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52. The Assessment of Endothelial Function

Author

Flammer, Andreas J, Anderson, Todd, Celermajer, David S, Creager, Mark A, Deanfield, John, Ganz, Peter, Hamburg, Naomi M, Lüscher, Thomas F, Shechter, Michael, Taddei, Stefano, Vita, Joseph A, and Lerman, Amir

Subjects
Animals, Biomedical Research, Cardiovascular Diseases, Clinical Trials as Topic, Endothelium, Vascular, Humans, Regional Blood Flow, atherosclerosis, endothelium, risk factors, endothelium-derived factors, prevention, prognosis, nitric oxide, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Public Health and Health Services, Cardiovascular System & Hematology
Abstract

The discovery of the endothelium as a crucial organ for the regulation of the vasculature to physiological needs and the recognition of endothelial dysfunction as a key pathological condition - which is associated with most if not all cardiovascular risk factors - led to a tremendous boost of endothelial research in the past 3 decades. Despite the possibility to measure endothelial function in the individual and its widespread use in research, its use as a clinical tool in daily medicine is not established yet. We review the most common methods to assess vascular function in humans and discuss their advantages and disadvantages. Furthermore we give an overview about clinical settings were endothelial function measurements may be valuable in individual patients. Specifically, we provide information why endothelial function is not only a risk marker for cardiovascular risk but may also provides prognostic information beyond commonly used risk scores in primary prevention, and in patients with already established coronary disease. We conclude, that non-invasive endothelial function measurements provide valuable additional information, however, to ascertain its use for daily clinical practice, future research should determine whether endothelial function can be used to guide treatment in the individual and if this translates into better outcomes.

Published
2012

53. Advocacy at the Eighth World Congress of Pediatric Cardiology and Cardiac Surgery

Author

Zheleva, Bistra, primary, Verstappen, Amy, additional, Overman, David M., additional, Ahmad, Farhan, additional, Ali, Sulafa K.M., additional, Al Halees, Zohair Y., additional, Atallah, Joumana Ghandour, additional, Badhwar, Isabella E., additional, Baker-Smith, Carissa, additional, Balestrini, Maria, additional, Basken, Amy, additional, Bassuk, Jonah S., additional, Benson, Lee, additional, Capelli, Horacio, additional, Carollo, Santo, additional, Chowdhury, Devyani, additional, Çiçek, M. Sertaç, additional, Cohen, Mitchell I., additional, Cooper, David S., additional, Deanfield, John E., additional, Dearani, Joseph, additional, del Valle, Blanca, additional, Dodds, Kathryn M., additional, Du, Junbao, additional, Edwin, Frank, additional, Ekure, Ekanem, additional, Fatema, Nurun Nahar, additional, Gomanju, Anu, additional, Hasan, Babar, additional, Henry, Lewis, additional, Hugo-Hamman, Christopher, additional, Iyer, Krishna S., additional, Jatene, Marcelo B., additional, Jenkins, Kathy J., additional, Karamlou, Tara, additional, Karl, Tom R., additional, Kirklin, James K., additional, Kreutzer, Christián, additional, Kumar, Raman Krishna, additional, Lopez, Keila N., additional, Macedo, Alexis Palacios, additional, Marino, Bradley S., additional, Marwali, Eva M., additional, Meijboom, Folkert J., additional, Mattos, Sandra S., additional, Najm, Hani, additional, Newlin, Dan, additional, Novick, William M., additional, Qureshi, Sir Shakeel A., additional, Rahmat, Budi, additional, Raylman, Robert, additional, Saltik, Irfan Levent, additional, Sable, Craig, additional, Sandoval, Nestor, additional, Saxena, Anita, additional, Scanlan, Emma, additional, Sholler, Gary F., additional, Smith, Jodi, additional, St Louis, James D., additional, Tchervenkov, Christo I., additional, Tiong, Koh Ghee, additional, Vida, Vladimiro, additional, Vosloo, Susan, additional, Weinstein, Douglas J. “DJ”, additional, Wilkinson, James L., additional, Zuhlke, Liesl, additional, and Jacobs, Jeffrey P., additional

Published
2023
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54. 36 An analysis of the virtual cardio-oncology research initiative (VICORI) resource: bleeding risk among acute coronary syndrome patients with cancer

Author

Ow, Kok Weng, primary, Van den Berg, Freek, additional, de Belder, Mark, additional, Deanfield, John, additional, Rutherford, Mark, additional, Peake, Michael, additional, Paley, Lizz, additional, Adlam, David, additional, Lambert, Paul, additional, Tyrer, Freya, additional, and Lai, Jennifer, additional

Published
2023
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57. Impact of intentional weight loss in cardiometabolic disease: what we know about timing of benefits on differing outcomes?

