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202. A Glycemia Risk Index (GRI) of Hypoglycemia and Hyperglycemia for Continuous Glucose Monitoring Validated by Clinician Ratings

Author

Klonoff, David C., primary, Wang, Jing, additional, Rodbard, David, additional, Kohn, Michael A., additional, Li, Chengdong, additional, Liepmann, Dorian, additional, Kerr, David, additional, Ahn, David, additional, Peters, Anne L., additional, Umpierrez, Guillermo E., additional, Seley, Jane Jeffrie, additional, Xu, Nicole Y., additional, Nguyen, Kevin T., additional, Simonson, Gregg, additional, Agus, Michael S. D., additional, Al-Sofiani, Mohammed E., additional, Armaiz-Pena, Gustavo, additional, Bailey, Timothy S., additional, Basu, Ananda, additional, Battelino, Tadej, additional, Bekele, Sewagegn Yeshiwas, additional, Benhamou, Pierre-Yves, additional, Bequette, B. Wayne, additional, Blevins, Thomas, additional, Breton, Marc D., additional, Castle, Jessica R., additional, Chase, James Geoffrey, additional, Chen, Kong Y., additional, Choudhary, Pratik, additional, Clements, Mark A., additional, Close, Kelly L., additional, Cook, Curtiss B., additional, Danne, Thomas, additional, Doyle, Francis J., additional, Drincic, Angela, additional, Dungan, Kathleen M., additional, Edelman, Steven V., additional, Ejskjaer, Niels, additional, Espinoza, Juan C., additional, Fleming, G. Alexander, additional, Forlenza, Gregory P., additional, Freckmann, Guido, additional, Galindo, Rodolfo J., additional, Gomez, Ana Maria, additional, Gutow, Hanna A., additional, Heinemann, Lutz, additional, Hirsch, Irl B., additional, Hoang, Thanh D., additional, Hovorka, Roman, additional, Jendle, Johan H., additional, Ji, Linong, additional, Joshi, Shashank R., additional, Joubert, Michael, additional, Koliwad, Suneil K., additional, Lal, Rayhan A., additional, Lansang, M. Cecilia, additional, Lee, Wei-An (Andy), additional, Leelarathna, Lalantha, additional, Leiter, Lawrence A., additional, Lind, Marcus, additional, Litchman, Michelle L., additional, Mader, Julia K., additional, Mahoney, Katherine M., additional, Mankovsky, Boris, additional, Masharani, Umesh, additional, Mathioudakis, Nestoras N., additional, Mayorov, Alexander, additional, Messler, Jordan, additional, Miller, Joshua D., additional, Mohan, Viswanathan, additional, Nichols, James H., additional, Nørgaard, Kirsten, additional, O’Neal, David N., additional, Pasquel, Francisco J., additional, Philis-Tsimikas, Athena, additional, Pieber, Thomas, additional, Phillip, Moshe, additional, Polonsky, William H., additional, Pop-Busui, Rodica, additional, Rayman, Gerry, additional, Rhee, Eun-Jung, additional, Russell, Steven J., additional, Shah, Viral N., additional, Sherr, Jennifer L., additional, Sode, Koji, additional, Spanakis, Elias K., additional, Wake, Deborah J., additional, Waki, Kayo, additional, Wallia, Amisha, additional, Weinberg, Melissa E., additional, Wolpert, Howard, additional, Wright, Eugene E., additional, Zilbermint, Mihail, additional, and Kovatchev, Boris, additional

Published
2022
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203. Association of Low- and No-Calorie Sweetened Beverages as a Replacement for Sugar-Sweetened Beverages With Body Weight and Cardiometabolic Risk

Author

McGlynn, Néma D., primary, Khan, Tauseef Ahmad, additional, Wang, Lily, additional, Zhang, Roselyn, additional, Chiavaroli, Laura, additional, Au-Yeung, Fei, additional, Lee, Jennifer J., additional, Noronha, Jarvis C., additional, Comelli, Elena M., additional, Blanco Mejia, Sonia, additional, Ahmed, Amna, additional, Malik, Vasanti S., additional, Hill, James O., additional, Leiter, Lawrence A., additional, Agarwal, Arnav, additional, Jeppesen, Per B., additional, Rahelić, Dario, additional, Kahleová, Hana, additional, Salas-Salvadó, Jordi, additional, Kendall, Cyril W. C., additional, and Sievenpiper, John L., additional

Published
2022
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204. FIBROBLAST GROWTH FACTOR-23, CARDIORENAL OUTCOMES, AND EFFICACY OF DAPAGLIFLOZIN IN PATIENTS WITH TYPE 2 DIABETES MELLITUS: AN ANALYSIS FROM DECLARE-TIMI 58

