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7. Burden of Uncontrolled Severe Asthma With and Without Elevated Type-2 Inflammatory Biomarkers

Author

del Olmo, Ricardo, Anderson, Gary, Reddel, Helen, Rabahi, Marcelo, McIvor, Andrew, Sadatsafavi, Mohsen, Weinreich, Ulla, Burgel, Pierre-Régis, Devouassoux, Gilles, Papi, Alberto, Inoue, Hiromasa, Rendon, Adrián, van den Berge, Maarten, Beasley, Richard, García-Navarro, Alvar Agusti, Faner, Rosa, Rivera, José Olaguibel, Janson, Christer, Bilińska-Izydorczyk, Magdalena, Fagerås, Malin, Fihn-Wikander, Titti, Franzén, Stefan, Keen, Christina, Ostridge, Kristoffer, Chalmers, James, Harrison, Timothy, Pavord, Ian, Price, David, Azim, Adnan, Belton, Laura, Blé, Francois-Xavier, Erhard, Clement, Gairy, Kerry, Hughes, Rod, Lassi, Glenda, Müllerová, Hana, Rapsomaniki, Eleni, Scott, Ian Christopher, Chipps, Bradley, Christenson, Stephanie, Make, Barry, Tomaszewski, Erin, Benhabib, Gabriel, Ruiz, Xavier Bocca, Lisanti, Raul Eduardo, Marino, Gustavo, Mattarucco, Walter, Nogueira, Juan, Parody, Maria, Pascale, Pablo, Rodriguez, Pablo, Silva, Damian, Svetliza, Graciela, Victorio, Carlos F., Rolon, Roxana Willigs, Yañez, Anahi, Baines, Stuart, Bowler, Simon, Bremner, Peter, Bull, Sheetal, Carroll, Patrick, Chaalan, Mariam, Farah, Claude, Hammerschlag, Gary, Hancock, Kerry, Harrington, Zinta, Katsoulotos, Gregory, Kim, Joshua, Langton, David, Lee, Donald, Peters, Matthew, Prassad, Lakshman, Sajkov, Dimitar, Santiago, Francis, Simpson, Frederick Graham, Tai, Sze, Thomas, Paul, Wark, Peter, Delfini Cançado, José Eduardo, Cunha, Thúlio, Lima, Marina, Cardoso, Alexandre Pinto, FitzGerald, J. Mark, Anees, Syed, Bertley, John, Bell, Alan, Cheema, Amarjit, Chouinard, Guy, Csanadi, Michael, Dhar, Anil, Dhillon, Ripple, Kanawaty, David, Kelly, Allan, Killorn, William, Landry, Daniel, Luton, Robert, Mandhane, Piushkumar, Pek, Bonavuth, Petrella, Robert, Stollery, Daniel, Wang, Chen, Chen, Meihua, Chen, Yan, Gu, Wei, Christopher Hui, Kim Ming, Li, Manxiang, Li, Shiyue, Lijun, Ma, Qin, Guangyue, Song, Weidong, Tan, Wei, Tang, Yijun, Wang, Tan, Wen, Fuqiang, Wu, Feng, Xiang, PingChao, Xiao, Zuke, Xiong, Shengdao, Yang, Jinghua, Yang, Jingping, Zhang, Caiqing, Zhang, Min, Zhang, Ping, Zhang, Wei, Zheng, Xiaohe, Zhu, Dan, Bueno, Carlos Matiz, Grimaldos, Fabio Bolivar, Arboleda, Alejandra Cañas, Molina de Salazar, Dora, Bendstrup, Elisabeth, Hilberg, Ole, Kjellerup, Carsten, Raherison, Chantal, Bonniaud, Philippe, Brun, Olivier, Chouaid, Christos, Couturaud, Francis, de Blic, Jacques, Debieuvre, Didier, Delsart, Dominique, Demaegdt, Axelle, Demoly, Pascal, Deschildre, Antoine, Egron, Carole, Falchero, Lionel, Goupil, François, Kessler, Romain, Le Roux, Pascal, Mabire, Pascal, Mahay, Guillaume, Martinez, Stéphanie, Melloni, Boris, Moreau, Laurent, Riviere, Emilie, Roux-Claudé, Pauline, Soulier, Michel, Vignal, Guillaume, Yaici, Azzedine, Bals, Robert, Aries, Sven Philip, Beck, Ekkehard, Deimling, Andreas, Feimer, Jan, Grimm-Sachs, Vera, Groth, Gesine, Herth, Felix, Hoheisel, Gerhard, Kanniess, Frank, Lienert, Thomas, Mronga, Silke, Reinhardt, Jörg, Schlenska, Christian, Stolpe, Christoph, Teber, Ishak, Timmermann, Hartmut, Ulrich, Thomas, Velling, Peter, Wehgartner-Winkler, Sabina, Welling, Juergen, Winkelmann, Ernst-Joachim, Barbetta, Carlo, Braido, Fulvio, Cardaci, Vittorio, Clini, Enrico