Author

Sattar, Naveed, Deanfield, John, and Delles, Christian

Subjects
*WEIGHT loss, *HEART metabolism disorders, *GASTRIC bypass, *HEART failure, *MYOCARDIAL infarction
Abstract

This article explores the impact of intentional weight loss on cardiometabolic disease and the timing of its benefits on various outcomes. It emphasizes that excess body weight is a significant risk factor for cardiometabolic conditions and that intentional weight loss can help prevent or treat these diseases. Rapid weight loss can lead to improvements in blood sugar levels, liver fat, lipid levels, and blood pressure within a short period of time. However, more research is needed to understand the timing and effects of weight loss on other outcomes, such as cardiovascular disease and chronic kidney disease. The article calls for further studies to investigate the mechanisms linking weight loss to reductions in blood pressure and cardiovascular outcomes, and highlights the potential link between elevated body mass index and heart failure. [Extracted from the article]

Published
2023
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60. Association of Factor V Leiden With Subsequent Atherothrombotic Events: A GENIUS-CHD Study of Individual Participant Data

Author

Mahmoodi, Bakhtawar K., Tragante, Vinicius, Kleber, Marcus E., Holmes, Michael V., Schmidt, Amand F., McCubrey, Raymond O., Howe, Laurence J., Direk, Kenan, Allayee, Hooman, Baranova, Ekaterina V., Braund, Peter S., Delgado, Graciela E., Eriksson, Niclas, Gijsberts, Crystel M., Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Pasterkamp, Gerard, Kotti, Salma, Kuukasjärvi, Pekka, Lenzini, Petra A., Levin, Daniel, Lyytikäinen, Leo-Pekka, Muehlschlegel, Jochen D., Nelson, Christopher P., Nikus, Kjell, Pilbrow, Anna P., Wilson Tang, W.H., van der Laan, Sander W., van Setten, Jessica, Vilmundarson, Ragnar O., Deanfield, John, Deloukas, Panos, Dudbridge, Frank, James, Stefan, Mordi, Ify R, Teren, Andrej, Bergmeijer, Thomas O., Body, Simon C., Bots, Michiel, Burkhardt, Ralph, Cooper-DeHoff, Rhonda M., Cresci, Sharon, Danchin, Nicolas, Doughty, Robert N., Grobbee, Diederick E., Hagström, Emil, Hazen, Stanley L., Held, Claes, Hoefer, Imo E., Hovingh, G. Kees, Johnson, Julie A., Kaczor, Marcin P., Kähönen, Mika, Klungel, Olaf H., Laurikka, Jari O., Lehtimäki, Terho, Maitland-van der Zee, Anke H., McPherson, Ruth, Palmer, Colin N., Kraaijeveld, Adriaan O., Pepine, Carl J., Sanak, Marek, Sattar, Naveed, Scholz, Markus, Simon, Tabassome, Spertus, John A., Stewart, Alexandre F.R., Szczeklik, Wojciech, Thiery, Joachim, Visseren, Frank L.J., Waltenberger, Johannes, Richards, A. Mark, Lang, Chim C., Cameron, Vicky A., Åkerblom, Axel, Pare, Guillaume, März, Winfried, Samani, Nilesh J., Hingorani, Aroon D., ten Berg, Jurriën M., Wallentin, Lars, Asselbergs, Folkert W., and Patel, Riyaz S.

Published
2020
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61. Effects of oral semaglutide on cardiovascular outcomes in individuals with type 2 diabetes and established atherosclerotic cardiovascular disease and/or chronic kidney disease: SOUL , a randomized trial, design and baseline characteristics

Author

McGuire, Darren K., primary, Busui, Rodica P., additional, Deanfield, John, additional, Inzucchi, Silvio E., additional, Mann, Johannes F. E., additional, Marx, Nikolaus, additional, Mulvagh, Sharon L., additional, Poulter, Neil, additional, Engelmann, Mads D. M., additional, Hovingh, G. Kees, additional, Sejersten Ripa, Maria, additional, Gislum, Mette, additional, Brown‐Frandsen, Kirstine, additional, and Buse, John B., additional