Author

Berg, David, primary, Wiviott, Stephen D., additional, Raz, Itamar, additional, Jarolim, Petr, additional, Goodrich, Erica L., additional, Mosenzon, Ofri, additional, Cahn, Avivit, additional, Bhatt, Deepak L., additional, Leiter, Lawrence A., additional, McGuire, Darren K., additional, Wilding, John PH, additional, Gause-Nilsson, Ingrid, additional, Hammarstedt, Ann, additional, Oscarsson, Jan, additional, Sabatine, Marc Steven, additional, and Morrow, David A., additional

Published
2022
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206. Bempedoic acid in patients with type 2 diabetes mellitus, prediabetes, and normoglycaemia: A post hoc analysis of efficacy and glycaemic control using pooled data from phase 3 clinical trials

Author

Leiter, Lawrence A., primary, Banach, Maciej, additional, Catapano, Alberico L., additional, Duell, P. Barton, additional, Gotto, Antonio M., additional, Laufs, Ulrich, additional, Mancini, G. B. John, additional, Ray, Kausik K., additional, Hanselman, Jeffrey C., additional, Ye, Zhan, additional, and Bays, Harold E., additional

Published
2022
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207. Additional file 1 of Epidemiology of the diabetes-cardio-renal spectrum: a cross-sectional report of 1.4 million adults

Author

Schechter, Meir, Melzer Cohen, Cheli, Yanuv, Ilan, Rozenberg, Aliza, Chodick, Gabriel, Bodegård, Johan, Leiter, Lawrence A., Verma, Subodh, Lambers Heerspink, Hiddo J., Karasik, Avraham, and Mosenzon, Ofri

Subjects
endocrine system diseases, nutritional and metabolic diseases
Abstract

Additional file 1: Figure S1. CONSORT diagram of subjects included in this analysis. Figure S2. Distribution by age of T2D, heart failure, and eGFR

Published
2022
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208. sj-pdf-1-dst-10.1177_19322968221085273 – Supplemental material for A Glycemia Risk Index (GRI) of Hypoglycemia and Hyperglycemia for Continuous Glucose Monitoring Validated by Clinician Ratings

Author

Klonoff, David C., Wang, Jing, Rodbard, David, Kohn, Michael A., Li, Chengdong, Liepmann, Dorian, Kerr, David, Ahn, David, Peters, Anne L., Umpierrez, Guillermo E., Seley, Jane Jeffrie, Xu, Nicole Y., Nguyen, Kevin T., Simonson, Gregg, Agus, Michael S. D., Al-Sofiani, Mohammed E., Armaiz-Pena, Gustavo, Bailey, Timothy S., Basu, Ananda, Battelino, Tadej, Bekele, Sewagegn Yeshiwas, Benhamou, Pierre-Yves, Bequette, B. Wayne, Blevins, Thomas, Breton, Marc D., Castle, Jessica R., Chase, James Geoffrey, Chen, Kong Y., Choudhary, Pratik, Clements, Mark A., Close, Kelly L., Cook, Curtiss B., Danne, Thomas, Doyle, Francis J., Drincic, Angela, Dungan, Kathleen M., Edelman, Steven V., Ejskjaer, Niels, Espinoza, Juan C., Fleming, G. Alexander, Forlenza, Gregory P., Freckmann, Guido, Galindo, Rodolfo J., Gomez, Ana Maria, Gutow, Hanna A., Heinemann, Lutz, Hirsch, Irl B., Hoang, Thanh D., Hovorka, Roman, Jendle, Johan H., Ji, Linong, Joshi, Shashank R., Joubert, Michael, Koliwad, Suneil K., Lal, Rayhan A., Lansang, M. Cecilia, Lee, Wei-An (Andy), Leelarathna, Lalantha, Leiter, Lawrence A., Lind, Marcus, Litchman, Michelle L., Mader, Julia K., Mahoney, Katherine M., Mankovsky, Boris, Masharani, Umesh, Mathioudakis, Nestoras N., Mayorov, Alexander, Messler, Jordan, Miller, Joshua D., Mohan, Viswanathan, Nichols, James H., Nørgaard, Kirsten, O’Neal, David N., Pasquel, Francisco J., Philis-Tsimikas, Athena, Pieber, Thomas, Phillip, Moshe, Polonsky, William H., Pop-Busui, Rodica, Rayman, Gerry, Rhee, Eun-Jung, Russell, Steven J., Shah, Viral N., Sherr, Jennifer L., Sode, Koji, Spanakis, Elias K., Wake, Deborah J., Waki, Kayo, Wallia, Amisha, Weinberg, Melissa E., Wolpert, Howard, Wright, Eugene E., Zilbermint, Mihail, and Kovatchev, Boris

Subjects
111708 Health and Community Services, FOS: Clinical medicine, 111199 Nutrition and Dietetics not elsewhere classified, Medicine, FOS: Health sciences, 110306 Endocrinology
Abstract