Maria, Costantino, Maria Teresa, Cuttitta, Giuseppina, di Gioacchino, Mario, Fois, Alessandro, Foschino-Barbaro, Maria Pia, Gammeri, Enrico, Inchingolo, Riccardo, Lavorini, Federico, Molino, Antonio, Nucera, Eleonora, Patella, Vincenzo, Pesci, Alberto, Ricciardolo, Fabio, Rogliani, Paola, Sarzani, Riccardo, Vancheri, Carlo, Vincenti, Rigoletta, Endo, Takeo, Fujita, Masaki, Hara, Yu, Horiguchi, Takahiko, Hosoi, Keita, Ide, Yumiko, Inomata, Minehiko, Inoue, Koji, Inoue, Sumito, Kato, Motokazu, Kawasaki, Masayuki, Kawayama, Tomotaka, Kita, Toshiyuki, Kobayashi, Kanako, Koto, Hiroshi, Nishi, Koichi, Saito, Junpei, Shimizu, Yasuo, Shirai, Toshihiro, Sugihara, Naruhiko, Takahashi, Ken-ichi, Tashimo, Hiroyuki, Tomii, Keisuke, Yamada, Takashi, Yanai, Masaru, Rendon, Adrian, Javier, Ruth Cerino, Peregrina, Alfredo Domínguez, Corzo, Marco Fernández, Gonzalez, Efraín Montano, Ramírez-Venegas, Alejandra, Boersma, Willem, Djamin, R.S., Eijsvogel, Michiel, Franssen, Frits, Goosens, Martijn, Graat-Verboom, Lidwien, Veen, Johannes in 't, Janssen, Rob, Kuppens, Kim, van de Ven, Mario, Bakke, Per, Brunstad, Ole Petter, Einvik, Gunnar, Høines, Kristian Jong, Khusrawi, Alamdar, Oien, Torbjorn, Yoon, Ho Joo, Chang, Yoon-Seok, Cho, Young Joo, Hwang, Yong Il, Kim, Woo Jin, Koh, Young-Il, Lee, Byung-Jae, Lee, Kwan-Ho, Lee, Sang-Pyo, Lee, Yong Chul, Lim, Seong Yong, Min, Kyung Hun, Oh, Yeon-Mok, Park, Choon-Sik, Park, Hae-Sim, Park, Heung-Woo, Rhee, Chin Kook, Yoon, Hyoung-Kyu, Andújar, Rubén, Anoro, Laura, García, María Buendía, Mozo, Paloma Campo, Campos, Sergio, Maldonado, Francisco Casas, Martínez, Manuel Castilla, Serrano, Carolina Cisneros, Casanova, Lorena Comeche, Corbacho, Dolores, Del Campo Matías, Felix, Echave-Sustaeta, Jose, Corral, Gloria Francisco, Setién, Pedro Gamboa, Clemente, Marta García, Núñez, Ignacio García, Robaina, Jose García, Salmones, Mercedes García, Marín Trigo, Jose Maria, Fernandez, Marta Nuñez, Palomo, Sara Nuñez, Pérez de Llano, Luis, Bastida, Ana Pueyo, Rañó, Ana, González-Moro, José Rodríguez, Reig, Albert Roger, Garrido, José Velasco, Curiac, Dan, Lif-Tiberg, Cornelia, Luts, Anders, Råhlen, Lennart, Rustscheff, Stefan, Adams, Frances, Bradman, Drew, Broughton, Emma, Cosgrove, John, Flood-Page, Patrick, Fuller, Elizabeth, Hartley, David, Hattotuwa, Keith, Jones, Gareth, Lewis, Keir, McGarvey, Lorcan, Morice, Alyn, Pandya, Preeti, Patel, Manish, Roy, Kay, Sathyamurthy, Ramamurthy, Thiagarajan, Swaminathan, Turner, Alice, Vestbo, Jorgen, Wedzicha, Wisia, Wilkinson, Tom, Wilson, Pete, Al-Asadi, Lo’Ay, Anholm, James, Averill, Francis, Bansal, Sandeep, Baptist, Alan, Campbell, Colin, Campos, Michael A., Crook, Gretchen, DeLeon, Samuel, Eid, Alain, Epstein, Ellen, Fritz, Stephen, Harris, Hoadley, Hewitt, Mitzie, Holguin, Fernando, Hudes, Golda, Jackson, Richard, Kaufman, Alan, Kaufman, David, Klapholz, Ari, Krishna, Harshavardhan, Lee, Daria, Lin, Robert, Maselli-Caceres, Diego, Mehta, Vinay, Moy, James N., Nwokoro, Ugo, Parikh, Purvi, Parikh, Sudhir, Perrino, Frank, Ruhlmann, James, Sassoon, Catherine, Settipane, Russell A., Sousa, Daniel, Sriram, Peruvemba, Wachs, Richard, Ding, Bo, Chen, Stephanie, Quinton, Anna, Cook, William, and Reddel, Helen K.