Published
2023
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62. Medical history predicts phenome-wide disease onset

Author

Eils, Roland, primary, Steinfeldt, Jakob, additional, Wild, Benjamin, additional, Buergel, Thore Manuel, additional, Pietzner, Maik, additional, Upmeier zu Belzen, Julius Valten, additional, Vauvelle, Andre, additional, Hegselmann, Stefan, additional, Denaxas, Spiros, additional, Hemingway, Harry, additional, Langenberg, Claudia, additional, Landmesser, Ulf, additional, and Deanfield, John, additional

Published
2023
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63. Acute heart failure presentation, management and outcomes in cancer patients: a national longitudinal study

Author

Coles, Briana, primary, Welch, Catherine A, additional, Motiwale, Rishabh S, additional, Teece, Lucy, additional, Oliver-Williams, Clare, additional, Weston, Clive, additional, de Belder, Mark A, additional, Lambert, Paul C, additional, Rutherford, Mark J, additional, Paley, Lizz, additional, Kadam, Umesh T, additional, Lawson, Claire A, additional, Deanfield, John, additional, Peake, Michael D, additional, McDonagh, Theresa, additional, Sweeting, Michael J, additional, and Adlam, David, additional

Published
2023
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64. Abstract P6-08-04: Geographical variation of social deprivation, cardiovascular and other comorbidities in 226,516 patients with early breast cancer in England: results from a National Registry Dataset Analysis

Author

Waterhouse, Jasmin V, primary, Welch, Catherine A., additional, Battisti, Nicolo M.L., additional, Adlam, David, additional, Sweeting, Michael J., additional, Paley, Lizz, additional, Lambert, Paul, additional, Deanfield, John E., additional, de Belder, Mark, additional, Peake, Michael D, additional, and Ring, Alistair, additional

Published
2023
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74. Atherosclerosis

Author

Libby, Peter, Buring, Julie E., Badimon, Lina, Hansson, Göran K., Deanfield, John, Bittencourt, Márcio Sommer, Tokgözoğlu, Lale, and Lewis, Eldrin F.

Published
2019
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75. Associations between arterial stiffening and brain structure, perfusion, and cognition in the Whitehall II Imaging Sub-study: A retrospective cohort study

Author

Suri, Sana, Chiesa, Scott T., Zsoldos, Eniko, Mackay, Clare E., Filippini, Nicola, Griffanti, Ludovica, Mahmood, Abda, Singh-Manoux, Archana, Shipley, Martin J., Brunner, Eric J., Kivimäki, Mika, Deanfield, John E., and Ebmeier, Klaus P.

Subjects
Aging -- Health aspects -- Physiological aspects, Cerebral circulation -- Health aspects, Cognition disorders -- Risk factors, Vascular resistance -- Health aspects, Biological sciences
Abstract

