Prognostic Properties of the GOLD 2023 Classification System

Kristian Brat,1– 3 Michal Svoboda,4 Jaromir Zatloukal,5,6 Marek Plutinsky,1,2 Eva Volakova,5,6 Patrice Popelkova,7,8 Barbora Novotna,9 Tomas Dvorak,10 Vladimir Koblizek11,12 1Department of Respiratory Diseases, University Hospital Brno, Brno, Czech Republic; 2Faculty of Medicine, Masaryk University, Brno, Czech Republic; 3International Clinical Research Center, St. Anne’s University Hospital, Brno, Czech Republic; 4Institute of Biostatistics and Analyses, Ltd., Brno, Czech Republic; 5Pulmonary Department, University Hospital Olomouc, Olomouc, Czech Republic; 6Faculty of Medicine, Palacky University, Olomouc, Czech Republic; 7Pulmonary Department, University Hospital Ostrava, Ostrava, Czech Republic; 8Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic; 9Pulmonary Department, Bulovka Hospital, Prague, Czech Republic; 10Pulmonary Department, Mlada Boleslav Hospital, Mlada Boleslav, Czech Republic; 11Pulmonary Department, University Hospital Hradec Kralove, Hradec Kralove, Czech Republic; 12Faculty of Medicine in Hradec Kralove, Charles University, Hradec Kralove, Czech RepublicCorrespondence: Kristian Brat, Department of Respiratory Diseases, University Hospital Brno and Faculty of Medicine, Masaryk University, Jihlavska street 20, Brno, 62500, Czech Republic, Tel +420 532 232 556, Email [email protected]: Recently, the Global Initiative for Chronic Obstructive Lung Disease (GOLD) has published an update on the Global Strategy for Prevention, Diagnosis and Management of COPD, introducing a new classification of chronic obstructive pulmonary disease (COPD). Our aim was to assess the prognostic value of the new GOLD classification system in comparison with the previous GOLD classification systems (GOLD stages I–IV and GOLD groups A-D) and the BODE index.Methods: We used the data of 784 patients with COPD from the Czech Multicenter Research Database of COPD. Patient survival was analyzed with the use of Kaplan–Meier estimate and Cox model of proportional risks. ROC analysis and area under curve (AUC) were used for comparison of GOLD classifications and BODE index. The analyses were performed with the use of software R (version 4.2.0).Results: We analyzed data of 782 patients with complete data on GOLD classifications. The study population comprised 72.9% of men, 89.1% current or former smokers, with a mean age of 66.6 years, a mean BMI of 27.4 and a mean FEV1 44.9% of predicted. Probability of 5-year survival differed by GOLD classification. Application of the 2023 GOLD classification showed increased risk of death in group B (HR 1.82, 95% CI 1.14– 2.92; p = 0.013) and in group E (HR 2.48, 95% CI 1.54– 3.99; p˂0.001). The ROC analysis showed that the overall prognostic value of the 2023 GOLD classification was similarly weak to previous A-D GOLD classification schemes (AUCs 0.557– 0.576) and was lower compared to the GOLD 1– 4 system (AUC 0.614) and even lower when compared to the BODE index (AUC 0.715).Conclusion: We concluded that the new GOLD classification system has poor prognostic properties and that specific prediction tools (eg, the BODE index) should be used for mortality risk assessment.Keywords: GOLD classification, COPD, mortality, prognosi

Respiratory parameters predict poor outcome in COPD patients, category GOLD 2017 B