Published
2024
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10. Cluster Analyses From the Real-World NOVELTY Study: Six Clusters Across the Asthma-COPD Spectrum

Author

Olmo, Ricardo del, Anderson, Gary, Reddel, Helen, Rabahi, Marcelo, McIvor, Andrew, Sadatsafavi, Mohsen, Weinreich, Ulla, Burgel, Pierre-Régis, Devouassoux, Gilles, Papi, Alberto, Inoue, Hiromasa, Rendon, Adrián, van den Berge, Maarten, Beasley, Richard, García-Navarro, Alvar Agusti, Faner, Rosa, Olaguibel Rivera, José, Janson, Christer, Bilińska-Izydorczyk, Magdalena, Fagerås, Malin, Fihn-Wikander, Titti, Franzén, Stefan, Keen, Christina, Ostridge, Kristoffer, Chalmers, James, Harrison, Timothy, Pavord, Ian, Price, David, Azim, Adnan, Belton, Laura, Blé, Francois-Xavier, Erhard, Clement, Gairy, Kerry, Hughes, Rod, Lassi, Glenda, Müllerová, Hana, Rapsomaniki, Eleni, Scott, Ian Christopher, Chipps, Bradley, Christenson, Stephanie, Make, Barry, Tomaszewski, Erin, Benhabib, Gabriel, Ruiz, Xavier Bocca, Lisanti, Raul Eduardo, Marino, Gustavo, Mattarucco, Walter, Nogueira, Juan, Parody, Maria, Pascale, Pablo, Rodriguez, Pablo, Silva, Damian, Svetliza, Graciela, Victorio, Carlos F., Rolon, Roxana Willigs, Yañez, Anahi, Baines, Stuart, Bowler, Simon, Bremner, Peter, Bull, Sheetal, Carroll, Patrick, Chaalan, Mariam, Farah, Claude, Hammerschlag, Gary, Hancock, Kerry, Harrington, Zinta, Katsoulotos, Gregory, Kim, Joshua, Langton, David, Lee, Donald, Peters, Matthew, Prassad, Lakshman, Sajkov, Dimitar, Santiago, Francis, Simpson, Frederick Graham, Tai, Sze, Thomas, Paul, Wark, Peter, Cançado, José Eduardo Delfini, Cunha, Thúlio, Lima, Marina, Cardoso, Alexandre Pinto, FitzGerald, J. Mark, Anees, Syed, Bertley, John, Bell, Alan, Cheema, Amarjit, Chouinard, Guy, Csanadi, Michael, Dhar, Anil, Dhillon, Ripple, Kanawaty, David, Kelly, Allan, Killorn, William, Landry, Daniel, Luton, Robert, Mandhane, Piushkumar, Pek, Bonavuth, Petrella, Robert, Stollery, Daniel, Wang, Chen, Chen, Meihua, Chen, Yan, Gu, Wei, Christopher Hui, Kim Ming, Li, Manxiang, Li, Shiyue, Lijun, Ma, Qin, Guangyue, Song, Weidong, Tan, Wei, Tang, Yijun, Wang, Tan, Wen, Fuqiang, Wu, Feng, Xiang, PingChao, Xiao, Zuke, Xiong, Shengdao, Yang, Jinghua, Yang, Jingping, Zhang, Caiqing, Zhang, Min, Zhang, Ping, Zhang, Wei, Zheng, Xiaohe, Zhu, Dan, Bueno, Carlos Matiz, Grimaldos, Fabio Bolivar, Arboleda, Alejandra Cañas, de Salazar, Dora Molina, Bendstrup, Elisabeth, Hilberg, Ole, Kjellerup, Carsten, Raherison, Chantal, Bonniaud, Philippe, Brun, Olivier, Chouaid, Christos, Couturaud, Francis, de Blic, Jacques, Debieuvre, Didier, Delsart, Dominique, Demaegdt, Axelle, Demoly, Pascal, Deschildre, Antoine, Egron, Carole, Falchero, Lionel, Goupil, François, Kessler, Romain, Le Roux, Pascal, Mabire, Pascal, Mahay, Guillaume, Martinez, Stéphanie, Melloni, Boris, Moreau, Laurent, Riviere, Emilie, Roux-Claudé, Pauline, Soulier, Michel, Vignal, Guillaume, Yaici, Azzedine, Bals, Robert, Aries, Sven Philip, Beck, Ekkehard, Deimling, Andreas, Feimer, Jan, Grimm-Sachs, Vera, Groth, Gesine, Herth, Felix, Hoheisel, Gerhard, Kanniess, Frank, Lienert, Thomas, Mronga, Silke, Reinhardt, Jörg, Schlenska, Christian, Stolpe, Christoph, Teber, Ishak, Timmermann, Hartmut, Ulrich, Thomas, Velling, Peter, Wehgartner-Winkler, Sabina, Welling, Juergen, Winkelmann, Ernst-Joachim, Barbetta, Carlo, Braido, Fulvio, Cardaci, Vittorio, Clini, Enrico