Background Aortic stiffness is closely linked with cardiovascular diseases (CVDs), but recent studies suggest that it is also a risk factor for cognitive decline and dementia. However, the brain changes underlying this risk are unclear. We examined whether aortic stiffening during a 4-year follow-up in mid-to-late life was associated with brain structure and cognition in the Whitehall II Imaging Sub-study. Methods and findings The Whitehall II Imaging cohort is a randomly selected subset of the ongoing Whitehall II Study, for which participants have received clinical follow-ups for 30 years, across 12 phases. Aortic pulse wave velocity (PWV) was measured in 2007-2009 (Phase 9) and at a 4-year follow-up in 2012-2013 (Phase 11). Between 2012 and 2016 (Imaging Phase), participants received a multimodal 3T brain magnetic resonance imaging (MRI) scan and cognitive tests. Participants were selected if they had no clinical diagnosis of dementia and no gross brain structural abnormalities. Voxel-based analyses were used to assess grey matter (GM) volume, white matter (WM) microstructure (fractional anisotropy (FA) and diffusivity), white matter lesions (WMLs), and cerebral blood flow (CBF). Cognitive outcomes were performance on verbal memory, semantic fluency, working memory, and executive function tests. Of 542 participants, 444 (81.9%) were men. The mean (SD) age was 63.9 (5.2) years at the baseline Phase 9 examination, 68.0 (5.2) at Phase 11, and 69.8 (5.2) at the Imaging Phase. Voxel-based analysis revealed that faster rates of aortic stiffening in mid-to-late life were associated with poor WM microstructure, viz. lower FA, higher mean, and radial diffusivity (RD) in 23.9%, 11.8%, and 22.2% of WM tracts, respectively, including the corpus callosum, corona radiata, superior longitudinal fasciculus, and corticospinal tracts. Similar voxel-wise associations were also observed with follow-up aortic stiffness. Moreover, lower mean global FA was associated with faster rates of aortic stiffening (B = -5.65, 95% CI -9.75, -1.54, Bonferroni-corrected p < 0.0125) and higher follow-up aortic stiffness (B = -1.12, 95% CI -1.95, -0.29, Bonferroni-corrected p < 0.0125). In a subset of 112 participants who received arterial spin labelling scans, faster aortic stiffening was also related to lower cerebral perfusion in 18.4% of GM, with associations surviving Bonferroni corrections in the frontal (B = -10.85, 95% CI -17.91, -3.79, p < 0.0125) and parietal lobes (B = -12.75, 95% CI -21.58, -3.91, p < 0.0125). No associations with GM volume or WMLs were observed. Further, higher baseline aortic stiffness was associated with poor semantic fluency (B = -0.47, 95% CI -0.76 to -0.18, Bonferroni-corrected p < 0.007) and verbal learning outcomes (B = -0.36, 95% CI -0.60 to -0.12, Bonferroni-corrected p < 0.007). As with all observational studies, it was not possible to infer causal associations. The generalisability of the findings may be limited by the gender imbalance, high educational attainment, survival bias, and lack of ethnic and socioeconomic diversity in this cohort. Conclusions Our findings indicate that faster rates of aortic stiffening in mid-to-late life were associated with poor brain WM microstructural integrity and reduced cerebral perfusion, likely due to increased transmission of pulsatile energy to the delicate cerebral microvasculature. Strategies to prevent arterial stiffening prior to this point may be required to offer cognitive benefit in older age. Trial registration ClinicalTrials.gov NCT03335696, Author(s): Sana Suri 1,2,*, Scott T. Chiesa 3, Eniko Zsoldos 1,2, Clare E. Mackay 1,2, Nicola Filippini 1,2, Ludovica Griffanti 1,2, Abda Mahmood 1, Archana Singh-Manoux 4,5, Martin J. Shipley [...]

Published
2020
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76. Effects of once-weekly semaglutide 2.4 mg on C-reactive protein in adults with overweight or obesity (STEP 1, 2, and 3): exploratory analyses of three randomised, double-blind, placebo-controlled, phase 3 trials

Author

Verma, Subodh, primary, Bhatta, Meena, additional, Davies, Melanie, additional, Deanfield, John E., additional, Garvey, W. Timothy, additional, Jensen, Camilla, additional, Kandler, Kristian, additional, Kushner, Robert F., additional, Rubino, Domenica M., additional, and Kosiborod, Mikhail N., additional

Published
2023
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77. GWAS and colocalization analyses implicate carotid intima-media thickness and carotid plaque loci in cardiovascular outcomes