Supplemental material, sj-pdf-1-dst-10.1177_19322968221085273 for A Glycemia Risk Index (GRI) of Hypoglycemia and Hyperglycemia for Continuous Glucose Monitoring Validated by Clinician Ratings by David C. Klonoff, Jing Wang, David Rodbard, Michael A. Kohn, Chengdong Li, Dorian Liepmann, David Kerr, David Ahn, Anne L. Peters, Guillermo E. Umpierrez, Jane Jeffrie Seley, Nicole Y. Xu, Kevin T. Nguyen, Gregg Simonson, Michael S. D. Agus, Mohammed E. Al-Sofiani, Gustavo Armaiz-Pena, Timothy S. Bailey, Ananda Basu, Tadej Battelino, Sewagegn Yeshiwas Bekele, Pierre-Yves Benhamou, B. Wayne Bequette, Thomas Blevins, Marc D. Breton, Jessica R. Castle, James Geoffrey Chase, Kong Y. Chen, Pratik Choudhary, Mark A. Clements, Kelly L. Close, Curtiss B. Cook, Thomas Danne, Francis J. Doyle, Angela Drincic, Kathleen M. Dungan, Steven V. Edelman, Niels Ejskjaer, Juan C. Espinoza, G. Alexander Fleming, Gregory P. Forlenza, Guido Freckmann, Rodolfo J. Galindo, Ana Maria Gomez, Hanna A. Gutow, Lutz Heinemann, Irl B. Hirsch, Thanh D. Hoang, Roman Hovorka, Johan H. Jendle, Linong Ji, Shashank R. Joshi, Michael Joubert, Suneil K. Koliwad, Rayhan A. Lal, M. Cecilia Lansang, Wei-An (Andy) Lee, Lalantha Leelarathna, Lawrence A. Leiter, Marcus Lind, Michelle L. Litchman, Julia K. Mader, Katherine M. Mahoney, Boris Mankovsky, Umesh Masharani, Nestoras N. Mathioudakis, Alexander Mayorov, Jordan Messler, Joshua D. Miller, Viswanathan Mohan, James H. Nichols, Kirsten Nørgaard, David N. O’Neal, Francisco J. Pasquel, Athena Philis-Tsimikas, Thomas Pieber, Moshe Phillip, William H. Polonsky, Rodica Pop-Busui, Gerry Rayman, Eun-Jung Rhee, Steven J. Russell, Viral N. Shah, Jennifer L. Sherr, Koji Sode, Elias K. Spanakis, Deborah J. Wake, Kayo Waki, Amisha Wallia, Melissa E. Weinberg, Howard Wolpert, Eugene E. Wright, Mihail Zilbermint and Boris Kovatchev in Journal of Diabetes Science and Technology

Published
2022
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213. The 2011 Canadian Hypertension Education Program Recommendations for the Management of Hypertension: Blood Pressure Measurement, Diagnosis, Assessment of Risk, and Therapy

Author

Rabi, Doreen M., Daskalopoulou, Stella S., Padwal, Raj S., Khan, Nadia A., Grover, Steven A., Hackam, Daniel G., Myers, Martin G., McKay, Donald W., Quinn, Robert R., Hemmelgarn, Brenda R., Cloutier, Lyne, Bolli, Peter, Hill, Michael D., Wilson, Thomas, Penner, Brian, Burgess, Ellen, Lamarre-Cliché, Maxime, McLean, Donna, Schiffrin, Ernesto L., Honos, George, Mann, Karen, Tremblay, Guy, Milot, Alain, Chockalingam, Arun, Rabkin, Simon W., Dawes, Martin, Touyz, Rhian M., Burns, Kevin D., Ruzicka, Marcel, Campbell, Norman R.C., Vallée, Michel, Prasad, G.V. Ramesh, Lebel, Marcel, Campbell, Tavis S., Lindsay, M. Patrice, Herman, Robert J., Larochelle, Pierre, Feldman, Ross D., Arnold, J. Malcolm O., Moe, Gordon W., Howlett, Jonathan G., Trudeau, Luc, Bacon, Simon L., Petrella, Robert J., Lewanczuk, Richard, Stone, James A., Drouin, Denis, Boulanger, Jean-Martin, Sharma, Mukul, Hamet, Pavel, Fodor, George, Dresser, George K., Carruthers, S. George, Pylypchuk, George, Gilbert, Richard E., Leiter, Lawrence A., Jones, Charlotte, Ogilvie, Richard I., Woo, Vincent, McFarlane, Philip A., Hegele, Robert A., Poirier, Luc, and Tobe, Sheldon W.