Maria, Costantino, Maria Teresa, Cuttitta, Giuseppina, di Gioacchino, Mario, Fois, Alessandro, Foschino-Barbaro, Maria Pia, Gammeri, Enrico, Inchingolo, Riccardo, Lavorini, Federico, Molino, Antonio, Nucera, Eleonora, Patella, Vincenzo, Pesci, Alberto, Ricciardolo, Fabio, Rogliani, Paola, Sarzani, Riccardo, Vancheri, Carlo, Vincenti, Rigoletta, Endo, Takeo, Fujita, Masaki, Hara, Yu, Horiguchi, Takahiko, Hosoi, Keita, Ide, Yumiko, Inomata, Minehiko, Inoue, Koji, Inoue, Sumito, Kato, Motokazu, Kawasaki, Masayuki, Kawayama, Tomotaka, Kita, Toshiyuki, Kobayashi, Kanako, Koto, Hiroshi, Nishi, Koichi, Saito, Junpei, Shimizu, Yasuo, Shirai, Toshihiro, Sugihara, Naruhiko, Takahashi, Ken-ichi, Tashimo, Hiroyuki, Tomii, Keisuke, Yamada, Takashi, Yanai, Masaru, Rendon, Adrian, Cerino Javier, Ruth, Domínguez Peregrina, Alfredo, Fernández Corzo, Marco, Montano Gonzalez, Efraín, Ramírez-Venegas, Alejandra, Boersma, Willem, Djamin, R.S., Eijsvogel, Michiel, Franssen, Frits, Goosens, Martijn, Graat-Verboom, Lidwien, Veen, Johannes in 't, Janssen, Rob, Kuppens, Kim, van de Ven, Mario, Bakke, Per, Brunstad, Ole Petter, Einvik, Gunnar, Høines, Kristian Jong, Khusrawi, Alamdar, Oien, Torbjorn, Yoon, Ho Joo, Chang, Yoon-Seok, Cho, Young Joo, Hwang, Yong Il, Kim, Woo Jin, Koh, Young-Il, Lee, Byung-Jae, Lee, Kwan-Ho, Lee, Sang-Pyo, Lee, Yong Chul, Lim, Seong Yong, Min, Kyung Hun, Oh, Yeon-Mok, Park, Choon-Sik, Park, Hae-Sim, Park, Heung-Woo, Rhee, Chin Kook, Yoon, Hyoung-Kyu, García-Navarro, Alvar Agustí, Andújar, Rubén, Anoro, Laura, Buendía García, María, Mozo, Paloma Campo, Campos, Sergio, Casas Maldonado, Francisco, Castilla Martínez, Manuel, Cisneros Serrano, Carolina, Comeche Casanova, Lorena, Corbacho, Dolores, Campo Matías, Felix Del, Echave-Sustaeta, Jose, Corral, Gloria Francisco, Gamboa Setién, Pedro, García Clemente, Marta, Núñez, Ignacio García, García Robaina, Jose, García Salmones, Mercedes, Marín Trigo, Jose Maria, Fernandez, Marta Nuñez, Palomo, Sara Nuñez, Pérez de Llano, Luis, Pueyo Bastida, Ana, Rañó, Ana, Rodríguez González-Moro, José, Reig, Albert Roger, Velasco Garrido, José, Curiac, Dan, Lif-Tiberg, Cornelia, Luts, Anders, Råhlen, Lennart, Rustscheff, Stefan, Adams, Frances, Bradman, Drew, Broughton, Emma, Cosgrove, John, Flood-Page, Patrick, Fuller, Elizabeth, Hartley, David, Hattotuwa, Keith, Jones, Gareth, Lewis, Keir, McGarvey, Lorcan, Morice, Alyn, Pandya, Preeti, Patel, Manish, Roy, Kay, Sathyamurthy, Ramamurthy, Thiagarajan, Swaminathan, Turner, Alice, Vestbo, Jørgen, Wedzicha, Wisia, Wilkinson, Tom, Wilson, Pete, Al-Asadi, Lo’Ay, Anholm, James, Averill, Francis, Bansal, Sandeep, Baptist, Alan, Campbell, Colin, Campos, Michael A., Crook, Gretchen, DeLeon, Samuel, Eid, Alain, Epstein, Ellen, Fritz, Stephen, Harris, Hoadley, Hewitt, Mitzie, Holguin, Fernando, Hudes, Golda, Jackson, Richard, Kaufman, Alan, Kaufman, David, Klapholz, Ari, Krishna, Harshavardhan, Lee, Daria, Lin, Robert, Maselli-Caceres, Diego, Mehta, Vinay, Moy, James N., Nwokoro, Ugo, Parikh, Purvi, Parikh, Sudhir, Perrino, Frank, Ruhlmann, James, Sassoon, Catherine, Settipane, Russell A., Sousa, Daniel, Sriram, Peruvemba, Wachs, Richard, Bansal, Aruna T., Agustí, Alvar, Fageras, Malin, Alacqua, Marianna, and Reddel, Helen K.