Author

Franceschini, Nora, Giambartolomei, Claudia, de Vries, Paul S., Finan, Chris, Bis, Joshua C., Huntley, Rachael P., Lovering, Ruth C., Tajuddin, Salman M., Winkler, Thomas W., Graff, Misa, Kavousi, Maryam, Dale, Caroline, Smith, Albert V., Hofer, Edith, van Leeuwen, Elisabeth M., Nolte, Ilja M., Lu, Lingyi, Scholz, Markus, Sargurupremraj, Muralidharan, Pitkänen, Niina, Franzén, Oscar, Joshi, Peter K., Noordam, Raymond, Marioni, Riccardo E., Hwang, Shih-Jen, Musani, Solomon K., Schminke, Ulf, Palmas, Walter, Isaacs, Aaron, Correa, Adolfo, Zonderman, Alan B., Hofman, Albert, Teumer, Alexander, Cox, Amanda J., Uitterlinden, André G., Wong, Andrew, Smit, Andries J., Newman, Anne B., Britton, Annie, Ruusalepp, Arno, Sennblad, Bengt, Hedblad, Bo, Pasaniuc, Bogdan, Penninx, Brenda W., Langefeld, Carl D., Wassel, Christina L., Tzourio, Christophe, Fava, Cristiano, Baldassarre, Damiano, O’Leary, Daniel H., Teupser, Daniel, Kuh, Diana, Tremoli, Elena, Mannarino, Elmo, Grossi, Enzo, Boerwinkle, Eric, Schadt, Eric E., Ingelsson, Erik, Veglia, Fabrizio, Rivadeneira, Fernando, Beutner, Frank, Chauhan, Ganesh, Heiss, Gerardo, Snieder, Harold, Campbell, Harry, Völzke, Henry, Markus, Hugh S., Deary, Ian J., Jukema, J. Wouter, de Graaf, Jacqueline, Price, Jacqueline, Pott, Janne, Hopewell, Jemma C., Liang, Jingjing, Thiery, Joachim, Engmann, Jorgen, Gertow, Karl, Rice, Kenneth, Taylor, Kent D., Dhana, Klodian, Kiemeney, Lambertus A. L. M., Lind, Lars, Raffield, Laura M., Launer, Lenore J., Holdt, Lesca M., Dörr, Marcus, Dichgans, Martin, Traylor, Matthew, Sitzer, Matthias, Kumari, Meena, Kivimaki, Mika, Nalls, Mike A., Melander, Olle, Raitakari, Olli, Franco, Oscar H., Rueda-Ochoa, Oscar L., Roussos, Panos, Whincup, Peter H., Amouyel, Philippe, Giral, Philippe, Anugu, Pramod, Wong, Quenna, Malik, Rainer, Rauramaa, Rainer, Burkhardt, Ralph, Hardy, Rebecca, Schmidt, Reinhold, de Mutsert, Renée, Morris, Richard W., Strawbridge, Rona J., Wannamethee, S. Goya, Hägg, Sara, Shah, Sonia, McLachlan, Stela, Trompet, Stella, Seshadri, Sudha, Kurl, Sudhir, Heckbert, Susan R., Ring, Susan, Harris, Tamara B., Lehtimäki, Terho, Galesloot, Tessel E., Shah, Tina, de Faire, Ulf, Plagnol, Vincent, Rosamond, Wayne D., Post, Wendy, Zhu, Xiaofeng, Zhang, Xiaoling, Guo, Xiuqing, Saba, Yasaman, MEGASTROKE Consortium, Dehghan, Abbas, Seldenrijk, Adrie, Morrison, Alanna C., Hamsten, Anders, Psaty, Bruce M., van Duijn, Cornelia M., Lawlor, Deborah A., Mook-Kanamori, Dennis O., Bowden, Donald W., Schmidt, Helena, Wilson, James F., Wilson, James G., Rotter, Jerome I., Wardlaw, Joanna M., Deanfield, John, Halcox, Julian, Lyytikäinen, Leo-Pekka, Loeffler, Markus, Evans, Michele K., Debette, Stéphanie, Humphries, Steve E., Völker, Uwe, Gudnason, Vilmundur, Hingorani, Aroon D., Björkegren, Johan L. M., Casas, Juan P., and O’Donnell, Christopher J.

Published
2018
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81. Genome-wide association study of longitudinal urinary albumin excretion in patients with type 1 diabetes

Author

Hutchinson, Anna M, primary, Chen, Wei-Min, additional, Onengut-Gumuscu, Suna, additional, Benitez-Aguirre, Paul, additional, Cameron, Fergus J, additional, Chiesa, Scott T, additional, Couper, Jennifer J, additional, Craig, Maria E, additional, Dalton, Neil R., additional, Daneman, Denis, additional, Davis, Elizabeth A, additional, Deanfield, John E, additional, Donaghue, Kim C, additional, Jones, Timothy W, additional, Mahmud, Farid H, additional, Marshall, Sally M, additional, Neil, Andrew, additional, Rich, Stephen S, additional, Marcovecchio, M. Loredana, additional, and Wallace, Chris, additional

Published
2022
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82. Comparison of hospital variation in acute myocardial infarction care and outcome between Sweden and United Kingdom : population based cohort study using nationwide clinical registries

Author

SWEDEHEART/RIKS-HIA (Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies/Register of Information and Knowledge about Swedish Heart Intensive care Admissions), NICOR/MINAP (National Institute for Cardiovascular Outcomes Research/Myocardial Ischaemia National Audit Project), CALIBER (CAardiovascular disease research using linked bespoke studies and electronic health records), Chung, Sheng-Chia, Sundström, Johan, Gale, Chris P, James, Stefan, Deanfield, John, Wallentin, Lars, Timmis, Adam, Jernberg, Tomas, and Hemingway, Harry