Published
2011
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214. Identification and Management of Cardiometabolic Risk in Canada: A Position Paper by the Cardiometabolic Risk Working Group (Executive Summary)

Author

Leiter, Lawrence A., Fitchett, David H., Gilbert, Richard E., Gupta, Milan, Mancini, G.B. John, McFarlane, Philip A., Ross, Robert, Teoh, Hwee, Verma, Subodh, Anand, Sonia, Camelon, Kathryn, Chow, Chi-Ming, Cox, Jafna L., Després, Jean-Pierre, Genest, Jacques, Harris, Stewart B., Lau, David C.W., Lewanczuk, Richard, Liu, Peter P., Lonn, Eva M., McPherson, Ruth, Poirier, Paul, Qaadri, Shafiq, Rabasa-Lhoret, Rémi, Rabkin, Simon W., Sharma, Arya M., Steele, Andrew W., Stone, James A., Tardif, Jean-Claude, Tobe, Sheldon, and Ur, Ehud

Published
2011
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215. Cardiometabolic Risk in Canada: A Detailed Analysis and Position Paper by the Cardiometabolic Risk Working Group

Author

Leiter, Lawrence A., Fitchett, David H., Gilbert, Richard E., Gupta, Milan, Mancini, G.B. John, McFarlane, Philip A., Ross, Robert, Teoh, Hwee, Verma, Subodh, Anand, Sonia, Camelon, Kathryn, Chow, Chi-Ming, Cox, Jafna L., Després, Jean-Pierre, Genest, Jacques, Harris, Stewart B., Lau, David C.W., Lewanczuk, Richard, Liu, Peter P., Lonn, Eva M., McPherson, Ruth, Poirier, Paul, Qaadri, Shafiq, Rabasa-Lhoret, Rémi, Rabkin, Simon W., Sharma, Arya M., Steele, Andrew W., Stone, James A., Tardif, Jean-Claude, Tobe, Sheldon, and Ur, Ehud

Published
2011
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218. Dulaglutide and incident atrial fibrillation or flutter in patients with type 2 diabetes: A post hoc analysis from the REWIND randomized trial

Author

Raubenheimer, Peter J., primary, Cushman, William C., additional, Avezum, Alvaro, additional, Basile, Jan, additional, Conget, Ignacio, additional, Dagenais, Gilles, additional, Hoover, Anastasia, additional, Jansky, Petr, additional, Lanas, Fernando, additional, Leiter, Lawrence A., additional, Lopez‐Jaramillo, Patricio, additional, Pogosova, Nana, additional, Probstfield, Jeffrey, additional, Rao‐Melacini, Purnima, additional, Rydén, Lars, additional, Sheu, Wayne H.‐H., additional, Temelkova‐Kurktschiev, Theodora, additional, and C. Gerstein, Hertzel, additional

Published
2022
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219. Effect of Dapagliflozin on Hematocrit in Patients With Type 2 Diabetes at High Cardiovascular Risk: Observations From DECLARE-TIMI 58

Author

Kolkailah, Ahmed A., primary, Wiviott, Stephen D., additional, Raz, Itamar, additional, Murphy, Sabina A., additional, Mosenzon, Ofri, additional, Bhatt, Deepak L., additional, Leiter, Lawrence A., additional, Wilding, John P.H., additional, Gause-Nilsson, Ingrid, additional, Sabatine, Marc S., additional, and McGuire, Darren K., additional

Published
2022
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220. Association of Baseline HbA1c With Cardiovascular and Renal Outcomes: Analyses From DECLARE-TIMI 58

Author

Cahn, Avivit, primary, Wiviott, Stephen D., additional, Mosenzon, Ofri, additional, Goodrich, Erica L., additional, Murphy, Sabina A., additional, Yanuv, Ilan, additional, Rozenberg, Aliza, additional, Bhatt, Deepak L., additional, Leiter, Lawrence A., additional, McGuire, Darren K., additional, Wilding, John P.H., additional, Gause-Nilsson, Ingrid A.M., additional, Langkilde, Anna Maria, additional, Sabatine, Marc S., additional, and Raz, Itamar, additional

Published
2022
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222. Long-Term Efficacy and Safety of Inclisiran in Patients with High Cardiovascular Risk and Elevated Low-Density Lipoprotein Cholesterol (ORION-3): Results from the 4-Year Open-Label Extension of the ORION-1 Trial

Author

Ray, Kausik K., primary, Troquay, Roel PT, additional, Visseren, Frank LJ, additional, Leiter, Lawrence A., additional, Wright, Scott, additional, Vikarunnessa, Sheikh, additional, Talloczy, Zsolt, additional, Zang, Xiao, additional, Maheux, Pierre, additional, Lesogor, Anastasia, additional, and Landmesser, Ulf, additional

Published
2022
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224. A Web-Based Health Application to Translate Nutrition Therapy for Cardiovascular Risk Reduction in Primary Care (PortfolioDiet.app): Quality Improvement and Usability Testing Study (Preprint)

Author

Kavanagh, Meaghan E, primary, Chiavaroli, Laura, additional, Glenn, Andrea J, additional, Heijmans, Genevieve, additional, Grant, Shannan M, additional, Chow, Chi-Ming, additional, Josse, Robert G, additional, Malik, Vasanti S, additional, Watson, William, additional, Lofters, Aisha, additional, Holmes, Candice, additional, Rackal, Julia, additional, Srichaikul, Kristie, additional, Sherifali, Diana, additional, Snelgrove-Clarke, Erna, additional, Udell, Jacob A, additional, Juni, Peter, additional, Booth, Gillian L, additional, Farkouh, Michael E, additional, Leiter, Lawrence A, additional, Kendall, Cyril WC, additional, Jenkins, David JA, additional, and Sievenpiper, John L, additional