Published
2023
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30. Digital twins and Bayesian dynamic borrowing: Two recent approaches for incorporating historical control data.

Author

Burman, Carl‐Fredrik, Hermansson, Erik, Bock, David, Franzén, Stefan, and Svensson, David

Subjects
DIGITAL twins, FALSE positive error, CLINICAL trials, MACHINE learning, SAMPLE size (Statistics)
Abstract

Recent years have seen an increasing interest in incorporating external control data for designing and evaluating randomized clinical trials (RCT). This may decrease costs and shorten inclusion times by reducing sample sizes. For small populations, with limited recruitment, this can be especially important. Bayesian dynamic borrowing (BDB) has been a popular choice as it claims to protect against potential prior data conflict. Digital twins (DT) has recently been proposed as another method to utilize historical data. DT, also known as PROCOVA™, is based on constructing a prognostic score from historical control data, typically using machine learning. This score is included in a pre‐specified ANCOVA as the primary analysis of the RCT. The promise of this idea is power increase while guaranteeing strong type 1 error control. In this paper, we apply analytic derivations and simulations to analyze and discuss examples of these two approaches. We conclude that BDB and DT, although similar in scope, have fundamental differences which need be considered in the specific application. The inflation of the type 1 error is a serious issue for BDB, while more evidence is needed of a tangible value of DT for real RCTs. [ABSTRACT FROM AUTHOR]

Published
2024
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31. #1302 Maintained renin-angiotensin-aldosterone system inhibitor therapy with sodium zirconium cyclosilicate in patients with chronic kidney disease

Author

Rastogi, Anjay, primary, Pollack, Charles V, additional, Lázaro, Ignacio José Sánchez, additional, Lesén, Eva, additional, Arnold, Matthew, additional, Franzén, Stefan, additional, Allum, Alaster, additional, Hernández, Ignacio, additional, Murohara, Toyoaki, additional, and Kanda, Eiichiro, additional

Published
2024
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33. #1303 Hyperkalaemia-related RAASi reduction and estimated number needed to treat to avoid a first hospitalisation by maintaining RAASi

Author

Svensson, Maria K Eriksson, primary, Fischereder, Michael, additional, Kalra, Paul R, additional, Lázaro, Ignacio José Sánchez, additional, Lesén, Eva, additional, Franzén, Stefan, additional, Allum, Alaster, additional, Cars, Thomas, additional, Breitbart, Philipp, additional, and Arroyo, David, additional

Published
2024
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35. Maintained renin–angiotensin–aldosterone system inhibitor therapy with sodium zirconium cyclosilicate following a hyperkalaemia episode: a multicountry cohort study

Author

Rastogi, Anjay, primary, Pollack, Charles V, additional, Sánchez Lázaro, Ignacio José, additional, Lesén, Eva, additional, Arnold, Matthew, additional, Franzén, Stefan, additional, Allum, Alaster, additional, Hernández, Ignacio, additional, Murohara, Toyoaki, additional, and Kanda, Eiichiro, additional

Published
2024
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40. Long-Term Safety of Roflumilast in Patients with Chronic Obstructive Pulmonary Disease : a Multinational Observational Database Cohort Study

Author

Garbe, Edeltraut, Hoti, Fabian, Schink, Tania, Svendsen, Kristian, Al-Eid, Haydar, Arkhammar, Per, Carlholm, Marie, Fjällbrant, Harald, Franzén, Stefan, Hedlund, Cecilia, Kollhorst, Bianca, Kumar, Atul, Lobier, Muriel, Mushnikov, Vasili, Persson, Tore, Qiao, Xu, Salosensaari, Aaro, Schäfer, Wiebke, Sicignano, Nicholas M., Johansson, Gunnar, Dareng, Eileen O., Garbe, Edeltraut, Hoti, Fabian, Schink, Tania, Svendsen, Kristian, Al-Eid, Haydar, Arkhammar, Per, Carlholm, Marie, Fjällbrant, Harald, Franzén, Stefan, Hedlund, Cecilia, Kollhorst, Bianca, Kumar, Atul, Lobier, Muriel, Mushnikov, Vasili, Persson, Tore, Qiao, Xu, Salosensaari, Aaro, Schäfer, Wiebke, Sicignano, Nicholas M., Johansson, Gunnar, and Dareng, Eileen O.

Abstract

Purpose This study evaluated the long-term safety of roflumilast in patients with chronic obstructive pulmonary disease or chronic bronchitis using electronic healthcare databases from Germany, Norway, Sweden, and the United States (US). Patients and Methods The study population consisted of patients aged ≥40 years who had been exposed to roflumilast and a matched cohort unexposed to roflumilast. The matching was based on sex, age, calendar year of cohort entry date (2010–2011, 2012, or 2013), and a propensity score that included variables such as demographics, markers of chronic obstructive pulmonary disease (COPD) severity and morbidity, and comorbidities. In comparison to the unexposed matched cohort (never use), three exposure definitions were used for the exposed matched cohort: ever use, use status (current, recent, past use), and cumulative duration of use. The main outcome was 5-year all-cause mortality. Cox regression models were used to estimate crude and adjusted hazard ratios (HRs) and 95% confidence intervals (CI). Results 112,541 unexposed and 23,239 exposed patients across countries were included. Some variables remained unbalanced after matching, indicating higher COPD disease severity among the exposed patients. Adjusted HRs of 5-year all-cause mortality for “ever use” of roflumilast, compared to “never use”, were 1.12 (95% CI, 1.08–1.17) in Germany, 1.00 (95% CI, 0.92–1.08) in Norway, 0.98 (95% CI, 0.92–1.04) in Sweden, and 1.16 (95% CI, 1.12–1.20) in the US. Compared to never users, there was a decrease in 5-year mortality risk observed among “current users” in Germany (HR: 0.93, 95% CI: 0.88–0.98), Norway (HR: 0.77, 95% CI: 0.67–0.87), and Sweden (HR: 0.80, 95% CI: 0.73–0.88). Conclusion There was no observed increase in 5-year mortality risk with the use of roflumilast in Sweden or Norway. A small increase in 5-year mortality risk was observed in Germany and the US in the ever versus never comparison, likely due to residual confounding by indica