Published
2015

84. Treatment With Once-weekly Semaglutide 2.4 mg Improves Cardiometabolic Risk Factors in Adults With Overweight or Obesity and Type 2 Diabetes: STEP 2 Post Hoc Analysis

Author

Lau, David, primary, Deanfield, John E, additional, Davies, Melanie, additional, Garvey, Timothy W, additional, Jeppesen, Ole K, additional, Khalid, Usman, additional, Kosiborod, Mikhail, additional, Kushner, Robert F, additional, Laursen, Peter N, additional, Rubino, Domenica M, additional, and Verma, Subodh, additional

Published
2022
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86. Constructing custom-made radiotranscriptomic signatures of vascular inflammation from routine CT angiograms: a prospective outcomes validation study in COVID-19

Author

Kotanidis, Christos P, primary, Xie, Cheng, additional, Alexander, Donna, additional, Rodrigues, Jonathan C L, additional, Burnham, Katie, additional, Mentzer, Alexander, additional, O’Connor, Daniel, additional, Knight, Julian, additional, Siddique, Muhammad, additional, Lockstone, Helen, additional, Thomas, Sheena, additional, Kotronias, Rafail, additional, Oikonomou, Evangelos K, additional, Badi, Ileana, additional, Lyasheva, Maria, additional, Shirodaria, Cheerag, additional, Lumley, Sheila F, additional, Constantinides, Bede, additional, Sanderson, Nicholas, additional, Rodger, Gillian, additional, Chau, Kevin K, additional, Lodge, Archie, additional, Tsakok, Maria, additional, Gleeson, Fergus, additional, Adlam, David, additional, Rao, Praveen, additional, Indrajeet, Das, additional, Deshpande, Aparna, additional, Bajaj, Amrita, additional, Hudson, Benjamin J, additional, Srivastava, Vivek, additional, Farid, Shakil, additional, Krasopoulos, George, additional, Sayeed, Rana, additional, Ho, Ling-Pei, additional, Neubauer, Stefan, additional, Newby, David E, additional, Channon, Keith M, additional, Deanfield, John, additional, Antoniades, Charalambos, additional, Ahern, David J, additional, Ai, Zhichao, additional, Ainsworth, Mark, additional, Allan, Chris, additional, Allcock, Alice, additional, Angus, Brian, additional, Ansari, M Azim, additional, Arancibia-Cárcamo, Carolina, additional, Aschenbrenner, Dominik, additional, Attar, Moustafa, additional, Baillie, J Kenneth, additional, Barnes, Eleanor, additional, Bashford-Rogers, Rachael, additional, Bashyal, Archana, additional, Beer, Sally, additional, Berridge, Georgina, additional, Beveridge, Amy, additional, Bibi, Sagida, additional, Bicanic, Tihana, additional, Blackwell, Luke, additional, Bowness, Paul, additional, Brent, Andrew, additional, Brown, Andrew, additional, Broxholme, John, additional, Buck, David, additional, Byrne, Helen, additional, Camara, Susana, additional, Ferreira, Ivan Candido, additional, Charles, Philip, additional, Chen, Wentao, additional, Chen, Yi-Ling, additional, Chong, Amanda, additional, Clutterbuck, Elizabeth, additional, Coles, Mark, additional, Conlon, Christopher, additional, Cornall, Richard, additional, Cribbs, Adam, additional, Curion, Fabiola, additional, Davenport, Emma, additional, Davidson, Neil, additional, Davis, Simon, additional, Dendrou, Calliope, additional, Dequaire, Julie, additional, Dib, Lea, additional, Docker, James, additional, Dold, Christina, additional, Dong, Tao, additional, Downes, Damien, additional, Drakesmith, Hal, additional, Dunachie, Susanna, additional, Duncan, David, additional, Eijsbouts, Chris, additional, Esnouf, Robert, additional, Espinosa, Alexis, additional, Etherington, Rachel, additional, Fairfax, Benjamin, additional, Fairhead, Rory, additional, Fang, Hai, additional, Fassih, Shayan, additional, Felle, Sally, additional, Fernandez Mendoza, Maria, additional, Ferreira, Ricardo, additional, Fischer, Roman, additional, Foord, Thomas, additional, Forrow, Aden, additional, Frater, John, additional, Fries, Anastasia, additional, Gallardo Sanchez, Veronica, additional, Garner, Lucy, additional, Geeves, Clementine, additional, Georgiou, Dominique, additional, Godfrey, Leila, additional, Golubchik, Tanya, additional, Gomez Vazquez, Maria, additional, Green, Angie, additional, Harper, Hong, additional, Harrington, Heather, additional, Heilig, Raphael, additional, Hester, Svenja, additional, Hill, Jennifer, additional, Hinds, Charles, additional, Hird, Clare, additional, Hoekzema, Renee, additional, Hollis, Benjamin, additional, Hughes, Jim, additional, Hutton, Paula, additional, Jackson-Wood, Matthew, additional, Jainarayanan, Ashwin, additional, James-Bott, Anna, additional, Jansen, Kathrin, additional, Jeffery, Katie, additional, Jones, Elizabeth, additional, Jostins, Luke, additional, Kerr, Georgina, additional, Kim, David, additional, Klenerman, Paul, additional, Kumar, Vinod, additional, Kumar