Published
2021
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226. Abstract 11033: Efficacy and Safety of Inclisiran by Baseline Glycemic Status: A Post Hoc Pooled Analysis of the ORION-10 and ORION-11 Phase III Randomized Controlled Trials

Author

Leiter, Lawrence A, primary, Kallend, David G, additional, Koenig, Wolfgang, additional, Landmesser, Ulf, additional, Raal, Frederick J, additional, Ray, Kausik K, additional, Schwartz, Gregory G, additional, chiang, yanntong, additional, Garcia Conde Orozco, Lorena, additional, and Wright, R S, additional

Published
2021
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227. Abstract 11143: Efficacy and Safety of Inclisiran by Baseline Body Mass Index: A Post Hoc Pooled Analysis of the ORION-9, ORION-10 and ORION-11 Phase III Randomized Controlled Trials

Author

Leiter, Lawrence A, primary, Kallend, David G, additional, Koenig, Wolfgang, additional, Landmesser, Ulf, additional, Ray, Kausik K, additional, Schwartz, Gregory G, additional, Wright, R S, additional, chiang, yanntong, additional, Garcia Conde Orozco, Lorena, additional, and Raal, Frederick J, additional

Published
2021
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228. Abstract 13182: Dapagliflozin and Changes in Metabolic Syndrome in Patients With Type 2 Diabetes: A DECLARE TIMI 58 Sub-Analysis

Author

Moura, Filipe A, primary, RAZ, Itamar, additional, Cahn, Avivit, additional, Goodrich, Erica, additional, Bhatt, Deepak L, additional, Leiter, Lawrence A, additional, WILDING, JOHN, additional, Gause-nilsson, Ingrid A, additional, Mosenzon, Ofri, additional, Sabatine, Marc S, additional, and Wiviott, Stephen D, additional

Published
2021
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230. Blood-Pressure and Cholesterol Lowering in Persons without Cardiovascular Disease

Author

Yusuf, Salim, Lonn, Eva, Pais, Prem, Bosch, Jackie, López-Jaramillo, Patricio, Zhu, Jun, Xavier, Denis, Avezum, Alvaro, Leiter, Lawrence A., Piegas, Leopoldo S., Parkhomenko, Alexander, Keltai, Matyas, Keltai, Katalin, Sliwa, Karen, Chazova, Irina, Peters, Ron J.G., Held, Claes, Yusoff, Khalid, Lewis, Basil S., Jansky, Petr, Khunti, Kamlesh, Toff, William D., Reid, Christopher M., Varigos, John, Accini, Jose L., McKelvie, Robert, Pogue, Janice, Jung, Hyejung, Liu, Lisheng, Diaz, Rafael, Dans, Antonio, and Dagenais, Gilles

Published
2016
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231. Blood-Pressure Lowering in Intermediate-Risk Persons without Cardiovascular Disease

Author

Lonn, Eva M., Bosch, Jackie, López-Jaramillo, Patricio, Zhu, Jun, Liu, Lisheng, Pais, Prem, Diaz, Rafael, Xavier, Denis, Sliwa, Karen, Dans, Antonio, Avezum, Alvaro, Piegas, Leopoldo S., Keltai, Katalin, Keltai, Matyas, Chazova, Irina, Peters, Ron J.G., Held, Claes, Yusoff, Khalid, Lewis, Basil S., Jansky, Petr, Parkhomenko, Alexander, Khunti, Kamlesh, Toff, William D., Reid, Christopher M., Varigos, John, Leiter, Lawrence A., Molina, Dora I., McKelvie, Robert, Pogue, Janice, Wilkinson, Joanne, Jung, Hyejung, Dagenais, Gilles, and Yusuf, Salim

Published
2016
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232. Cholesterol Lowering in Intermediate-Risk Persons without Cardiovascular Disease

Author

Yusuf, Salim, Bosch, Jackie, Dagenais, Gilles, Zhu, Jun, Xavier, Denis, Liu, Lisheng, Pais, Prem, López-Jaramillo, Patricio, Leiter, Lawrence A., Dans, Antonio, Avezum, Alvaro, Piegas, Leopoldo S., Parkhomenko, Alexander, Keltai, Katalin, Keltai, Matyas, Sliwa, Karen, Peters, Ron J.G., Held, Claes, Chazova, Irina, Yusoff, Khalid, Lewis, Basil S., Jansky, Petr, Khunti, Kamlesh, Toff, William D., Reid, Christopher M., Varigos, John, Sanchez-Vallejo, Gregorio, McKelvie, Robert, Pogue, Janice, Jung, Hyejung, Gao, Peggy, Diaz, Rafael, and Lonn, Eva

Published
2016
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233. Inclisiran and cardiovascular events: a patient-level analysis of phase III trials.