Published
2024
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41. Risk of fracture in adults with type 2 diabetes in Sweden: A national cohort study

Author

Axelsson, Kristian F., Litsne, Henrik, Kousoula, Konstantina, Franzén, Stefan, Eliasson, Björn, and Lorentzon, Mattias

Subjects
Fractures -- Risk factors -- Demographic aspects, Type 2 diabetes -- Complications and side effects, Biological sciences
Abstract

Background Type 2 diabetes mellitus (T2DM) is considered a risk factor for fracture but the evidence regarding the impact of T2DM on fracture risk is conflicting. The objective of the study was to determine if patients with T2DM have increased fracture risk and if T2DM-related risk factors could be identified. Methods and findings In this national cohort study in Sweden, we investigated the risk of fracture in 580,127 T2DM patients, identified through the national diabetes register including from both primary care and hospitals, and an equal number of population-based controls without diabetes matched for age, sex, and county from 2007 to 2017. The mean age at entry was 66.7 years and 43.6% were women. During a median follow-up time of 6.6 (interquartile range (IQR) 3.1 to 9.8) years, patients with T2DM had a marginally but significantly increased risk of major osteoporotic fracture (MOF) (hazard ratio (HR) 1.01 (95% confidence interval [CI] 1.00 to 1.03)) and hip fracture (HR 1.06 (95% CI 1.04 to 1.08)) compared to controls, associations that were only minimally affected (HR 1.05 (95% CI 1.03 to 1.06) and HR 1.11 (95% CI 1.09 to 1.14), respectively) by multivariable adjustment (age, sex, marital status, and an additional 20 variables related to general morbidity, cardiovascular status, risk of falls, and fracture). In a multivariable-adjusted Cox model, the proportion of the risk for all fracture outcomes (Heller's R2) explained by T2DM was below 0.1%. Among the T2DM patients, important risk factors for fracture were a low BMI ( Conclusion In this study, we observed only a marginally increased fracture risk in T2DM, a condition that explained less than 0.1% of the fracture risk. Consideration of the herein identified T2DM-related risk factors could be used to stratify T2DM patients according to fracture risk., Author(s): Kristian F. Axelsson 1,2, Henrik Litsne 1, Konstantina Kousoula 1,3, Stefan Franzén 4, Björn Eliasson 3,5, Mattias Lorentzon 1,6,7,* Introduction It has been estimated that 151 million people have [...]

Published
2023
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50. Cluster Analyses From the Real-World NOVELTY Study: Six Clusters Across the Asthma-COPD Spectrum