Sharma, Piyush, additional, Kurupati, Prathiba, additional, Kwok, Andrew, additional, Lee, Angela, additional, Linder, Aline, additional, Lockett, Teresa, additional, Lonie, Lorne, additional, Lopopolo, Maria, additional, Lukoseviciute, Martyna, additional, Luo, Jian, additional, Marinou, Spyridoula, additional, Marsden, Brian, additional, Martinez, Jose, additional, Matthews, Philippa, additional, Mazurczyk, Michalina, additional, McGowan, Simon, additional, McKechnie, Stuart, additional, Mead, Adam, additional, Mi, Yuxin, additional, Monaco, Claudia, additional, Montadon, Ruddy, additional, Napolitani, Giorgio, additional, Nassiri, Isar, additional, Novak, Alex, additional, O'Brien, Darragh, additional, O'Connor, Daniel, additional, O'Donnell, Denise, additional, Ogg, Graham, additional, Overend, Lauren, additional, Park, Inhye, additional, Pavord, Ian, additional, Peng, Yanchun, additional, Penkava, Frank, additional, Pereira Pinho, Mariana, additional, Perez, Elena, additional, Pollard, Andrew, additional, Powrie, Fiona, additional, Psaila, Bethan, additional, Quan, T Phuong, additional, Repapi, Emmanouela, additional, Revale, Santiago, additional, Silva-Reyes, Laura, additional, Richard, Jean-Baptiste, additional, Rich-Griffin, Charlotte, additional, Ritter, Thomas, additional, Rollier, Christine, additional, Rowland, Matthew, additional, Ruehle, Fabian, additional, Salio, Mariolina, additional, Sansom, Stephen Nicholas, additional, Sanches Peres, Raphael, additional, Santos Delgado, Alberto, additional, Sauka-Spengler, Tatjana, additional, Schwessinger, Ron, additional, Scozzafava, Giuseppe, additional, Screaton, Gavin, additional, Seigal, Anna, additional, Semple, Malcolm, additional, Sergeant, Martin, additional, Simoglou Karali, Christina, additional, Sims, David, additional, Skelly, Donal, additional, Slawinski, Hubert, additional, Sobrinodiaz, Alberto, additional, Sousos, Nikolaos, additional, Stafford, Lizzie, additional, Stockdale, Lisa, additional, Strickland, Marie, additional, Sumray, Otto, additional, Sun, Bo, additional, Taylor, Chelsea, additional, Taylor, Stephen, additional, Taylor, Adan, additional, Thongjuea, Supat, additional, Thraves, Hannah, additional, Todd, John, additional, Tomic, Adriana, additional, Tong, Orion, additional, Trebes, Amy, additional, Trzupek, Dominik, additional, Tucci, Felicia Anna, additional, Turtle, Lance, additional, Udalova, Irina, additional, Uhlig, Holm, additional, van Grinsven, Erinke, additional, Vendrell, Iolanda, additional, Verheul, Marije, additional, Voda, Alexandru, additional, Wang, Guanlin, additional, Wang, Lihui, additional, Wang, Dapeng, additional, Watkinson, Peter, additional, Watson, Robert, additional, Weinberger, Michael, additional, Whalley, Justin, additional, Witty, Lorna, additional, Wray, Katherine, additional, Xue, Luzheng, additional, Yuen Yeung, Hing, additional, Yin, Zixi, additional, Young, Rebecca, additional, Youngs, Jonathan, additional, Zhang, Ping, additional, Zurke, Yasemin-Xiomara, additional, Banning, Adrian, additional, Antonopoulos, Alexios, additional, Kelion, Andrew, additional, Kardos, Attila, additional, Hudson, Benjamin, additional, Koo, Bon-Kwon, additional, Kotanidis, Christos, additional, Mahon, Ciara, additional, Berry, Colin, additional, Newby, David, additional, Connolly, Derek, additional, Scaletta, Diane, additional, Nicol, Ed, additional, McAlindon, Elisa, additional, Oikonomou, Evangelos, additional, Pugliese, Francesca, additional, Pontone, Gianluca, additional, Benedetti, Giulia, additional, He, Guo-Wei, additional, West, Henry, additional, Kondo, Hidekazu, additional, Benedek, Imre, additional, Das, Intrajeet, additional, Graby, John, additional, Greenwood, John, additional, Rodrigues, Jonathan, additional, Ge, Junbo, additional, Channon, Keith, additional, Fabritz, Larissa, additional, Fan, Li-Juan, additional, Kingham, Lucy, additional, Guglielmo, Marco, additional, Schmitt, Matthias, additional, 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Published
2022
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99. Effects of oral semaglutide on cardiovascular outcomes in individuals with type 2 diabetes and established atherosclerotic cardiovascular disease and/or chronic kidney disease: Design and baseline characteristics of SOUL, a randomized trial.