Author

Ray, Kausik K, Raal, Frederick J, Kallend, David G, Jaros, Mark J, Koenig, Wolfgang, Leiter, Lawrence A, Landmesser, Ulf, Schwartz, Gregory G, Lawrence, David, Friedman, Andrew, Conde, Lorena Garcia, Wright, R Scott, and investigators, ORION Phase III

Subjects
CLINICAL trials, MAJOR adverse cardiovascular events, LDL cholesterol, STROKE
Abstract

Background Inclisiran, an siRNA administered twice-yearly, significantly reduced LDL cholesterol (LDL-C) in Phase III trials. Whether lowering LDL-C with inclisiran translates into a lower risk of cardiovascular (CV) events is not yet established. Methods and results Patient-level, pooled analysis of ORION-9, −10 and −11, included patients with heterozygous familial hypercholesterolaemia, atherosclerotic CV disease (ASCVD), or ASCVD risk equivalent on maximally tolerated statin-therapy, randomized 1:1 to receive 284 mg inclisiran or placebo on Days 1, 90, and 6-monthly thereafter for 18 months. Prespecified exploratory endpoint of major cardiovascular events (MACEs) included non-adjudicated CV death, cardiac arrest, non-fatal myocardial infarction (MI), and fatal and non-fatal stroke, evaluated as part of safety assessments using a standard Medical Dictionary for Regulatory Activities basket. Although not prespecified, total fatal and non-fatal MI, and stroke were also evaluated. Mean LDL-C at baseline was 2.88 mmol/L. At Day 90, the placebo-corrected percentage reduction in LDL-C with inclisiran was 50.6%, corresponding to an absolute reduction of 1.37 mmol/L (both P < 0.0001). Among 3655 patients over 18 months, 303 (8.3%) experienced MACE, including 74 (2.0%) fatal and non-fatal MIs, and 28 (0.8%) fatal and non-fatal strokes. Inclisiran significantly reduced composite MACE [OR (95% CI): 0.74 (0.58–0.94)], but not fatal and non-fatal MIs [OR (95% CI): 0.80 (0.50–1.27)] or fatal and non-fatal stroke [OR (95% CI): 0.86 (0.41–1.81)]. Conclusion This analysis offers early insights into the potential CV benefits of lowering LDL-C with inclisiran and suggests potential benefits for MACE reduction. These findings await confirmation in the larger CV outcomes trials of longer duration. [ABSTRACT FROM AUTHOR]

Published
2023
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234. Efficacy and Safety of Dapagliflozin by Baseline Insulin Regimen and Dose: Post Hoc Analyses From DECLARE-TIMI 58.

Author

Pollack, Rena, Raz, Itamar, Wiviott, Stephen D., Goodrich, Erica L., Murphy, Sabina A., Yanuv, Ilan, Rozenberg, Aliza, Mosenzon, Ofri, Langkilde, Anna Maria, Gause-Nilsson, Ingrid A.M., Bhatt, Deepak L., Leiter, Lawrence A., McGuire, Darren K., Wilding, John P.H., Sabatine, Marc S., and Cahn, Avivit

Subjects
INSULIN therapy, DAPAGLIFLOZIN, SODIUM-glucose cotransporter 2 inhibitors, SYSTOLIC blood pressure, SALT-free diet, DIABETIC acidosis, INSULIN pumps
Abstract

Objective: The cardiorenal benefits of adding sodium-glucose cotransporter 2 (SGLT2) inhibitor therapy for patients on insulin, particularly those on intensive regimens that include short-acting (SA) insulin, have not been explored.Research Design and Methods: In Dapagliflozin Effect on Cardiovascular Events trial (DECLARE-TIMI 58), 17,160 patients with type 2 diabetes were randomized to dapagliflozin or placebo for a median follow-up of 4.2 years. Cardiovascular (CV), renal, metabolic, and safety outcomes with dapagliflozin versus placebo by insulin dose and regimen were studied with Cox regression models.Results: The study included 7,013 insulin users at baseline, with 4,650 (66.3%) patients on regimens including SA insulin. Insulin doses varied, with 2,443 (34.8%) patients receiving <0.5 IU/kg, 2,795 (39.9%) 0.5 to ≤1 IU/kg, and 1,339 (19.1%) >1 IU/kg. Dapagliflozin reduced CV death/hospitalization for heart failure among overall insulin users (hazard ratio [HR] 0.82 [95% CI 0.69-0.97]) and consistently in patients on insulin regimens with or without SA insulin (0.83 [0.67-1.03] and 0.78 [0.57-1.07], respectively, Pinteraction = 0.75). No heterogeneity was observed by insulin dose (Pinteraction = 0.43). The HR for major adverse CV events with dapagliflozin among insulin users (0.84 [0.74-0.97]) was similar irrespective of regimen or dose (Pinteraction = 0.75 and 0.07). Dapagliflozin reduced the rate of adverse renal outcomes overall and consistently across subgroups of insulin users. Decreases in HbA1c, weight, and systolic blood pressure with dapagliflozin were seen regardless of insulin dose or regimen. The known safety profile of dapagliflozin was unchanged in patients on intensive insulin regimens.Conclusions: The benefits and safety of dapagliflozin were maintained in high-risk patients receiving high-dose or intensive insulin regimens including SA insulin.Article Highlights: Limited data exist regarding the cardiorenal, metabolic, and safety outcomes of SGLT2 inhibitors in patients on high-dose or intensive insulin regimens including short-acting insulin. In DECLARE-TIMI 58, 17,160 patients including 7,013 baseline insulin users were randomized to dapagliflozin versus placebo. Outcomes among insulin users by insulin dose and regimen were studied. Our results suggest that use of dapagliflozin by patients with type 2 diabetes managed with insulin, including high-dose or intensive insulin regimens, provided significant cardiovascular, renal, and metabolic benefits, in line with overall trial results. Adverse events associated with dapagliflozin, including hypoglycemia and diabetic ketoacidosis, were rare in this cohort. [ABSTRACT FROM AUTHOR]