Kristian Brat,1 Marek Plutinsky,1 Karel Hejduk,2 Michal Svoboda,2 Patrice Popelkova,3 Jaromir Zatloukal,4 Eva Volakova,4 Miroslava Fecaninova,5 Lucie Heribanova,6 Vladimir Koblizek7 1Department of Respiratory Diseases, Faculty of Medicine, University Hospital Brno, Masaryk University, Brno, Czech Republic; 2Faculty of Medicine, Institute of Biostatistics and Analyses, Masaryk University, Brno, Czech Republic; 3Pulmonary Department, University Hospital, Ostrava, Czech Republic; 4Pulmonary Department, University Hospital, Olomouc, Czech Republic; 5Department of Pneumology, Bulovka Hospital, Prague, Czech Republic; 6Department of Respiratory Medicine, Thomayer Hospital, Prague, Czech Republic; 7Pulmonary Department, Faculty of Medicine in Hradec Kralove, University Hospital Hradec Kralove, Charles University, Hradec Kralove, Czech Republic Background: Respiratory parameters are important predictors of prognosis in the COPD population. Global Initiative for Obstructive Lung Disease (GOLD) 2017 Update resulted in a vertical shift of patients across COPD categories, with category B being the most populous and clinically heterogeneous. The aim of our study was to investigate whether respiratory parameters might be associated with increased all-cause mortality within GOLD category B patients. Methods: The data were extracted from the Czech Multicentre Research Database, a prospective, noninterventional multicenter study of COPD patients. Kaplan–Meier survival analyses were performed at different levels of respiratory parameters (partial pressure of oxygen in arterial blood [PaO2], partial pressure of arterial carbon dioxide [PaCO2] and greatest decrease of basal peripheral capillary oxygen saturation during 6-minute walking test [6-MWT]). Univariate analyses using the Cox proportional hazard model and multivariate analyses were used to identify risk factors for mortality in hypoxemic and hypercapnic individuals with COPD. Results: All-cause mortality in the cohort at 3 years of prospective follow-up reached 18.4%. Chronic hypoxemia (PaO2 <7.3 kPa), hypercapnia (PaCO2 >7.0 kPa) and oxygen desaturation during the 6-MWT were predictors of long-term mortality in COPD patients with forced expiratory volume in 1 second ≤60% for the overall cohort and for GOLD B category patients. Univariate analyses confirmed the association among decreased oxemia (<7.3 kPa), increased capnemia (>7.0 kPa), oxygen desaturation during 6-MWT and mortality in the studied groups of COPD subjects. Multivariate analysis identified PaO2 <7.3 kPa as a strong independent risk factor for mortality. Conclusion: Survival analyses showed significantly increased all-cause mortality in hypoxemic and hypercapnic GOLD B subjects. More important, PaO2 <7.3 kPa was the strongest risk factor, especially in category B patients. In contrast, the majority of the tested respiratory parameters did not show a difference in mortality in the GOLD category D cohort. Keywords: mortality, hypoxemia, hypercapnia, COPD, GOLD 2017 updat

FOCUS 1: a randomized, double-blinded, multicentre, Phase III trial of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in community-acquired pneumonia

International audienc

Serious Asthma Events with Fluticasone plus Salmeterol versus Fluticasone Alone

BACKGROUND: The safe and appropriate use of long-acting beta-agonists (LABAs) for the treatment of asthma has been widely debated. In two large clinical trials, investigators found a potential risk of serious asthma-related events associated with LABAs. This study was designed to evaluate the risk of administering the LABA salmeterol in combination with an inhaled glucocorticoid, fluticasone propionate. METHODS: In this multicenter, randomized, double-blind trial, adolescent and adult patients (age, ≥12 years) with persistent asthma were assigned to receive either fluticasone with salmeterol or fluticasone alone for 26 weeks. All the patients had a history of a severe asthma exacerbation in the year before randomization but not during the previous month. Patients were excluded from the trial if they had a history of life-threatening or unstable asthma. The primary safety end point was the first serious asthma-related event (death, endotracheal intubation, or hospitalization). Noninferiority of fluticasone-salmeterol to fluticasone alone was defined as an upper boundary of the 95% confidence interval for the risk of the primary safety end point of less than 2.0. The efficacy end point was the first severe asthma exacerbation. RESULTS: Of 11,679 patients who were enrolled, 67 had 74 serious asthma-related events, with 36 events in 34 patients in the fluticasone-salmeterol group and 38 events in 33 patients in the fluticasone-only group. The hazard ratio for a serious asthma-related event in the fluticasone-salmeterol group was 1.03 (95% confidence interval [CI], 0.64 to 1.66), and noninferiority was achieved (P=0.003). There were no asthma-related deaths; 2 patients in the fluticasone-only group underwent asthma-related intubation. The risk of a severe asthma exacerbation was 21% lower in the fluticasone-salmeterol group than in the fluticasone-only group (hazard ratio, 0.79; 95% CI, 0.70 to 0.89), with at least one severe asthma exacerbation occurring in 480 of 5834 patients (8%) in the fluticasone-salmeterol group, as compared with 597 of 5845 patients (10%) in the fluticasone-only group (P<0.001). CONCLUSIONS: Patients who received salmeterol in a fixed-dose combination with fluticasone did not have a significantly higher risk of serious asthma-related events than did those who received fluticasone alone. Patients receiving fluticasone-salmeterol had fewer severe asthma exacerbations than did those in the fluticasone-only group