Author

Hughes, Rod, primary, Rapsomaniki, Eleni, additional, Bansal, Aruna T., additional, Vestbo, Jørgen, additional, Price, David, additional, Agustí, Alvar, additional, Beasley, Richard, additional, Fageras, Malin, additional, Alacqua, Marianna, additional, Papi, Alberto, additional, Müllerová, Hana, additional, Reddel, Helen K., additional, Olmo, Ricardo del, additional, Anderson, Gary, additional, Reddel, Helen, additional, Rabahi, Marcelo, additional, McIvor, Andrew, additional, Sadatsafavi, Mohsen, additional, Weinreich, Ulla, additional, Burgel, Pierre-Régis, additional, Devouassoux, Gilles, additional, Inoue, Hiromasa, additional, Rendon, Adrián, additional, van den Berge, Maarten, additional, García-Navarro, Alvar Agusti, additional, Faner, Rosa, additional, Olaguibel Rivera, José, additional, Janson, Christer, additional, Bilińska-Izydorczyk, Magdalena, additional, Fagerås, Malin, additional, Fihn-Wikander, Titti, additional, Franzén, Stefan, additional, Keen, Christina, additional, Ostridge, Kristoffer, additional, Chalmers, James, additional, Harrison, Timothy, additional, Pavord, Ian, additional, Azim, Adnan, additional, Belton, Laura, additional, Blé, Francois-Xavier, additional, Erhard, Clement, additional, Gairy, Kerry, additional, Hughes, Rod, additional, Lassi, Glenda, additional, Scott, Ian Christopher, additional, Chipps, Bradley, additional, Christenson, Stephanie, additional, Make, Barry, additional, Tomaszewski, Erin, additional, Benhabib, Gabriel, additional, Ruiz, Xavier Bocca, additional, Lisanti, Raul Eduardo, additional, Marino, Gustavo, additional, Mattarucco, Walter, additional, Nogueira, Juan, additional, Parody, Maria, additional, Pascale, Pablo, additional, Rodriguez, Pablo, additional, Silva, Damian, additional, Svetliza, Graciela, additional, Victorio, Carlos F., additional, Rolon, Roxana Willigs, additional, Yañez, Anahi, additional, Baines, Stuart, additional, Bowler, Simon, additional, Bremner, Peter, additional, Bull, Sheetal, additional, Carroll, Patrick, additional, Chaalan, Mariam, additional, Farah, Claude, additional, Hammerschlag, Gary, additional, Hancock, Kerry, additional, Harrington, Zinta, additional, Katsoulotos, Gregory, additional, Kim, Joshua, additional, Langton, David, additional, Lee, Donald, additional, Peters, Matthew, additional, Prassad, Lakshman, additional, Sajkov, Dimitar, additional, Santiago, Francis, additional, Simpson, Frederick Graham, additional, Tai, Sze, additional, Thomas, Paul, additional, Wark, Peter, additional, Cançado, José Eduardo Delfini, additional, Cunha, Thúlio, additional, Lima, Marina, additional, Cardoso, Alexandre Pinto, additional, FitzGerald, J. Mark, additional, Anees, Syed, additional, Bertley, John, additional, Bell, Alan, additional, Cheema, Amarjit, additional, Chouinard, Guy, additional, Csanadi, Michael, additional, Dhar, Anil, additional, Dhillon, Ripple, additional, Kanawaty, David, additional, Kelly, Allan, additional, Killorn, William, additional, Landry, Daniel, additional, Luton, Robert, additional, Mandhane, Piushkumar, additional, Pek, Bonavuth, additional, Petrella, Robert, additional, Stollery, Daniel, additional, Wang, Chen, additional, Chen, Meihua, additional, Chen, Yan, additional, Gu, Wei, additional, Christopher Hui, Kim Ming, additional, Li, Manxiang, additional, Li, Shiyue, additional, Lijun, Ma, additional, Qin, Guangyue, additional, Song, Weidong, additional, Tan, Wei, additional, Tang, Yijun, additional, Wang, Tan, additional, Wen, Fuqiang, additional, Wu, Feng, additional, Xiang, PingChao, additional, Xiao, Zuke, additional, Xiong, Shengdao, additional, Yang, Jinghua, additional, Yang, Jingping, additional, Zhang, Caiqing, additional, Zhang, Min, additional, Zhang, Ping, additional, Zhang, Wei, additional, Zheng, Xiaohe, additional, Zhu, Dan, additional, Bueno, Carlos Matiz, additional, Grimaldos, Fabio Bolivar, additional, Arboleda, Alejandra Cañas, additional, de Salazar, Dora Molina, additional, Bendstrup, Elisabeth, additional, Hilberg, Ole, additional, Kjellerup, Carsten, additional, Raherison, Chantal, additional, Bonniaud, Philippe, additional, Brun, Olivier, additional, Chouaid, Christos, additional, Couturaud, Francis, additional, de Blic, Jacques, additional, Debieuvre, Didier, additional, Delsart, Dominique, additional, Demaegdt, Axelle, additional, Demoly, Pascal, additional, Deschildre, Antoine, additional, Egron, Carole, additional, Falchero, Lionel, additional, Goupil, François, additional, Kessler, Romain, additional, Le Roux, Pascal, additional, Mabire, Pascal, additional, Mahay, Guillaume, additional, Martinez, Stéphanie, additional, Melloni, Boris, additional, Moreau, Laurent, additional, Riviere, Emilie, additional, Roux-Claudé, Pauline, additional, Soulier, Michel, additional, Vignal, Guillaume, additional, Yaici, Azzedine, additional, Bals, Robert, additional, Aries, Sven Philip, additional, Beck, Ekkehard, additional, Deimling, Andreas, additional, Feimer, Jan, additional, Grimm-Sachs, Vera, additional, Groth, Gesine, additional, Herth, Felix, additional, Hoheisel, Gerhard, additional, Kanniess, Frank, additional, Lienert, Thomas, additional, Mronga, Silke, additional, Reinhardt, Jörg, additional, Schlenska, Christian, additional, Stolpe, Christoph, additional, Teber, Ishak, additional, Timmermann, Hartmut, additional, Ulrich, Thomas, additional, Velling, Peter, additional, Wehgartner-Winkler, Sabina, additional, Welling, Juergen, additional, Winkelmann, Ernst-Joachim, additional, Barbetta, Carlo, additional, Braido, Fulvio, additional, Cardaci, Vittorio, additional, Clini, Enrico