Published
2023
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235. Effect of inclisiran on lipids in primary prevention: the ORION-11 trial.

Author

Ray, Kausik K, Kallend, David, Leiter, Lawrence A, Raal, Frederick J, Koenig, Wolfgang, Jaros, Mark J, Schwartz, Gregory G, Landmesser, Ulf, Conde, Lorena Garcia, Wright, R Scott, and Investigators, ORION-11

Subjects
LIPIDS, LDL cholesterol, APOLIPOPROTEIN B, RNA, LIPOPROTEINS
Abstract

Aims Patients often require combination therapies to achieve LDL cholesterol (LDL-C) targets for the primary prevention of atherosclerotic cardiovascular disease. This study investigates the effect of inclisiran, a small interfering ribonucleic acid targeting hepatic proprotein convertase subtilisin/kexin type 9 production, in primary prevention patients with elevated LDL-C despite statins. Methods and results This pre-specified analysis of the placebo-controlled, randomized ORION-11 trial included 203 individuals at risk of, but without prior, cardiovascular events and LDL-C ≥2.6 mmol/L, despite maximally tolerated statins. Inclisiran 284 mg or placebo was administered on Days 1, 90, and thereafter every 6 months up to 540 days. Co-primary endpoints were percentage LDL-C change from baseline to Day 510 and time-adjusted change from baseline after Day 90 and up to Day 540. Key secondary endpoints included percentage and absolute changes in atherogenic lipoproteins. Safety was assessed over 540 days. The mean baseline (SD) LDL-C was 3.6 (1.5) mmol/L. At Day 510, the placebo-corrected LDL-C change with inclisiran was −43.7% [95% confidence interval (CI): −52.8 to −34.6] with a corresponding time-adjusted change of −41.0% (95% CI: −47.8 to −34.2); (P < 0.0001). The placebo-corrected absolute change in LDL-C at Day 510 with inclisiran was −1.5 mmol/L (95% CI: −1.8 to −1.2), with a respective time-adjusted change of −1.3 mmol/L (95% CI: −1.6 to −1.1). Inclisiran significantly lowered non-HDL cholesterol and apolipoprotein B (apoB) at Day 510 vs. placebo (P < 0.0001 for both), with a greater likelihood of attaining lipoprotein and apoB goals, and was well-tolerated except for mainly mild, treatment-emergent adverse events at the injection site. Conclusion Inclisiran was generally well-tolerated in primary prevention patients with elevated LDL-C, who derived significant reductions in atherogenic lipoprotein levels with twice-yearly maintenance dosing. [ABSTRACT FROM AUTHOR]

Published
2022
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238. The 2010 Canadian Hypertension Education Program recommendations for the management of hypertension: Part 2 – therapy

Author

Hackam, Daniel G., Khan, Nadia A., Hemmelgarn, Brenda R., Rabkin, Simon W., Touyz, Rhian M., Campbell, Norman R.C., Padwal, Raj, Campbell, Tavis S., Patrice Lindsay, M., Hill, Michael D., Quinn, Robert R., Mahon, Jeff L., Herman, Robert J., Schiffrin, Ernesto L., Ruzicka, Marcel, Larochelle, Pierre, Feldman, Ross D., Lebel, Marcel, Poirier, Luc, Arnold, J. Malcolm O., Moe, Gordon W., Howlett, Jonathan G., Trudeau, Luc, Bacon, Simon L., Petrella, Robert J., Milot, Alain, Stone, James A., Drouin, Denis, Boulanger, Jean-Martin, Sharma, Mukul, Hamet, Pavel, Fodor, George, Dresser, George K., George Carruthers, S., Pylypchuk, George, Burgess, Ellen D., Burns, Kevin D., Vallée, Michel, Ramesh Prasad, G.V., Gilbert, Richard E., Leiter, Lawrence A., Jones, Charlotte, Ogilvie, Richard I., Woo, Vincent, McFarlane, Philip A., Hegele, Robert A., and Tobe, Sheldon W.

