm3, P < .001), operating room time (D0 = 79 minutes, DF = 241 minutes, P < .001) and length of stay (D0 <1 day, DF = 4 days, P < .001) were significantly less in the D0 group. Preoperative and 1-year postoperative patient-reported outcomes were similar in both groups. Three patients in the D0 group and 2 patients in the DF group required revision. Regression analysis showed that presence of listhesis, extent of facet resection and fusion were not associated with the 12-month Oswestry Disability Index (ODI) score. Conclusion: For a first episode recurrent disc herniation, surgeons can expect similar outcomes whether patients are treated with decompression alone or decompression and fusion.


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