Author

McGuire, Darren K., Busui, Rodica P., Deanfield, John, Inzucchi, Silvio E., Mann, Johannes F. E., Marx, Nikolaus, Mulvagh, Sharon L., Poulter, Neil, Engelmann, Mads D. M., Hovingh, G. Kees, Ripa, Maria Sejersten, Gislum, Mette, Brown‐Frandsen, Kirstine, and Buse, John B.

Subjects
TYPE 2 diabetes, CHRONIC kidney failure, CARDIOVASCULAR diseases, SEMAGLUTIDE, GLUCAGON-like peptide-1 receptor, INSULIN, GLUCAGON receptors
Abstract

Aim: To describe the design of the SOUL trial (Semaglutide cardiOvascular oUtcomes triaL) and the baseline clinical data of its participants. Materials and methods: In SOUL, the effects of oral semaglutide, the first oral glucagon‐like peptide‐1 receptor agonist, on the risk of cardiovascular (CV) events in individuals with type 2 diabetes and established atherosclerotic CV disease (ASCVD) and/or chronic kidney disease (CKD) will be assessed. SOUL is a randomized, double‐blind, parallel‐group, placebo‐controlled CV outcomes trial comparing oral semaglutide (14 mg once daily) with placebo, both in addition to standard of care, in individuals aged ≥50 years with type 2 diabetes and evidence of ASCVD (coronary artery disease [CAD], cerebrovascular disease, symptomatic peripheral arterial disease [PAD]) and/or CKD (estimated glomerular filtration rate <60 mL/min/1.73 m2). The primary outcome is time from randomization to first occurrence of a major adverse CV event (MACE; a composite of CV death, nonfatal myocardial infarction or nonfatal stroke). This event‐driven trial will continue until 1225 first adjudication‐confirmed MACEs have occurred. Enrolment has been completed. Results: Overall, 9650 participants were enrolled between June 17, 2019 and March 24, 2021 (men 71.1%, White ethnicity 68.9%, mean age 66.1 years, diabetes duration 15.4 years, body mass index 31.1 kg/m2, glycated haemoglobin 63.5 mmol/mol [8.0%]). The most frequently used antihyperglycaemic medications at baseline were metformin (75.7%), insulin and insulin analogues (50.5%), sulphonylureas (29.1%), sodium‐glucose cotransporter‐2 inhibitors (26.7%) and dipeptidyl peptidase‐4 inhibitors (23.0%). At randomization, 70.7% of participants had CAD, 42.3% had CKD, 21.1% had cerebrovascular disease and 15.7% had symptomatic PAD (categories not mutually exclusive). Prevalent heart failure was reported in 23.0% of participants. Conclusion: SOUL will provide evidence regarding the CV effects of oral semaglutide in individuals with type 2 diabetes and established ASCVD and/or CKD. [ABSTRACT FROM AUTHOR]

Published
2023
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