Published
2010
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242. Impact of kidney function on the safety and efficacy of insulin degludec versus insulin glargine U300 in people with type 2 diabetes: A post hoc analysis of the CONCLUDE trial

Author

Pieber, Thomas R., primary, Bajaj, Harpreet S., additional, Heller, Simon R., additional, Jia, Ting, additional, Khunti, Kamlesh, additional, Klonoff, David C., additional, Ladelund, Steen, additional, Leiter, Lawrence A., additional, Wagner, Lily, additional, and Philis‐Tsimikas, Athena, additional

Published
2021
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243. A Biomarker-Based Score for Risk of Hospitalization for Heart Failure in Patients With Diabetes

Author

Berg, David D., primary, Wiviott, Stephen D., primary, Scirica, Benjamin M., primary, Zelniker, Thomas A., primary, Goodrich, Erica L., primary, Jarolim, Petr, primary, Mosenzon, Ofri, primary, Cahn, Avivit, primary, Bhatt, Deepak L., primary, Leiter, Lawrence A., primary, McGuire, Darren K., primary, Wilding, John P.H., primary, Johanson, Per, primary, Langkilde, Anna Maria, primary, Raz, Itamar, primary, Braunwald, Eugene, primary, Sabatine, Marc S., primary, and Morrow, David A., primary

Published
2021
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244. Obesity and effects of dapagliflozin on cardiovascular and renal outcomes in patients with type 2 diabetes mellitus in the DECLARE–TIMI 58 trial

Author

Oyama, Kazuma, primary, Raz, Itamar, additional, Cahn, Avivit, additional, Kuder, Julia, additional, Murphy, Sabina A, additional, Bhatt, Deepak L, additional, Leiter, Lawrence A, additional, McGuire, Darren K, additional, Wilding, John P H, additional, Park, Kyong Soo, additional, Goudev, Assen, additional, Diaz, Rafael, additional, Špinar, Jindřich, additional, Gause-Nilsson, Ingrid A M, additional, Mosenzon, Ofri, additional, Sabatine, Marc S, additional, and Wiviott, Stephen D, additional

Published
2021
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245. Different Food Sources of Fructose-Containing Sugars and Fasting Blood Uric Acid Levels: A Systematic Review and Meta-Analysis of Controlled Feeding Trials

Author

Ayoub-Charette, Sabrina, primary, Chiavaroli, Laura, additional, Liu, Qi, additional, Khan, Tauseef Ahmad, additional, Zurbau, Andreea, additional, Au-Yeung, Fei, additional, Cheung, Annette, additional, Ahmed, Amna, additional, Lee, Danielle, additional, Choo, Vivian L, additional, Blanco Mejia, Sonia, additional, de Souza, Russell J, additional, Wolever, Thomas Ms, additional, Leiter, Lawrence A, additional, Kendall, Cyril Wc, additional, Jenkins, David Ja, additional, and Sievenpiper, John L, additional

Published
2021
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246. The Effect of Dapagliflozin on Albuminuria in DECLARE-TIMI 58

Author

Mosenzon, Ofri, primary, Wiviott, Stephen D., additional, Heerspink, Hiddo J.L., additional, Dwyer, Jamie P., additional, Cahn, Avivit, additional, Goodrich, Erica L., additional, Rozenberg, Aliza, additional, Schechter, Meir, additional, Yanuv, Ilan, additional, Murphy, Sabina A., additional, Zelniker, Thomas A., additional, Gause-Nilsson, Ingrid A.M., additional, Langkilde, Anna Maria, additional, Fredriksson, Martin, additional, Johansson, Peter A., additional, Bhatt, Deepak L., additional, Leiter, Lawrence A., additional, McGuire, Darren K., additional, Wilding, John P.H., additional, Sabatine, Marc S., additional, and Raz, Itamar, additional

Published
2021
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248. Canadian Cardiovascular Harmonized National Guidelines Endeavour (C-CHANGE): 2014 update

Author

Tobe, Sheldon W., Stone, James A., Walker, Kimberly M., Anderson, Todd, Bhattacharyya, Onil, Cheng, Alice Y.Y., Gregoire, Jean, Gubitz, Gord, L'Abbe, Mary, Lau, David C.W., Leiter, Lawrence A., Oh, Paul, Padwal, Raj, Poirier, Luc, Selby, Peter, Tremblay, Mark, Ward, Richard A., Hua, Diane, and Liu, Peter P.

Subjects
Practice guidelines (Medicine) -- Analysis, Cardiovascular diseases -- Care and treatment -- Research, Health
Abstract

In Canada, the multiple chronic conditions and cardiovascular risk factors of our aging population continue to challenge health care providers and burden health systems. Cardiovascular disease is a major contributor [...]

Published
2014
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