Maria, additional, Costantino, Maria Teresa, additional, Cuttitta, Giuseppina, additional, di Gioacchino, Mario, additional, Fois, Alessandro, additional, Foschino-Barbaro, Maria Pia, additional, Gammeri, Enrico, additional, Inchingolo, Riccardo, additional, Lavorini, Federico, additional, Molino, Antonio, additional, Nucera, Eleonora, additional, Patella, Vincenzo, additional, Pesci, Alberto, additional, Ricciardolo, Fabio, additional, Rogliani, Paola, additional, Sarzani, Riccardo, additional, Vancheri, Carlo, additional, Vincenti, Rigoletta, additional, Endo, Takeo, additional, Fujita, Masaki, additional, Hara, Yu, additional, Horiguchi, Takahiko, additional, Hosoi, Keita, additional, Ide, Yumiko, additional, Inomata, Minehiko, additional, Inoue, Koji, additional, Inoue, Sumito, additional, Kato, Motokazu, additional, Kawasaki, Masayuki, additional, Kawayama, Tomotaka, additional, Kita, Toshiyuki, additional, Kobayashi, Kanako, additional, Koto, Hiroshi, additional, Nishi, Koichi, additional, Saito, Junpei, additional, Shimizu, Yasuo, additional, Shirai, Toshihiro, additional, Sugihara, Naruhiko, additional, Takahashi, Ken-ichi, additional, Tashimo, Hiroyuki, additional, Tomii, Keisuke, additional, Yamada, Takashi, additional, Yanai, Masaru, additional, Rendon, Adrian, additional, Cerino Javier, Ruth, additional, Domínguez Peregrina, Alfredo, additional, Fernández Corzo, Marco, additional, Montano Gonzalez, Efraín, additional, Ramírez-Venegas, Alejandra, additional, Boersma, Willem, additional, Djamin, R.S., additional, Eijsvogel, Michiel, additional, Franssen, Frits, additional, Goosens, Martijn, additional, Graat-Verboom, Lidwien, additional, Veen, Johannes in 't, additional, Janssen, Rob, additional, Kuppens, Kim, additional, van de Ven, Mario, additional, Bakke, Per, additional, Brunstad, Ole Petter, additional, Einvik, Gunnar, additional, Høines, Kristian Jong, additional, Khusrawi, Alamdar, additional, Oien, Torbjorn, additional, Yoon, Ho Joo, additional, Chang, Yoon-Seok, additional, Cho, Young Joo, additional, Hwang, Yong Il, additional, Kim, Woo Jin, additional, Koh, Young-Il, additional, Lee, Byung-Jae, additional, Lee, Kwan-Ho, additional, Lee, Sang-Pyo, additional, Lee, Yong Chul, additional, Lim, Seong Yong, additional, Min, Kyung Hun, additional, Oh, Yeon-Mok, additional, Park, Choon-Sik, additional, Park, Hae-Sim, additional, Park, Heung-Woo, additional, Rhee, Chin Kook, additional, Yoon, Hyoung-Kyu, additional, García-Navarro, Alvar Agustí, additional, Andújar, Rubén, additional, Anoro, Laura, additional, Buendía García, María, additional, Mozo, Paloma Campo, additional, Campos, Sergio, additional, Casas Maldonado, Francisco, additional, Castilla Martínez, Manuel, additional, Cisneros Serrano, Carolina, additional, Comeche Casanova, Lorena, additional, Corbacho, Dolores, additional, Campo Matías, Felix Del, additional, Echave-Sustaeta, Jose, additional, Corral, Gloria Francisco, additional, Gamboa Setién, Pedro, additional, García Clemente, Marta, additional, Núñez, Ignacio García, additional, García Robaina, Jose, additional, García Salmones, Mercedes, additional, Marín Trigo, Jose Maria, additional, Fernandez, Marta Nuñez, additional, Palomo, Sara Nuñez, additional, Pérez de Llano, Luis, additional, Pueyo Bastida, Ana, additional, Rañó, Ana, additional, Rodríguez González-Moro, José, additional, Reig, Albert Roger, additional, Velasco Garrido, José, additional, Curiac, Dan, additional, Lif-Tiberg, Cornelia, additional, Luts, Anders, additional, Råhlen, Lennart, additional, Rustscheff, Stefan, additional, Adams, Frances, additional, Bradman, Drew, additional, Broughton, Emma, additional, Cosgrove, John, additional, Flood-Page, Patrick, additional, Fuller, Elizabeth, additional, Hartley, David, additional, Hattotuwa, Keith, additional, Jones, Gareth, additional, Lewis, Keir, additional, McGarvey, Lorcan, additional, Morice, Alyn, additional, Pandya, Preeti, additional, Patel, Manish, additional, Roy, Kay, additional, Sathyamurthy, Ramamurthy, additional, Thiagarajan, Swaminathan, additional, Turner, Alice, additional, Wedzicha, Wisia, additional, Wilkinson, Tom, additional, Wilson, Pete, additional, Al-Asadi, Lo’Ay, additional, Anholm, James, additional, Averill, Francis, additional, Bansal, Sandeep, additional, Baptist, Alan, additional, Campbell, Colin, additional, Campos, Michael A., additional, Crook, Gretchen, additional, DeLeon, Samuel, additional, Eid, Alain, additional, Epstein, Ellen, additional, Fritz, Stephen, additional, Harris, Hoadley, additional, Hewitt, Mitzie, additional, Holguin, Fernando, additional, Hudes, Golda, additional, Jackson, Richard, additional, Kaufman, Alan, additional, Kaufman, David, additional, Klapholz, Ari, additional, Krishna, Harshavardhan, additional, Lee, Daria, additional, Lin, Robert, additional, Maselli-Caceres, Diego, additional, Mehta, Vinay, additional, Moy, James N., additional, Nwokoro, Ugo, additional, Parikh, Purvi, additional, Parikh, Sudhir, additional, Perrino, Frank, additional, Ruhlmann, James, additional, Sassoon, Catherine, additional, Settipane, Russell A., additional, Sousa, Daniel, additional, Sriram, Peruvemba, additional, and Wachs, Richard, additional

Published
2023
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